[House Hearing, 117 Congress]
[From the U.S. Government Publishing Office]
GLOBAL HUMAN RIGHTS, RE: PROGRESS AND PRESENT CHALLENGES ON COVID-19 IN
AFRICA
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON AFRICA, GLOBAL HEALTH,
AND GLOBAL HUMAN RIGHTS
OF THE
COMMITTEE ON FOREIGN AFFAIRS
HOUSE OF REPRESENTATIVES
ONE HUNDRED SEVENTEENTH CONGRESS
SECOND SESSION
__________
MARCH 31, 2022
__________
Serial No. 117-112
__________
Printed for the use of the Committee on Foreign Affairs
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Available: http://www.foreignaffairs.house.gov/, http://docs.house.gov,
or http://www.govinfo.gov
______
U.S. GOVERNMENT PUBLISHING OFFICE
47-168 PDF WASHINGTON : 2022
COMMITTEE ON FOREIGN AFFAIRS
GREGORY W. MEEKS, New York, Chairman
BRAD SHERMAN, California MICHAEL T. McCAUL, Texas, Ranking
ALBIO SIRES, New Jersey Member
GERALD E. CONNOLLY, Virginia CHRISTOPHER H. SMITH, New Jersey
THEODORE E. DEUTCH, Florida STEVE CHABOT, Ohio
KAREN BASS, California SCOTT PERRY, Pennsylvania
WILLIAM KEATING, Massachusetts DARRELL ISSA, California
DAVID CICILLINE, Rhode Island ADAM KINZINGER, Illinois
AMI BERA, California LEE ZELDIN, New York
JOAQUIN CASTRO, Texas ANN WAGNER, Missouri
DINA TITUS, Nevada BRIAN MAST, Florida
TED LIEU, California BRIAN FITZPATRICK, Pennsylvania
SUSAN WILD, Pennsylvania KEN BUCK, Colorado
DEAN PHILLIPS, Minnesota TIM BURCHETT, Tennessee
ILHAN OMAR, Minnesota MARK GREEN, Tennessee
COLIN ALLRED, Texas ANDY BARR, Kentucky
ANDY LEVIN, Michigan GREG STEUBE, Florida
ABIGAIL SPANBERGER, Virginia DAN MEUSER, Pennsylvania
CHRISSY HOULAHAN, Pennsylvania AUGUST PFLUGER, Texas
TOM MALINOWSKI, New Jersey PETER MEIJER, Michigan
ANDY KIM, New Jersey NICOLE MALLIOTAKIS, New York
SARA JACOBS, California RONNY JACKSON, Texas
KATHY MANNING, North Carolina YOUNG KIM, California
JIM COSTA, California MARIA ELVIRA SALAZAR, Florida
JUAN VARGAS, California JOE WILSON, South Carolina
VICENTE GONZALEZ, Texas
BRAD SCHNEIDER, Illinois
Jason Steinbaum, Staff Director
Brendan Shields, Republican Staff Director
------
Subcommittee on Africa, Global Health, and Global Human Rights
KAREN BASS, California, Chair
DEAN PHILLIPS, Minnesota CHRISTOPHER SMITH, New Jersey,
ILHAN OMAR, Minnesota Ranking Member
AMI BERA, California DARRELL ISSA, California
SUSAN WILD, Pennsylvania GREG STEUBE, Florida
TOM MALINOWSKI, New Jersey DAN MEUSER, Pennsylvania
SARA JACOBS, California YOUNG KIM, California
DAVID CICILLINE, Rhode Island RONNY JACKSON, Texas
C O N T E N T S
----------
Page
WITNESSES
Ogwell, Dr. Ahmed, Deputy Director, Africa Centres for Disease
Control........................................................ 8
Soon-Shiong, Dr. Patrick, Founder and Executive Chairman,
Nantworks...................................................... 14
Bottazzi, Dr. Maria Elena, Co-Director, Texas Childrens Hospital
Center for Vaccine Development................................. 23
Masisi, Dr. Mokgweetsi E.K., President the Republic of Botswana.. 50
INFORMATION SUBMITTED FOR THE RECORD
Informaton submitted for the record.............................. 54
APPENDIX
Hearing Notice................................................... 67
Hearing Minutes.................................................. 68
Hearing Attendance............................................... 69
OPENING REMARKS FROM CHAIRMAN BASS
Opening remarks from Chairman Bass............................... 70
RESPONSES TO QUESTIONS SUBMITTED FOR THE RECORD
Responses to questions submitted for the record.................. 76
GLOBAL HUMAN RIGHTS, RE: PROGRESS AND
PRESENT CHALLENGES ON COVID-19 IN AFRICA
Thursday, March 31, 2022
House of Representatives,
Subcommittee on Africa, Global Health, and Global
Human Rights,
Committee on Foreign Affairs,
Washington, DC.
