[Senate Hearing 117-406]
[From the U.S. Government Publishing Office]


                                                        S. Hrg. 117-406

                   STOPPING THE SPREAD OF MONKEYPOX:
                     EXAMINING THE FEDERAL RESPONSE

=======================================================================

                                HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                    ONE HUNDRED SEVENTEENTH CONGRESS

                             SECOND SESSION

                                   ON

  EXAMINING STOPPING THE SPREAD OF MONKEYPOX, FOCUSING ON THE FEDERAL 
                                RESPONSE
                               __________

                           SEPTEMBER 14, 2022
                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions
                                
                                
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                               __________

                    U.S. GOVERNMENT PUBLISHING OFFICE
                    
48-917 PDF                WASHINGTON : 2024           
        

          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                    PATTY MURRAY, Washington, Chair
BERNIE SANDERS (I), Vermont          RICHARD BURR, North Carolina, 
ROBERT P. CASEY, JR., Pennsylvania       Ranking Member
TAMMY BALDWIN, Wisconsin             RAND PAUL, M.D., Kentucky
CHRISTOPHER S. MURPHY, Connecticut   SUSAN M. COLLINS, Maine
TIM KAINE, Virginia                  BILL CASSIDY, M.D., Louisiana
MAGGIE HASSAN, New Hampshire         LISA MURKOWSKI, Alaska
TINA SMITH, Minnesota                MIKE BRAUN, Indiana
JACKY ROSEN, Nevada                  ROGER MARSHALL, M.D., Kansas
BEN RAY LUJAN, New Mexico            TIM SCOTT, South Carolina
JOHN HICKENLOOPER, Colorado          MITT ROMNEY, Utah
                                     TOMMY TUBERVILLE, Alabama
                                     JERRY MORAN, Kansas

                     Evan T. Schatz, Staff Director
               David P. Cleary, Republican Staff Director
                  John Righter, Deputy Staff Director

                            C O N T E N T S

                              ----------                              

                               STATEMENTS

                     WEDNESDAY, SEPTEMBER 14, 2022

                                                                   Page

                           Committee Members

Murray, Hon. Patty, Chair, Committee on Health, Education, Labor, 
  and Pensions, Opening statement................................     1
Burr, Hon. Richard, Ranking Member, a U.S. Senator from the State 
  of North Carolina, Opening statement...........................     4

                               Witnesses

Walensky, Rochelle, M.D., M.P.H., Director, United States Centers 
  for Disease Control and Prevention, Atlanta, GA................     9
    Prepared statement...........................................    11
Fauci, Anthony, M.D., Director, National Institute of Allergy and 
  Infectious Diseases, National Institutes of Health, Bethesda, 
  MD.............................................................    15
    Prepared statement...........................................    17
Califf, Robert, M.D., Commissioner, United States Food and Drug 
  Administration, Silver Spring, MD..............................    19
    Prepared statement...........................................    21
O'Connell, Dawn, Assistant Secretary for Preparedness and 
  Response, Administration for Strategic Preparedness and 
  Response, Washington, DC.......................................    26
    Prepared statement...........................................    27

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.
Smith, Hon. Tina:
    Prepared statement from AIDS United, submitted for the Record    60
Baldwin, Hon. Tammy:
    ``Fact Check of Fauci's 2004 Comments Do not Contradict His 
      Pandemic Stance'', submitted for the Record................    63

 
                   STOPPING THE SPREAD OF MONKEYPOX:
                     EXAMINING THE FEDERAL RESPONSE

                              ----------                              


                     Wednesday, September 14, 2022

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 10:03 a.m., in 
room 216, Hart Senate Office Building, Hon. Patty Murray, Chair 
of the Committee, presiding.

    Present: Senators Murray [presiding], Casey, Baldwin, 
Murphy, Kaine, Hassan, Smith, Rosen, Hickenlooper, Burr, Paul, 
Collins, Cassidy, Braun, Marshall, Romney, and Tuberville.

                  OPENING STATEMENT OF SENATOR MURRAY

    The Chair. Good morning. The Senate Health, Education, 
Labor, and Pensions Committee will please come to order. Today 
we are having a hearing on the Federal response to the 
monkeypox outbreaks, as we work to stop the spread of this 
virus.

    I will have an opening statement followed by Senator Burr, 
and then we will introduce our witnesses. Before we start, I 
do--I want to take a moment to congratulate one of our 
witnesses, Dr. Fauci, on announcing his upcoming retirement.

    Dr. Fauci, you have served through multiple decades and 
Presidents and public health threats, and worked to save 
countless lives, and I hope you know that you have the thanks 
of a grateful nation for your incredible service to this 
country. So, thank you and thank you for being here today.

    After the witnesses give their testimony, Senators will 
each have 5 minutes for a round of questions. And while we are 
unable, again, to have this hearing fully open to the public or 
media for in-person attendance, live video is available on our 
Committee website at help.senate.gov. If anyone is in need of 
accommodations including closed captioning, please reach out to 
the Committee or the Office of Congressional Accessibility 
Services.

    According to the Centers for Disease Control and 
Prevention, the U.S. now has over 21,000 confirmed cases of 
monkeypox, more than anyone else in the world, and my home 
State of Washington has over 500 cases. I have heard from 
families who are rightly concerned about how bad this has 
gotten.

    Public health officials, including back in Washington 
State, who are frustrated to see the response, run into issues 
we should be prepared for by now. That is why I have continued 
to push the Biden administration about my concerns with the 
monkeypox response and urge quick action on testing, on 
treatments, on vaccines, and on clear guidance to the public, 
to their health care providers, and state public health 
officials.

    It is reassuring to see that we are making progress on 
testing, capacity has increased 1,000 percent, and FDA just 
approved a faster track for additional tests. On vaccines, 
BARDA is helping to stand up a new vaccine fill and finish site 
in Michigan. HHS is working to expand the number of 
distribution sites and states, and the Administration's advice 
for splitting doses has greatly stretched our vaccine supply.

    On outreach, the Administration has started working with 
states to make vaccines available at events with many people 
from the LGBTQ community in attendance. And perhaps most 
importantly, the rate of new cases is going down. Now, that is 
all encouraging news, but let me be clear, we must remain 
vigilant in our response.

    These promising improvements do not excuse the issues I 
have been hearing about from communities, from state health 
officials, and advocates from the very start of this outbreak. 
Patients have spoken out about how hard it is to get tested. 
Some even waited days despite having clear symptoms. Providers 
have had to jump through hoops to get their patients 
treatments.

    I am constantly talking to public health officials in my 
state who have told me how communications with states could 
have been far clearer and faster, and how the challenges in 
accessing tests and vaccines have delayed the response. I know 
states have especially struggled with the Federal Government's 
decision to forgo the system we typically use to distribute 
vaccines, the one we are already using for COVID vaccines.

    When it comes to vaccine distribution, some shipments have 
been sent to the wrong state and even spoiled after storage at 
the wrong temperature. There have been issues with vaccine 
supply as well, like when thousands of vaccine doses were 
delayed because FDA had yet to inspect the new plants they were 
coming from, or when the Biden administration missed an 
opportunity to procure more vaccines at a crucial point in this 
outbreak.

    Again, we are seeing inequities worse in this outbreak for 
some communities. Advocates in the LBGTQ community, who face 
the vast majority of cases, have also made clear they feel they 
are being overlooked or in some instances, stigmatized.

    We need to keep focusing and improving on outreach, and on 
getting information and resources like vaccines to those who 
are most in need and most at risk. And that must include 
communities of color who we know do not have equitable access 
to vaccines. This is especially important, as early data 
suggests that Black and Latino communities are 
disproportionately burdened by this outbreak.

    We have to do better. We need to be applying what we 
learned from the COVID response and providing the resources 
communities have made clear they need. Of course, there is an 
enormous difference between this and the COVID pandemic, which 
is thanks to decades of investment in smallpox research, we 
already had tests and treatments and vaccines ready to go 
before this crisis began.

    That should serve as a reminder to all of us about the 
immense value of investing in public health preparedness. But 
it is also why the stumbles in getting these tools deployed 
were especially frustrating and inexcusable. To learn from 
this, we need to be clear eyed about what went wrong, not just 
on the challenges we faced in the last several months, but that 
we have faced for decades.

    Challenges that, to be frank, has spanned many 
Administrations, not just this one. For example, we had over 20 
million vials of smallpox vaccine in our national stockpile, 
but they were not replaced as they expired over the course of a 
decade. I know I join my Ranking Member and Members of this 
Committee when I say we have got to do better, not just on 
COVID, not just on monkeypox, but on public health threats, 
period, because we know there will be more.

    Just last week, New York declared an emergency due to 
polio, yet another public health risk we need to watch closely. 
I want to hear from our witnesses today about not just what 
they are doing right now to improve our response to the 
monkeypox outbreak and fast, but also how we can fix this in 
the long term and make sure the stumbles of the past couple of 
months never happen again.

    I want to know what you and the Administration are doing to 
make sure we have enough tests and treatments and vaccines for 
this outbreak and get them where they need to go, while also 
maintaining an adequate stock of supplies for any smallpox 
threats.

    What you are doing to improve outreach to the LGBTQ 
community, address disproportionate harm to Black and Latino 
communities, fight stigma and misinformation, and right the 
inequities we have seen in our response so far?

    How are we making the most of new research to develop 
promising vaccines and therapeutics, and then make them more 
quickly available, while continuing to uphold the gold standard 
of safety and effectiveness? And are we getting schools and 
colleges everything they need to stay open and keep students 
and schools, communities safe?

    I am glad CDC has provided guidance for K-12 schools. And 
fortunately, the science tells us elementary and secondary 
school kids are not at high risk. And CDC has also released 
resources for colleges, which is critical with students 
returning to campus this fall. We need to make sure that 
colleges and universities are equipped to prevent potential 
outbreaks as students move into dorms and live in close 
quarters with each other.

    I realize you have got your work cut out for you in all of 
this, especially with COVID still raging, but there is no 
reason for us to fall behind. I am going to keep pushing you 
here because families back in Washington State and across the 
country are counting on all of you to get it right. That is 
also why I am going to keep pushing my colleagues here in 
Congress about the need for funding to support all of this 
work.

    I know I am not the only one here with concerns about the 
monkeypox response, but we can't just say this isn't working 
without providing the funding to end this outbreak and build 
the public health system Americans deserve. I will continue to 
work with colleagues on both sides of the aisle and push to 
deliver the resources that will help get families the testing, 
treatments, and vaccines they need.

    I am interested in hearing from the witnesses on what the 
needs are when it comes to investing in our monkeypox response. 
It is also important to me we continue to keep our eyes on the 
horizon when it comes to future outbreaks and pandemics and 
build a stronger public health system for whatever threat comes 
next.

    As the saying goes, an ounce of prevention is worth a pound 
of cure, and that starts with building a world class public 
health system rather than one that lags behind our peers. Our 
communities deserve to be as safe as anyone in the world, which 
is why Senator Burr, and I are continuing to work to pass our 
Prevent Pandemics Act.

    Our bipartisan legislation implements the lessons from our 
COVID response and improves our policies and processes on 
issues like strengthening supply chains, improving management 
of our national stockpile, modernizing data systems, and other 
items which would address many of the challenges we faced with 
monkeypox.

    But a strong public health system also requires strong 
investments, because our public health system was underfunded 
before COVID struck, and it has been overwhelmed ever since. We 
have to end the cycle of crisis and complacency by making 
sustained investments that allow us to build and maintain 
robust public health infrastructure at all levels.

    I will keep pushing for all of these steps because we 
should all know by now just how much is at stake. I can tell 
you that families in Seattle know, parents in Spokane know, 
nurses in Yakima know, workers in Olympia know, people across 
Washington State and across the country know.

    COVID was never going to be the last public health crisis 
we face, and neither is monkeypox. The question is not whether 
there will be a new threat, it is when it will strike and 
whether we will be ready. The truth is, the monkeypox response 
so far has not been encouraging.

    But there are some clear signs of progress, and there are 
clear steps that we can and should take to improve. I don't 
want to just hear today about the steps we will be taking, I do 
want to see action, and I will be watching closely.

    I hope we can work together to build on the progress and 
end this crisis and make the kind of improvements we need to 
put our public health security on solid footing once and for 
all. Thank you very much, and I will turn it over to Senator 
Burr for his opening remarks.

                   OPENING STATEMENT OF SENATOR BURR

    Senator Burr. Thank you, Madam Chair.

    Good morning. I am glad that we are finally here having a 
hearing on monkeypox outbreak, and it is--as it hits our 
Nation.

    Well, monkeypox is now a public health emergency. It didn't 
have to become one. I think the one promising thing that can be 
said this morning is the infection rate has slowed. That may be 
the only thing.

    Since May, when the first transmission was reported in the 
UK, in Europe, I have been pressing the Administration for 
strategy and a plan. After almost 3 years of the COVID 
pandemic, you would think that the public health agencies 
responsible for our preparedness and response would be prepared 
for anything, particularly a threat like monkeypox, which we 
have known about for decades, and for which we have vaccines 
and treatments.

    Dr. Fauci has talked to this Committee before about 
monkeypox. It is almost definition--It is almost a definitional 
case of what CDC and ASPR, and their sister agencies, should be 
prepared to tackle, a virus that spreads through physical 
contact, a virus that spreads when one--when an infected person 
has an obvious sign of infection.

    This is not like COVID, which was a newly emerged virus 
that spreads asymptomatic infection. But by any measure, in 
fact by every measure, the response from the Biden 
administration on monkeypox crisis has been a catastrophic 
failure.

    You repeated each of the mistakes from the early days of 
COVID response, and the cultural arrogance from public health 
officials, who were supposed to be at the forefront of our 
response, let this country down again. Since the COVID pandemic 
started, this Committee has held 13 hearings on the response 
during both the Trump and the Biden administrations. I think 
you were sick of being called to the carpet and us having to 
hold you accountable for systematic failures.

    But it seems that nothing has changed. You can't blame the 
last Administration on this failure. The first confirmed 
monkeypox case in 2022 was May 7th in the United Kingdom. The 
first case of monkeypox in this outbreak was reported in the 
U.S. on May 18th. We had warning. We had warning that this was 
coming. We should have been prepared to manage what came when 
it arrived.

    Let's review. We failed testing. Although you eventually 
made testing available through laboratory response networks, 
these tests were too hard to access. It took weeks before 
doctors were able to get their patients tested without having 
to first consult public health officials.

    There was also a significant delay in engaging the private 
sector on testing at the beginning of the outbreak. We waited 
until June 22d to announce that engagement with the private 
sector. Still, after that, companies interested in developing 
additional diagnostic tests, that could help address some of 
the slow turnaround times and improve access, had been left 
waiting months for samples needed to develop those test.

    Without delay--upon delay, you failed on vaccines. An 
enhanced strategy to offer vaccines to at risk individuals 
known--in known contact was announced June 28. But this was 
already after some local jurisdictions had already taken upon 
themselves to use the vaccine in this manner, and a full month 
after the UK Joint Committee on Vaccines and Immunizations met 
to discuss a similar strategy for their citizens.

    Why do we continue to be behind? Meanwhile, decisions about 
vaccine administration in the U.S. have made--seem to have been 
made seemingly on the fly. Even when FDA issued an emergency 
use authorization last month, allowing vaccines to be 
administered intradermal injections, there were no public 
meetings of FDA, CDC, outside experts to discuss relevant 
questions on the minds of impacted Americans and inform these 
decisions.

    Health professionals were confused about the initial 
decision and patients were scared that they were being 
experimented on. To make matters worse, states had no time to 
prepare for this change in vaccine administration. Right after 
the FDA made its decision, ASPR reduced state vaccine 
allocations under the assumption that every vial would yield 
five doses.

    Yet you know that this has not been the case in every 
state, resulting in some vaccine--some vaccinating fewer, not 
more at risk people. You failed at having a plan. Monkeypox 
outbreaks have been occurring in Nigeria and other places with 
increasing frequency. It was identified a threat under our 
threat matrix, and a threat for which we had countermeasures in 
our stockpile.

    I might also add that our earliest purchase of the Bavarian 
Nordic vaccine in bulk was in 2017. But it seems there was no 
real plan on how to respond and what information and research 
we needed to understand this outbreak. Only after both I and 
the Chair sent separate letters asking for a plan, that the 
Office of Science Technology Policy blogged about their 
research priorities.

    But the priorities were vague. It is not clear what 
research activities HHS has actually undertaking in response. 
These failures have allowed the disease spread. 31 cases in May 
quickly turn into 650 cases in June, more than 6,000 cases in 
July and more than 12,000 cases in August, and near 22,000 so 
far in September.

    It should have been obvious to all of us that the timing of 
these early cases, coupled with evidence that the cases were 
not linked, would create a perfect storm for a large outbreak. 
Monkeypox is a virus that largely transmits through skin to 
skin contact, most easily and frequently transmitted between 
sexual partners.

    Monkeypox arrived just before the Pride celebrations across 
the country, and after 2 years of lockdown and social 
distancing, your agency should have been screaming from the 
rooftops about what you knew or suspected about how monkeypox 
was spread. Instead, we remain silent. People got sick because 
of that silence.

    This isn't rocket science. But consenting adults need to be 
told what behavioral changes they should consider to avoid 
getting a preventable disease like monkeypox. You failed at a 
time when the communities most at risk needed you. Disease 
control and prevention and preparedness and response is 
literally in the name of two of your agencies.

    Yet you did none of that. It was no surprise to me that the 
Administration, after months of floundering, appointed a new 
czar at the White House to coordinate the response. It shows 
why this Committee passed the PREVENT Act to create a mission 
control. Secretary of HHS has been totally absent, and when he 
has been involved, it only seems it makes matters worse.

    But new ad-hoc groups within Government are exactly the 
problem. We need a consistent, coherent, Government wide 
response to be effective, and that can only be led by the White 
House. I hope that in the coming weeks we will be able to get 
that legislation over the finish line, and I will commit to 
spending my remaining weeks in the U.S. Senate doing everything 
I can to help the White House set up the new office with a 
lasting mission and clear agenda.

    If I were not retiring, I would spend the next several 
years conducting a thorough examination of each of your 
agencies, highlighting each and every one of the systematic and 
bureaucratic failures that we have seen now and seen in 
response after response and demand accountability for the 
American people. This isn't a question of authority. You have 
the authority. It is a question of--it isn't a question of 
money.

    You have been given astonishing amounts of money. It is a 
question of leadership. It is a question of focus. It is a 
question of squashing the typical bureaucratic roadblocks, 
arrogance and ineptitude. You need to do better.

    We learned in Operation Warp Speed that when you press 
outside the box, when you focus on public-private partnerships, 
when you get bureaucracy tamed so that it serves the American 
people and doesn't try to control them, we can actually make 
Government work.

    I would ask you for your plan, but you don't have one. I 
would ask you for what you changed, but your agency seem to 
think that they are doing everything right. I would ask you who 
you are going to hold accountable, but failures at each of your 
agencies show that you don't believe in that type of 
accountability.

    Instead, I will express my outrage and hope that eventually 
we will get people in your agencies who will do the job to 
protect the American people instead of protecting their 
bureaucracies. Madam Chair, before I close, I want to address a 
serious issue. The last time we were here, there was a 
coordinated assault pretending that somehow Republicans were at 
fault for there not being additional money for the pandemic.

    Let's revisit some of the facts, if we can. The Senate on a 
bipartisan basis actually passed extra funding for COVID, $15.6 
billion, in March in the omnibus for testing, treatment, 
vaccines, and global aid. But the Speaker of the House either 
couldn't pass that legislation or didn't think pandemic money 
was a priority so she stripped it out.

    I have worked with her for a long time, and I am pretty 
sure she is a Democrat. Then Democrats--then Senator Romney and 
Blunt and myself engaged in deep negotiations with the Majority 
Leader and the Chair of the Committee, and we reached a deal 
for $10 million in domestic funding for COVID.

    But the Majority Leader didn't want to take a vote against 
lifting a COVID restriction on the Southern border, probably 
because he knew it would pass so the deal was killed. I am 
pretty sure Chuck is a Democrat. So then at our last meeting, 
the Chair and each of you got together and pretended that 
somehow Republicans were at fault.

    The Republicans tried twice to provide additional funding 
for COVID, but Democrats couldn't take yes for an answer. Then 
last month, Democrats conducted a partisan spending exercise 
where Republicans weren't even in the room. They dramatically 
raised taxes by hundreds of billions of dollars, provided 
funding for 87,000 IRS agents to audit the middle class, and 
spent hundreds of billions of dollars on green new deals that 
will mostly impact billionaires and millionaires.

    Those same Democrats who complain about no COVID spending 
didn't spend a dime of those new taxes on pandemic expenses. I 
often hear my colleagues say that your budget shows your 
priorities. But Democrats have the power to spend money on 
pandemic and chose not to. I guess making energy more expensive 
was more important.

    I think all of you know, I have had in my jacket pocket a 
card with four simple requests from this Administration and 
told them all they needed to do for me to get my Senate 
colleagues, my Republican colleagues to support additional 
funding was to provide answers to those four things.

    Give us a detailed plan for COVID. Detailed accounting of 
where the money has been spent. Offsets to match new spending 
for pandemics. And a simple vote on a COVID restriction at the 
border. I first started that in April. Today, none of those 
four things have been presented. So to date, the Administration 
has failed to deliver.

    Maybe they don't want to actually have transparency on what 
they have spent. Or maybe they don't want to come clean to the 
American people what their plan is until after the election. 
Not sure what it is. I am tired of being the one that is 
blamed. I have got just as much as invested as anybody on this 
Committee in making sure that your agencies are successful for 
the American people. I will continue to do that, whether I am 
in Congress or not.

    Tony, I can't thank you enough for your years of service. 
It has been incredibly beneficial to the American people and to 
the health care of this country. I hate to see you go, but I 
also look forward to that day in January where we both are on 
the other side of this mountain, and I can actually not have to 
plan to fly on a Monday and I can spend some time with my wife 
and grandchildren.

    Having said that, Madam Chair, let's have a reset this 
morning. Let's quit blaming everybody and let's start showing 
some leadership. If the Administration needs money, then send 
us a budget requests money. There is no increased spending for 
COVID in next year's request.

    They believe that this is all going to happen by an 
emergency, that the American people shouldn't be held 
accountable. That's wrong. Get the Administration to request 
the money. Let's work through the normal appropriations 
process. My hope is that there is a plan and someday they will 
share it with us. I yield back.

