[Congressional Record Volume 166, Number 183 (Saturday, October 24, 2020)]
[Senate]
[Pages S6429-S6432]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]



                             Vaccine Safety

  Mr. President, I come to the floor to speak on another subject. I 
want to talk about science and vaccines.
  The Governors of New York and California have announced they are 
creating their own State review panels to review COVID-19 vaccine data 
as it becomes available. New York Gov. Andrew Cuomo said: ``Frankly, 
I'm not going to trust the Federal Government's opinion.''
  In California, Gov. Gavin Newsom has Stated the vaccine won't be 
distributed in California until it is reviewed by a State panel of 
experts. The Governor of California said on October 20: ``Of course, we 
won't take anyone's word for it.''
  Every day, Americans take the word of Food and Drug Administration's 
career scientists on the safety and effectiveness of the prescriptions 
they approve when we purchase 3.8 billion prescriptions a year. Let me 
say that again. We take the word of the FDA career scientists every day 
when we purchase 3.8 billion prescriptions each year.
  I asked Dr. Stephen Hahn, the FDA Commissioner, on September 23, 
about the safety of a potential COVID-19 vaccine. He was testifying on 
COVID-19 in front of the Health Committee, which I chair and of which 
the Senator from Indiana is a valued member. I asked him:

       Dr. Hahn, who makes decisions about safety and efficacy at 
     the FDA? Do you do it? Do career scientists do it? Or does 
     the White House do it?

  Dr. Hahn replied:

       Career scientists at the FDA do it. That's very clear. I'm 
     briefed on all major medical product decisions. Overruling a 
     center's decision is a very rare event. I have expressed on 
     multiple occasions my intention, and have done so during this 
     COVID-19 pandemic, to make sure that those decisions are made 
     by career scientists in the centers.

  I followed up by asking Dr. Hahn's confidence in taking a COVID-19 
vaccine himself. I said:

       You referred to this, but once FDA approves a vaccine, and 
     as we've said today, we're going to have tens of millions of 
     doses ready, none can be distributed until FDA approves it. 
     Will you be willing to take that vaccine for you and for your 
     family?

  He replied:

       Absolutely. Yes. Mr. Chairman, I have complete and absolute 
     faith in the expertise of the scientists who are terrific at 
     FDA. If they were to make a determination that a vaccine 
     would be safe and effective, I would do that. And I would 
     encourage my family to take the vaccine.