The subcommittee met, pursuant to notice, at 2:25 p.m., via
Webex, Hon. Karen Bass [chairwoman of the subcommittee]
presiding.
Ms. Bass. The Subcommittee on Africa, Global Health, and
Global Human Rights will come to order.
Without objection, the chair is authorized to declare a
recess of the subcommittee at any point. And all members will
have 5 days to submit statements, extraneous material, and
questions for the record, subject to the length limitation in
the rules.
To insert something into the record, please have your staff
email the previously mentioned address or contact full
committee staff.
As a reminder to members, please keep your video function
on at all times, even when you are not recognized by the chair.
Members are responsible for muting and unmuting themselves. And
please remember to mute yourself after you finish speaking.
Consistent with House Resolution 965 and the accompanying
regulations, staff will only mute members and witnesses as
appropriate, when they are not under recognition, to eliminate
background noise.
I see that we have a quorum, and I will now recognize
myself for opening statements.
Pursuant to notice, we are holding a hearing on the
progress and present challenges to COVID-19 in Africa, to
receive an update on the ongoing COVID pandemic in Africa, and
to examine the continued challenges the continent is facing. It
is my hope that with this discussion we can identify
opportunities the United States and the greater international
community can take to work with African leaders and the African
Union in addressing these challenges.
To lead that conversation, I want to thank our witnesses
for being here today: Dr. Ahmed Ogwell, deputy director of the
Africa Centres for Disease Control; Dr. Patrick Soon-Shiong,
founder and executive chairman of NantWorks; and Dr. Maria
Elena Bottazzi, codirector of Texas Children's Hospital Center
for Vaccine Development. I welcome your testimony and the
discussion surrounding it.
I look forward to hearing our experts describe what has or
has not changed in the past 13 months since the subcommittee's
last COVID-19 hearing. I also look forward to hearing the
various ways in which the U.S. and the greater international
community can work with African leaders to assist with
treatments, vaccines, manufacturing on the continent, and how
COVID-19 has impacted the economies of African nations and the
livelihoods of their people.
I must also note today that the Russian war on Ukraine has
exacerbated the already damaging effects that COVID-19 has had
on the world, including on the Continent of Africa. Economies
that have been suffering due to the pandemic have worsened,
national security of all countries have been threatened, and
the global food crisis has been dangerously exacerbated.
Several African countries rely heavily on Ukrainian imports
to feed their populations, so an unnecessary and unjustifiable
war, coupled with the ongoing pandemic, is a grave cause for
concern. The witnesses might speak to that or might make
reference to that if they have such information.
For the past 2 years, there have been nearly 8 million
COVID cases on the continent, and the disease has taken the
lives of over 160,000 Africans. With the most recent wave of
the Omicron variant, new variants continuing to emerge, and
without a clear end date to this pandemic in sight, it is a
priority to get vaccines in the arms of as many Africans as
possible.
Africa has notably lagged behind the rest of the world in
terms of vaccination rates, with only about 11 percent of the
total population being vaccinated. In recent efforts, the Biden
Administration has surged $250 million of its global vaccine
access funding to 11 countries in Sub-Saharan Africa based on
the burden of COVID-19 on their populations, the capacity of
their health system, and their readiness to quickly administer
vaccine doses.
The U.S. Agency for International Development has led this
interagency initiative, with a focus on vaccine delivery,
meaning not just providing vaccines, but also the requisite
support to get them into people's arms as trends have shown
throughout the pandemic that donations alone are not sufficient
to sustain a continent. This is why I believe manufacturing on
the continent is essential, not only for the current pandemic,
but also for future health threats.
Currently, only five countries have capacity for vaccine
production on the continent. One of our witnesses here today,
Dr. Patrick Soon-Shiong, has opened a COVID-19 manufacturing
plant in South Africa. The steps we are seeing in South Africa
are also being taken in other countries on the continent such
as Rwanda. I look forward to hearing about more of those
manufacturing plans.