    The Chair. Thank you, Senator Burr. I will now introduce 
today's witnesses. Dr. Rochelle Walensky is the Director of the 
Centers for Disease Control and Prevention and the 
Administrator of the Agency for Toxic Substances and Disease 
Registry. Dr. Anthony Fauci, the Director of the National 
Institute of Allergy and Infectious Diseases and the Chief 
Medical Adviser on President Biden's COVID-19 response team.

    Dr. Robert Califf is the Commissioner of the Food and Drug 
Administration. Don O'Connell is the Assistant Secretary for 
Preparedness and Response. Dr. Walensky, Dr. Fauci, 
Commissioner Califf, and Assistant Secretary O'Connell, thank 
you all for being here today. We all look forward to your 
testimony.

    With that, we will begin with Dr. Walensky.

STATEMENT OF ROCHELLE WALENSKY, M.D., M.P.H., DIRECTOR, UNITED 
 STATES CENTERS FOR DISEASE CONTROL AND PREVENTION, ATLANTA, GA

    Dr. Walensky. Chair Murray, Ranking Member Burr, and 
Members of the Committee, I appreciate the opportunity to 
discuss monkeypox and CDC's response to this global outbreak. 
To date, there have been over 59,000 cases of monkeypox 
reported globally, including over 22,000 cases and one 
confirmed death in the United States.

    In the current outbreak, the first cases were diagnosed in 
the United Kingdom on May 14th, and within days, additional 
countries began identifying case clusters. On May 17th, a case 
was reported in Massachusetts and was confirmed by CDC the 
following day.

    CDC immediately began its work searching for additional 
cases, educating clinicians and the public about this disease, 
and supporting our state and local public health partners in 
their response. In less than 1 week, CDC reached out to 
commercial labs to increase testing capacity and began to scale 
up an incident response.

    Over the last several weeks, we have been pleased to see a 
decline in the growth of new cases here and abroad, though 
there are areas in the United States where the rate of rise in 
new cases is still increasing. We approach this news with 
cautious optimism, recognizing that we must continue to 
aggressively respond to our--use with our entire toolkit, 
including vaccination, testing, and education about risk to 
inform behavior change.

    This outbreak has been notable for transmission primarily, 
but not exclusively, through sexual contact. It has 
disproportionately affected gay, bisexual, and other men who 
have sex with men, with a large majority of cases in this 
population. CDC has been studying monkeypox for decades and has 
contributed to the creation of the test, experimental 
therapeutics, and vaccines that are available today.

    But as a relatively rare disease, almost no providers in 
the U.S. have seen or even heard of monkeypox. Provider 
education has been a key component, indeed a remarkable 
challenge, but critical to our response.

    CDC has issued four health advisories, each reaching over a 
million people, and host clinician outreach calls joined by 
tens of thousands of clinicians. We have also shared monkeypox 
information for congregate living and K-12 schools to prevent 
monkeypox spread in these settings.

    Initially, our public health laboratory response network 
labs across the country were able to collectively test up to 
6,000 clinical specimens each week using a diagnostic test 
developed to detect orthopox viruses, including monkeypox.

    CDC worked with our public health partners to quickly 
expand testing capacity and engage commercial laboratories to 
increase capacity to 80,000 tests per week. While weekly 
testing volume is currently 14 percent of total testing 
capacity, we are working with academic medical centers, 
commercial and public health laboratories to make testing even 
more accessible to all who need it.

    From the beginning of this response, CDC has worked closely 
with ASPR to make JYNNEOS vaccine available to jurisdictions 
based on their case numbers and underlying population at 
increased risk. Based on data from 39 jurisdictions reporting 
to CDC, a total of over 540,000 JYNNEOS vaccine doses have been 
administered.

    Collaboration with communities most affected by the 
outbreak, including the LGBTQ+ community, is critical to our 
response. We rely on our partners across public health and 
LGBTQ+ advocates and community based organizations to 
contribute to their expertise to our response, to challenge us 
to continue to do better, and to amplify our public health 
messages.

    In recent weeks, CDC has provided technical assistance and 
support for vaccination efforts and other monkeypox response 
activities at large events serving LGBTQ+ audiences like 
Charlotte Pride and Atlanta Black Gay Pride weekend. These 
efforts and others have facilitated delivery of vaccines to 
those who may face unique barriers to access, including racial, 
ethnic, and geographically diverse populations.

    The robust response required for public health threats like 
monkeypox underscores the importance of sustained investments 
in the core capabilities that should constitute the foundation 
of a 21st century public health system. In addition, CDC needs 
additional policy levers to enable the timely reporting of data 
necessary to take the informed action the public expects of us.

    Despite having a vaccine distribution strategy since June 
28th, it took until early September to complete all 61 data use 
agreements needed to receive vaccine administration data. While 
we work to control this outbreak in the United States, we 
anticipate that monkeypox will continue to be a global threat.

    Once this outbreak is controlled, we will need to maintain 
vigilance, education, and vaccination efforts so that another 
outbreak does not emerge. That is why now it is important for 
Congress to act upon the supplemental request.

    CDC will use the additional resources to support testing 
and laboratory capacity expansion, vaccination efforts, 
surveillance, epidemiologic investigations, outreach, 
education, and global efforts.

    Together, we can meet the fast evolving threat of 
monkeypox, successfully end the current outbreak, and prepare 
for any future outbreaks. Thank you. I look forward to your 
questions.

    [The prepared statement of Dr. Walensky follows:]

                prepared statement of rochelle walensky
    Chair Murray, Ranking Member Burr, and distinguished Members of 
this Committee, it is my honor to appear before you today to discuss 
the Centers for Disease Control and Prevention's (CDC) response to the 
global outbreak of monkeypox. The world is experiencing an 
unprecedented outbreak of monkeypox, with tens of thousands of cases 
reported worldwide, predominantly in countries where this disease is 
not endemic. We are still learning more about this outbreak every day 
but are relying on the tools we have--diagnostics, vaccines, 
therapeutics, and community education and outreach--to continue our 
public health response efforts.
                         State of the Outbreak
    On May 17, 2022, the Massachusetts Department of Public Health 
contacted CDC about a case of suspected monkeypox in the United States. 
CDC's Laboratory Response Network (LRN) testing confirmed orthopoxvirus 
infection and, the next day, testing at CDC confirmed the patient was 
infected with monkeypox virus. The case was identified as Clade II 
(formerly known as the West African strain), which is associated with 
less severe disease than Clade I (formerly known as Congo Basin 
strain). This case, and many of the first cases identified in the 
United States in this outbreak, were among persons with a history of 
international travel to Europe or Canada, countries that were also 
reporting clusters of cases. From detection of the first case, CDC 
immediately began enhancing surveillance and testing to identify 
additional cases; supporting jurisdictions in post-exposure 
prophylactic vaccination of close contacts; educating clinicians, 
public health partners, and the public; conducting outreach to LGBTQ+ 
organizations, and advocates to share information and amplify 
messaging; and preparing for community spread of monkeypox within the 
United States. On June 28, 2022, CDC elevated its response to monkeypox 
by activating its agency-wide Emergency Operations Center. On July 23, 
2022, the World Health Organization declared the current outbreak and 
Public Health Emergency of International Concern, and Department of 
Health and Human Services (HHS) Secretary Xavier Becerra declared a 
U.S. Public Health Emergency on August 4. In the United States, as of 
September 12, there have been 21,985 reported monkeypox cases, one 
confirmed death, and two additional deaths currently under 
investigation. Globally, there have been 57,016 cases reported with 19 
deaths.

    Monkeypox can be transmitted through close, personal contact. This 
is often skin-to-skin-contact, including hugging and intimate activity, 
but also through respiratory secretions during prolonged face-to-face 
contact and skin contact with fabrics and surfaces used by persons with 
monkeypox--although respiratory droplet and indirect transmission do 
not appear to be significant drivers of the current outbreak. While 
anyone who comes into close contact with an infected person or 
contaminated items like bedding or clothing could contract monkeypox, 
the current outbreak is disproportionately affecting gay, bisexual, and 
other men who have sex with men. The characteristic rash of monkeypox 
can initially look like pimples or blisters and can appear on the 
hands, feet, chest, face, mouth, or anogenital region, and may 
sometimes occur with other flu-like symptoms. Monkeypox is 
transmissible from the time symptoms begin until the rash has healed, 
all scabs have fallen off, and a fresh layer of skin has formed. 
Infection typically lasts for two-to 4-weeks. CDC recommends people 
with monkeypox isolate at home, keep rashes covered until they have 
fully healed, and notify close contacts, including sexual partners. The 
clinical presentation in this outbreak is atypical. The characteristic 
rash is still common, but lesions associated with this outbreak have 
often occurred in the anogenital region or in the mouth, and rash may 
be confined to only a few lesions or even a single lesion. In addition, 
prior to and after the rash, other symptoms may be mild or non-
existent.

    Similar to COVID-19 and many other public health challenges before 
it, the burden of monkeypox is not distributed equitably. In this 
outbreak, and based on available data, over 90 percent of U.S. cases 
have occurred among gay, bisexual, and other men who have sex with men. 
Although case data for race and ethnicity are incomplete, Hispanic/
Latinx and Black men have represented more than 50 percent of cases in 
recent weeks among those case reports for which we have data on race 
and ethnicity. Where the data is clear, we know that we must act to 
address the monkeypox outbreak in communities that are 
disproportionately impacted. And where a lack of complete data 
constrains our ability to understand the full extent of these 
disparities, we are working to better understand these impacts.

    The monkeypox response is impacted by one of the fundamental 
constraints CDC faces in its response to public health threats--we are 
often limited in our ability to quickly and reliably access the data we 
need to maximize the impact of our public health response. We need to 
bring the Nation's public health data infrastructure into the 21st 
century so that CDC and state, Tribal, local and territorial health 
agencies may review, analyze, and report data in real time. The public 
health workforce is stretched thin, and sustained investment in the 
workforce is needed to provide Americans with a data-fluent, pandemic-
ready public health system. Our nation's public health laboratories are 
essential to early detection, and equipping these labs with the best 
available resources enables a faster response. Committing to rebuilding 
public health infrastructure through a revitalized public health 
workforce, modern data pathways, and strong laboratories supports the 
foundation for an immediate and robust response to public health 
emergencies like monkeypox.
                           Diagnostic Testing
    Since 2003, CDC's LRN has provided state and local health 
departments with a way to test and identify orthopoxvirus cases, 
including monkeypox. CDC has a Food and Drug Administration-cleared 
test capable of detecting non-variola orthopoxviruses like monkeypox 
pre-positioned within the LRN due to previous work in smallpox public 
health preparedness supported by investments from Congress. These 
nearly 70 laboratories that are part of the LRN could test about 6,000 
specimens per week at the start of the outbreak, a capacity which CDC 
worked quickly to expand to about 10,000 tests per week. A positive 
orthopoxvirus test result is enough for clinicians and patients to act 
to prevent additional spread. States may also send samples to CDC for 
further viral characterization and genomic sequencing.

    Even while testing capacity through LRN labs greatly exceeded 
demand, CDC and FDA began working with five U.S. commercial laboratory 
companies to improve the accessibility of orthopoxvirus testing to the 
Nation's providers. In June 2022, CDC began shipping orthopoxvirus 
tests to these five commercial laboratories. By July, testing capacity 
in the United States increased to 80,000 tests per week. As of 
September 7, orthopoxvirus testing throughput is at about 14 percent of 
total capacity. This Administration is preparing for potential 
increased demand for testing in the future and is exploring all 
available avenues to make testing more accessible.
                       Vaccines and Therapeutics
    Through Federal investments in public health preparedness, the U.S. 
supported the development of vaccines and therapeutics for 
orthopoxviruses, like monkeypox, before detection of the first U.S. 
case associated with the 2022 outbreak. The FDA-cleared non-variola 
orthopoxvirus test, antiviral tecovirimat (also known as TPOXX), and 
ACAM2000 and JYNNEOS vaccines were all developed as part of the 
Smallpox Research Agenda. Under this ongoing U.S. smallpox preparedness 
work, CDC has collaborated with other U.S. public health officials to 
work to ensure medical countermeasure tools are available in the event 
of a smallpox outbreak. Unlike COVID-19, the monkeypox virus is not a 
novel pathogen, and our response benefited from our ability to mobilize 
existing countermeasures and move swiftly to acquire more.

    From the beginning of the outbreak, CDC has worked closely with the 
Administration for Strategic Preparedness and Response and its 
Strategic National Stockpile to make vaccines available quickly, 
efficiently, and equitably. CDC's role in the monkeypox response 
vaccine strategy is to prioritize the allocation of our limited supply 
of the JYNNEOS vaccine to maximize public health impact. Allocations to 
jurisdictions are based on two factors: recent population-adjusted case 
incidence and the number of people who have the highest risk for 
disease in the current outbreak, as estimated by the number of gay, 
bisexual, and other men who have sex with men who are living with HIV 
or are eligible for HIV pre-exposure prophylaxis within a jurisdiction.

    In light of FDA's August 9, 2022 Emergency Use Authorization for 
the JYNNEOS vaccine allowing for intradermal administration for 
individuals 18 years of age and older who are determined to be at high 
risk for monkeypox infection, CDC released interim clinical 
considerations with relevant information on how to administer the 
JYNNEOS vaccine intradermally. This approach provides a level of immune 
response comparable to that achieved by subcutaneous administration 
without compromising safety and can extend the vaccine supply by 
administering 0.1mL doses, allowing multiple doses to be administered 
from one 0.5mL vial.

    Equitable allocation of vaccines and therapeutics for those at 
greatest risk of monkeypox is not possible without robust data. Vaccine 
and therapeutic administration data are important to verify that 
vaccines and therapeutics are going to the populations most affected by 
this outbreak. Other data, such as race and ethnicity data or HIV 
status, are also important to contextualize the distribution and 
administration. For example, we know that in the current monkeypox 
outbreak, more than one third of U.S. cases are occurring in people 
living with HIV. CDC has published Clinical Considerations for 
Treatment and Prophylaxis of Monkeypox Virus Infection in People with 
HIV and, with additional data, will continue to share treatment and 
prophylaxis considerations with clinicians. CDC is building on the 
approach and infrastructure established for COVID-19 to receive 
monkeypox vaccine administration data, including race and ethnicity, 
and has a data use agreement in place with every state to receive these 
data. On August 15, 2022, we began receiving vaccine administration 
data from high-burden jurisdictions and currently, a total of 35 
jurisdictions are reporting these data to CDC.

    CDC also is committed to increasing access to therapeutics for 
monkeypox patients. We acted quickly on reports from our state, local, 
and territorial health partners to reduce the burden of administering 
the FDA-approved smallpox treatment, tecovirimat or TPOXX, through the 
Expanded Access Investigational New Drug protocol. We did this because 
TPOXX has shown promising efficacy in preventing serious illness from 
monkeypox based on animal studies. To balance the need for safety and 
efficacy information with the need for timely administration, we worked 
closely with FDA to revise the protocol to allow for telemedicine 
check-ups, make laboratory sample collection optional, and streamline 
regulatory reporting.
                Community Outreach and Public Awareness
    While anyone--irrespective of age, gender identity, or sexual 
orientation--can contract monkeypox if they are exposed, engaging with 
populations currently disproportionately affected by the monkeypox 
outbreak is a cornerstone of the government-wide response. CDC is 
committed to collaborating and sharing timely knowledge with members of 
the LGBTQ+ community, especially gay and bisexual men. We know that 
successful public health efforts depend on authentic collaboration 
where the community is at the table, leading discussions, informing and 
grounding decisions based in the reality of those affected, and 
otherwise making vital contributions to our public health response. We 
are working closely with partner organizations and offices like AIDS 
United, UnidosUS, the Ryan White HIV/AIDS Program, Southern AIDS 
Coalition, and event organizers who bring LGBTQ+ people together across 
the country. Trusted community leaders are providing a voice to amplify 
messages for prevention, testing, and treatment. We are also working 
with our core public health partners at the local and state level to 
provide technical assistance on engaging local community partners to 
support prevention, vaccination, and testing. HHS launched pilot 
programs to provide additional vaccine allocations to state and local 
health departments in jurisdictions that are hosting large events that 
attract gay, bisexual, and other men who have sex with men and to 
ensure more vaccines reach populations that face additional barriers to 
access through support for equity interventions. CDC will continue to 
provide technical assistance and support to jurisdictions for these 
large events and equity interventions, such as helping to develop 
testing and vaccine strategies, providing messaging and communication 
resources, and developing tools for information-gathering from event 
participants.

    Stigmatization of diseases and groups of people hinders public 
health efforts and contributes to poorer health outcomes. CDC is 
drawing on what we have learned through decades of work in sexually 
transmitted infections (STIs) and HIV to ensure that CDC messaging does 
not contribute to the stigmatization of gay, bisexual, and other men 
who have sex with men. CDC is conducting community listening sessions 
and working closely with LGBTQ+, sexual health, and HIV advocacy 
organizations to take our fight against stigma to the next level by 
creating messaging that is sex-positive and LGBTQ-affirming. We will 
work with healthcare providers, organizations of all kinds, and public 
health partners to support better approaches that reach affected 
communities.

    CDC uses a variety of mechanisms including the Morbidity and 
Mortality Weekly Report to disseminate information to public health 
partners and healthcare providers about outbreaks of rare pathogens 
like monkeypox. Our monkeypox clinical considerations have received 
hundreds of thousands of page views. On May 20, 2022, CDC released the 
first Health Alert Network Health Advisory on the monkeypox outbreak, 
and we have issued three subsequent advisories, each reaching over 1 
million people. CDC regularly hosts Clinician Outreach and 
Communication Activity calls where subject matter experts provide the 
latest information and considerations for tens of thousands of 
clinicians. The agency continues to work closely with clinical and core 
public health partners to amplify messaging to their members, including 
the American Medical Association, Infectious Disease Society of 
America, American Academy of Pediatrics, American Academy of HIV 
Medicine, Council of State and Territorial Epidemiologists, Association 
of State and Territorial Health Officials, National Association of 
County and City Health Officials, Association of Public Health 
Laboratories, National Coalition of STD Directors, Big Cities Health 
Coalition, and National Indian Health Board.

    CDC is also providing information to a wider U.S. audience about 
the symptoms of monkeypox and how to mitigate the spread of the 
disease. Because of how monkeypox is transmitted, CDC recognizes that 
individuals may be concerned about the spread of monkeypox in group 
settings. CDC has developed recommendations for reducing infection risk 
in group settings and will continue to adapt and refine these 
recommendations based on what we learn about virus transmission. A 
priority of our response to monkeypox is to support early 
identification of monkeypox spread in congregate living settings, like 
dormitories, correctional facilities, shelters, and others. 
Informational resources for populations that could be at increased risk 
continue to be developed. CDC has also posted responses to frequently 
asked questions from facilities serving children to provide 
administrators, parents, and caregivers with information as their 
students return to school.
                             Looking Ahead
    There is much more research to be done to better understand this 
unique monkeypox outbreak and other diseases with pandemic potential. 
Flexible, disease-agnostic investments are critical to inform our 
efforts to respond to emerging public health threats. Additionally, 
sustained support for core capabilities--such as modernized data 
systems, public health infrastructure, and a diverse public health 
workforce--are critical for an effective and equitable disease response 
at the national, state, Tribal, local, and territorial levels. 
Epidemiologic studies on the characteristics of monkeypox and spread in 
this outbreak can provide better understanding to improve the efficacy 
of prevention and intervention efforts.

    Access to timely and actionable data has been a challenge during 
the initial stages of the monkeypox outbreak given our Nation's 
fragmented streams of data collection and reporting. The COVID-19 
pandemic demonstrated and the monkeypox outbreak has reaffirmed that 
nothing about public health data in the United States is easy--it is a 
complex, de-centralized landscape with many points of friction that can 
keep data from getting from its source to where it is needed to inform 
public health action. CDC's new Center for Forecasting and Outbreak 
Analytics is already enabling timelier, more effective decision-making 
in responding to monkeypox, but its work in modeling and analytics 
hinges on our ability to collect and integrate high-quality data.

    CDC has deep collaborative partnerships with state and local 
jurisdictions to help navigate these challenges, but the fact remains 
that ongoing modernization and support from Congress is needed to 
provide CDC additional policy levers to enable timely reporting of 
actionable data before the next threat arrives. In particular, COVID-19 
and monkeypox have showed the importance of timely and comprehensive 
data to support decision-making at Federal, state, and local levels. 
This data is most effective when collected before and during an 
outbreak to mount a fully effective response. To achieve this goal, CDC 
will need support from Congress for an updated authority to set a 
common framework for how data is reported to support Federal, state, 
and local decision-making. In the absence of this authority, CDC must 
spend precious time negotiating bespoke data use agreements with many 
dozens of jurisdictions and rely on voluntary data reporting--a process 
that took months for both the COVID-19 and monkeypox responses for key 
data elements.

    As COVID-19 demonstrated, and as we see again now with monkeypox, 
the American public health system is fragile due to years of 
underinvestment in national preparedness and in state, Tribal, local, 
and territorial public health agencies. And yet, our Nation's security 
depends on the strength of its public health system. It is for this 
reason that long-term, foundational investments must be made to ensure 
we are prepared to respond rapidly and effectively to future pandemics 
and other public health threats. Moving from reliance on unpredictable 
supplemental resources to reliable multi-year funding will enable us to 
transition the infrastructure built for the COVID-19 response to a 
sustained core infrastructure--including data, workforce, and 
laboratories--capable of addressing current and future public health 
challenges. Investment in laboratory capacity and standards across the 
country, regardless of the diseases they are used for, ensures that 
laboratories can process tests quickly and effectively when a health 
threat arrives. Workforce funding gives health departments the 
personnel they need to pivot and respond to new threats, untethered to 
a specific funding line or program activity. The fiscal year 2023 
President's Budget included a 5-year request for $88 billion for 
pandemic preparedness, including $28 billion for CDC to transform our 
public health capacities nationwide, which is urgently needed to ensure 
we are prepared for any infectious disease threat that comes our way.
                               Conclusion
    As CDC continues to contribute to a robust whole-of-government 
response to this outbreak, we are working with governmental and non-
governmental partners to ensure easy, safe, and equitable access to 
diagnostic tests, vaccines, and therapeutics. We will continue to 
educate healthcare providers and the American public on monkeypox, with 
a particular emphasis on the disproportionately impacted community of 
gay, bisexual, and other men who have sex with men. We are working to 
share scientific findings and data faster; to translate science into 
practical, easy-to-understand policy; and to optimize public 
communications. The current outbreak demonstrates that the work of 
public health is never done and that we must continue to make 
investments and structural changes now to address the long-standing 
vulnerabilities in our public health system. We must stay vigilant in 
global disease surveillance and efforts to modernize the public health 
data landscape. Resources to support public health preparedness and 
infrastructure, including at the state, Tribal, local, and territorial 
levels, remain as necessary as they have been during and prior to the 
COVID-19 pandemic. I am committed to working with Congress to advance 
these efforts and build a more resilient public health system that 
contributes to a healthier, safer, and more secure future for all 
Americans.