  Those are the words of the man whose job it is to finally approve any 
COVID-19 vaccine.
  But then, at the beginning of this month, as FDA was preparing to 
issue additional guidance on the data needed from vaccine developers to 
demonstrate safety and efficacy for an emergency use authorization, 
there were serious questions about whether the White House was 
politicizing the FDA's approval of vaccines for COVID-19.
  The FDA had submitted its guidance. That guidance was written by 
career scientists. Those scientists had decades of experience, and what 
they wrote were the standards that were going to be used for the 
approval of vaccines against COVID-19.
  Then news reports of White House interference came out which 
suggested the White House was going to change the FDA guidance or that 
the White House was not going to allow the FDA to release its own 
guidance. Many were concerned about that, including me.
  The New York Times, on October 5, had a big headline: ``White House 
Blocks New Coronavirus Vaccine Guidelines.'' And it went on to say, 
``The F.D.A. proposed stricter guidelines for emergency approval of a 
coronavirus vaccine, but the White House chief of staff objected to 
provisions that would push approval past Election Day.'' That was the 
New York Times.
  And FOX News said: ``Trump administration to block FDA guidelines 
that could delay coronavirus vaccine.'' That is FOX News. ``The FDA 
proposed stricter guidance last month that could prolong the timeline 
for a vaccine,'' FOX News said.
  There were many stories to this effect. I could barely leave my 
office without some reporter asking me if I was concerned about this, 
about the politicization of the vaccine review process.
  So I telephoned White House Chief of Staff Mark Meadows, and I asked 
him about it. I said to him: ``Please do not interfere with the 
standards set by the career scientists at FDA for the approval of a 
COVID-19 vaccine.'' The White House did exactly what I urged the White 
House to do. The White House respected the decisions of the career 
scientists. They did not change one word of the standards set by the 
career scientists for the approval of COVID-19 vaccines.
  So I would suggest that the Governors of New York and California do 
the same. They should show the same respect to the FDA career 
scientists that the White House did. Undermining the FDA's gold 
standard of safety and efficacy by setting up State review panels could 
delay approval, discourage Americans from taking the vaccine, and cost 
lives.
  There is a reason why we Americans rely on the Federal Government's 
Food and Drug Administration for the safety and efficacy of vaccines. 
In 1902, Congress decided, when it passed the Biologics Control Act, 
that the Federal Government should regulate vaccines after tragic 
incidents of children dying from contaminated diphtheria antitoxin and 
smallpox vaccines.
  This law charged the Federal laboratory that would later become the 
National Institutes of Health in 1930 with ensuring the ``safety, 
purity, and potency'' of biologic products such as vaccines.
  Then, in 1972, the regulation of vaccines moved to the Food and Drug 
Administration, to what is now called the Center for Biologics 
Evaluation and Research.
  FDA, therefore, has had almost 50 years of experience to refine the 
process for reviewing safety and efficacy for vaccines, including what 
data to look at and how to design clinical trials to prove that the 
vaccines work and that the vaccines are safe.
  Earlier this week, the FDA convened independent scientific and 
medical experts to discuss this. They talked about the development, 
authorization, and approval of vaccines for COVID-19. This is not a new 
process for assessing vaccines. The FDA routinely convenes these type 
of independent panels to help inform its review. Dr. Peter Marks, head 
of the Center for Biologics

[[Page S6430]]

Evaluation and Research, at FDA, wrote this about the vaccine advisory 
committee's role on FDA's website:

       The committee will hear presentations from experts in 
     COVID-19 disease and vaccine development, as well as from 
     career FDA scientists. Topics will include studies needed to 
     support authorization or approval, post-marketing safety 
     studies needed following an approval, and what would be 
     necessary for ongoing safety monitoring following issuance of 
     an emergency use authorization for COVID-19 vaccine.

  Dr. Marks continued:

       There will also be a part of the meeting during which 
     members of the public will have an opportunity to speak and 
     provide input, and this will be followed by a thorough 
     discussion of the issues by the committee members. The 
     members of this committee are external scientific and public 
     health experts from around the country, specializing in 
     fields such as immunology, virology, infectious diseases, 
     pediatrics, vaccine development, and vaccine safety.