Unfortunately, the COVID-19 pandemic caused unemployment,
income loss, and pushed tens of millions of Africans into
extreme poverty. It was learned in February, during this
subcommittee's hearing on education, that learning losses are
likely to have consequences for future educational attainment
and lead to challenges in finding employment. And COVID-19
disrupted the learning of 1.6 billion students.
That is why just this week, I, along with my colleague and
Ranking Member Smith, introduced the READ Act Reauthorization
of 2022 to expand access to basic education for children around
the globe, particularly marginalized children, including women
and girls. This reauthorization will allow for a total of 10
years of access to quality basic education across the globe.
With that in mind, my colleagues and I will be interested to
hear from the witnesses how COVID-19 impacts on poverty, food
insecurity, and implications on trade and investment.
As the continent continues to strive for self-
sustainability, U.S. partnerships in trade and investment are
essential to enhance the vitality of the economies on the
continent and here in the U.S.
Finally, it is critical to learn today from our witnesses
what other steps need to be taken to see progress. Though
vaccine donations remain essential to safeguard health and save
lives in the short-term, donations must be combined with
strategies that include funding and investments and help
infrastructure, technology, healthcare professionals to create
a self-sustainable continent, capable of ending this pandemic
in Africa, and prepare it against future epidemics and health
threats.
I now recognize the ranking member for the purpose of
making an opening statement.
Mr. Smith.
Mr. Smith. Thank you very much, Madam Chair. And I want to
especially thank you for convening this important hearing on
the challenges and the progress of COVID-19 in Africa in trying
to mitigate its terrible consequences.
Our hearing and discourse need to recommit to assisting
Africa not only in the fight against COVID-19, but also against
other looming crises, in particular and you made mention of it
as well, a food insecurity that will undoubtedly be exacerbated
by the disruption of the supply chain in wheat shortages due to
Vladimir Putin's ongoing barbaric invasion of Ukraine.
Obviously, we live in an interrelated and interdependent
world. Mindful of that, I am especially happy and want to thank
one of our witnesses, His Excellency President Masisi for
Botswana, along with 27 other African nations voting in favor
of U.N. General Assembly's resolution condemning Russia's war
on Ukraine.
Thank you, Mr. President, for not only what you are doing
on COVID-19, but also for peace in Ukraine and throughout the
world.
As we are joined together in this fight against Vladimir
Putin's brutality, we are also unified in building Africa's
resilience against COVID-19 food insecurity, as well as Chinese
Communist Party and the Russian influence in that region. To
that end, I would also note that Botswana has demonstrated a
commitment to democracy in elections, which is one of the best
in Sub-Saharan Africa.
Again, thank you, Mr. President, for that leadership.
We all know that COVID-19 has hit Africa particularly hard
and has pushed tens of millions into extreme poverty, meaning
that ground once gained has now been lost in the battle against
hunger and poverty, a ground that we must make up.
Although Africa witnessed fewer cumulative confirmed cases
in deaths per capita than other parts of the world,
notwithstanding low vaccination rates, we wonder how much of
this is due to underreporting, perhaps sometimes something our
witnesses can address at this hearing today.
I would also like our witnesses, if they could, to give
their frank opinions with regards to Russia and China's vaccine
diplomacy and whether it comes with strings attached. Are there
concerns as well about the efficacy of those vaccines?
I would also appreciate your frank appraisal of the role
that the WHO and Dr. Tedros, someone with whom I have met with
many times. I do believe that he has a lot to answer for, not
only for what I believe was his covering up for the People's
Republic of China with disinformation the WHO spread during the
early days and weeks of COVID, but also his role as Ethiopian
health minister, where I first met him, where he covered up a
cholera outbreak in Ethiopia.
I would also like to hear your perspective on whether there
is truly a shortage of vaccines or, rather, a distribution and
supply chain issue. It has been reported that in Nigeria, one
million expired doses had to be destroyed late last year. Other
countries, including DR Congo, Liberia, South Sudan, earlier
had reported destroying collectively nearly half a million
expired vaccines. In Namibia, 268,000 doses it was reported
were slated to be destroyed last November due to slow uptake
and due to vaccine hesitancy.