    Thank you, and I look forward to your questions.
                                 ______
                                 
    The Chair. Thank you.

    Dr. Fauci.

STATEMENT OF ANTHONY FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE 
  OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL INSTITUTES OF 
                      HEALTH, BETHESDA, MD

    Dr. Fauci. Madam Chair, Ranking Member Burr, Members of the 
Committee, thank you for giving me the opportunity to discuss 
with you the role of the National Institute of Allergy and 
Infectious Diseases in conducting and supporting research to 
address the ongoing monkeypox public health emergency.

    I will outline how long standing NIAID supported research 
efforts have enhanced our preparedness for, response to the 
emergence of monkeypox virus. First, I want to provide some 
historical context that relates to past, current, and future 
NIAID research efforts. It is worth noting that the emerging 
epidemiological pattern of monkeypox cases bears a striking 
resemblance to the early cases of HIV/AIDS.

    In the United States and other non-endemic countries, 
monkeypox is disproportionately affecting men who have sex with 
men. However, anyone exposed to the circulating virus can get 
infected with monkeypox regardless of their age, gender 
identity, or sexual orientation.

    Thus, we would be wise to heed an observation I made 40 
years ago in an article I published in the Annals of Internal 
Medicine in 1982 during the first year of the HIV/AIDS pandemic 
when I referred to what we would soon call AIDS, a disease that 
did not even have a name at that time.

    I quote from that publication, ``any assumption that it 
would remain restricted to a particular segment of our society 
is truly an assumption without a scientific basis.'' And so 
although we must focus our efforts on the group that is most 
predominantly afflicted and at risk, there is still much we 
must learn about this disease.

    Additional epidemiological and observational cohort 
studies, surveys, ongoing surveillance for new cases are of 
critical importance. In addition, much work needs to be done in 
virology, immunology, transmission, and animal reservoirs, as 
well as diagnostics, therapeutics, and vaccine, which I will 
address in a moment.

    There are certainly some sharp differences between the 
early years of AIDS and our current situation with monkeypox. 
Unlike the situation at the start of the AIDS outbreak, the 
etiologic agent of monkeypox has been known for decades and 
medical countermeasures have been developed, namely a vaccine, 
JYNNEOS, and an antiviral, tecovirimat or TPOXX.

    This is the result of decades of NIAID supported research 
on monkeypox virus and other orthopox viruses, including the 
variola virus that causes smallpox. NIAID supported research 
was essential to the development of the JYNNEOS vaccine.

    We funded a number of studies of JYNNEOS from the pre-
clinical stage through phase two clinical trials to evaluate 
safety, immunogenicity, duration of protection, and route of 
administration. We then transitioned the vaccine to BARDA, 
which supported advanced clinical evaluation, and we have 
recently launched a clinical trial further evaluating 
alternative routes of administration.

    In the area of therapeutics, NIAID funded the discovery of 
tecovirimat and the preclinical studies to determine the 
mechanisms of action and its safety and efficacy in animals. 
Again, together with BARDA, we also funded phase one and phase 
two clinical trials of tecovirimat.

    Clinical trials to evaluate this drug in humans with 
monkeypox are needed to gather additional data about the safety 
and efficacy of the drug in the context of the current 
outbreak. NIAID supported investigators have recently launched 
a phase three clinical trial of tecovirimat, focused on 
outpatient setting in the United States through the AIDS 
clinical trials group.

    A separate NIAID clinical study of tecovirimat in 
collaboration with researchers in the Democratic Republic of 
the Congo will begin imminently. It is worth noting that the 
study in the DRC was planned prior to the current global 
outbreak as part of our preparedness efforts to study high 
consequence pathogens in key international locations where they 
are endemic.

    Lessons learned during the response to AIDS and COVID-19, 
such as avoiding stigma and ensuring the medical 
countermeasures get to where they are needed most, should help 
us in our efforts to respond to the ongoing monkeypox 
emergency.

    In addition, the U.S. response to monkeypox should in turn 
help to inform our response to the inevitable next emerging or 
reemerging infectious disease of pandemic potential. Thank you 
for your attention. I would be happy to answer your questions 
following the presentation of my colleagues.

    [The prepared statement of Dr. Fauci follows:]

                  prepared statement of anthony fauci
    Madam Chair, Ranking Member Burr, and Members of the Committee:

    Thank you for the opportunity to discuss the role of the National 
Institute of Allergy and Infectious Diseases (NIAID) in the research 
response to the ongoing monkeypox public health emergency. Within the 
Department of Health and Human Services (HHS) and the National 
Institutes of Health (NIH), NIAID is responsible for conducting and 
supporting basic and clinical research on emerging and re-emerging 
infectious diseases, including monkeypox. As the Director of NIAID and 
the Chief Medical Advisor to the President, I am pleased to discuss 
NIAID research addressing the U.S. monkeypox outbreak. NIAID is 
committed to accelerating efforts to answer critical monkeypox research 
questions in alignment with the U.S. Monkeypox Research Priorities 
identified by the White House Office of Science and Technology Policy.
  Pandemic Preparedness and Prototype Pathogen Approaches for Medical 
                            Countermeasures
    The monkeypox virus is part of the Orthopoxvirus genus, which 
includes the variola virus that causes smallpox. Available medical 
countermeasures against monkeypox were made possible by decades of 
NIAID-supported research on orthopoxviruses. Our orthopoxvirus research 
is an example of the NIAID prototype pathogen approach to pandemic 
preparedness, in which basic research and countermeasures for a 
prototype pathogen within a given family of viruses can be used to help 
treat and prevent diseases caused by closely related pathogens within 
that family.

    As part of its longstanding investment in biodefense research, 
NIAID supported early stage development of the second-generation 
smallpox vaccine ACAM2000. NIAID further identified the need for a 
vaccine to overcome the limitations of ACAM2000, which cannot be used 
by individuals with weakened immune systems. In close collaboration 
with the Biomedical Advanced Research and Development Authority (BARDA) 
and the U.S. Food and Drug Administration (FDA), NIAID played a key 
role in developing a third-generation vaccine against smallpox and 
monkeypox now known as JYNNEOS (Imvamune or Imvanex).

    NIAID-supported research also facilitated the development of an 
antiviral for smallpox called tecovirimat (TPOXX). This drug is now 
being used to treat patients with monkeypox under an expanded-access 
investigational new drug protocol. NIAID is supporting new clinical 
trials of tecovirimat to gather additional safety and efficacy data to 
inform clinical and regulatory decision-making on the use of 
tecovirimat for the treatment of monkeypox. In addition, NIAID-
supported scientists continue to conduct basic research to better 
understand monkeypox virus transmission and disease, and to identify 
additional antiviral candidates. NIAID researchers at the Vaccine 
Research Center (VRC) are isolating antibodies for evaluating vaccine-
induced immune responses as well as the development of immune assays, 
diagnostic reagents, and therapeutics in the form of monoclonal 
antibodies.
                 Vaccines to Prevent Monkeypox Disease
    As noted, NIAID-supported research was essential to the development 
of the JYNNEOS vaccine made by Bavarian Nordic A/S and approved in the 
United States and other countries for the prevention of monkeypox (and 
smallpox). JYNNEOS features a weakened form of live vaccinia virus 
(modified vaccinia Ankara-Bavarian Nordic [MVA-BN]) that does not 
replicate or cause disease. MVA is an orthopoxvirus related to the 
viruses that cause monkeypox and smallpox. NIAID provided significant 
support for the research and development of JYNNEOS as an alternative 
to the ACAM2000 smallpox vaccine, which contains replication-competent 
vaccinia virus and can cause severe adverse events in people with 
weakened immune systems and individuals with eczema. NIAID has funded 
studies of JYNNEOS from the preclinical stage through Phase 2 clinical 
trials to evaluate safety, immunogenicity, duration of protection, and 
route of administration. NIAID then transitioned the vaccine to BARDA, 
which supported advanced clinical evaluation.

    In 2019, FDA approved JYNNEOS for individuals at high risk for 
smallpox or monkeypox virus infection. On August 9, 2022, FDA issued an 
emergency use authorization (EUA) for JYNNEOS to allow healthcare 
providers to administer the vaccine by intradermal injection, an 
alternative to the standard subcutaneous route of administration. The 
FDA EUA will increase the total number of available JYNNEOS vaccine 
doses by up to five-fold. The EUA decision was informed by an NIAID-
supported clinical study of the vaccine published in 2015 demonstrating 
that the intradermal route of administration--using just one fifth of 
the vaccine volume--produced a similar immune response to subcutaneous 
administration.

    NIAID recently launched a clinical study of the JYNNEOS vaccine via 
different routes of inoculation, including intradermal administration, 
in adults 18 years of age and older at high risk for monkeypox virus 
infection. This study may be expanded to provide data to support use of 
the vaccine against monkeypox for individuals who are pregnant or under 
the age of 18 years, or to inform potential Centers for Disease Control 
and Prevention (CDC) Advisory Committee on Immunization Practices 
(ACIP) recommendations for a lower dose vaccination regimen.

    NIAID VRC scientists are developing mRNA-based monkeypox vaccines 
in collaboration with Moderna, Inc., and will conduct efficacy studies 
in animal models to select lead vaccine candidates. Blood samples from 
these and other VRC studies will be used to isolate monoclonal 
antibodies for vaccine antigen design and for evaluation as potential 
monkeypox therapeutics and diagnostic reagents.
                Therapeutics to Treat Monkeypox Disease
    Currently, no specific treatment is approved by the FDA for 
monkeypox virus infection. However, the antiviral tecovirimat (TPOXX), 
developed to treat smallpox, is being used to treat patients with 
monkeypox under an expanded-access investigational new drug protocol. 
NIAID funded the discovery of tecovirimat as well as preclinical 
studies to determine its mechanism of action and its safety and 
efficacy in animals. NIAID and BARDA also have funded Phase 1 and Phase 
2 clinical trials to test the safety and pharmacokinetics of an oral 
formulation of tecovirimat. The FDA approved the oral formulation of 
tecovirimat in 2018 for treating smallpox in adults and children and 
this formulation is part of the U.S. Strategic National Stockpile. An 
intravenous formulation of tecovirimat subsequently received FDA 
approval. Although this antiviral was approved for the treatment of 
smallpox, the drug's FDA approval was based on studies in animals 
infected with monkeypox virus. Clinical trials to evaluate tecovirimat 
in humans with monkeypox are needed to gather additional data about the 
safety and efficacy of the drug in the context of the current outbreak 
to aid clinical and regulatory decision-making.

    In this regard, NIAID-supported investigators have launched a Phase 
3, randomized, placebo-controlled, double-blind trial of tecovirimat 
for the treatment of monkeypox in outpatient settings in the United 
States through the AIDS Clinical Trials Group (ACTG). Using this 
established and successful HIV clinical trials infrastructure will 
facilitate community engagement and help researchers ensure that vital 
community input is reflected in the conduct of the study. The study 
also has an open-label component to ensure that certain high-risk 
populations (e.g., pregnant or breastfeeding individuals, those who are 
heavily symptomatic, and those with severe immune deficiencies) are not 
randomized to placebo, while also providing a means to collect 
important data on the safety and pharmacokinetics of tecovirimat in 
these populations.

    NIAID, in collaboration with Institut National de Recherche 
Biomedicale of the Democratic Republic of Congo (DRC), also is planning 
a double-blind, randomized controlled trial of the safety and efficacy 
of tecovirimat for treating adult and pediatric patients diagnosed with 
monkeypox. The study in the DRC was planned prior to the current global 
outbreak as part of NIAID preparedness efforts to study high-
consequence pathogens in key international locations where they are 
endemic.

    NIAID also supports early stage research to help identify 
additional candidate antivirals for monkeypox. It is possible that 
monkeypox virus will develop resistance to tecovirimat. This is one of 
the reasons NIAID-supported scientists are screening novel compounds to 
help find new antiviral candidates to treat monkeypox.
          Understanding Monkeypox Transmission and Reservoirs
    Monkeypox is disproportionately affecting men who have sex with men 
in non-endemic countries. However, anyone exposed to the circulating 
virus can get monkeypox regardless of their age, gender identity, or 
sexual orientation. Of note, the previous outbreak of monkeypox in the 
United States in 2003 was driven by animal-to-person spread and 
involved domesticated prairie dogs that were infected by small mammals 
imported from West Africa. NIAID scientists are conducting animal 
studies to understand the human-animal interface with monkeypox virus 
and its suspected reservoir hosts, such as Gambian pouched rats, rope 
squirrels, and dormice. NIAID also is supporting the development of 
animal models to evaluate vaccine-induced immune responses to monkeypox 
virus.

    In addition, NIAID-supported scientists are performing genomic 
sequencing to better understand the monkeypox virus and its various 
strains. Investigators with the NIAID-funded Centers for Research in 
Emerging Infectious Diseases (CREID) are supporting clinical 
surveillance in the DRC, Nigeria, and Sierra Leone. CREID investigators 
also are providing validated molecular primers and probes to help 
strengthen diagnostic capacity in Kenya, Tanzania, Panama, and Brazil. 
In addition, the NIAID International Centers for Excellence in Research 
(ICER) program has helped enhance diagnostic capacity in Mali, Ghana, 
Republic of the Congo, and Cambodia.

    NIAID scientists also are developing a high-throughput serologic 
assay that can distinguish between individuals infected with monkeypox 
virus and people who may have received a vaccinia-based vaccine, such 
as JYNNEOS or ACAM2000. In collaboration with the CDC and other U.S. 
and international researchers, NIAID will use this assay to conduct 
retrospective and prospective serological studies to better understand 
the extent of monkeypox virus circulating in the United States and 
worldwide. In addition, NIAID is making viral isolates available, free-
of-charge, for distribution to the global research and surveillance 
community via the NIAID-funded BEI Resources repository. Distribution 
of these resources will facilitate additional priority research 
throughout the broader scientific community, particularly in the areas 
of diagnosis and surveillance.
                               Conclusion
    NIAID continues to expand research on the biology, pathogenesis, 
and clinical manifestations of monkeypox virus infection as well as 
studies of existing and potential interventions to diagnose, treat, and 
prevent monkeypox. NIAID also is committed to working in partnership 
with those populations, including men who have sex with men, that 
currently are most at-risk of monkeypox to help identify and address 
key monkeypox research questions. These efforts will improve our 
response to the ongoing public health emergency.
                                 ______
                                 
    The Chair. Thank you.

    Dr. Califf.

 STATEMENT OF ROBERT CALIFF, M.D., COMMISSIONER, UNITED STATES 
        FOOD AND DRUG ADMINISTRATION, SILVER SPRING, MD

    [Technical problems.]

    The Chair. Turn on your mic.

    Dr. Califf. There we go. Chair Murray, Ranking Member Burr, 
Members of the Committee, thanks for the opportunity to provide 
information on FDA's ongoing work related to the monkeypox 
virus public health emergency. FDA has been actively working 
with our Government and private sector collaborators to respond 
to the continuing public health threat since the first 
monkeypox case came to the U.S.

    We have been working diligently to help ensure access and 
proper information regarding vaccines, diagnostics, and 
treatments for those who need the most. There is currently one 
FDA licensed vaccine, JYNNEOS, available for the prevention of 
monkeypox. We originally approved this Modified Vaccinia Ankara 
vaccine for the prevention of smallpox.

    Following reports of monkey pox in May, FDA recognized that 
production for this vaccine would need to be accelerated. FDA 
and BARDA worked together to expedite the submission of a 
manufacturing supplement that would allow more doses to be used 
in the United States.

    FDA approved that supplement in July, following an 
inspection of the manufacturing facility in Europe. In August, 
we granted an emergency use authorization for intradermal 
Administration of the vaccine, which has helped to increase the 
supply of vaccine available to Americans up to five fold.

    The authorization allowed additional review of a 2015 
clinical study that evaluated a two dose series of JYNNEOS, 
given intradermal versus subcutaneously in individuals aged 18 
years or older.

    Consistent with previous studies, and extensive experience 
with a similar vaccine in Germany, data indicated that 
intradermal administration produced a similar immune response 
to subcutaneous administration with a modestly different 
reaction profile at the injection site.

    The combination of vaccination and preventive measures to 
reduce the risk of contact with the virus remains the best way 
to prevent the spread of monkeypox. The vaccine is available 
via intradermal administration for individuals 18 years of age 
and older, determined to be at high risk for monkeypox 
infection, and available via subcutaneous administration to 
those under the age of 18 determined to be at high risk for 
monkeypox infection.

    It is important to recognize that we do not have clinical 
data on safety and efficacy, so FDA continues to monitor safety 
data we are receiving following the administration of JYNNEOS 
nationwide. Additionally, as you have heard from Dr. Fauci, NIH 
has initiated a clinical trial to obtain further data. FDA has 
also worked closely with CDC, manufacturers, and laboratories 
to support diagnostic test development.

    Currently, CDC has an FDA cleared test that can detect non-
variola orthopox viruses, including monkeypox, by a swab from 
the lesion. This test is available through 67 CDC laboratory 
response network labs, as well as through five large commercial 
labs. On September 7th, following an emergency declaration from 
HHS, FDA issued an EUA for an additional test from a commercial 
developer.

    We also issued guidance on the development of diagnostic 
tests and hope it will increase the diversity and availability 
of tests for monkeypox. Currently, there are no FDA approved 
treatments for monkeypox. TPOXX or tecovirimat is an FDA 
approved treatment for smallpox currently made available to 
monkeypox patients under a CDC expanded access investigational 
new drug protocol.

    TPOXX was originally approved for smallpox using FDA's 
animal rule. The animal rule is an approval pathway that relies 
on animal studies and can be used only when human trials are 
not ethical or feasible.

    Because monkeypox remains endemic in countries around the 
world, and we now have a large outbreak in the U.S., human 
clinical trials are both ethical and feasible in a way that 
they were not feasible for smallpox, and smallpox has been 
eradicated and has a 30 to 50 percent mortality rate.

    Without human trials, we don't know if TPOXX is beneficial 
for patients with monkeypox. Drugs that show efficacy in 
animals are not always effective in humans. Therefore, clinical 
trials, one of which is now underway, as Dr. Fauci has 
mentioned, through the NIH, will be necessary for FDA to 
determine if TPOXX is safe and effective to treat monkeypox.

    In the meantime, because there is a significant risk of the 
development of our resistance to TPOXX, judicious use of TPOXX 
and careful monitoring for the development of resistance are a 
paramount importance for stewardship of this potentially 
beneficial drug while we study it in clinical trials.

    FDA has dedicated staff continue to work to ensure an 
appropriate and robust response to the monkeypox outbreak. 
Thanks for the opportunity to testify today and I look forward 
to answering your questions.

    [The prepared statement of Dr. Califf follows:]

                  prepared statement of robert califf
    Chair Murray, Ranking Member Burr, distinguished Members of the 
Committee, thank you for this opportunity to testify before you today 
to describe the Food and Drug Administration's (FDA's or the Agency's) 
monkeypox disease response efforts. All of our efforts are in close 
coordination and collaboration with our partners, both within the 
Department of Health and Human Services (HHS) and across the Federal 
Government, to help ensure the development, authorization, licensure, 
approval, and availability of critical, safe, and effective medical 
products to address the monkeypox virus public health emergency.

    We are closely monitoring the situation and responding 
aggressively, while also preparing for potential changes and shifts as 
the public health emergency continues. The Agency is using lessons 
learned from the coronavirus disease 2019 (COVID-19) response effort to 
inform our decision-making going forward and aid in our response to 
monkeypox disease. For eligible Americans, getting vaccinated and 
following Centers for Disease Control and Prevention (CDC) guidance 
remain the best way to protect themselves and their families.

    Presently, JYNNEOS is the only FDA-licensed vaccine in the United 
States that is approved for the prevention of monkeypox disease. 
JYNNEOS, the Modified Vaccinia Ankara (MVA) vaccine, is approved for 
the prevention of smallpox and monkeypox disease in adults 18 years of 
age and older determined to be at high risk for smallpox or monkeypox 
infection. JYNNEOS was approved in 2019. The recent Emergency Use 
Authorization (EUA) allowing for intradermal administration of JYNNEOS 
for individuals 18 years of age and older determined to be at high risk 
of monkeypox infection will increase the supply of available doses by 
up to five-fold.

    In addition, the CDC has an FDA-cleared test that can detect non-
variola orthopoxviruses, including monkeypox. FDA also recently granted 
the first EUA for a monkeypox test, and we have issued policy guidance 
to support development of additional validated monkeypox tests and 
expand access to tests. \1\
---------------------------------------------------------------------------
    \1\  U.S. Food and Drug Administration, ``Monkeypox Update: FDA 
Takes Significant Action to Help Expand Access to Testing,'' September 
7, 2022, available at https://www.fda.gov/news-events/press-
announcements/monkeypox-update-fda-takes-significant-action-help-
expand-access-testing.

    While there is no FDA-approved treatment for monkeypox, through the 
use of existing FDA authorities, tecovirimat (TPOXX), an antiviral 
medication, is available to patients under an Expanded Access 
---------------------------------------------------------------------------
Investigational New Drug protocol (EA-IND).

    Since the first positive case of monkeypox disease in the United 
States, FDA has taken an active role in responding to the ongoing 
public health threat posed by the spread of monkeypox. This testimony 
is only a snapshot of the continued work the Agency is doing to address 
the monkeypox outbreak.
             Supporting Timely Access to Monkeypox Vaccines
    FDA's Center for Biologics Evaluation and Research (CBER) continues 
to use every tool available to help facilitate the development of 
biological products to aid in the Agency's larger effort to respond to 
the monkeypox public health emergency.

    JYNNEOS is the only vaccine that is FDA-approved for the prevention 
of monkeypox disease. JYNNEOS is a live virus vaccine that contains 
MVA-Bavarian Nordic, a weakened, non-replicating orthopoxvirus, and was 
developed for use in certain populations (e.g., immunocompromised 
individuals) as an alternative to ACAM2000, a licensed vaccine, in the 
event of a smallpox bioterrorist attack. This virus strain has been 
safely administered to thousands of individuals intradermally in the 
past, both as a smallpox vaccine and in investigational studies for 
other zoonotic orthopoxviruses and variola viruses. \2\ Further, 
JYNNEOS may be safely used in significantly immunocompromised 
individuals, including individuals with Human Immunodeficiency Virus 
(HIV), for whom it may not be advisable to receive certain live 
vaccines.
---------------------------------------------------------------------------
    \2\  For detailed information on the study, please visit Sharon E. 
Fry et al., ``Comparison of lyophilized versus liquid modified vaccinia 
Ankara (MVA) formulations and subcutaneous versus intradermal routes of 
administration in healthy vaccinia-na--ve subjects,'' Vaccine, 33:39, 
September 22, 2015, pp. 5225-34, available at https://
www.sciencedirect.com/science/article/pii/S0264410X15008762--via 
percent3Dihub.