  This meeting, and any other FDA advisory committee meeting, can be 
viewed by the public. At the Senate Health Committee hearing on 
September 23, where FDA Commissioner Stephen Hahn testified, I reviewed 
the three steps that have to happen before FDA will approve a vaccine: 
No. 1, independent experts overseeing clinical trials determine whether 
there is enough data available for the FDA to review.
  No. 2, after demonstrating safety and efficacy based on clinical 
trials, the vaccine manufacturer submits an application to the FDA.
  And No. 3, FDA experts conduct their review and make the final 
determination whether or not it is safe and that it works.
  In other words, no one knows when the vaccine will be ready to 
distribute. No one knows that, even Dr. Hahn. And why does he not know 
it? Because there is this elaborate, independent, public process 
established by career scientists, with not a word changed by the White 
House, that will review the data and then make a decision. Because of 
the work of Congress and the administration, tens of millions of doses 
are being manufactured. So when that approval comes--whether it is 
November, December, or January--there will be tens of millions of doses 
of vaccine ready to distribute to the American people. But that 
approval won't come until the career scientists' rules are followed.
  The FDA is considered the gold standard in the world, in part because 
it is one of the few regulatory agencies in the world that looks at 
detailed clinical trial data as part of its review, rather than 
summaries of clinical trial data.
  The FDA Division making the decision to approve or authorize a 
vaccine for COVID-19 is led by experts with decades of experience, 
including Dr. Peter Marks, whom I mentioned, the head of the Center for 
Biologics Evaluation and Research. He has been at the center since 
2012. Dr. Celia Witten has been at FDA since 1996. The Vaccine Division 
of the Center for Biologics Evaluation and Research is led by Dr. 
Marion Gruber, who has over 20 years of experience in regulatory review 
and approval of vaccines and biologics. The Deputy Director of the 
Vaccine Division, Dr. Philip Krause, has 10 years of experience at FDA 
working on vaccines. FDA will also have the advice of independent 
advisory committees.
  California and New York--no State will be able to assemble a 
scientific panel of experts with the same high level of knowledge and 
experience reviewing safety and efficacy information as exists at the 
Food and Drug Administration. Democratic Governors in those two States 
should not both be telling President Trump that he ought to follow the 
advice of scientists like Dr. Fauci, which he should do, but at the 
same time undermine the review and the work of similar career 
scientists at the Food and Drug Administration.
  Vaccines save lives. We have heard testimony in our Health Committee 
demonstrating that. Undermining public confidence in vaccine risks not 
only our ability to combat COVID-19 but acceptance of other vaccines as 
well.
  If California and New York can override the FDA on vaccines, what 
would prevent Republican Governors from banning RU-486, the abortion 
drug, in their States? If that were to happen, I am sure my Democratic 
colleagues would cry politics and suggest that if FDA has reviewed and 
approved a drug and said it is safe and effective, then, States should 
not be able to say that it is unsafe.
  FDA is the right agency to review and approve vaccines and drugs and 
medical devices. I would urge the Governors of California and New York 
not to set up their State review panels but instead focus their time 
and resources on planning to distribute the vaccine and improving 
testing and contract tracing, using the resources that Congress has 
given to States, rather than second-guessing the efforts of scientists 
at the Food and Drug Administration
  I yield the floor.
  I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The bill clerk called the roll.
  Mr. SCHUMER. Mr. President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.


                   Unanimous Consent Request--H.R. 1

  Mr. SCHUMER. Mr. President, well, for more than year and a half, 
Leader McConnell and Senate Republicans have refused to take action on 
the House-passed For the People Act at a time when our democracy is 
under siege in so many ways. The For the People Act is a bold proposal 
that will restore people's trust in our democratic system, a trust that 
is fading. It is for the people. In order to make a more perfect Union, 
it would shore up our elections from threats from abroad. That is 
something we have just recently read more and more about. Why aren't we 
doing more on that?
  In fact, when Senator Van Hollen, a few days ago, put on the floor a 
UC of an act that would say Russia should have sanctions imposed on it 
if they interfere with our elections, the other side blocked it. I hope 
they are not following Donald Trump's obeisance to Russia and his view 
that Putin is just OK.
  It would also dismantle systematic hurdles that discourage voter 
participation. One of the worst things the Supreme Court has done--and 
there are quite a few under this conservative majority--is the Shelby 
decision, where Justice Roberts, leading the charge, said: We can 
dismantle the toughest protections under the Voting Rights Act. He 
said: States aren't going to discriminate anymore.
  And within a year, 20 States passed laws making it harder to vote. 
That is despicable. That is an awful case.
  It would help beat back decades of loose finance rules that empowered 
special interests at the expense of the American people. We all know 
about the dark money that is cascading into our system. In fact, 
Sheldon Whitehouse yesterday asked to make that public, to disclose 
those kinds of contributions when it came to the Supreme Court, where 
rightwing money pours in to make sure that rightwing nominees get on 
the Court and move to pull the American agenda so much further to the 
right than the American people ever would.
  Well, in general, there is too much dark money, too much special 
interest money. This would undo it. As election interference remains an 
urgent threat, as efforts to disenfranchise voters--especially voters 
of color, young voters, and low-income voters--persist, and as powerful 
special interests continue to exercise outside influence in our 
elections, the need for this legislation couldn't be more clear.
  Unfortunately, the Republican leader has other priorities. Rather 
than strengthen our democracy, rather than protecting our right to 
vote, rather than fighting big money or tackling corruption, rather 
than addressing any of the myriad of problems in our democracy that 
this country faces, Leader McConnell is undoing democracy by rushing 
through a lifetime appointment to the Supreme Court mere days before an 
election.
  You couldn't find a more different set of priorities from that of 
everyday Americans if you tried. I urge Leader McConnell to stop this 
unprecedented and nakedly partisan process and instead put this 
important legislation on the Senate floor for a vote now. Let's discuss 
it. Let's debate it. Let's not just reject it at a time when we need to 
do so much of this.
  In order to proceed to the consideration of H.R. 1, For the People 
Act, I