Meanwhile, in Somalia, the government of Mogadishu has
politicized the distribution of vaccines due to the ambiguous
international status of the de facto independent nation of
Somaliland. The government in Mogadishu was the recipient of
doses to be given to Somaliland, which they allegedly dropped
off at the border 2 days before expiration, leaving them
sitting out in the sun and rendering them useless. Any comments
on that by our distinguished witnesses' insights would be
helpful.
To build Africa's long-term resilience in the face of
COVID-19 and a future health crisis, we thus should work with
governments in mitigating obstacles to vaccine distribution,
including the approval process, scaling complex manufacturing
and, most importantly, resolving transportation challenges,
given the limited shelf life and ultra cold storage needed for
at least some of the vaccines.
There is also an untapped potential for Africa, and this is
really exciting, to produce and manufacture its own vaccines,
which will help get doses to individual's arms quicker, while
developing its biotechnology sector and encouraging cross-
country collaboration by licensing agreements.
Why shouldn't Africa become a manufacturing center, a hub
for pharmaceuticals instead of, for example, the People's
Republic of China? To do so, however, we need to be cognizant
to have protection of intellectual property rights, incentives,
R&D, as well as it ensures the quality and, again, the efficacy
of vaccines to ensure uninterrupted standard.
Yet Africa has fallen victim, like many countries, to
criminal syndicates infiltrating the market with fake vaccines
and medicines. With Africa producing just 1 percent of its
vaccines, the need to immediately address the root problems,
innovation and prosperity gaps caused by weak legal and
political frameworks for property rights in Africa, as well as
trade barriers that suppress innovation and partnerships.
While the issue of patents remains controversial,
especially in the wake of the closed-door compromise 2 weeks
ago on the Trade-Related Aspects on Intellectual Property
Rights, or TRIPS, waiver presented to the WTO led by India and
South Africa, there are also many promising initiatives that
side step some of the controversy.
The idea behind a patent-free option financed by private
philanthropy such as Corbevax, a vaccine developed by Texas
Children's Hospital--and I think it is a good one--we need to
look toward to hearing our witnesses--I look forward, we all
do--including Dr. Maria Bottazzi, to elaborate on that.
Again, I want to thank Chairwoman Bass for convening this
hearing, and look forward to our witnesses' statements.
I yield back.
Ms. Bass. Thank you Representative Smith.
I would like to welcome Dr. Ami Bera to our committee, who
is a global health expert. And then, without objection, we are
glad to welcome our colleague, Representative Sheila Jackson
Lee, to participate in today's subcommittee hearing after our
subcommittee members have been recognized.
With that, I would like to introduce our witnesses for
today's hearing. First, we have Dr. Ahmed Ogwell, who currently
serves as the first deputy director at the Africa Centre for
Diseases Control and Prevention. In his capacity, he works
closely with governments and other partners to safeguard the
health and well-being of African nations.
Dr. Ogwell is a well-respected expert in public health,
with over 25 years of experience in different settings, ranging
from the national government NGO's to the U.N. system and the
AU. His area of expertise includes responses to health
emergencies, prevention and control of noncommunicable
diseases, influencing health policy, and health global
diplomacy.
Our second witness, Dr. Patrick Soon-Shiong, is a surgeon,
scientist, inventor, and philanthropist, with over 500 issued
worldwide patents and 100 scientific publications. He serves as
chairman and chief executive officer of NantWorks, an
organization that addresses healthcare, clean energy, and
communication. He also has an ecosystem of other companies with
developments in a wide variety of complex industries, from
medical science to biomaterials, from data transport to AI, and
from communications to mobilities.
Final witness is Dr. Maria Elena Bottazzi. She is an
internationally recognized tropical and emerging disease
vaccinologist, global health advocate, and cocreator of patent-
free open science COVID-19 vaccine technology that led to the
development of Corbevax, a COVID-19 vaccine for the world. She
pioneers and leads innovative partnerships for the advancement
of a robust vaccine development portfolio, tackling diseases
that affect disproportionately the world's poorest populations,
making significant contributions to catalyze policies and
disseminate science information to reach a diverse set of
audiences.
In 2022, alongside vaccine researcher, Peter Hotez, she was
nominated for the Nobel Peace Prize.