    ACAM2000 is an FDA-licensed live replicating vaccinia virus vaccine 
approved for the prevention of smallpox disease. It is associated with 
a higher risk of certain serious adverse reactions compared to JYNNEOS, 
including myocarditis and pericarditis, which are inflammation and 
swelling of the heart and surrounding tissues, respectively. The risk 
of accidental infection by someone who just received ACAM2000 can also 
present serious health complications in certain populations, including 
those who are pregnant. The ACAM2000 vaccine also causes a blister to 
develop at the vaccination site. Exposure to the blister and its 
contents may lead to accidental infection. This risk of accidental 
infection following vaccination does not occur with JYNNEOS, as the 
---------------------------------------------------------------------------
vaccination does not cause a blister to form at the injection site.

    In late May 2022, following reports of monkeypox in the United 
States, FDA worked with the Biomedical Advanced Research and 
Development Authority (BARDA) to expedite the submission of a 
manufacturing supplement to FDA to facilitate JYNNEOS production at an 
additional site that was originally planned for fall 2022. After 
receiving the supplemental application for the additional facility, FDA 
immediately expedited our evaluation of the application and 
corresponding inspection of the facility. FDA evaluated the information 
required to validate product quality and determined that the vaccine 
meets our quality standards. The evaluation and inspection were 
necessary to help ensure the quality and safety of the vaccine.

    On July 26, 2022, FDA approved a supplemental biologics license 
application for JYNNEOS, which allowed for additional doses 
manufactured at a facility in Europe to be further distributed and 
administered in the United States to help address the monkeypox 
outbreak.

    Given the emerging public health need, FDA facilitated advance 
shipments of manufactured doses to the United States for prepositioning 
so that they would be onshore and ready to be distributed once we 
completed our inspection and approved the manufacturing changes.

    On August 9, 2022, FDA issued an EUA for JYNNEOS to allow 
healthcare providers to administer the vaccine intradermally (between 
the layers of the skin) for individuals 18 years of age and older 
determined to be at high risk for monkeypox infection. The EUA also 
allows for use of the vaccine in individuals younger than 18 years of 
age determined to be at high risk for monkeypox infection; in these 
individuals, JYNNEOS is administered by subcutaneous injection. For all 
age groups, JYNNEOS is given as a two-dose series, 4 weeks apart. In 
issuing this EUA, FDA determined that the known and potential benefits 
of JYNNEOS outweigh the known and potential risks for the authorized 
uses.

    A 2015 clinical study \3\ evaluated a two-dose series of JYNNEOS 
given intradermally compared to subcutaneously in individuals 18 years 
of age and older. Individuals who received the vaccine intradermally 
received a lower volume (one-fifth) of the vaccine than individuals who 
received the vaccine subcutaneously. The results of this study 
demonstrated that intradermal administration produced a similar immune 
response to subcutaneous administration. Administration by the 
intradermal route resulted in more redness, firmness, itchiness, and 
swelling at the injection site, but less pain.
---------------------------------------------------------------------------
    \3\  Ibid.
---------------------------------------------------------------------------
    The JYNNEOS EUA will increase the total number of doses available 
for use by up to five-fold.

    To support FDA's authorization of two doses of JYNNEOS administered 
by the subcutaneous route of administration in individuals younger than 
18 years of age, FDA considered the available JYNNEOS safety and immune 
response data in adults as well as the historical data with use of live 
vaccinia virus smallpox vaccine in pediatric populations.

    Following the EUA, the Agency has participated in calls with 
healthcare providers to discuss the newly authorized administration 
method and provide the most up-to-date information to those 
administering the vaccine. \4\ It is important to recognize that we do 
not have clinical data on safety and efficacy of JYNNEOS, so FDA will 
continue to monitor the safety data received from jurisdictions as 
administration of JYNNEOS increases across the United States. 
Additionally, NIH has initiated a prospective clinical trial to obtain 
these data.
---------------------------------------------------------------------------
    \4\  The most up-to-date information can be found on FDA's 
monkeypox homepage: U.S. Food and Drug Administration, ``FDA Monkeypox 
Response,'' updated continuously, available at https://www.fda.gov/
emergency-preparedness-and-response/mcm-issues/fda-monkeypox-response.
---------------------------------------------------------------------------
      Supporting Monkeypox Test Development and Timely Test Access
    Since the first case of monkeypox was detected in the United 
States, FDA's Center for Devices and Radiological Health (CDRH) has 
been working closely with CDC, laboratories, and commercial 
manufacturers to support test development and help make monkeypox tests 
more readily available to consumers who need them. CDC has an FDA-
cleared test that can detect non-variola orthopoxviruses, including 
monkeypox, by a swab from a lesion (rash or growth). The Agency engaged 
early with CDC and other agencies to support 67 CDC Laboratory Response 
Network laboratories' use of the FDA-cleared test. FDA and Federal 
authorities subsequently worked with industry to help make this test 
available through five large commercial laboratories (LabCorp, Mayo, 
Aegis, Sonic, and Quest). Presently, more testing capacity for 
monkeypox exists than is being used. \5\ However, FDA knows the value 
of assuring patients have test options and timely access to test 
results--and we have continued working toward expansion of testing 
capacity nationwide in an effort to stem the spread of the virus.
---------------------------------------------------------------------------
    \5\  For the latest data on testing capacity and positivity rates 
please visit CDC's website: Centers for Disease Control and Prevention, 
``Monkeypox Signs and Symptoms,'' available at https://www.cdc.gov/
poxvirus/monkeypox/index.html.
---------------------------------------------------------------------------
    FDA has been working proactively with commercial manufacturers on 
the development and validation of both laboratory-based molecular 
diagnostic tests and rapid molecular or antigen tests for use at the 
point-of-care (such as clinics) or at home.

    As part of this close work with CDC and the private sector, FDA has 
undertaken additional efforts that are critical to support test 
developers, laboratories, and patients as the Nation responds to the 
monkeypox virus outbreak. To increase the availability, accessibility, 
and throughput of the CDC test, FDA has updated the test's clearance 
and provided temporary enforcement discretion as needed regarding the 
test's use with additional instruments, extraction reagents, and 
automated extractions. FDA has also been monitoring the availability of 
test components and testing supplies and provided temporary enforcement 
discretion regarding the use of substitute components to help address 
shortage issues. Subsequently, these laboratories have had additional 
options and flexibility, which helps to improve timely patient access 
to monkeypox tests throughout the country. FDA also has provided 
temporary enforcement discretion regarding laboratories' reporting of 
test results from the CDC test, allowing results reported as 
``detected,'' and ``positive,'' rather than ``presumed positive,'' so 
that samples do not need to be sent to CDC for confirmation prior to 
initiating treatment.

    In addition, FDA has reached out to commercial control 
manufacturers to encourage them to produce orthopoxvirus and monkeypox 
control material that can be used for test development and test 
validation as well as batch testing once clinical testing has been 
launched. Control material is now available from at least two sources--
the National Institute of Standards and Technology and a commercial 
provider. This control material is another important resource for 
laboratories that are working to develop additional tests for 
monkeypox.

    On September 8, 2022, Secretary Xavier Becerra signed a declaration 
under section 564 of the Federal Food, Drug, and Cosmetic Act to allow 
the FDA Commissioner to issue emergency use authorizations for in vitro 
diagnostics to expand the availability of tests for monkeypox. On the 
same day, FDA issued the first EUA for a monkeypox in vitro 
diagnostic--the Quest Diagnostics Monkeypox Virus Qualitative Real-Time 
PCR \6\ intended to detect monkeypox and other non-variola 
orthopoxvirus DNA using lesion swab specimens.
---------------------------------------------------------------------------
    \6\ 1A U.S. Food and Drug Administration, letter (EUA) to Quest 
Diagnostics Incorporated, September 7, 2022, available at https://
www.fda.gov/media/161454/download.

    As part of the guidance, FDA has provided voluntary templates that 
test developers may use when validating a test or when submitting an 
EUA request. These templates include recommendations--not 
requirements--for how a developer could validate a test to help ensure 
it is appropriately accurate and reliable. FDA intends to update its 
---------------------------------------------------------------------------
recommendations, as needed, in response to the developing emergency.

    FDA will also continue its partnership with the National Institutes 
of Health's (NIH) Independent Test Assessment Program (ITAP), \7\ which 
helped streamline validation and authorization of COVID tests. ITAP 
showed the great value of an independent validation program for tests 
and, based on this experience, we will partner with NIH/ITAP to help 
streamline validation and authorization of point-of-care and home 
monkeypox virus tests. On September 7, 2022, ITAP announced it is 
accepting proposals. \8\
---------------------------------------------------------------------------
    \7\  U.S. Department of Health and Human Services, ``New HHS 
Actions Add to Biden administration Efforts to Increase Access to Easy-
to-Use Over-the-Counter COVID-19 Tests,'' October 25, 2021, available 
at https://www.hhs.gov/about/news/2021/10/25/new-hhs-actions-add-biden-
administration-efforts-increase-access-easy-use-over-counter-covid-19-
tests.html.
    \8\  National Institute of Biomedical Imaging and Bioengineering, 
``Independent Test Assessment Program (ITAP): Announcement: See New 
Opportunity for Monkeypox Virus Diagnostics Below,'' available at 
https://www.nibib.nih.gov/covid--19/radx-tech-program/ITAP.

    FDA continues actively working with private and public entities on 
monkeypox test development and availability. This includes meeting 
regularly with the CDC, academic, commercial, and public health 
laboratories and addressing monkeypox during FDA's monthly virtual town 
hall series for test developers. \9\ FDA is also fully engaged with CDC 
and key stakeholders in the laboratory community under a memorandum of 
understanding to collaborate on enhancing diagnostic surge testing 
capacity during public health emergencies. \10\ This has helped 
facilitate communications between FDA, our Federal partners, and 
laboratory professional associations and large commercial laboratories, 
including, for example, helping gain an understanding of willingness to 
participate in developing increased testing capacity, any barriers to 
such participation, and suggestions on next steps.
---------------------------------------------------------------------------
    \9\  U.S. Food and Drug Administration, ``Virtual Town Hall 
Series--Coronavirus (COVID-19) Test Development and Validation,'' 
August 24, 2022, available at https://www.fda.gov/medical-devices/
workshops-conferences-medical-devices/virtual-town-hall-series-
coronavirus-covid-19-test-development-and-validation-07272022.
    \10\  MOU 225-22-020, ``Memorandum of Understanding for Diagnostic 
Surge Capacity for Public Health Emergencies,'' effective May 6, 2022, 
available at https://www.cdc.gov/csels/dls/documents/2022-revised-mou-
for-surge-capacity--final--signed.pdf.

    FDA will continue working with our U.S. Government partners, 
laboratories, and commercial manufacturers to support access to the CDC 
test and the development of additional tests. FDA's efforts are 
critical to help ensure patients can depend on their test results and 
receive care as needed, and to avoid or mitigate further spread of 
monkeypox.
    Supporting Timely Access to and Careful Evaluation of Monkeypox 
                              Therapeutics
    Currently there are no FDA-approved products for the treatment of 
monkeypox. Tecoviramat, or TPOXX, was approved for the treatment of 
smallpox in adults and children in 2018 under FDA's ``Animal Rule'' and 
is being made available for the treatment of monkeypox under an EA-IND 
through FDA's Expanded Access program.

    The Animal Rule \11\ allows efficacy to be established based on 
adequate and well-controlled animal efficacy studies when the results 
of those studies establish that the drug is reasonably likely to 
produce clinical benefit in humans for the disease of interest and when 
conducting clinical trials in humans is not feasible or ethical. 
Smallpox is caused by the variola virus. Animal studies using variola 
virus are not consistently reproducible and do not mimic human disease. 
They are extremely challenging to conduct as research is restricted to 
two maximum-containment laboratories located in the United States and 
Russia. TPOXX's efficacy for the treatment of smallpox was established, 
and the drug approved, based on studies in animal models using 
orthopoxviruses related to the smallpox virus--specifically, nonhuman 
primates infected with monkeypox virus and rabbits infected with 
rabbitpox virus. Safety data was obtained in healthy human volunteers 
without monkeypox virus infection.
---------------------------------------------------------------------------
    \11\  For more information on the Animal Rule, please visit U.S. 
Food and Drug Administration, ``Animal Rule Approvals,'' June 2, 2022, 
available at https://www.fda.gov/drugs/nda-and-bla-approvals/animal-
rule-approvals.

    The Animal Rule can be used only when it is not feasible or ethical 
to conduct human clinical trials, as was the case with smallpox. Human 
studies of TPOXX's efficacy against smallpox disease were not ethical 
or feasible as smallpox has been eradicated. The Animal Rule was not a 
viable regulatory pathway to approve tecovirimat for the treatment of 
monkeypox as the disease was endemic in West and Central Africa, and it 
---------------------------------------------------------------------------
was both feasible and ethical to conduct clinical trials in humans.

    It is important to note that drugs that show efficacy in animal 
studies are not always effective in humans. Currently there are no 
human data demonstrating the efficacy of TPOXX for the treatment of 
monkeypox or its safety and pharmacokinetic profile in patients with 
monkeypox; therefore we do not know if TPOXX will be beneficial in 
treating patients with monkeypox.

    Thus, conducting randomized, controlled trials to assess 
tecovirimat's safety and efficacy in humans is essential.

    In parallel with planning for a randomized controlled trial, access 
to TPOXX for the treatment of monkeypox has been made available through 
an EA-IND held by CDC under FDA's Expanded Access program. FDA has 
worked closely with CDC to streamline the protocol based on input from 
stakeholders to reduce data collection and reporting requirements.

    We understand, however, that challenges remain with the current EA-
IND mechanism, and we continue to consider all potential regulatory 
options to best address this situation. Regardless of the regulatory 
mechanism used to facilitate access to TPOXX, it is important that 
access does not compromise the ability to conduct randomized, 
controlled trials that can establish whether TPOXX helps patients with 
monkeypox. Such clinical trials will be key to any potential 
consideration of approval of TPOXX.

    It is also critical to note that viral resistance to tecovirimat is 
a concern. TPOXX works by inhibiting a protein called VP37 that all 
orthopoxviruses share. Even a small change to the VP37 protein can have 
a large impact on the antiviral activity of tecovirimat. Therefore, 
judicious use of TPOXX and careful monitoring for the development of 
viral resistance are of paramount importance for stewardship of this 
potentially beneficial drug while we study it in clinical trials.
                               Conclusion
    FDA continues to advance its mission to protect and promote public 
health by helping to ensure the safety of human and animal food, and 
the safety and effectiveness of medical products. We take our public 
health mandate very seriously and will continue to work each day to 
help end the monkeypox public health emergency. FDA and our HHS 
partners are working tirelessly to ensure a robust and comprehensive 
response to monkeypox that considers the ever-changing nature of the 
outbreak. We continue to communicate with the American public and make 
regulatory decisions based on data and sound science. The Agency looks 
forward to working with sponsors to increase vaccine supply, increase 
testing options and capacity, and increasing the number of available 
treatments, while ensuring that the products meet applicable standards 
for safety and effectiveness. I hope to continue working with the 
Committee on these efforts. Thank you again for the opportunity to 
testify today.
                                 ______
                                 
    The Chair. Thank you.

    Assistant Secretary O'Connell.

     STATEMENT OF DAWN O'CONNELL, ASSISTANT SECRETARY FOR 
    PREPAREDNESS AND RESPONSE, ADMINISTRATION FOR STRATEGIC 
           PREPAREDNESS AND RESPONSE, WASHINGTON, DC

    Ms. O'Connell. Chair Murray, Ranking Member Burr, and 
distinguished Members of the Committee, it is an honor to 
testify before you today on ASPR's work and the ongoing 
monkeypox response. Let me start by sharing the work ASPR has 
done to procure and distribute vaccines. The Strategic National 
Stockpile stores vaccines that can be used in a smallpox 
outbreak.

    Among the vaccines it stores is a small stockpile of 
JYNNEOS, a relatively new vaccine for those that are 
immunocompromised and unable to tolerate the live replicating 
virus and the other smallpox vaccines. And since JYNNEOS is 
also licensed for monkeypox, we have deployed these vaccines 
for the current response.

    When the first case of monkeypox in the U.S. was 
identified, the SNS had 2,400 vials of JYNNEOS in its on hand 
inventory, and immediately deployed vaccine to support the 
first cases. And when there were still only two known cases in 
the U.S., ASPR requested 36,000 JYNNEOS vaccine vials be 
shipped to the SNS from our U.S. Government owned reserve 
stored by Bavarian Nordic. When there were only 13 known cases, 
ASPR ordered an additional 36,000 vials from its reserve. And 
when there were only 35 known cases, ASPR ordered an additional 
300,000 vials from its reserve. All of this was done to stay 
ahead of the virus.

    Though case counts were very low in the United States, we 
were watching the quick spread of cases in Europe, which was 
about 2 to 3 weeks ahead of us, and we moved out quickly, 
anticipating similar spread in the U.S. in the weeks to come.

    ASPR has made over 1.1 million vials of JYNNEOS available 
to states and jurisdictions for use against the current 
outbreak, and we have purchased 5.5 million more to arrive over 
the next months. Bringing JYNNEOS manufacturing capability 
onshore has been another focus of mine at ASPR.

    This summer when we purchased the second 2.5 million doses 
from BN to be filled and finished, our contract required that 
those doses be filled and finished in the U.S., and we have 
been pleased to support BN's arrangement with GRAM to do that 
fill finish in Michigan. We have provided GRAM with $11 million 
to secure the equipment and staff it needs to ramp up quickly.

    I visited GRAM 2 weeks ago as they are bringing on this new 
line and was pleased with the progress that I saw, and to hear 
that they will be adding over 70 new jobs in Michigan to 
support this work. Vaccines are not the only medical 
countermeasure ASPR has made available in this outbreak. We 
have also made available the therapeutic TPOXX.

    Prior to the start of the outbreak, the SNS held more than 
1.7 million courses of TPOXX. To date, over 37,000 courses have 
been distributed. I have been pleased to make both of these 
medical countermeasures available for the current monkeypox 
outbreak. It is the right thing to do. But I have not lost 
sight of the fact that both JYNNEOS and TPOXX were developed 
and stockpiled for use in a smallpox outbreak.

    I have consulted with the PHEMCE, the inter-agency body 
responsible for advising HHS on medical countermeasures, 
development, and procurement, and they have agreed with the 
approach we have taken. It is important, however, that as we 
move forward with our response, we consider ways to preserve 
our smallpox capability.

    We have also applied several lessons learned from the 
COVID-19 response to our work in monkeypox. As we digitized the 
SNS countermeasure ordering system, we opted to use a program 
that allows states to order both vaccines and therapeutics from 
the same system, rather than using separate non-interoperable 
systems for each as they have had to do in the COVID-19 
response.

    Using this multi-platform ordering system is a step toward 
modernizing our public health infrastructure for the current 
response and for future responses. We have also expanded the 
number of sites to which the SNS delivers. At the start of the 
outbreak, the SNS only delivered to five sites in each 
jurisdiction.

    This was more than enough for the high consequence, large 
scale events the SNS has been deploying to, such as hurricanes 
and tornadoes. However, after seeing the advantage of multiple 
distribution sites and the COVID-19 vaccine and therapeutics 
effort, the SNS contracted to create a similar distribution 
network for its countermeasures.

    These are just two of the examples of the lessons we have 
taken from the ongoing COVID-19 response and applied to the 
current monkeypox response. Responses cannot be static. They 
must continue to evolve and calibrate to the current set of 
circumstances and regularly account for new information and 
evolving scientific understanding.

    This has been true of the monkeypox response thus far and 
will be true as it continues. Thank you again for inviting me 
to testify before you on efforts within ASPR to support the 
ongoing monkeypox response. I look forward to answering your 
questions.

    [The prepared statement of Ms. O'Connell follows:]

                  prepared statement of dawn o'connell
    Chair Murray, Ranking Member Burr, and distinguished Members of the 
Committee, it is an honor to testify before you today on the efforts 
within the U.S. Department of Health and Human Services (HHS) 
Administration for Strategic Preparedness and Response (ASPR) to 
support the ongoing response to the monkeypox outbreak. I am grateful 
for this opportunity to address this Committee and appreciate your 
continued support for the ongoing response efforts.

    ASPR's core mission is to ensure that we are prepared and able to 
respond to public health and medical emergencies. In ASPR's 16-year 
history, ASPR has invested in a range of efforts to prepare for threats 
identified by the Department of Homeland Security (DHS). One of the key 
identified threats--by DHS, ASPR, and Congress--is smallpox. ASPR and 
other Federal partners have invested in preparing for the threat of 
smallpox for over a decade. We have a number of countermeasures within 
the Strategic National Stockpile (SNS) to aid in a response, should 
this country experience any sort of smallpox attack. Certain medical 
countermeasures we procured and stockpiled for smallpox also protect 
against and treat the symptoms of monkeypox. We are grateful to be in a 
position where our existing smallpox medical countermeasure portfolio 
can be leveraged against monkeypox. In doing so we must not lose sight 
of the need to maintain a strong smallpox preparedness posture and 
replace those countermeasures intended for smallpox that we have 
distributed in response to the current monkeypox outbreak.

    Since becoming the ASPR in the summer of 2021, one of my priorities 
has been to ensure that programs within the organization are 
appropriately resourced. The SNS has played a large role in the current 
response. One of the biggest challenges ASPR faces is fully funding the 
SNS. Despite growing responsibilities, the SNS has had a relatively 
flat budget for a number of years. The Administration requested $975 
million in the fiscal year 2023 President's Budget to ensure SNS could 
better carry out its mission. As this Committee knows well, ASPR's 
authorizing structure is such that the Biomedical Advanced Research and 
Development Authority (BARDA) advances the development of medical 
countermeasures, the Public Health and Emergency Medical 
Countermeasures Enterprise--or PHEMCE--makes a recommendation regarding 
their usefulness in our stockpile, and then SNS is supposed to be able 
to purchase the products PHEMCE determines to be needed within 
available resources.