[[Page S6431]]

ask unanimous consent that the Senate proceed to legislative session.
  The PRESIDING OFFICER. Is there objection?
  The Senator from Indiana.
  Mr. BRAUN. Mr. President, reserving the right to object, I want to go 
through just a few--and it is really more than a few; it is a lot--of 
what is embedded in this bill. I would call it the ``Democratic 
Politician Protection Act.'' Let's listen to a few of these things.
  The Constitution vests primary responsibility in the States to set 
time, place, and manner of elections. States and localities have 
determined how to conduct elections for a long, long time. H.R. 1, 
through a top-down, Federal approach, completely reverses this 
longstanding tradition. Rather than strengthening the election process, 
it paves the way for rampant, I think, fraud, abuse, and litigation 
that diminishes the value of a legitimate vote, by doing these rushed 
reforms.
  Let's look at the 2018 midterm elections. Polling showed that 92 
percent of voters found their experience very easy or somewhat easy. 
Why fix it if it isn't broken? It imposes a DC-style election process 
on the States, requiring all State agencies and Federal agencies, 
including colleges and universities, to automatically register voters, 
including those who are 16 and 17 years old. It preempts State 
registration deadlines and requires same-day registration without 
verification safeguards. It expands the number of agencies that must 
contribute voter records, even to those who have no experience or 
expertise in voter enrollment, forcing States to accept a sworn 
statement as proof of identity, instead of photo identification, and to 
record the vote as a regular ballot. It expands absentee ballot 
availability and requires States to provide prepaid postage for all 
mail-in ballots.
  It does so many things that are different from what we currently have 
in a system that in most places is working fine. It does not include 
provisions that require or encourage States to remove inaccurate voter 
information. It reduces the integrity of voter rolls by restricting the 
State ability to maintain voter rolls and records that ensure voter 
identity accuracy.
  There are no penalties for anyone who is falsely registered. It 
prohibits States from being able to continue routine maintenance on 
their own voter lists. It also creates numerous private rights of 
action that pave the way for trial lawyers to sue when the results of 
an election are not to their liking.
  It makes the Federal Election Commission a partisan body. It 
politicizes the FEC by changing the neutral, evenly divided, six-member 
body into a five-member panel. It makes a new partisan FEC. It changes 
the latitude to determine and interpret the subjective enforcement test 
established by this bill. It, in essence, takes what is working and 
complicates it with a top-down Federal system.

  We should not be rushing into something like this that is that 
comprehensive. We should be paying attention to the process of getting 
a bona fide judge across the finish line, which I think most of us 
intend to do.
  Therefore, I object to this bill and to moving to legislative 
session.
  The PRESIDING OFFICER (Mr. Romney). Objection is heard.
  The Democratic leader.