We appreciate all of you for being here today and look
forward to your testimony. Your written statements will appear
in the hearing record. And under committee rule 6, each witness
should limit your oral presentation to a 5-minute summary of
your written statement. And you can see the 5-minute clock that
is there. After each of you provide testimony, we will have a
round of questions from committee members.
Thank you very much. And why do not we go to our first
witness, Dr. Ogwell.
STATEMENT OF DR. AHMED OGWELL, DEPUTY DIRECTOR, AFRICA CENTRES
FOR DISEASE CONTROL
Dr. Ogwell. Thank you very much Chairperson Bass, Ranking
Member Smith, and all the distinguished members of this
subcommittee.
I bring you greetings from the Africa CDC and the African
Union. And we are pleased with the invitation to come and
testify at this hearing today.
Africa has faced a lot of challenges in addressing the
control of this COVID-19 pandemic on the continent. And when we
look at it from different perspectives, including public
health, social and economic factors, Africa has really been hit
quite hard by the pandemic over the last 2 years.
African Union has, through the Africa CDC, been leading the
work of coordinating the response to this pandemic on the
continent. And then our experience has seen significant
adjustments to the way that we handle health security on the
continent. As you know, Africa CDC has the mandate of
coordinating the health security agenda on the continent. And,
in fact, we see this investment in the Africa CDC by the
African Union heads of States as one very smart investment
indeed.
You will recall that Africa CDC is really an institution
that was borne out of the crisis in West Africa during the
Ebola disease outbreak, and it has brought together many
possibilities of Africa responding differently. And we have
seen that happening during the COVID-19 pandemic.
Africa CDC is a very young organization, only 5 years old.
And the mandate that we have been given by the heads of States
of the African Government goes to show that Africa is changing
and investing in areas that before were being handled by
nonindigenous organizations.
When we look at the last 5 years of existence of Africa
CDC, it has gone through many different phases. Most recently,
in February, the African Union assembly has elevated the Africa
CDC to be an autonomous health body of the union, and in this
way giving it more possibilities of responding faster, engaging
with more partners and, therefore, protecting and safeguarding
the health of the continent in a more effective way.
Africa has gone through four waves. And right now, although
we are at the bottom of the--just past the fourth wave, we
still have challenges, particularly around vaccinations. The
African Union established the Africa Vaccines Acquisition Task
Team, and working together with COVAX, we have actually
facilitated the delivery of over 750 million doses to the
continent. The major challenge still remains how do we get
those doses into people's arms.
We propose some very clear areas of how we can be able to
address these challenges on the continent. And the three
recommendations that we would like to give the committee today
is, one, support for Africa CDC's vaccination rollout
initiative across the continent. We are working very closely
with our partners and our member States to try and increase the
rate of vaccination because we are only at 15 percent at the
moment.
Second is we are recommending that support is given to the
use of existing health assets to improve COVID-19 vaccination.
This is particularly important when we look at infrastructure
for HIV, for example, that PEPFAR has been
[inaudible] over a long period of time, if those are able
to be deployed for use in vaccination rollout.
And finally is to support the strengthening of the--whole
of the health system. Particularly, the cold chain capacity on
the continent needs to be increased and improved so that we do
not end up with any vaccines being lost.
With these three recommendations, I put it to ourselves
that if we address these, we are going to be able to get much
better vaccination rollout on the continent than we are
currently facing.
I thank you for the opportunity.
[The prepared statement of Dr. Ogwell follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Ms. Bass. Thank you very much.
Dr. Soon-Shiong?
I think you are--oh, there you go.
STATEMENT OF DR. PATRICK SOON-SHIONG, FOUNDER AND EXECUTIVE
CHAIRMAN, NANTWORKS
Dr. Soon-Shiong. Sorry. So thank you for inviting me today.
I am a surgeon, scientist, and have devoted my career to
cancer, infectious diseases. And I was born in South Africa,
which gives me unique perspective of the unmet needs of Africa.
In 1997, I launched an injectable pharmaceutical company in
the United States called American Pharmaceutical Partners. And
by 2017, we were manufacturing a million vials a day of key
injectable products. Our company was one of the only major
remaining safe supplier of a blood thinner called heparin
during the heparin crisis. And this highlighted for me the
urgent need for our Nation to establish and manufacture in
biological capacity for national global preparedness and
readiness for pandemics such as COVID.
As has been said, we are not safe until we are all safe.