    While BARDA has been successful in supporting the advanced 
development of a number of medical countermeasures to aid our 
preparedness and response portfolio, the SNS's flat budget has made it 
challenging to fully meet PHEMCE-identified goals for these 
countermeasures. We are fortunate to have products in the SNS to combat 
the ongoing monkeypox outbreak, but there will be lasting impacts on 
overall preparedness against other threats, such as smallpox, because 
of the realignment of medical countermeasures for this outbreak.

    The Administration's continuing resolution proposal requests $3.9 
billion for HHS to aid in the continued monkeypox response and ensure 
stockpile preparedness is restored. I look forward to continuing to 
brief Congress on preparedness levels and the impact that the current 
response is having on our overall future preparedness efforts.

    For the current response to the monkeypox outbreak, ASPR is 
partnering with many sister agencies within HHS and across the Federal 
Government, industry representatives, as well as state, tribal, and 
other jurisdictional health leaders to accelerate progress on vaccines 
and treatments--and strengthen our response. I will now highlight 
ASPR's efforts to support development, procurement, and distribution of 
vaccines and therapeutics and how we are disseminating information 
relevant to these efforts.
                       National Vaccine Strategy
    Since the first reported case of monkeypox in the United States on 
May 18, 2022, ASPR has worked tirelessly to accelerate the acquisition 
and delivery of vaccines and therapeutics to jurisdictions.

    This important work first started with an examination of our 
holdings within the SNS. As reported publicly, the SNS contains both 
ACAM2000--our first line of defense to vaccinate Americans in the event 
of accidental or intentional release of smallpox--and JYNNEOS, for 
which we keep a small stockpile to routinely vaccinate laboratory 
workers at risk of exposure to smallpox and other orthopoxviruses such 
as monkeypox. In addition to the 2,400 doses the SNS kept on-hand for 
rapid deployment, ASPR kept an additional 1.4 million vials of JYNNEOS 
in -50 degree storage at Bavarian Nordic (BN) to be available if needed 
for response to a larger outbreak. Those doses are now being deployed 
for use in the current outbreak. ASPR also had an additional 16.5 
million vial equivalents in bulk drug substance to be lyophilized (or 
``freeze dried'') in the coming years for easier storage and longer 
shelf-life. 5.5 million vial equivalents of that bulk drug substance 
are being filled and finished now and in the coming months to respond 
to the current outbreak.

    ACAM2000, which is not approved or authorized by the U.S. Food and 
Drug Administration (FDA) for emergency use to prevent monkeypox 
disease, contains live, replicating virus and may not be advisable for 
those who are immune compromised. Given the potential of monkeypox 
cases in persons who may also have HIV or other immune compromising 
conditions, ASPR worked with other HHS agencies and offices to 
determine the JYNNEOS vaccine was our best line of defense against this 
monkeypox outbreak.

    On Wednesday, May 18, the first case was identified in the United 
States. By Friday, May 20, there were two known cases of monkeypox in 
the United States, and CDC recommended those known to be exposed to the 
virus get vaccinated. On Sunday, May 22, the SNS deployed the first 
vials of JYNNEOS vaccines to Massachusetts to be used as post-exposure 
prophylaxis for those first exposures.

    At this time, while there were still only two known cases of 
monkeypox in the US, ASPR requested 36,000 JYNNEOS vaccine vials be 
shipped to the SNS from our U.S. government-owned reserve stored by BN 
in Denmark. When there were only 13 known cases, ASPR ordered an 
additional 36,000 vials from its reserve. And when there were only 35 
known cases, ASPR ordered an additional 300,000 vials from its reserve. 
All of this was done to stay ahead of the virus. Though case counts 
were very low in the United States, we were watching the quick spread 
of cases in Europe, which was about 2-3 weeks ahead of us, and moved 
out quickly anticipating similar rapid transmission in the weeks to 
come.

    Ultimately, of the additional 5.5 million vials we have ordered 
filled and finished, we anticipate that deliveries will begin arriving 
at the SNS in the next few weeks and will continue through early 2023. 
To support this effort, 3 million vials will be manufactured at BN's 
line in Denmark and 2.5 million will be manufactured here in the United 
States at Grand River Aseptic Manufacturing (GRAM) in Grand Rapids, 
Michigan. The GRAM facility is the first fill and finish line for the 
JYNNEOS vaccine in the U.S. and not only supports our current response 
to monkeypox but enhances preparedness for smallpox as well. Within 
ASPR, we helped spur this agreement and the technology transfer that 
was necessary for this production at GRAM and have invested $11 million 
in securing supplies and staff to ensure the line is up and running as 
quickly as possible. The transfer is on track to start manufacturing 
later this year. I was pleased to visit GRAM on August 29, where I met 
with the CEO and leadership team, and observed the hard work being done 
to bring the line up as quickly as possible.

    ASPR has made over 1.1 million vials of JYNNEOS available to states 
and jurisdictions for use against the current outbreak--the largest 
JYNNEOS monkeypox vaccine program in the world. Moving fast and 
distributing the product ensures equity and access for those who 
require the product. To support the allocation and distribution of 
vaccine, in late June 2022, HHS announced an enhanced National Vaccine 
Strategy (Strategy) to mitigate the spread of monkeypox. This Strategy 
outlines efforts to ensure that those at higher risk of monkeypox 
disease receive vaccine, vaccines are prioritized for areas with the 
highest numbers of cases, and that guidance is provided to state, 
territorial, tribal, and local health officials to aide their planning 
and response efforts. Using this strategy we have made vaccine 
available in phases throughout the summer. Phase 4 of the Strategy that 
focuses on distribution and allocation efforts is well underway. 
Currently, allocation amounts are based on a combination of case counts 
and population (population is based on the estimated size of the 
underlying population in the jurisdiction that might benefit from 
expanded vaccination at this point in the outbreak). Jurisdictions are 
eligible to draw down doses against their allocations once they have 
attested to adequate utilization of their currently allocated vials. 
Requiring jurisdictions to inform HHS of their administration data 
plays an important role in informing the response and ensuring 
monkeypox doses make it into the arms of those most at risk, rather 
than sitting on shelves. Once jurisdictions receive vaccine, they are 
responsible for distributing vaccine within the jurisdiction and 
setting their eligibility criteria for vaccination. Jurisdictions may 
choose to expand eligibility in the future depending on the state of 
the outbreak and the available supply of the JYNNEOS vaccine as it 
continues to increase.

    Currently, doses are held in a small stockpile within the SNS and, 
as such, distribution of the product has been managed by the SNS. The 
SNS' traditional distribution framework is based on getting material 
into jurisdictions quickly to respond to high-consequence events such 
as hurricanes and other large-scale disasters. Having access to five 
distribution points in any given jurisdiction has been satisfactory 
under these traditional circumstances to move the necessary medical 
units and countermeasures into place. As the SNS is now being asked to 
distribute vaccines nationwide from its stockpile, something it has not 
traditionally done, it is in the process of making arrangements with a 
large distributor to increase distribution to more sites. This is not a 
static response effort. At each point that I receive feedback from 
jurisdictions on ways to make the response easier for them to manage, I 
have worked with the programs here to adjust and incorporate the 
feedback just as we are doing now with SNS distribution efforts. You 
have my commitment that I will continue to do that throughout this and 
future responses.

    We are also providing a portion of vaccine for distribution through 
existing Federal channels (the Departments of Veterans Affairs and 
State, and agencies within HHS including the Health Resources and 
Services Administration, the Indian Health Service, and the National 
Institutes of Health). ASPR is working closely with HRSA to ensure they 
are able to vaccinate individuals via their Ryan White networks; IHS is 
able to vaccinate tribal members, often in rural and remote areas of 
the country; VA is able to vaccinate our Nation's veterans; NIH is 
receiving doses to conduct research; and DoS is able to ensure at-risk 
personnel serving overseas are protected.
               Treatment to Combat Symptoms of Monkeypox
    Tecovirimat (TPOXX), a therapeutic drug licensed for smallpox 
treatment, was developed with BARDA support and can be used to treat 
individuals with monkeypox with an appropriate regulatory mechanism. 
CDC currently holds, through FDA's Expanded Access program, an Expanded 
Access Investigational New Drug (IND) protocol that allows its use for 
monkeypox.

    Prior to the start of the outbreak, the SNS held more than 1.7 
million courses of TPOXX, or tecovirimat, in its immediate holdings. In 
addition to deploying bottles directly to those who qualify under CDC's 
IND protocol, on August 18, ASPR made available 50,000 patient courses 
of TPOXX for pre-positioning throughout the country. Jurisdictions have 
been allocated courses of TPOXX using a formula based 75 percent on the 
number of cases in their jurisdiction and 25 percent on the number of 
individuals who are at the highest risk of contracting the virus, 
including individuals who are living with HIV or who could benefit from 
HIV pre-exposure prophylaxis. This allocation is in addition to the 
over 20,000 courses ASPR deployed to jurisdictions from the SNS prior 
to August 18.
           Engaging Those at Highest Risk for Severe Disease
    HHS has launched two pilot programs to provide additional vaccine 
allocations to state and local health departments. The first provides 
doses to jurisdictions that are hosting large events that attract gay, 
bisexual, and other men who have sex with men in the coming weeks and 
months and the second provides doses to smaller more targeted outreach 
efforts. The larger pilot program is setting aside 10,000 vials of 
vaccine from the SNS that jurisdictions can request to order on top of 
their existing vaccine allocations and supply. The number of additional 
doses made available to a jurisdiction will be based on the size and 
nature of the event, and the ability to reach attendees at highest risk 
for monkeypox. The smaller pilot program is setting aside 10,000 vials 
of vaccine from the SNS that jurisdictions can also request on top of 
their existing vaccine. Working with CDC, ASPR is pleased to provide 
these additional doses for targeted equity interventions.
                               Conclusion
    Thank you again for inviting me to testify before you on efforts 
within ASPR to support the ongoing monkeypox response. I look forward 
to answering your questions and working with my team at ASPR and our 
colleagues across HHS to mitigate the impact of this virus.
                                 ______
                                 
    The Chair. Thank you. Thank you very much to all of our 
witnesses for your testimony and for being here today. We will 
now begin a round of 5 minute questions of our witnesses, and I 
ask my colleagues to keep track of your time. As always, 
hopefully you can stay within those 5 minutes.

    I know each of your agencies have worked relentlessly to 
respond first to COVID and now monkeypox, but I have to say, 
frankly, too many missteps were made early on in the response 
and a couple hundred cases turned into 21,000. It is 
unacceptable to communities who already experience barriers to 
accessing health care, like the LGBTQ+ and the Black and Latino 
communities that are hardest hit by this outbreak.

    Access to testing was an early challenge in the monkeypox 
response, with many people reporting significant delays in both 
accessing the tests and learning their results. To continue to 
have these challenges around testing is just simply 
unacceptable.

    Dr. Walensky, let me start with you. How is the CDC working 
to make sure tests are more accessible and results are 
available earlier?

    Dr. Walensky. Thank you, Senator, for that question. One of 
the big challenges that we had in terms of access to testing 
was both patients understanding what they--that they were 
presenting with a new infection, and providers understanding 
that this was a new infection that they had to test for.

    Indeed, another important clinical consideration was that 
people were coming in requesting a test when they had no 
symptoms, and they had no rash. As Dr. Califf noted, the test 
for this infection is a swab of the rash.

    In fact, there is no other FDA approved test. We need to 
have a rash in order to conduct those tests. So much of what we 
have done--and I should mention that we have always had more 
capacity than we have had tests coming in. To date where we 
have used about 14 to 20 percent of our capacity.

    But to address these access issues, we had to work with 
clinicians, we had to work with patients. We had to do an 
extraordinary amount of outreach so that providers would 
understand how to test patients, would understand when to come 
in for a test, and our public health partners would know not to 
gatekeeping those tests.

    That was the work that we did early on as we were scaling 
up testing, knowing that we may need more testing coming 
forward. So through the laboratory response network, we 
increased our capacity to test through expanding the manual 
extraction to automated extraction.

    Then we worked, as you heard, through our commercial labs 
to expand testing across the country, and simultaneously 
working with outreach and education to providers, clinicians, 
patients, and public health. Thank you.

    The Chair. Thank you. Dr. Califf, Secretary Becerra 
recently declared that FDA can use the emergency use 
authorization pathway for monkeypox tests. How will that 
improve the availability of new tests, and what steps are you 
taking to improve on the progress that you have made?

    Dr. Califf. First of all, let me concur with Dr. Walensky. 
There has never been a shortage of tests but there has been a 
shortage of access to tests because of inefficiencies in the 
system. So the EUA authority has enabled us--we have given one 
EUA already, but we also have five commercial labs which are 
offering the tests at this point.

    We issued a guidance just the other day which makes it 
clear that individual institutions that are developing 
laboratory developed tests should proceed ahead. And we have 
given people clear guidance and templates for developing their 
test and figuring out if they work.

    I would say on all fronts, the gates are open under a 
watchful eye because we also must keep in mind that one of the 
lessons from COVID was that when the gates were open, a lot of 
tests turned out not to be so good, got out there, and we had 
to rein them back in.

    The Chair. Well, look, I am encouraged by the decline in 
cases, but it really is imperative that we remain vigilant. And 
despite efforts by HHS to increase access to vaccines, some 
people in my home State of Washington still go to great lengths 
to get one, including crossing the border into Canada.

    Now people, understandably, want to be vaccinated before 
they get exposed, but that needs we need more vaccines. Ms. 
O'Connell, some serious stumbles were made this year when it 
came to our vaccine supply. What have you done to make sure 
that never happens again, and what are you doing to increase 
the supply and distribution of vaccines right now?

    Ms. O'Connell. Chair Murray, thank you so much for that 
question. What is most important to us is that those that need 
access to this vaccine get it. So if you continue to hear from 
constituents that are unable to access a vaccine or having to 
cross the border, please let us know.

    We are in the business right now of knocking down those 
hurdles and making sure the vaccine can be accessed. We did 
take a very small stockpile that was intended for smallpox, 
that was eventually intended to be lyophilized, freeze dried 
for smallpox, and converted it to this active monkeypox 
response.

    That required a couple of challenging problems to solve. We 
moved the first 372,000 vials, as I mentioned in my opening 
statement, immediately. We needed FDA to approve, and they were 
terrific partners moving quickly, to approve that second 
manufacturing line that began--drew the 800,000 vials we were 
waiting for.

    That is what it manufactured on. We needed that approval to 
happen before we could deploy those. FDA worked quickly and we 
got those out in July. We have also ordered an additional 5.5 
million vials of the bulk drug substance that was intended to 
be lyophilized for smallpox.

    We have ordered that to be filled and finished and shipped 
to the United States. 2.5 million of those will be manufactured 
in the United States. By adding a second line in GRAM, one that 
is onshore, domestic manufacturing, we will be able to access 
these vaccines much quicker in the future.

    It is a critical step forward in our preparedness, both for 
this monkeypox response and for future smallpox programs.

    The Chair. Senator Burr.

    Senator Burr. Thank you, Chair. Tony, last time you spoke 
on monkeypox here, you made it very clear that monkeypox is a 
result of animal to human transmission, and that happened 
abroad. Here is my question.

    If we allow monkeypox to circulate in our population 
indefinitely in the United States, what are the chances and has 
it been studied whether there can be a transmission from human 
to animal in the United States where we could have a threat 
that is--animal to human transmission then that is domestic?

    Dr. Fauci. It is certainly possible, Senator Burr. Whenever 
you have a situation where you have an animal reservoir, and 
the virus has already shown you from the standpoint of 
transmission that it can infect animal species and you actually 
have an individual who is infected, there is no real reason why 
that not could go the other way. I don't believe that we have 
seen that. But I would not be surprised if we do see a 
essentially going back and forth. That is possible.

    Senator Burr. That would present a real problem.

    Dr. Fauci. Well, that would present a problem of the 
propagation. I mean, when you want to eliminate an infection--I 
mean, there is eradication, there is elimination, and there is 
control. The best way to eradicate or eliminate it is if you 
keep it out of the realm of an animal reservoir which continues 
to re-feed into the human population.

    Senator Burr. Great. Thank you. Dawn, news outlets recently 
reported the Administration is evaluating whether some doses of 
JYNNEOS should be held back in the stockpile to meet our 
requirements for smallpox rather than distributed to support 
the current monkeypox response.

    This seems to conflict with FDA's recent decision to 
implement dose sparing strategies, which indicates that we need 
to maximize the number of available doses. Can you square this 
up for me?

    Ms. O'Connell. Thank you, Ranking Member, for that 
question. So we continue to maintain our smallpox preparedness. 
That is critical. Our front frontline vaccines continue to be 
available and have not been impacted by our monkeypox response.

    But we have added the capability to be able to provide the 
JYNNEOS vaccine to those that are immunocompromised in the case 
of a smallpox outbreak. And we are evaluating with each dose 
that we make available to the monkeypox outbreak what it means 
for that preparedness and smallpox.

    I have met with the PHEMCE. I have consulted with them to 
understand whether we need a separate monkeypox stockpile so we 
can pull those vaccines off the shelf and not worry about the 
preparedness for the immunocompromised in a smallpox outbreak.

    Senator Burr. Have you ever thought about the message you 
send to the at risk population when you suggest to them that 
though they are in the midst of an infection problem, that we 
are going to--we are discussing holding back in case we have an 
outbreak of smallpox.

    Let me just explain. We know that we have 13 to 15 million 
gay men in this country, in the United States. Tony, we have 
about 1.9 million HIV/AIDS positive gay men. There is your 
immunocompromised population, 1.9 million. Your risk pool of 
sexual for sexually transmitted monkeypox, about 13 to 15 
million. And somehow we are cheering the fact that we put out 
700,000 vaccines.

    If I am in that community, and then on top of that we have 
the subdermal decision, I am going to cut the amount that you 
get, and there is not sufficient public transparent information 
about that, you have got a population that is a little bit 
questioning whether you are doing everything to help them.

    That may be a reason that we have only had 461,000 people 
vaccinated out of a pool, a defined pool, of up to 15 million 
people, of which 1.9 million are immunocompromised because they 
are HIV positive. Dr. Califf, currently the FDA--I switched 
gears just real quick.

    Currently, the FDA authorizes COVID-19 vaccines and 
antiviral treatments to be purchased only by the Federal 
Government, prohibiting anyone else that is not Government from 
purchasing these vaccines.

    I believe we all agree on the crucial role vaccines and 
treatments play in stopping and reducing the spread of the 
virus. So why must every dose pass through the bureaucracy of 
Washington before it reaches a patient, and why are we still 
restricting access like that?

    Dr. Califf. Well, thank you, Senator Burr. It is--by the 
way, I am glad you are fully functional after your recent 
surgery, and you are definitely spry. You are showing good 
evidence of that.

    Let me just say that we have the vaccine. It is available. 
It is everywhere. You can just make your appointment and get 
it. And we expect that this will transition, as there has been 
much discussion, over the next period of time. But for right 
now, those are the rules under which we operate.

    Senator Burr. That is why a plan is somewhat important. Ms. 
Chairman, just one last question for Dr. Fauci, if I can. Tony, 
the pediatric immunization schedule recommends four doses of 
polio vaccine before one reaches the age of 6 years old.

    With new cases of polio being detected in New York State, I 
am wondering, do we know how long immunity for the vaccine 
lasts? To what extent is someone protected if they were 
completely polio vaccinated as a child?

    Dr. Fauci. It is not necessarily life long, but it is 
measured in decades and decades. So the--if a person has the 
full series of vaccinations, you could expect that they would 
be fully protected.

    The situation that we are concerned about are those who 
have either had no vaccination, like we saw with the case in 
Rockland County in New York, or individuals who have incomplete 
or did not complete their full course.

    But if you have a full course--however, since it isn't 
necessarily life long, when a person goes into a zone where 
there is a lot of polio, you would recommend that they would 
get a boost. But I would refer to perhaps that Dr. Walensky has 
something further to add to that.

    Dr. Walensky. I have nothing to add. That is exactly right.

    Senator Burr. I thank the Chair. Thank you.

    Senator Casey. Thank you, Senator Burr. I wanted to start 
by thanking the witnesses, and obviously thank you for their 
public service. I will start with Dr. Walensky. Part of the 
success of the COVID-19 vaccination campaign was the gradual 
shift from large vaccination sites to hyperlocal sites where 
people could find vaccines in their own neighborhood, for 
example, like at a local pharmacy.

    We have seen the way in which convenient and local access 
to vaccines can help with uptake, whether they are--whether we 
are talking about a vaccine for a new treatment like COVID-19--
or a new threat, I should say, like COVID-19, or for routine 
vaccines like influenza and childhood vaccines.

    Obviously people know and trust their own doctor and their 
providers, and they respond to community based and community 
member led efforts that meet them where they are.

    Doctor, how are you working with state and local partners 
to make sure we reach everyone who is at risk for infection, to 
make sure that they have the opportunity to get vaccinated if 
they so choose?

    Dr. Walensky. Thank you, Senator. A really important 
question in terms of outreach. So early on as vaccines were 
being distributed, we were doing it in places where people were 
seeking care. Many of that--many of those places were in sexual 
health clinics or state run clinics where people were receiving 
care. It is the case that not all members of this community 
have told their own clinicians about their sexual activity.

    It is very important that we do this in a sensitive and 
non-stigmatizing, affirming manner. So we were doing it in 
places initially where people were receiving care, but then 
many of the lessons again learned from COVID, as we have rolled 
out these vaccines and delivered over a half a million to 
members of these community, is that we need to do more and more 
outreach.

    We learned that we need trusted messengers, we need 
community based organizations. I am pleased to say that over 
the last several weeks, we have sponsored vaccine activities in 
several large scale distribution sites like Atlanta Black Gay 
Pride, like Charlotte Pride, like Boise Pride, and like 
Southern Decadence. When we have done so, we have had really 
successful campaigns.

    In the Atlanta Gay Pride, we vaccinated over 4,200 people. 
Similarly with Southern Decadence, around 4,000--3,000 people. 
What we need to do now is do those in smaller scale, and we are 
actively doing that scale up in smaller scale.

    Rather than these big events, we need to meet people where 
they are with community based organizations, trusted 
messengers, exactly as you say. Thank you.

    Senator Casey. Thanks, doctor. Next question will be for 
both you and Assistant Secretary O'Connell.

    We know that in the aftermath of the pandemic and now with 
the emergence of monkeypox as a public health threat, the need 
for ongoing, dedicated investment in our Nation's public health 
infrastructure, similar to what Chair Murray has called for and 
her Public Health Infrastructure Save Lives Act--our state and 
local health departments have been struggling for years after 
two and a half years of the COVID-19 pandemic and now with 
monkeypox in addition to that.