 Unanimous Consent Request--H.R. 5619, H.R. 5572, H.R. 4861, and H.R. 
                                  4585

  Mr. SCHUMER. Mr. President, I have another request.
  As Americans face job loss, health crises, isolation, and enormous 
daily stress during the pandemic, the risk of suicide has tragically 
gone up. The CDC found that since the pandemic began, twice as many 
Americans report serious consideration of suicide. The rate of suicide 
risk is especially high among young Americans, minorities, essential 
workers, and caregivers.
  Unfortunately, this is hitting our Armed Forces, as well. The Army's 
Chief of Staff, General McConville, stated that he sees a correlation 
between COVID and a rise in military suicides. My office recently 
received a note, a tragically sad note, from a veterans group in 
Rochester, NY, about a veteran in their region, 50 years of age, 
unemployed, and struggling during the pandemic. When he stopped 
receiving the $600 unemployment assistance, he was unable to make his 
mortgage payments and, unfortunately and sadly, very recently committed 
suicide.
  I have no doubt that there are more American veterans out there who 
are going through the same struggle. Each one is a separate and 
heartbreaking tragedy. These men and women who risked their lives for 
us are taking their own lives. It is incumbent upon us to do something 
about it.
  Congress can implement suicide prevention initiatives. We may be able 
to make a difference. The House has passed a number of bills to get 
suicide prevention funding and new resources out to communities.
  I am going to ask that we go into legislative session to consider 
four of those House-passed bills. This pandemic has taken so many 
lives, and we sometimes forget that it is not just those who contracted 
COVID, but those who are pushed to unimaginable stress and devastation 
because of what COVID has done to our economy, our friends, and our way 
of life. The Senate should be passing these bills and helping out those 
who may be hiding in the shadows but crying out for help.
  There are four bills. I think I will ask for consideration on the 
four of them en bloc; is that permitted?
  The PRESIDING OFFICER. It is by consent.
  Mr. SCHUMER. In order to proceed to the consideration of H.R. 5619, 
Suicide Prevention Act; H.R. 5572, Family Support Services for 
Addiction Act of 2020; H.R. 4861, Effective Suicide Screening and 
Assessment in the Emergency Department Act of 2020; and H.R. 4585, the 
Campaign to Prevent Suicide Act, I ask unanimous consent that the 
Senate proceed to legislative session.
  The PRESIDING OFFICER. Is there objection?
  The Senator from Wisconsin.
  Mr. JOHNSON. Reserving the right to object, when the COVID crisis 
first hit, this body, all of Congress, recognized how serious the 
situation was, and we acted. We acted in a very bipartisan fashion. We 
acted in a massive fashion, as a matter of fact.
  We understood that the American people, through no fault of their 
own--businesses were shutting down, people were unemployed--and we 
needed to provide a massive level of relief, and we did that in a 
bipartisan, almost unanimous fashion.
  All the needs have not been met. Republicans completely understand 
that, which is why we spent the August recess in daily calls, talking 
amongst ourselves, trying to focus and target where the relief is best 
directed.
  What we understood when we passed the more than $3 trillion of COVID 
relief in the early parts of this pandemic was that our efforts were 
going to be far from perfect, but they needed relief and, again, we 
supported it.
  One of the things we were trying to focus on, when we are already $27 
trillion in debt, was recognizing the fact that we don't have an 
unlimited credit card; that we had to really take the time and hone the 
next relief package.
  We did that over the August recess, and we came together with a very 
targeted, very appropriate, and still a very expensive package, over 
$600 billion when you add up the plus-up for unemployment benefits, 
$300 per week, a level that is sufficient but not so high that it 
actually provides incentive for people to stay on the sidelines and not 
enter the workforce.
  In my State of Wisconsin, one of the biggest problems employers have 
is they simply don't have the ability to track people off the sidelines 
when you have a $600 plus-up. We provided additional funding for PPP, 
particularly for small businesses that have been devastated. Owners 
have seen their life savings wiped out. That additional over $200 plus-
up in relief for small businesses would be targeted, would be 
appropriate, and it is necessary.
  There is over $100 billion for schools, tens of billions of dollars 
for additional testing and vaccines, billions of dollars for childcare 
and agriculture. In total, on top of $3 trillion, which is 14 percent 
of our GDP--by the way, a fair amount of that is still unspent and 
unobligated. We took a little bit of that which was unspent and 
unobligated and repurposed it for this new targeted package.
  Fifty-two Republican Senators voted for that bill twice. Rather than 
take yes for an answer, rather than saying: Thank you, we will support 
this level of relief for the American people, our colleagues on the 
other side of the aisle just said no.