The coronavirus we are facing today is not influenza, as some
would like us to believe. Unlike flu, this virus enters into
our body through a receptor in our blood vessels. Since it uses
a receptor in blood vessels, it reaches any organ of the body,
including the lungs, the heart, the brain, and even the
pancreas. So my concern is the long-term consequences of a
COVID infection, even asymptomatic. We may be facing the next
generation of concerns we do now refer to a long COVID.
My fear is the complacency of stating that today's vaccines
prevent death and, therefore, are OK and that we should learn
to live with COVID is misguided. Already we are seeing young
people with stroke, with cardiac disease, and even with a high
chance of diabetes unless we kill this virus. Once it enters
the cell and reduces its load and prevents transmission, we may
be faced with large increases of heart disease, neurological
disease, and diabetes, all devastating for the population to
the healthcare systems.
So why does this pandemic rage on 2 years in? Largely
because we have not heeded the warnings that it would be
inevitable and expected that the virus would mutate and that
merely short-lived antibody-based vaccines as has been
developed to date would become ineffective against these
mutations. Rapid mutational change in COVID has now been seen
as we all predicted, especially in patients who are
immunosuppressed with HIV and TB, where mutations will thrive.
In Africa, we have an estimated 25 million people living
with HIV and 2.5 million with TB, providing a fertile
environment for viral mutations.
With each new variant, we are faced with efficacy
questions. Protection is declining rapidly over months, not
years. The question that remains open, therefore, is it viable
to subject the population to four shots of an antibody-based
vaccine, especially in Africa where cold chain issues exist and
logistics of even getting a single vaccine is a problem? Could
multiple boosts of a vaccine with declining efficacy and
questionable potential protect against variants against which a
virus can easily mutate be the answer?
While this necessitates, then, the development of a
durable, broad acting pan-vaccine that offers protection
against all coronavirus of today and tomorrow--and it is even
more vital with Africa--I cannot emphasize more strongly to the
committee the need for us to generate a second-generation
vaccine that drives T cells which will kill the virus so that
it does not propagate in our body and spread, the need to
develop a universal COVID vaccine predicting against infection
regardless of variants generated against a spike protein.
So utilizing our own resources, and unfortunately without
any Federal support, we have attempted since the COVID outbreak
to develop this durable second-generation vaccine and bring
self-reliance in Africa to reduce risk for all.
First, we have developed second-gen vaccines across
multiple platforms, some now in phase 3 clinical trials, that
has a potential to be delivered at room temperature and thus
avoid the cold chain issues.
Second, we have built manufacturing plants in the United
States, in South Africa, and in Botswana to enable self-
reliance and build human capital in Africa. I think the
opportunity for our country to export know-how and knowledge
transfer as diplomatic foreign policy is critically important.
Third, we have initiated the process of enhancing the
regulatory authorities capabilities in Sub-Saharan Africa and
are collaborating with regulatory authorities to support
education and improving the standards there.
And, finally, we have acquired a large manufacturing
facility in the State of New York, bringing our vaccine
capability to a billion doses a year, and thus helping to
establish a national preparedness for the Nation for a
universal COVID vaccine and to be ready with large-scale
biological capacity for the inevitable next pandemic.
So, in closing, Madam Chair, I propose three solutions
which sorely need support: One, the development of a second
generation, universal, durable COVID-19 vaccine; two,
establishment of State-of-the-art biomanufacturing capacity in
Africa, but with quality standards matching the FDA; and three,
the support for a national preparedness program that addresses
a universal COVID vaccine that is durable, can be stored at
room temperature, and can be rapidly deployed to face any viral
challenge facing the Nation and the world.
I thank you for this opportunity to present today and would
be happy to answer any questions.
[The prepared statement of Dr. Soon-Shiong follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Ms. Bass. Thank you very much.
And our final witness is Dr. Maria Elena Bottazzi.
STATEMENT OF DR. MARIA ELENA BOTTAZZI, CO-DIRECTOR, TEXAS
CHILDRENS HOSPITAL CENTER FOR VACCINE DEVELOPMENT
Dr. Bottazzi. Chair Bass, Ranking Member Smith, and
distinguished members of the subcommittee, thank you for the
invitation to testify today. I am honored.
As you know from my testimony, I am codirector of Texas
Children's Hospital Center for Vaccine Development, associate
dean and professor of the National School of Tropical Medicine
at Baylor College of Medicine.