    They simply don't have the resources they need for routine 
public health work. So when an emergency comes up, they have to 
move funds around and sacrifice from their core programing.

    Other programing, like the ongoing opioid epidemic, lead 
screenings, anti-tobacco efforts, cancer screenings, routine 
vaccinations, on and on. So how would additional sustained 
funding for local public health infrastructure help us be 
better prepared for new threats like a new viral outbreak? 
Maybe I will start with you, Assistant Secretary O'Connell.

    Ms. O'Connell. Thank you so much, Chair, for this question. 
We continue to see states, jurisdictions, or public health 
departments worn out, tired, exhausted.

    We know they have been working for two and a half years 
around the clock, and we have been relying on them to 
distribute vaccines and therapeutics, both in the COVID-19 
outbreak, as well as this new monkeypox outbreak. So one of the 
most critical investments we can make would be in additional 
staffing and not just throwing supplemental funds out that hire 
people but don't sustain them.

    It is important that we have multiyear funding that 
supports our public health departments. It is also critical 
that they can build these systems. I talked about the HPOP 
system that we put in place for the SNS digitized ordering, 
which is interoperable.

    That we are no longer having them trained on something 
called VTrckS that CDC sets up, and then HPOP that H-CORE sets 
up, but we have it on one system that talks to each other. They 
can order their vaccines and their therapeutics.

    By introducing that in this outbreak, we knew that the 
states were tired, and we worked very carefully with them on 
making sure they understood why we made this decision. And 
while it was hard, it does push us forward in a supportive way 
as we face this current outbreak and future ones.

    Dr. Walensky, I know that you might want to say more.

    Dr. Walensky. Thank you. If I could just briefly add that 
the core public health infrastructure is key. This needs to be 
disease agnostic and long term sustainable rather than from 
crisis to complacency. I will just give you the example that 
our public health partners in the states and local 
jurisdictions do not have a line item for monkeypox resources.

    They have had to respond, trying to be flexible with other 
resources that sometimes are not legally allowed. So as you 
know, the key core public health infrastructure are the 
workforce, diverse as the communities they serve, laboratory 
infrastructure so we can scale up new labs swiftly, and then 
data infrastructure, so we have interoperable data, just as the 
ASPR noted. Thank you.

    Senator Casey. Thanks very much.

    Senator Paul.

    [C-SPAN video clip playing].

        LNews Anchor. ``--But she has had the flu for 14 days. 
        Should she get a flu shot?''

        LDr. Fauci. ``Well, no. If she got the flu for 14 days, 
        she is as protected as anybody can be because the best 
        vaccination is to get infected yourself.''

        LNews Anchor. ``And--''.

        LDr. Fauci. ``If she really has the flu--if she really 
        has the flu, she definitely doesn't need a flu 
        vaccine--if she really has the flu.''

        LNews Anchor. ``She should not get it again?''

        LDr. Fauci. ``She doesn't need it because it is the 
        best--it is the most potent vaccination is getting 
        infected yourself.''

    [End of video clip.]

    Senator Paul. This is an ongoing question. And we have had 
ever evolving opinions from you, Dr. Fauci. Currently, antibody 
surveys show that 80 percent of children, approximately 80 
percent of children have had COVID.

    Yet there are no guidelines coming from you or anybody in 
the Government to take into account their naturally acquired 
immunity. You seem quite certain of yourself in 2004, but in 
2022 there is a lot less certainty. One of the things that we 
also know after looking at this for 2 to 3 years, is that the 
mortality from COVID is very similar, if not less than 
influenza.

    When we look at this, we wonder why you seem to really 
embrace basic immunology back in 2004, and how you or why you 
seem to reject it now.

    Dr. Fauci. Well, I don't reject basic immunology, Senator, 
and I have never denied that there is importance of the 
protection following infection.

    However, as we have said many times and as has been 
validated by the authorization of the--by the FDA through their 
committee and the recommendation by the CDC through their 
committee, that a vaccination following infection gives an 
added extra boost, and that film that you showed is really 
taken out of context.

    I believe that was when someone called in who had a 
reaction to a vaccine and asked me through a telephone in the 
interview if they should get vaccinated again. So it was in the 
context of someone who had a reaction.

    As a matter of fact, Reuters fact check looked at that and 
said, Fauci's 2004 comments do not contradict his pandemic 
claim.

    Senator Paul. Actually, words don't lie. If you look at the 
words behind me, we can go over them a little bit at a time. 
``She doesn't need it because the most potent vaccination is 
getting infected yourself.''

    Dr. Fauci. It is true. It is true, Senator. It is a very 
potent way to protect.

    Senator Paul. When you are trying to tell us that kids need 
a third or a fourth vaccine, are you including the variability 
or the variable of previous infection in the studies? No, you 
are not. Because when you have approved vaccines in recent 
times, in the committees that have approved it for children, 
don't report anything on hospitalization or death or 
transmission.

    They only report that if you give them the jab, they will 
make antibodies. And you can give kids hundreds of jabs and 
they will make antibodies every time, but that does not prove 
efficacy. So what you are doing is denying the very fundamental 
premise of immunology that previous infection does provide some 
sort of immunity. It is not in any of your studies.

    Almost none of your studies from the CDC or from the 
Government have the variable of whether or not you have been 
previously infected. So let's look at adults. I have had three 
infections. Should I get a fourth one?

    If you are going to measure whether you get a fourth one, 
you need a category that has a fourth one in it and you need 
one that has nothing in it, no vaccine or the fourth vaccine. 
But you also need to know whether they have been infected. If 
you ignore whether they have been infected, you are ignoring a 
vaccine basically, so you are ignoring a variable.

    What you are giving us is this--you decry, and people decry 
vaccine hesitancy. It is coming from the gobbledy-gook that you 
give us. You are not paying attention to the science. The very 
basic science is that previous infection provides a level of 
immunity.

    If you ignore that in your studies, if you don't present 
that in your committees, you are not being truthful or honest 
with us.

    Dr. Fauci. Senator, if I might respond, I have never, ever 
denied fundamental immunology. In fact, I wrote the chapter in 
the textbook of medicine on fundamental immunology. You know--
--

    Senator Paul. Is it--any of the guidelines for vaccines--
any of the guidelines for vaccines from the Government include 
previous infection as something to base your decision-making on 
with vaccines? Do any of the guidelines involve previous 
infection?

    That is why you are ignoring previous infection, because it 
doesn't involve any of the guidelines. And furthermore, we have 
been asking you and you refuse to answer whether anybody on the 
vaccine committees gets royalties from the pharmaceutical 
companies.

    I asked you last time and what was your response? We don't 
have to tell you. We have demanded them through Freedom of 
Information Act, and what have you said? We are not going to 
tell you.

    But I tell you this, when we get in charge, we are going to 
change the rules and you will have to divulge where you get 
your royalties from, from what companies, and if anybody in the 
Committee has a conflict of interest. We are going to learn 
about it, I promise you that.

    Dr. Fauci. Mr. Chair, can I respond to that, please?

    Senator Casey. You may.

    Dr. Fauci. Okay. There are two aspects for what you said. 
You keep saying, you approve, you do this, you do that. The 
committees that give the approval are FDA through their 
advisory committee.

    The committees that recommend are CDC through their 
advisory committee. And you keep saying I'm the one that's 
approving a vaccine based on certain data. I don't really 
understand, with all due respect, Senator----

    Senator Paul. You are the one that said you would not 
reveal--you would not reveal what company gave you royalties or 
what company gave the other scientists royalties----

    Senator Casey. We have got to move on.

    Senator Paul. That is what you told the Committee.

    Senator Casey. Senator Paul----

    Dr. Fauci. Sir, could I please answer that?

    Senator Casey. Briefly, yes.

    Dr. Fauci. You keep asking committees--they are not my 
committee. They are the VRBPAC committee for the FDA and the 
ACIP for the CDC. I don't have any idea what goes on----

    Senator Paul. They won't reveal, as well as you, won't 
reveal what companies----

    Senator Casey. We are going to move on. We are over time.

    Senator Paul [continuing]. royalties from.

    Senator Casey. Senator Paul, you are over. Everyone is over 
a little bit. I just want to make sure we keep on time here. 
For the record, I know Chair Murray and previous Chairs of this 
Committee of both parties, both parties have found videos to be 
out of order, and I will note for the record, the video is out 
of order.

    We will move to Senator Smith.

    Senator Smith. Thank you, Mr. Chair.

    Mr. Chair, I ask unanimous consent to submit a letter from 
AIDS United, the AIDS Institute, the National Alliance of State 
and Territorial AIDS Directors, the National Coalition of STD 
Directors, and the National Minority AIDS Council outlining 
recommendations for a comprehensive approach to the monkeypox 
response...Mr. Chair, can I have unanimous consent for that, 
please?

    Senator Casey. Yes. So ordered.

    [The following information can be found on page 60 in 
Additional Material:]

    Senator Smith. Thank you very much. Thank you to our 
witnesses. I want to add my gratitude to Dr. Fauci for your 
service to our Country during some of our Country's most 
challenging times.

    Thank you so much. I want to also start by associating 
myself with Senator Murray's remarks about the importance of 
Congress coming together to make sure the Administration has 
the resources that it needs to respond to the monkeypox public 
health emergency.

    I also agree on the need to sharpen our response and to 
work effectively with public health departments, including in 
Minnesota. Assistant Secretary O'Connell, we had a good 
discussion last week about distribution of the monkeypox 
vaccine, and I want to follow-up on that.

    We talked about some of the challenges that the Minnesota 
Department of Health has experienced. The issue is that ASPR 
has opted to use the HPOP system, the health partner order 
portal, as I understand it, to distribute vaccines rather than 
the VTrckS system, which is how COVID vaccines were distributed 
and what the Department is used to.

    As I understand it from ASPR's perspective, the HPOP system 
works better for distributing both monkeypox vaccines and 
treatments directly from the Strategic National Stockpile. 
There are also some challenges with interoperability, as I 
understand it, with the VTrckS system.

    But of course, the issue, as we discussed, is that by using 
two different systems, one for COVID vaccines and one for 
monkeypox vaccines, this is a real challenge for the Minnesota 
Department of Health, and I suspect that this is a challenge 
for other agencies as well.

    Of course, this is happening at a time when these 
challenges are falling on public health departments and staff 
that are exhausted and burned out after the last two and a half 
years of responding to COVID-19 and learning a new system in 
the midst of all of this is really a challenge.

    It is sort of exacerbated, I think, by the Department 
having trouble tracking shipments of vaccines through VTrckS 
and sometimes monkeypox doses just showing up unexpectedly. So 
could you just address for me--I appreciate you talked about 
this in your written testimony.

    Could you address what steps you are taking to work with 
state health departments that are in similar situations to 
Minnesota's to help improve how this distribution process is 
working?

    Ms. O'Connell. Senator Smith, thank you and thank you for 
the good conversation we had last week, and an opportunity to 
talk about some of these challenges. So most important to us is 
that those that need vaccines can get them.

    If anyone continues to find this to be a difficult system, 
please reach out and let me know. We want to knock down these 
hurdles to ensure that folks have access. We now have enough 
vaccine supply to meet demand, so it is important that people 
are able to access it.

    We have a similar challenge that Dr. Walensky mentioned it 
with the states. The states aren't able to use their COVID 
funding for the monkeypox response. We haven't been able to use 
our COVID funding for the monkeypox response either. So when it 
came to digitizing the SNS process, we were going to have to 
put new money into either the VTrckS system or the HPOP system.

    The HPOP system is currently being used in COVID-19 to 
order therapeutics, so states do have familiarity with HPOP, 
VTrckS was being used for the vaccines. Only HPOP could do 
both. And we were faced with putting annual budget funding into 
one of these systems in order to digitize the SNS ordering.

    We chose to put it into the system that could actually do 
both. We believe that was an important step in moving forward. 
But we do acknowledge, Senator Smith, that our public health 
department colleagues are worn out and tired.

    We have had countless office hours with them to make sure 
they understand the system. If they are running into any 
problems, we are available to answer them. And as hard as this 
changed management is in the middle of two responses, it was 
the right thing to do to move forward to an interoperable 
system.

    We also have added additional distribution sites. That is 
one of the things we did with the SNS. We could not just 
piggyback on the COVID-19 distribution network. That was funded 
with COVID dollars. We had to go with the SNS, do an entirely 
new contract with a different distributor with annual funds, 
and set that up.

    That was one of the reasons why there was a delay. We have 
needed to overcome this, and we will look forward to working 
with Congress on making response dollars more fungible in the 
future.

    Senator Smith. I know that would be helpful, and I 
appreciate your continuing to work the Department. And you 
know, obviously getting the distribution right is everything 
when it comes to getting vaccines and making sure that people 
have access to vaccines.

    Mr. Chair, I am out of time, but I will submit a question 
for the record about the importance of tribal consultation to 
our witnesses and look forward to your response.

    Senator Casey. Thank you, Senator Smith.

    Senator Collins.

    Senator Collins. Thank you, Mr. Chairman. Secretary 
O'Connell, I want to follow-up on the statement you just made. 
I don't recall any requests from the Administration to use 
leftover COVID money for monkeypox.

    Moreover, it is not at all clear to me that you could not 
submit a reprograming request to the Senate Appropriations and 
House Appropriations committees for those--that purpose.

    What exactly are you implying when you say that you haven't 
been able to transfer funds? You have taken funds for other 
purposes, including sending it to the border.

    Ms. O'Connell. Senator Collins, thank you so much for your 
question and for the conversations we have had recently about 
issues. We have been advised by our legal counsel and by our 
appropriations team, our budget and finance team, that the 
money that is currently in the contract for McKesson, which is 
our distribution network that each H-CORE is managing, could 
not be--we could not piggyback on that same contract to set up 
a monkeypox distribution network.

    The way those funds work, we were restricted to supporting 
COVID response efforts and not additional response efforts. But 
I would be more than happy to meet with you and your team again 
and see if it is possible to do a reprograming.

    But that was what we were advised, and so we took 
additional funds, different funds, non-COVID funds, and set up 
a different contract with AmerisourceBergen for the SNS to set 
up a distribution network.

    Senator Collins. Let me turn to another issue that we have 
discussed several times, and I do appreciate the fact that you 
have made yourself available. We have statements from Dr. Jha 
from OMB back in March that laments the decline of domestic 
manufacturing for COVID tests.

    It talks--OMB in its March supplemental request talks about 
the volatility, which makes it difficult to preserve 
manufacturing, domestic manufacturing of tests. Dr. Jha says 
the U.S. Government put a lot of efforts and resources into 
building up domestic manufacturing.

    What we are seeing day by day, week by week, is that is 
beginning to go away. I would suggest that it is the 
Administration's contracting policies that have weakened our 
domestic manufacturing of COVID tests. As you and I have 
discussed before, the majority of the at home tests the 
Administration purchased for COVID were manufactured outside 
the United States.

    For example, the Administration awarded a Chinese company, 
iHealth, a $1.3 billion contract. That is roughly four times 
the size of the contract that was awarded to an American 
company, AVID, which has a considerable presence in my state.

    How is it that the Administration is working with domestic 
testing manufacturing when you are at the same time awarding 
contracts to Chinese companies? That does not help to preserve 
domestic manufacturing.

    Ms. O'Connell. Senator Collins, thank you. Domestic 
manufacturing of tests is a critical mission of ours in ASPR, 
making sure it is supported and an enduring part of the COVID-
19 response. When it moves from an acute response to a steady 
state, we will always want to know whether we have had COVID, 
whether someone we have interacted with had COVID.

    Testing is critical and domestic manufacturing of tests are 
also critical. And regarding the iHealth contract, you will 
recall when the President made the announcement that he was 
going to make 1 billion tests available through the U.S. Postal 
Service distribution system, the covidtest.gov.

    He also vowed at the time that he would not interrupt the 
commercial market, that he would not take tests that were 
currently going to the pharmacies and into other stores, he 
would not take them out of the market and put them into the 
covidtest.gov program

    In order not to disrupt that, the domestic manufacturers at 
the time were seeding the local pharmacies, we pulled in tests 
internationally so as not to interfere with what was available 
at the pharmacies.

    As soon as that leveled out, we made a commitment in the 
spring to only support domestic tests moving forward, but that 
initial decision was to not interrupt the domestic tests that 
were currently feeding the schools, the pharmacies, and the 
other pieces of the response. We wanted those to remain 
available.

    Senator Collins. Dr. Fauci, I just want to wish you well in 
your retirement. And a very quick question for you. And it is 
based on what you have written recently about the lessons of 
the AIDS pandemic.

    Though monkeypox cases are overwhelmingly related to sexual 
transmission and men who have sex with other men, should we be 
doing more to look at community spread and cases in the broader 
community, such as, for example, testing anyone with an 
atypical case of herpes or shingles regardless of their sexual 
history?

    Dr. Fauci. Thank you for that question, Senator. The answer 
is yes, we are doing now sero surveys and surveillance that go 
beyond the well-established high level of infection in certain 
demographic groups.

    That was part of the five pillars that I mentioned in my 
statement about virology, immunology, transmission, reservoirs, 
and serosurveillance. We are doing that in some of our studies, 
but the CDC is also doing that.

    We are actually doing it in collaboration with them, using 
some of our cohorts in collaboration with the CDC's capability 
to do that. Perhaps you want to comment.

    Dr. Walensky. Yes, maybe I will add, and thank you Dr. 
Fauci, that among our health advisory networks that we send to 
clinicians and our outreach, for example, to the American 
Academy of Pediatrics, we make recommendations just like that 
say, if there is an atypical rash, please consider monkeypox 
and test for it on your differential diagnosis. We make those 
recommendations. Thank you.

    Senator Collins. Thank you.

    Senator Casey. Thank you, Senator Collins.

    We will turn next to Senator Baldwin.

    Senator Baldwin. Thank you, Mr. Chair.

    First, I would like to ask unanimous consent to enter into 
the record an April 11th, 2022, article from Reuters entitled, 
Fact Check of Fauci's 2004 Comments Do not Contradict His 
Pandemic Stance.

    Senator Casey. Without objection.

    [The following information can be found on page 63 in 
Additional Material:]

    Senator Baldwin. Thank you. I want to join my colleagues, 
Dr. Fauci, in wishing you very well in your retirement and 
thank you so much for your service to this country. I want to 
start with you for a question on basic research.

    I think we are falling short when it comes to providing 
sustained investments in preparedness. That is why I led the 
Disease X Act to provide sustained funding for BARDA to focus 
on medical countermeasure development for viral families of 
concern.

    We can't just keep on responding to the threat in front of 
us. Dr. Fauci, can you explain how investments in smallpox 
research have made us better prepared for this outbreak had 
we--than had we not made those investments?

    Dr. Fauci. Thank you very much for that very important 
question, because it relates not only to smallpox and the 
extrapolation of knowledge to monkeypox, but it relates to 
virtually all elements of fundamental basic research, that 
ultimately when you get to a problem that is a public health 
problem, it can be applied.

    As I mentioned in my written and in my oral statement, the 
original work that had been done on orthopox viruses dating 
back to 2001 and 2002 following the anthrax attacks, when we 
put a lot of work into developing the countermeasures that 
Assistant Secretary O'Connell mentioned regarding smallpox, 
allowed us by getting another type of vaccine that is less 
reactogenic and has less adverse events, which led to JYNNEOS, 
which is now the primary vaccine for monkeypox.

    The relationship between the smallpox research that had 
been done for decades on orthopox viruses and the acceleration 
of that research when we had the bioterror threat in 2001 and 
2002, allowed us to respond rapidly with already developed 
countermeasures in the form of TPOXX and JYNNEOS.

    Senator Baldwin. Thank you. Dr. Walensky, for me, as we had 
a chance to speak earlier, monkeypox is all too reminiscent of 
our initial response to HIV/AIDS. I actually started my career 
in 1986 on the Dane County Board of Supervisors. In that year, 
the first cases of HIV/AIDS were reported in Wisconsin.

    There was a tremendous amount of fear and paranoia and 
sorrow in our community. We had to fight both the disease, and 
the fear and the stigma and the discrimination that was present 
in the community.

    Dr. Walensky, can you describe CDC's efforts to work with 
the LGBTQ+ community to combat misinformation, to reduce 
stigma, and to ensure that folks have access to care?

    Dr. Walensky. Thank you, Senator, for that question. Their 
involvement and integration into our response has been 
critical.

    One of the first thing that we did when we heard about the 
case on May 17th was outreach between our smallpox branch and 
our HIV branch, because we knew that it was--both those 
communities, both those scientists that were going to need to 
come together to make our--to make a robust response. We have 
had extraordinary outreach with the LGBTQ community.

    We have met several times with the Human Rights Campaign, 
the LGBTQ serving FQHCs, inter-pride and pride organizers. We 
have facilitated best practice exchanges with tourism hubs. We 
have palm cards for Provincetown, Fire Island, Palm Springs. 
And then we have supported these large events like Black Gay 
Pride, and Boise Pride, Charlotte Pride.

    Importantly, one of the things that we did early on, and 
this was one of the lessons learned from HIV decades ago, was 
that on May 27th, we first published an iteration of sexual 
health information on monkeypox for the LGBTQ community, so 
they would understand what practices would decrease their risk 
of monkeypox.

    All of this engaging a very robust, very active, and very 
helpful and informed LGBT community that have been essential in 
not only working with us, but in educating their own community. 
Thank you.

    Senator Baldwin. Thank you. I will enter my last question 
into the record for Secretary O'Connell on what ASPR is doing 
to ensure this delay in vaccine availability is not a problem 
in the future, and anything you need from Congress to help 
address this.

    Thank you, Mr. Chairman.

    Senator Casey. Thank you, Senator Baldwin.

    I will be turning the gavel over to Senator Baldwin, and 
our next Senator, Senator Cassidy.

    Senator Cassidy. Thank you, Mr. Chair. I was a medical 
resident in 1983 to 1986 during the HIV epidemic when HIV just 
exploded, so I am very aware of the need to have a robust 
research and public health response to infectious diseases.

    Now, Dr. Walensky, part of this has got to be predicated 
upon trust between the American people and the agencies, that 
the agencies are functioning as best as they can. I feel like 
that trust is frankly been dissipated. I am sorry to say that 
because I respect you as a clinician, as a person.

    But I have asked you on multiple occasions as to what 
percent of the CDC workforce is actually showing up. Frankly, 
you have always blocked that. You have never given a straight 
answer. I would like to enter for the record an article from 
the Epoch Times in which they did a FOIA request to find out 
how many folks at CDC were actually working, showing up, so to 
speak.