[[Page S6432]]

  An analogy I have been using would be, Mr. President, if I said: Mr. 
President, give me $200. The Presiding Officer would look at me in 
shock, but because he is a generous individual, he would say: Maybe not 
$200, but I will give you $100. But just because the Presiding Officer 
didn't give me the full $200, I would go stomping off, and I don't even 
take the $100. That is, in effect, what the Senators on the other side 
of the aisle are doing.
  We are offering and we supported $600 billion on top of $3 trillion 
in relief--necessary relief, needed relief for unemployment benefits, 
for small businesses, for vaccines, for testing, for education, for 
childcare. It is there for the taking. All they have to do is say yes. 
Yet they say no because they would rather have an issue rather than 
result.
  Are they serious about helping the American public or do they just 
want to play politics? I think the answer is quite obvious.
  I object.
  The PRESIDING OFFICER. Objection is heard.
  The Democratic leader
  Mr. SCHUMER. The emaciated bill filled with poison pills that the 
Senator from Wisconsin talks about was never intended to pass. In fact, 
the Republican majority leader waited 5 months before doing anything 
while people were suffering. The bill does not contain close to what is 
needed.
  Basically, his analogy is incorrect. The analogy would be saying: You 
have a series of serious illnesses; let's treat one because we don't 
want to pay for the others--even though we were willing to increase the 
deficit by close to $2 trillion by giving a tax break to the wealthy.
  So this cry about deficit, when it comes to helping middle-class 
people, hurting people, unemployed people, people who can't feed their 
kids, no, it is the deficit. When it comes to giving a big tax break to 
wealthy corporations and wealthy people, that is fine.
  As much as I respect my colleague from Wisconsin, I don't really take 
his words very seriously. Our Republican friends put this emaciated 
bill on the floor at the last minute because they got such pressure for 
doing nothing. They know it can't pass the House. They know it is 
totally inadequate.
  This is the greatest economic crisis since the Great Depression, the 
greatest healthcare crisis for 100 years since the Spanish pandemic 
flu, and our colleagues do next to nothing in terms of the crisis. This 
is loaded with poison pills so they know it can't pass. They know it 
can't pass the House, and they waited 5 months.
  The American people know it. When they are asked: Who wants to solve 
this problem, they know that it is the Democrats in the Senate and 
House who want to and the Republicans have resisted. There is no 
question about it.
  The bills I just asked for are small bills, not very expensive, that 
deal with suicide. Of course, the answer is no again. It is sad and 
unfortunate. Fortunately, the American people will be able to have a 
real say, not on the Supreme Court Justice they are rushing through but 
on who will be the next administration and who will do more. We will 
see what their answer is.
  Mr. BROWN. Will the Democratic leader yield?
  Mr. SCHUMER. I would be happy to yield.
  Mr. BROWN. I hear Senator Johnson talk about employers can't find 
workers. There are 600,000 in my State who lost their unemployment 
insurance just like that at the end of July. Six hundred thousand 
people lost $600 a week.
  I go back to March, when we passed this bill that was so important it 
passed unanimously. There was one amendment Republicans wanted for this 
$2.5 trillion bill. It was to strip out unemployment insurance so that 
those workers didn't get the $600 a week. What are they to live on? Six 
hundred thousand people in my State can't find work, 100,000 in 
Wisconsin, even more in New York, tens of thousands in Iowa and Utah. 
What are they to do?
  We know there is going to be a wave of evictions and foreclosures as 
people are thrown out of their apartments and their homes.
  This Congress continues to--the Senate just won't do its job. Do your 
job. If Senator McConnell would do his job, we could do our job and get 
this economy back on track.
  Thank you.
  Mr. SCHUMER. I would add one final thing. The bill that the Senator 
from Wisconsin talks about was totally partisan, which they know can't 
pass. Then, when Leader McConnell put it on the floor, he filled the 
tree so it couldn't even be amended.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from Iowa.