Our academic and children's hospital-based center for
vaccine development has a 20-year track record leading and
advancing vaccines for poverty-related neglected tropical and
emerging infectious diseases of pandemic importance. The
scientists in our center create and make vaccines right in our
laboratories in Houston, Texas. We transfer our knowledge in
vaccines with a philosophy that ensures open science, the
removal of barriers such as intellectual property protections,
and with transparent communications, to help incentivize,
build, and strengthen the capacity for vaccine development
locally and with foreign nations. In doing so, we guide and
influence policy and advocacy through vaccine diplomacy,
bridging national and international cooperation and
partnerships, achieving vaccine equity and access, leading to
self-reliance, solidarity, prosperity and peace.
Our model vaccine development works. We are the first
center to develop a safe, effective, and affordable COVID-19
vaccine technology suitable for global access. There are five
principles we use: A technology that can be produced at large
scales, easy to learn, and adaptable as the vaccine needs
change; a known technology by many vaccine manufacturers,
including those in middle-income countries, with an existing
work force infrastructure and a supply chain ecosystem; a
technology with long shelf life and easy cold chain
requirements for storage and distribution, affordability due to
the economies of scale, and prior track record of safety and
efficacy,facilitating the regulatory review and approval and
leading to increased consumer confidence.
The conventional recombinant protein technology using
microbial fermentation and yeast checks all these five boxes.
This approach has been used for decades, producing a highly
effective, safe recombinant hepatitis B vaccine for adults and
children. It was also shown to be highly successful against
SARS in preclinical studies.
We were able to accelerate the development of our yeast
protein vaccine technology by leveraging a decade of research
developing SARS and MERS vaccines, relying on transparent and
high-performing partnerships, and with nimble funding, almost
exclusively from private philanthropists based in Texas, New
York, and elsewhere.
Corbevax, developed in partnership with India-based
Biological E, has now received emergency authorization in India
and in Botswana. Its production capacity exceeds 140 million
vaccine doses per month. And both governments combined
committed to purchase 400 million doses to date. In less than 2
weeks after deployment, more than 16 million doses of Corbevax
have reached the arms of kids 12 to 14 years of age. In
parallel, our technology, which has no patents, is advancing as
a halal vaccine in Indonesia and Bangladesh. Yeast technology
is vegan and contains no animal-derived products or human cell
lines.
Importantly, our partnership with ImmunityBio and Nant in
Botswana is contributing to the establishment of vaccine
production capacity in Africa, setting the precedent of a
scalable blueprint for vaccine development and distribution in
the continent.
Corbevax has the capacity to fill the access gaps created
by the more expensive vaccine technologies, rapidly reach the
countries in Africa with less than 20 percent of vaccinated
populations. In clinical trials, it showed superior
effectiveness greater than 90 percent, including variants of
concerns, with responses that are persistent against B and T
cells and, therefore, is ideal for a vaccination strategy to
expand access in children as a booster or second generation,
and sustain the need of surplus doses.
There are four overarching needs: ensure investments for
multiple technologies, sustain vaccine research and
development, support and strengthen the creation of the hubs
for vaccine manufacturing, invest in training the next
generation of vaccine scientists, and increase partnerships
with research universities, supply chain actors, and strengthen
national regulatory authorities.
Thanks for your attention. Happy to answer any questions.
[The prepared statement of Dr. Bottazzi follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Ms. Bass. Thank you. Thank you so much.
Let me thank all of our witnesses. And now we will go into
questions, and each member will have 5 minutes.
Dr. Soon-Shiong, I wanted to know, you mentioned the need
for a second generation of vaccines. And I wanted to know,
where are we in that development, from your own efforts and
also from the efforts that you know in the U.S. and in the
world?
Dr. Soon-Shiong. Well, we are right now in phase 3 clinical
trials in South Africa. We completed phase 1 in the United
States. I think the idea of the second generation is to derive
vaccines that actually drive T cells. It is now very clear that
T cells can actually overcome all these mutations and, more
importantly, drive memory. So we are now in clinical trials
both in Africa, Botswana, and United States.
Ms. Bass. Could you briefly explain the difference between
that, driving T cells and the current vaccines?