    Roughly 2,772 out of roughly 13,000 employees are showing 
up every day, but 78 percent are working completely remotely or 
come in maybe only twice every 2 months. Now, why is that 
important? First, that was a knowable fact, but it was not 
shared with Congress, we the representatives of the American 
people. I think the American people would like to know that if 
CDC is not functioning well, how many of the people are 
actually showing up?

    Now, I mentioned CDC is not functioning well because I now 
reference an article which I will enter for the record from New 
York Times on August 17th, in which you frankly, to your credit 
point out, CDC has not been working well and that there is need 
for wholesale change.

    At the end of the article, they quote an acting director 
of--under President Obama, Dr. Besser, who says that it is 
hard--first pointing out that you are still working remotely, 
you, yourself are working remotely, at least of August 17th, 
and then he says, but it is hard to see how Dr. Walensky could 
execute wholesale changes when she only sees most of her staff 
at a distance.''

    I don't know how you motivate and inspire culture change 
when people aren't together.'' Now CDC is requesting billions 
of dollars for public health initiatives in an agency which, by 
your assessment, is not functioning well, in which only about 
22 percent of the people are showing up every day, and in which 
previous Obama officials are doubtful that you are going to 
affect change because you don't show up every day.

    I say that kind of painfully because I want the CDC to 
work. And yet--and one example, and I am sure there is a reason 
for it, but there has been a lot of talk about the need for 
local agencies to have to modernize.

    But the CDC was given $200 million under the CARES Act for 
data modernization to be awarded to 64 different state, 
territorial, local jurisdictions. And maybe this is HHS, maybe 
it is not CDC, but most of it has not yet been spent or 
allocated.

    This is according to the CRS. So it is incredibly 
frustrating that a deliberate decision was made to not be 
transparent with the American people as regards the amount of 
people who actually shown up for work. It takes a FOIA request 
from a newspaper and now you are asking for billions more, why 
should we trust?

    Dr. Walensky. Thank you, Senator, for that comment. I will 
say that we are an agency of 13,000 people. The people who need 
to be at CDC are at CDC, of course, our laboratory workers. We 
have many people in the field. We have people in 60 different 
countries.

    Senator Cassidy. Yes, but the article points out that there 
are many--that it is just wide open. That there is nobody 
showing up. That the offices are empty. So to suggest that all 
these people are field workers, I think, again, is another 
example of being opaque.

    Dr. Walensky. I don't imply that they are all field 
workers. I am saying that many of them are field workers. Many 
of them are working at CDC and then deployed in responses, and 
many of them are on the road. I myself was in Atlanta last week 
for a day, but I was in New Mexico with tribal visits and doing 
a Secretaries tribal advisory committee meeting. So many of us 
are on the road. I am here today, and I am working----

    Senator Cassidy. I am sorry, what percent of CDC employees 
before the pandemic actually showed up for work every day as 
opposed to the only 22 percent now?

    Dr. Walensky. I don't have those numbers for you.

    Senator Cassidy. Yes, that is--I just feel like, how 
should--and let me go back to, why should we trust CDC with 
billions when it is very difficult to get, I would say, a 
straight answer on what is the workforce in-person effort, and 
particularly when by your own assessment, the agency is working 
so poorly?

    Dr. Walensky. The review that we did on August 17th was to 
demonstrate the lessons learned from the COVID-19 response. 
That people of the CDC are working well, they are working hard, 
and they don't necessarily need to be onsite in Atlanta. In 
fact, oftentimes they are more productive offsite, in the 
field, doing the work of public health.

    Senator Cassidy. I would just--we are out of time but let 
me just say that the former Acting Director of CDC from 
President Obama, when he said in the last paragraph of The New 
York Times article, he did not see how you were going to be 
able to, speaking of you in particular, affect change when you 
only see people every now and then.

    He was both suggesting that it was not a work completed, 
but it was something that had to happen now, and that when 
people not working together made that more difficult to 
execute.

    I don't think anybody in here or anybody watching really 
thinks that only 22 percent of the CDC employees showed up for 
work at the building every day before the pandemic. They think 
it was probably 78 percent and now the number is reversed.

    It is going to be hard for me to support more 
appropriations until we have a better relationship, a more 
trusting relationship, a more transparent relationship between 
the agency and Congress, which you are asking to fund your 
activities. With that, I yield.

    Senator Baldwin. Next, Senator Hickenlooper.

    Senator Hickenlooper. Great. Thank you, Madam Chair. And 
thank all of you for your service through obviously one of the 
great challenges this country has ever faced in its public 
health history, the pandemic.

    Then coming out of the pandemic, now we see other 
challenges. Let me talk a little bit about COVID-19 and the 
lessons learned. And we learned what to do and also what not to 
do. Again, we are back here with another public health 
emergency.

    I guess I would ask you, Dr. Fauci, and I would want to 
echo also my gratitude and salutations for--I know that you 
won't really retire because I don't think you are capable of 
not contributing to the public good, but I know you will try.

    But the pathogen research at NIAID was critical to the 
development of orthodox vaccines and treatments, obviously a 
big help with monkeypox. But we may not have stockpiled 
vaccines for the next pandemic similar to COVID.

    I am just asking, in terms of the next public health 
emergency, how concerned are you that this next one, the next 
public health emergency will be one that we don't have vaccines 
or therapeutics for?

    Dr. Fauci. Thank you for that question, Senator. We always 
are concerned when you get a brand new infection that you have 
had no experience with, that you are not going to have 
countermeasures, particularly vaccines, that are ready in a 
timely fashion. So there are two approaches to that.

    We have described in detail in several publications and in 
some of our white papers what is called the prototype pandemic 
and prototype pathogen response. In other words, to look at 
multiple families, and there are about seven or eight high 
priority families.

    By families we mean alphaviruses, arenaviruses, 
filoviruses, flaviviruses, and to do fundamental core research, 
for example, to get commonalities among the pathogens within a 
family, and to start to develop vaccines, put them in phase 
one, and have them ready to go. With the new mRNA technologies, 
it is very simple to switch one epitope or one antigen in and 
out of the vaccine.

    That is the core of our approach right now, and I think you 
will probably be hearing more about it, because that is the 
thing that we are putting forth as the NIH's contribution to 
the Government wide pandemic preparedness, is the prototype 
pathogen approach.

    Senator Hickenlooper. I support that approach. I think that 
is the right direction to go and to be make sure that we are as 
prepared as one can be for what is unknowable and respect the 
challenges of that preparation but also the urgency.

    We can agree and argue about--I think that the Government 
agencies across the board are going through the issues of how 
many people are going to work and how many of people are 
working remotely. Every large corporation is dealing with this 
right now and we are going to have to process through that.

    But in the meantime, we have got to make sure that we have 
the funding for pandemic preparedness because that is essential 
to the long term future of this country in almost every way. 
Let me switch to this outbreak of monkeypox. When it broke out, 
we had almost 800,000 vials sitting at the manufacturers 
facility in Denmark. But the shipment of these critically 
needed vaccines to the U.S. was held up pending.

    There was an FDA inspection of the facility even though 
European regulators had approved it. Dr. Califf, I would ask 
you, how do--how can we help the FDA better balance safety 
protocols with the urgency and the need to respond quickly to 
these emergencies?

    Dr. Califf. Thanks, Senator. You know, the issue that 
occurred in this case was there was a new plan that the BN had 
switched to. It had not been inspected by the FDA. I probably 
don't need to remind you that we had more than one incidence in 
COVID times of a manufacturing facility not being up to par, 
which created a lot of difficulty and trouble. So we felt it 
was essential to get there.

    In fact, we got there very quickly after the application 
came in from the company to do it and the outbreak occurred. 
But I think the balance here is the risk of a vaccine which is 
not up to par with the time it takes to make sure that the 
vaccine coming out actually will do the job that is intended.

    I would also just add, Europe doesn't have a central 
inspections team for vaccine facilities. Each country does its 
own, and we have had some discordance historically between 
findings in some of those facilities and what we found in our 
inspection. So we really felt we had to get this right, even if 
it took a bit more time.

    Senator Hickenlooper. Okay, fair point, great.

    I yield back to the Chair.

    Senator Murphy. Senator Marshall.

    Senator Marshall. Thank you, Mr. Chair.

    To my panelists, as I read your testimony, listen to your 
testimony, what you described to me as an academic response to 
a problem. As opposed to being proactive, we are being 
reactive.

    I would challenge you all to change your culture so that we 
are more proactive, a more of a military response to a problem 
like this. When I look back through the history of this virus, 
July 2021, there was a case in Texas from Nigeria, November 
2021, a case in Maryland from Nigeria.

    In May 2022 of those cases in multiple countries, all 
linked to Nigeria. And there was a moment in time before the 
horse was out of the barn that we could have stopped this. And 
now I fear that this virus is being transmitted from human to 
animal. Once it is in the animal kingdom, we will never be able 
to get ahead of this.

    My question for Secretary O'Connell is, did you ever 
consider a travel ban or requiring vaccinations from people 
that have traveled from Africa before they get back in this 
country?

    Then you made a statement on June the 3d of 2022 that you 
said, I want to say we have enough on hand to manage this 
current outbreak. Do you still think that was the case then? 
And if so, why is it still exploding?

    Ms. O'Connell. Thank you. Senator Marshall, I would like to 
take the second one first, and then invite Dr. Walensky, who 
has----

    Senator Marshall. We don't have much time but go ahead.

    Ms. O'Connell. Okay. At the time that I made that 
statement, we were using the ring vaccination strategy, which 
is a strategy that has been effective in monkeypox outbreaks, 
including the ones that you just mentioned previously. It 
requires vaccine being administered to the person that has the 
virus and their close contacts.

    As the spread of the current outbreak began to indicate 
that anonymized partners would make it difficult for contact 
tracing to happen, we pivoted to those that were likely to be 
exposed and we expand----

    Senator Marshall. There is plenty of vaccines, and the 
problem was the execution and getting the vaccines to where 
they were needed?

    Ms. O'Connell. The strategy that we were using to vaccinate 
the at risk population changed as we were seeing the 
transmission change.

    Senator Marshall. Okay. Dr. Walensky, just briefly, yes or 
no, did you all consider some type of a travel ban or requiring 
people to have a vaccine before they came to this country?

    Dr. Walensky. Maybe if I could just clarify. The two cases 
in 2021, one in Texas, one in Maryland we were aware of, there 
were no contacts that ultimately had monkeypox. Those were 
isolated cases and----

    Senator Marshall. But they traveled to Nigeria--from 
Nigeria.

    Dr. Walensky. Yes. And we have known that monkeypox is 
endemic in Nigeria as well as DRC. And intermittently over 
years, including two last year, we have intermittent travel 
cases that have led to no further cases. That happened in 2021.

    This is a different outbreak. This is May 17th was our 
first case, when we had our first case. I spoke to the 
clinician who made the diagnosis. We called Public Health 
Canada as that patient had traveled from Canada and we 
immediately started outreach with our colleagues in UK as well.

    Senator Marshall. I think it is a no. But there was 
multiple cases across Europe already with most of them 
connected to Nigeria. I want to turn to fentanyl poisoning just 
a second, Dr. Walensky.

    Probably two people, one or two people have died with 
monkeypox in the United States that I am aware of, but everyday 
hundreds of Americans die from fentanyl poisoning. Why have you 
not declared this a public health emergency? Why have you not 
asked the Administration to shut down the border where 90 
percent of this fentanyl comes from?

    Dr. Walensky. The declaration of a public health emergency 
is under the Secretary, so I would have to defer that comment. 
I will say that----

    Senator Marshall. But you could recommend to him that would 
be done.

    Dr. Walensky. We have those conversations. But what I will 
say is that our ability to shut down the border at the CDC 
level is related to communicable diseases. And while the 
fentanyl challenge----

    Senator Marshall. You are turning your back on the 
fentanyl----

    Dr. Walensky. Not at all. I just said I don't have the 
authority----

    Senator Marshall. More people have died of the poisoning--
more Americans have died from fentanyl poisoning than we lost 
in Vietnam. This is what is killing Americans every day, is 
fentanyl. Do you not have a heart for these people, for these 
moms and dads and these kids?

    Dr. Walensky. I absolutely do. And in fact, through my 
career, I have cared for many of them. And it is tragic. And we 
are doing a lot at CDC----

    Senator Marshall. What are we doing?

    Dr. Walensky. But we do not at CDC have the authority to 
shut down the border on anything except a communicable disease.

    Senator Marshall. What are we doing?

    Dr. Walensky. We are doing outreach. We are doing mental 
health. We are doing community violence. We are doing 
surveillance. We are doing----

    Senator Marshall. But tons of fentanyl continue across the 
border. Really quickly, in 2017, there had been no cases in 
Nigeria for 40 years. Suddenly there was an outbreak, I guess 
218 cases since then.

    The CDC, Echo Health, UC Davis, funded by USAID were all 
doing research in Nigeria at the time. I think it is for Dr. 
Walensky as well as Dr. Fauci. Were you aware of this research? 
What was the purpose of the research? Was it just collecting or 
were we doing more than collecting? Were we concerned about lab 
outbreaks?

    I have got a list of questions related to that research, 
but Dr. Fauci, were you aware of that research in 2017?

    Dr. Fauci. No, I am not. But I could get that information 
to you, if--I will have to check with the staff. I was not 
aware of it myself personally.

    Senator Marshall. Dr. Walensky were you aware----

    Dr. Walensky. We have been conducting monkeypox research in 
Nigeria for years, and I would be happy to get you the details.

    Senator Marshall. You know what the purpose of that 
research is?

    Dr. Walensky. I would be happy to get you the details.

    Dr. Fauci. As I mentioned in my remarks, we are conducting, 
will be imminently conducting a clinical trial of JYNNEOS--of 
TPOXX, excuse me, in the Democratic Republic of the Congo. That 
is not fundamental basic research, that is a clinical trial in 
the Democratic Republic of the Congo.

    Senator Marshall. Thank you, and we look forward to your 
answers. I yield back.

    Senator Murphy. Senator Hassan.

    Senator Hassan. I want to thank the Chair and Ranking 
Member for this hearing, and all of our witnesses for your 
work. Ms. O'Connell, I want to start with a question for you to 
really just give you an opportunity to build on earlier 
testimony.

    The Department of Health and Human Services has been 
responding to COVID-19 now for over 2 years. You address this 
to some extent in your testimony, but could you just explain 
further how the Department's experience with COVID-19 is 
informing its monkeypox response?

    Ms. O'Connell. Thank you so much, Senator, for that 
opportunity. So we are continuing to actively respond to COVID-
19 but are continuing to pick up lessons as we go.

    One of the critical lessons is making sure that we have 
systems, when countermeasures are ordered, where states can 
order both the therapies and the vaccines on a same 
interoperable system.

    We have done that now as we have digitized the SNS's 
ordering process. It was also important that the SNS have 
multiple distribution sites across jurisdictions and states. 
Jurisdictions and states got used to that in our COVID-19 
response.

    The SNS up until this point has really only been able to do 
five distribution points in any state, consistent with the 
large scale high consequence incidents it has been responding 
to, like hurricanes, tornadoes. But now that we move to this 
national vaccine strategy, where we are trying to get vaccine 
out quickly to the high risk populations, having those 
additional distribution sites is critical.

    We have, the SNS has entered into a contract now with 
AmerisourceBergen, which will allow it to distribute to 
multiple places, 500 ambient, 500 frozen distributions a day 
for 5 days a week. So up to 5,000 distribution points. Another 
thing that we have done is we have created a framework to 
ensure that the vaccines aren't going to the wrong place.

    One of the things we saw when we seeded the country in 
COVID and made sure we were giving it out on a prorata basis, 
that sometimes it would end up in the wrong place and was not 
being administered.

    We have asked states to self-attest to 85 percent usage. Is 
it going to the right places? That has not been a barrier. We 
are continuing to work with states to ensure that their second 
courses don't count against their 85 percent, and that those 
that are in the field don't count against their 85 percent.

    But it has been a good framework for us to make sure shots 
are getting in arms, most important thing right now, and not 
sitting on shelves.

    Senator Hassan. Thank you very much. I am going to switch 
to a different topic with Dr. Califf. I want to build, Dr. 
Califf, on conversations we have had before to discuss another 
public health emergency, which is the opioid crisis. During 
your confirmation hearing, we discussed how the FDA helped fuel 
this crisis by approving and labeling opioids for long term 
use, despite a lack of strong evidence supporting those labels.

    I was encouraged when you told this Committee that under 
your leadership, the FDA would aggressively look at relabeling. 
But in the 6-months into your confirmation, the FDA has yet to 
change any labels.

    The opioid epidemic continues to ravage communities in New 
Hampshire and all across the country, as we have all 
acknowledged this morning, and your agency needs to move 
swiftly to correct its previous mistakes.

    You, yourself have repeatedly said that the FDA needs high 
quality evidence to support the long term use of opioids. The 
agency has the authority to remove labels from drugs now, given 
the absence of this evidence. So why is the process taking so 
long?

    Dr. Califf. I want to express appreciation for your 
question. And to mirror what has already been said here today, 
we are currently losing more people from opioids than we are 
from COVID. So this is a national issue that we need to all 
take seriously.

    I have taken the first 6 months to get an assay of 
everything that is going on inside the FDA and all of 
Government response, and also in the face of the fentanyl mail 
order issues that are going on with high dose fentanyl.

    None of that obviates the need to get back to the basics of 
the prescription of opioids. We published our framework last 
week. You will see changes over the next few months within the 
context of that framework.

    Senator Hassan. Are you telling me that you are considering 
that the framework calls for relabeling opioids?

    Dr. Califf. It is under active consideration and discussion 
within the FDA, yes.

    Senator Hassan. Because look, I just was at a recovery 
rally in my state with people who have engaged in peer to peer 
recovery. People who are helping pregnant women with their 
recovery, people, parents who have lost two children to 
fentanyl and to opioids.

    The FDA first approved and labeled opioids for long term 
use more than 25 years ago. That means that they have been on 
the market for more than 25 years without substantial evidence 
that they are effective for that purpose and with plenty of 
evidence about the harm that these drugs can cause.

    I appreciate that there is a framework out there, but what 
people are looking for right now is action. I will continue 
working with my colleagues on both sides of the aisle to ensure 
that it happens. And again, I thank you for your service and 
your attention to this.

    Dr. Califf. I appreciate that.

    Senator Murphy. Senator Rosen.

    Senator Rosen. Thank you, Chair Murphy, and for holding 
this important hearing. Thank you for everyone being here, 
doing all that you do in these trying times, that is for sure. 
I want to talk a little bit, though, however, about clinical 
guidance for all our practitioners, of course, their support 
staff, to prevent and treat monkeypox.

    Because I would say many clinicians, maybe a majority of 
clinicians, have not directly treated monkeypox and may have 
not seen a wide range of cases, so it is critical for clear 
guidance to be widely available to all medical professionals, 
and I would also say their support staff who don't--do answer 
the phones, take the questions in the room when they are doing 
their own histories and physicals. It is important for 
treatment and prevention.

    Regarding monkeypox prevention, I have concerns about the, 
not just the slow rollout of vaccines to vulnerable 
populations--and I appreciate that you have been doing 
significant work to make the vaccines more available.

    But with all these vaccines rolling out, there is a new 
COVID vaccine, the flu vaccine, there is a pneumonia, there is 
a shingles, of course, then there is other things that people 
might get, tetanus, this or that--for adults. I am talking 
about adult population. So a lot of confusion about boosters. 
Can I combine vaccines?

    I am really, really concerned that the CDC, Dr. Walensky, 
what are you doing to mount this public information campaign on 
the wide variety of vaccines, important ones available--we 
don't want someone and maybe not get a shingles.

    My parents both had it. It is very painful. How are we 
going to do that at pharmacies and public spaces, even besides 
our doctors--people may not be going to a doctor or a clinic, 
but maybe they are going into their local drugstore or grocery 
store every week, right?

    Dr. Walensky. Yes. So thank you, Senator, for that 
important question. I think one of the things you raise is one 
of the challenges that we have seen first with COVID, now with 
monkeypox, and one of the places I would really welcome 
Congress's help. We don't have a mechanism in this country by 
which we inform our clinicians of a new outbreak or a new 
disease.

    This has been through a lot of public education. We have 
had a massive amount of outreach. We have health advisory 
networks that we reach out to. When we put out a health 
advisory, and we have done four for monkeypox, they reach about 
a million clinicians.

    We have done what we call clinician outreach webinars and 
calls, COCA calls. They reach about 6,000 clinicians. We put 
them online, they are reaching about another 10,000 each one 
that we do. We have done several of those. I personally have 
sent a letter to all board of clinicians through the AAMC.

    I am working with each state to try and send letters out to 
inform people of a disease that they may have never heard of 
and may have never seen but tomorrow might walk into their 
clinic.

    What do they need to know, what are the protections that 
they need to take, and how would they diagnose, treat, and care 
for a patient with this infection. So that has been a lot of 
the work that we have had to do during this outbreak. I will 
say from a health worker safety standpoint, at least as far as 
monkeypox is concerned, we have seen very little outbreak in 
health care workers.

    We have had one diagnosed health care worker after a needle 
stick injury, but we have seen very little health care worker 
outbreak due to our personal protective equipment and the 
outreach that we have done in telling healthcare workers how to 
protect themselves.

    Senator Rosen. What about the broader idea of that we have 
this fall so many vaccines that are available, we will just say 
to the adult population, preventative vaccines for--that we 
normally have, flu, shingles, pneumonia for a few of those, now 
a COVID booster, now potentially a monkeypox shot. How are you 
going to just get this out to patients and consumers, people in 
general?

    Dr. Walensky. We do a lot of provider calls for that as 
well. Our advisory committee----

    Senator Rosen. What if you are not going to a provider, how 
are you going to get it to the average person?

    Dr. Walensky. Well, so we have been doing public--we have 
been doing press conferences, we have been doing advisories as 
we have rolled out both the BIVALENT booster. We have a massive 
flu campaign that we roll out in early October, which we will 
again do this year.

    One important thing I want to just highlight, though, is 
that we at CDC and we in this country do not have a mechanism 
like we do with children. You listed adult vaccines. I believe 
there are 13 of them that are advised. Adult vaccines, we do 
not have a mechanism in this country to finance adult vaccines 
the way we do it at Vaccines for Children's Program.

    When we look at the equity of getting vaccines to rural 
populations, to other populations, we do not have a mechanism 
by which to do that in an equitable fashion the way we do for 
children, and that is a big constraint that we have right now.

    Senator Rosen. Thank you. I know I only have 20 seconds 
left, but Dr. Fauci, I just want to ask you quickly, we have 
monkeypox, so medication to treat the infection, but their 
symptom management.

    We hear a lot of talk about opioids. I know it is very 
painful, monkeypox. I don't know what the treatment might be, 
but what kind of guidance are you giving the medical community 
about effective pain management as it relates to the 
neuropathy, I would imagine, that monkeypox causes.

    Dr. Fauci. There are medications for the neuropathy, but 
importantly, particularly when it is on the mucosal surface, be 
it the anal, rectal, mucosal, or the urethral mucosal, they can 
be extraordinarily painful. We recommend, and the hospitals do 
this anyway, I think that is pretty common knowledge--it is an 
acute not a chronic pain.

    It is the kind of thing that you would not hold back on any 
type of pain medication just because you are concerned about 
addiction. The discussion that we have been having about 
fentanyl and the opioids is not using it for chronic pain.

    This is not chronic pain. This is very acute pain that 
usually resolves itself within a period of a couple of weeks, 
but you certainly don't want your patient to suffer 
inordinately by holding back pain medications.

    Senator Rosen. Similar to that pain of shingles in that 
same way. Thank you. My time has expired. Thank you very much.

    Senator Murphy. Thanks, Senator Rosen. I will recognize 
myself for questions. I have two. One for you, Dr. Walensky, 
and one for Dr. Fauci. Dr. Walensky, one of the things I panic 
about is your access to data. And you have talked to this 
Committee about it. We have talked personally about it.

    But outside of emergency authorities, you are stuck in a 
position today in which you have to negotiate 50 different data 
sharing agreements with states all over the country. And we 
expect a lot of the CDC, but it is hard to expect too much of 
the CDC when you don't have the authorities, as I understand 
it, to get the data you need absent an emergency.

    When we look at what is happening today with monkeypox, you 
are getting data, but it is patchy. For instance, you are not 
getting full demographic data. So there is a lot of states that 
aren't reporting to you, for instance, breakdowns of cases on 
race or ethnicity. And that really hurts our ability to target 
who gets the vaccine, right, who gets resources.

    It is certainly in the context of monkeypox, but maybe more 
broadly, what position does it leave you in when you don't have 
the authorities to be able to compel states in a uniform way to 
get you good data?

    Dr. Walensky. Thank you, Senator, and thank you for the 
question and for your leadership in working with Senator Kaine 
and Senator Baldwin in trying to get us the authority so that 
we can provide these data to you.

    We have been working closely, tirelessly with state and 
local public health staff who have been doing the same to 
extract data on this outbreak specifically. We have actually 
negotiated now 61 data use agreements. We have navigated 
bureaucratic approvals for data to get flowing. We have set up 
voluntary arrangements directly with large commercial labs to 
send their data.

    But it has been hard, and it should not be this hard. And 
if we can't make informed decisions based on the best possible 
data coming into us, we are not making the best decisions for 
the American people. The existing patchwork of data systems is 
not working. It is not working to the best ability of the 
American people.

    For monkeypox specifically, I can tell you that I don't 
know the total number of people hospitalized with monkeypox, 
the data on laboratory testing in the United states, complete 
demographic data, as you noted. Which people with monkeypox 
have been vaccinated? We can't then link the monkeypox vaccine 
data to the laboratory data.

    Demographic data, as you noted, we get 27 percent of our 
demographic data on testing. We have received 47 percent of our 
demographic data on cases. 91 percent of our demographic data, 
because of these data use agreements, on vaccination.

    Senator Murphy. I would just much rather have you be in the 
business of fighting the public threats presented to the 
country than in constant negotiation over data sharing 
agreements. It seems like an essential function of the Federal 
Government to set up a uniform way in which you get data, 
rather than putting you in the position of negotiating over and 
over and over again these data use agreements.

    My hope is that soon we will be able to find a consensus on 
that here. Scary that you don't know how many people are 
hospitalized with monkeypox today because of your inability to 
get that data.

    Dr. Fauci, in the minute and a half remaining, I just want 
to talk a little bit about what we learned, what you learned 
over the course of the information distribution campaign for 
the COVID vaccine, and how that relates to what we are 
communicating about JYNNEOS. Because there has been some amount 
of information regarding questions about the level of 
protection, the duration of the immunity when it comes to the 
monkeypox vaccine.

    I don't know that this was necessarily your fault, but in 
the euphoria of the sort of early news of the COVID vaccine, we 
probably got out a little bit ahead of ourselves in terms of 
what level of protection it could provide.

    What did we learn about how to talk about a vaccine in its 
early distributions stages, and how does that inform how we 
should talk about the monkeypox vaccine?

    Dr. Fauci. Well, first of all, they are two entirely 
different pathogens. And the response and the durability of 
response to each is really quite different. It was a rather 
unique situation with COVID vaccine, where there was no doubt 
that the initial protection against symptomatic disease as well 
as severe disease, was well into the 90's.

    That was the really good news. The sobering news was the 
durability of protection, particularly against infection and 
symptomatic disease. Fortunately, the durability against severe 
disease lasted.

    But if you look at coronaviruses in general, which is 
usually a good parameter of what the response to a vaccine is, 
even with a coronavirus infection, the durability of protection 
against reinfection long before COVID came along, just the 
typical common coronaviruses, did not last very long.

    We see instances of reinfection with the same coronavirus. 
That poses a very different situation, which leads to the need 
for and the importance of updating vaccines and giving the 
boosters that are part of the regimen in addition to the 
primary regimen. When you are dealing with a pox virus, 
inherently pox viruses have a much greater durability of 
protection.

    We know that because smallpox itself, once you get 
infected, you are essentially protected for life, against 
reinfection. Once you get vaccinated with the standard smallpox 
vaccination, you can be sure that the durability is measured at 
least in decades and maybe lifetime.

    What we are dealing with now with JYNNEOS is that it likely 
is going to have a durability of protection if you get the two 
doses, not just one. We want to make sure people get their two 
doses. The durability very likely is going to be much greater 
than that shorten durability of the COVID because they are 
really fundamentally two different viruses.

    Senator Murphy. Thank you very much, Dr. Fauci.

    Senator Braun.

    Senator Braun. Thank you, Mr. Chairman. I have two 
questions. First for Dr. Walensky and then for Dr. Fauci. Over 
the last two decades, HHS has issued only four public health 
emergency declarations, H1N1, Zika, opioid crisis, and COVID-
19. On August 2d, declared monkeypox a nationwide public health 
emergency.

    Of the over 20,000 people diagnosed with monkeypox, since 
May 2022 there has been one fatality. I am concerned that the 
public health emergency declarations will not be taking 
seriously if it is a litany for every new challenge that comes 
along, the way we are going to get the public to buy into it.

    I guess I would like to ask, what are the criteria used for 
determining whether a disease or a disorder constitutes a 
public health emergency?

    Dr. Walensky. Thank you for that question, Senator. What we 
were seeing in late May, early June, was a doubling time of 
this, of new cases of about every 8 days. So increased number 
of new cases.

    Among the things that is important, I think, is we 
understand when a public health emergency--and in fact, I will 
invite the Secretary, Assistant Secretary O'Connell to maybe 
chime in here as well, is what are the things that public 
health emergency unlocks for us to be able to do, whether it be 
in flexibility of funding in resources, whether it be in 
emergency use authorizations, whether it be in other 
flexibilities, so that we have the capacity as an agency to 
deliver as much health as possible.

    I don't know if Dr. Califf or Secretary O'Connell want to 
chime in there.

    Ms. O'Connell. Just to concur with what Dr. Walensky said. 
The public health emergency created an atmosphere in which FDA 
was willing to use its emergency use authorization authority, 
on which it was easier for states to give us the data that 
Senator Murphy and Dr. Walensky just talked about.

    It makes it easier for local public health departments to 
shuffle employees around in order to put them toward the 
current response. So it created some flexibility. That was also 
an important signal to the community that we were paying 
attention, that this is an emergency in our view, and that we 
want to provide as much countermeasures and response mechanisms 
as possible.

    It also aligned with what WHO did. It declared a public 
health emergency of international concern. We have the most 
cases in the world. So it was consistent with what their 
determination was. Ultimately, it is the Secretary's decision, 
and he made that decision in August, as you said.

    Dr. Califf. Senator Braun, I would just chime in quickly. I 
agree on all the things that were unlocked. And the point is, 
we need to keep looking at our emergency capacity and our 
planning for it. I think we all agree we need to keep looking 
at this as a continuum because with climate change and 
everything else, there are going to be a lot more of these that 
come along.

    Senator Braun. I basically agree with that 
conscientiousness, that kind of a being ready for it. But you 
do have to keep in mind that if it does enter some kind of a 
sequence where it gets dismissed because it is being declared 
too often, to me it looks like you would want to develop some 
criteria that I know it is difficult to get everything into a 
subset, but I worry about how people will view it if it is a 
litany of public health crises.

    When we went through the COVID-19 journey, I learned so 
much about it along the way. And of course, it was the last 
time, I think, Dr. Fauci, you and I spoke. We were talking 
about shutting down the economy. And you said that we did that 
out of uncertainty.

    We probably never would want to do that again. And that 
cost trillions and trillions of dollars along the way. So we 
surely have learned a lot with that experience that we might 
use on others. Dr. Fauci, a lot of Americans are worried about 
the power of social media. And it was back over a year ago or--
yes, in July that we talked about, had there been any contact 
with your office?

    I know that here recently a Federal judge in Louisiana 
ruled that the Biden administration, including yourself, must 
turn over external communications with social media companies. 
So we will see what happens there.

    You said there had not been a contact up to that point. Had 
any social media company contacted you since July when we spoke 
last? I know it has been a decent amount of time, so I was just 
curious.

    Dr. Fauci. I don't believe that I said there was no 
contact. I have had over a period of time, and I would have to 
check the date, Senator--honestly, I would have to get the 
correct dates. That Mark Zuckerberg of Facebook had contacted 
me to make some Facebook live discussions about encouraging 
people to get vaccinated and how we can make sure that people 
understand the importance of vaccination.

    There has been, and that is public record. I think anybody 
who has access to the public face of that Facebook would see, I 
think there were three conversations that I had back and forth 
with him about promoting the use of vaccinations as a public 
health intervention.

    Senator Braun. I think on that particular public health 
advice about the benefits of a vaccine, it is probably not 
where that contention arises. I want to narrow in on this, and 
it would be the original discussion of where it came from, the 
leak. And then they used from a lab or from a wet market. And 
was there ever discussion on that? And to me, that is a 
different kind of issue to----

    Dr. Fauci. To my knowledge, there was not. I mean, I would 
want to make sure I get correct your question. If the question 
is, do we influencing social media in any way, the answer is a 
categorically no at that. And any communications that are made 
in that regard, as far as I am concerned, are an open book and 
available.

    The lawsuit that you mentioned, I think it is Missouri and 
Louisiana versus Biden and HHS and CDC and FDA and the entire 
Government, because it involves the President is under the 
Department of Justice right now.

    I have handed, and my staff have handed over every document 
that the Department of Justice has asked for, and it is up to 
them to make it available. But I have held nothing back from 
anything that I was asked to provide.

    Senator Braun. Thank you----

    Senator Murphy. Senator Braun, we have got a vote pending, 
so I want to turn it over to Senator Burr.

    Senator Braun. Thank you.

    Senator Murphy. Thank you.

    Senator Burr.

    Senator Burr. Thank you, Mr. Chairman. Let me conclude, if 
I can. I want to thank all of you and more importantly, thank 
your workforces for the work they have done over the last 3 
years. Tony. I wish you well in the transition. I want to state 
this, and I want to be perfectly clear, we don't act or react 
fast enough. I will say it again. We don't act or react fast 
enough.

    We have been focused on monkeypox. Let me do a recap real 
quick. May 17th, infection in the United States. 2 weeks prior, 
10 days prior, or 11 days prior we see this in the UK. We 
already owned a big bulk storage of vaccines sitting at BN in 
Denmark.

    BN apparently speeds up their fill finish line that wasn't 
supposed to go online until sometime in the fall. They apply. 
FDA on June 30 inspects. It is July 27th before the approval is 
made. Here is the concerning part. It is April 18th when we 
signed a deal for domestic fill finish somewhere else.

    Let me say that again. We start with May. We know we have 
got domestic infection. We are concerned with our ability to 
deal with this. And there is a big period that we don't look 
for domestic fill finish. I am not asking for a response, I am 
just making a point. That if we have a pandemic response plan, 
things like this get resolved.

    I don't know what the limitations that have been placed on 
any of you about sharing the specific plan, whether it was on 
COVID or whether it was on monkeypox. I don't really care 
today.

    What I do care about is that if you are in the role of 
leadership in your agency, or if somebody else is in the role 
of leadership in the future, the first thing they ought to be 
saying is, let's sit down as a group and let's put together a 
plan. Let's know what everybody is going to do. This BS of 
working independently, the turf wars that exist, we own 
testing, we own this, we own that, to hell with it.

    These are--when you declare a national emergency, this is 
no time to protect territorial turf. And every response to us 
is about money. Dawn, if you need something changed to 
reprogram, for God's sakes, ask us. Don't use it as an excuse 
as to why you couldn't do something. Rochelle, we have reached 
out many times, and the only thing I hear, data, data, data, 
money, money, money.

    Listen, take it to heart what the doctor said to you, when 
78 percent of the employees aren't coming in the office, you 
don't get much sympathy from us. Rob, it may be the wrong time 
to do a demonstration project about working remotely. You know, 
the biggest trouble we have got is putting people back in the 
office.

    Congress did it. The Government is not capable of doing it. 
Private sector is struggling with it. Post-COVID is very 
different, but the responsibilities that you have as the 
emergency response components haven't changed. You have got to 
look at your workforce. You have got to look at the challenges.

    You have got to look at the procedures that you have got in 
place and say, have we really learned from the last one? Now, I 
am not going to be here to see you probably again. I am not 
sure Patty will hold another hearing before now and the end of 
the year.

    But I want you to know, I look forward to working with you 
and I will continue to be a resource to any of you because I 
only have one goal, and that is that I know for the next one, 
we have got to respond a hell of a lot faster than we did for 
COVID, and we have got to do much better than we did on 
monkeypox.

    Because on the other side of this potentially is one that 
gets out of control with massive amounts of loss of life. Mr. 
Chairman, I thank you for your indulgence. I probably missed 
the vote, but that is okay, because I think this is more 
important. I yield back.

    Senator Murphy. Thank you very much, Senator Burr. Thanks 
all the Members of the Committee for participating. To all of 
our witnesses, Dr. Walensky, Dr. Fauci, Dr. Califf, Ms. 
O'Connell, thanks for this really important and thoughtful 
discussion about the response to the monkeypox outbreak.

    For any Senators who wish to submit additional questions, 
the record will be open for 10 business days. The HELP 
Committee is pretty generous. 10 business days. So you got 
until September 28 at 5.00 p.m. for additional questions for 
the record.

    With that, this Committee stands adjourned.
                                ------                                


                          ADDITIONAL MATERIAL

                                        AIDS United
                                                 September 13, 2022
Senator Patty Murray, Chair
Senator Richard Burr, Ranking Member
U.S. Senate Committee on Health, Education, Labor, and Pensions,
217 Russell Senate Office Building,
Washington, DC 20510.

    Dear Chair Murray and Ranking Member Burr:

    As the Administration and Congress respond to the ongoing monkeypox 
(MPV) outbreak in the United States, the Partnership to End HIV, STDs, 
and Hepatitis is concerned that opportunities to take a syndemic and 
comprehensive approach are not being utilized due to the urgency of the 
situation. Since the first days of the outbreak, we have heard of 
``lessons learned from HIV and COVID-19''; yet many of those lessons 
remain unimplemented--to the detriment of public health in the United 
States.

    Some of the lessons from the COVID-19 pandemic are positive ones. 
The creation and mass-distribution of easy-to-use diagnostics and 
vaccinations via partnerships with local trusted leaders and community 
providers proved very effective in ensuring testing and vaccinations 
were widely available. We hope the Department of Health and Human 
Services (HHS) will move quickly to replicate that approach as much as 
possible, and we applaud Secretary Becerra's decision to declare MPV a 
public health emergency. Yet, the early days of the pandemic also laid 
bare our Country's continued struggle with health inequities, ill-
equipped health care infrastructure, and conflicting and poorly 
disseminated communications. We must learn from these mistakes, lest we 
repeat them.

    Based on its current presentation, MPV is most similar to the HIV 
and STD epidemics in this country. Our collective experience with these 
epidemics gives our organizations a unique perspective and expertise, 
and we would like to take this opportunity to offer these 
recommendations for creating a more thoughtful and comprehensive 
response to MPV.
                  Resources should follow the disease.
    Right now, the vast majority of MPV cases is within the gay, 
bisexual, and other men-who-have-sex-with-men (GBM) community, with 
Black and Latino men experiencing the brunt of the outbreak. We ask 
that you continue to dedicate resources, education, vaccines, 
treatment, etc. within the GBM community, with specific attention to 
mitigating racial inequities.

    However, limited data collection on testing and treatment inhibits 
the government's ability to know where resources are most needed. 
Therefore, we also ask that you take swift and necessary action to use 
the recent declaration of a public health emergency to instruct the 
Centers for Disease Control and Prevention (CDC) to expand the 
collection of national demographic and geographic information beyond 
case counts, and vaccinations, to include testing and treatment 
information. We are specifically concerned, as evidenced in CDC data, 
that Black, Brown, and younger GBM are being disproportionately 
impacted. Whereas only 21 percent of first doses of the vaccine have at 
this point been administered to Black individuals, the same population 
makes up nearly 40 percent of cases. \1\ We ask that the Administration 
operate based on existing data showing that racial health inequities 
are present and work diligently to counter them. As with COVID-19, 
communities of color are going to be hardest hit, and the 
Administration must correct for that in the response.
---------------------------------------------------------------------------
    \1\  https://www.cdc.gov/poxvirus/monkeypox/response/2022/
index.html accessed September 12, 2022
---------------------------------------------------------------------------
                       Take a syndemic approach.
    The National Coalition of STD Directors (NCSD) conducted a survey 
of sexual health clinics early in the outbreak and found that 60 
percent of people presenting for monkeypox testing had an STD that was 
not MPV. \2\ This number has more recently been confirmed by the CDC, 
which found that 61 percent of MPV patients had either HIV or an STI. 
This is unfortunately not surprising. HIV and STD testing dropped 
dramatically during COVID-19, with testing for HIV dropping by nearly 
50 percent in 2020, \3\ which allows infections to move through the 
American population undetected and leads to rising rates. STD rates, 
for example, are at an all-time high for the sixth year in a row.
---------------------------------------------------------------------------
    \2\  https://www.ncsddc.org/wp-content/uploads/2022/06/Clinic-
Monkeypox-Capacity-Survey-Handout.pdf
    \3\  https://www.cdc.gov/mmwr/volumes/71/wr/mm7125a2.htm's--cid--
mm7125a2--w
---------------------------------------------------------------------------
    There is an opportunity, as individuals seek out testing and 
vaccination for MPV, to also educate on HAV, HBV, and meningitis 
vaccinations and conduct testing and treatment for HIV, hepatitis, and 
STDs, especially since--at this time--the communities being targeted 
for testing and treatment also ought to be offered HIV and STD testing. 
We ask HHS to create protocols and dedicate resources to incentivize 
providers to offer HIV, hepatitis, and STD testing alongside MPV 
testing and vaccination.

    Additionally, the very population currently being targeted for 
vaccination and education on MPV is the same population targeted for 
pre-exposure prophylaxis (PrEP). Right now, GBM across the country are 
seeking out care providers for vaccinations, testing, and information 
about the disease. This is a significant opportunity to simultaneously 
screen and educate for PrEP and increase uptake. And we ask that HHS 
create protocols and dedicate resources to incentivize providers to 
offer PrEP counseling and linkage to PrEP services at vaccination and 
testing appointments whenever feasible.
  Engage in accurate, honest, and culturally competent communication.
    Since the first days of the MPV outbreak, the public health field 
has worked scrupulously to mitigate stigma against GBM and monkeypox. 
However, in service of this work, national communications efforts to 
the GBM population have been muddled, leaving the most affected 
population without the information they need to make informed choices 
about their health. We ask the Administration to prioritize 
streamlining and improving culturally competent communication--in 
multiple languages--related to MPV for those most at risk.
               Properly equip the people doing the work.
    As you know, for decades, the United States has asked our public 
health infrastructure to do more with less. Currently, we are hearing 
from sexual health clinics around the country that they have 
essentially become MPV clinics. One provider shared that they spent an 
entire 10-hour shift enrolling four patients in TPOXX due to the still 
time-intensive administrative requirements. This is unacceptable.

    We ask that you immediately support the frontline public health 
employees and health care providers by expediting the creation and 
dissemination of provider trainings and education; funding public 
health departments and clinics' increased staffing and supplies needs; 
protecting health care providers with sufficient PPE and prioritizing 
those that work with MPV patients for vaccination; and lifting 
administrative burdens, such as the time-intensive protocols for TPOXX.

    These recommendations are intended to build upon other 
recommendations that have been made in response to the MPV outbreak, 
including greater access to vaccinations and testing, reduced 
administrative burdens, and increased funding.

    We are in an emergency situation, but it is also an opportunity to 
demonstrate the Administration's ability to respond agilely--and 
ultimately build on the lessons learned from HIV, STDs, and COVID-19 to 
create a stronger public health system. The partnership stands ready to 
help the Administration do so. If you have any questions or would like 
to discuss our recommendations, please reach out to the National 
Coalition of STD Directors' director of Federal policy, Rachel Deitch, 
via email at [email protected] or by phone at 847-804-6672, or Rachel 
Klein, Deputy Executive Director of The AIDS Institute by email at 
[email protected] or by phone at 202-815-2973.
            Sincerely,
                                           Jesse Milan, Jr.
                                                  President and CEO
                                                        AIDS United
                                              [email protected]
                                             Michael Ruppal
                                                 Executive Director
                                                 The AIDS Institute
                                                [email protected]
                                                Stephen Lee
                                                Executive Director,
                                                             NASTAD
                                                    [email protected]
                                               David Harvey
                                                 Executive Director
                         National Coalition of STD Directors (NCSD)
                                                 [email protected]
                                                Paul Kawata
                                                 Executive Director
                                                               NMAC
                                                   [email protected]
                                 ______
                                 
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                                ------                                

    [Whereupon, at 12:21 p.m., the hearing was adjourned.]

                                   [all]