Dr. Soon-Shiong. The current vaccines are derived so that
we can actually block the entry of the virus into the cell
using antibodies. That has been the traditional way of actually
creating vaccines. That is what we do for flu. However, this
virus, once it gets into the cell, has a way to mutate, not
only mutate but proliferate and transmit. So unless you can
kill the cell that is infected so you prevent propagation of
this virus and prevent transmission, the only way to do that is
with a T cell.
So our body has T cells, and when you had COVID equivalent
to about 17 years ago, the memory T cells of this virus is
present so that it can kill any mutation, any virus entering.
So it is a very big difference when you derive a vaccine that
can kill the factory versus just block the entry, and that is
the big difference.
Ms. Bass. That is a very clear description. And so what
contribution, if any, does the U.S. Government contribute to
this research? Is the only place that this research is
happening is South Africa?
Dr. Soon-Shiong. Unfortunately, you know, we have not been
recipient of any of the support. I have supported IDRI, which
is now called AAHI. We were redeveloping one, the self-
amplifying RNA, redeveloping an adeno, and redeveloping, as you
heard, the subunit protein with Baylor. But, actually, taking
these three platforms, and you can mix and match, you have a
mitigation of supply chain, you can actually derive now durable
responses, and you can actually have room temperature.
So we have taken the approach that this was necessary
despite the absence of support. And we have gone where we think
it is needed, which is in Africa. And we have built capacity
and self-reliance in South Africa, as well as in Botswana.
But I have also built manufacturing capacity in the United
States. We built in Los Angeles, Chicago, Colorado, and now in
New York. We have taken over a 400,000 square feet
manufacturing facility so we can have a million doses
available. I think national preparedness for this virus, as
well as the next pandemic, is so critical for the Nation.
Ms. Bass. Wonderful. Thank you.
I would like for you to, not at this time but maybe on a
second round, if you could quantify what you--what support from
the U.S. would look like.
And, Dr. Ogwell, I wanted to ask you that as well, because
you gave--in your three recommendations, you talked about
support for the CDC, the African CDC, support for access. And I
wanted to know specifically what kind of support. What
specifically? I mean, obviously dollars, but I am talking about
in terms of where or what.
Dr. Ogwell. Right. And I thank you. Thank you for the
question.
In as far as supporting the vaccination rollout is
concerned, there are three big buckets of activities that right
now we are focusing on which are open for partnership. One is
ensuring that there is a system of getting the vaccines from
the port of entry to the vaccination centers, wherever it is
they are in whichever country.
Two is ensuring that the vaccination centers are not
static. They need to have mobile capacity so that we are
reaching the public where they actually are, because the
economic situation is such that people have to go out to look
for their daily bread. And then to exchange that and go and
queue for vaccination at a static health center, that becomes
no choice. So they will not go for vaccination. But if you take
it to them where they are, whether it is a marketplace, you
know, the religious institutions, wherever, then it becomes
easy, and we have seen that change.
And the third bucket is actual engagement. Vaccine
hesitancy is not very high on the continent, but we need to get
members of the public to appreciate that there actually are
vaccines that can be able to be brought close to them. So that
public engagement is where we need to be.
And as far as where is concerned, across the continent,
most of the countries have this challenge. And as the pandemic
evolves, we can be able to provide a clearer list based on the
timing of that support.
Thank you.
Ms. Bass. Thank you.
And let me move to our ranking member, Representative
Smith.
Mr. Smith. Thank you very much, Madam Chair.
If I could, Dr. Soon-Shiong, the issue of therapeutics,
which we haven't touched on yet today, I know we are talking
about vaccines, and I think you made a great point about the
second generation producing T cells in the importance of
killing the COVID. And I am wondering if you could, are we
doing enough at our own NIH to focus on that kind of
capability?
Second, on the whole idea of long-haul COVID, there are a
number of long-haul COVID centers in my district that have
reached out because, you know, there is a growing recognition
that, you know, these people who even had mild symptoms can get
very sick. Matter of fact, there was a study from the
University of Washington that said that long-haul COVID
afflicts almost one in three people who contract coronavirus
and does not seem to discriminate based on a patient's age or
prior health.
So this secondary effect that is somewhat underappreciated,
if you could speak to that.
I mean, in my own State district, CentraState in Freehold,
has a center for the treatment of long-haul COVID, as does at
Robert Wood Johnson. So if you could speak to that as to how
patients in Africa are being addressed when it comes to this
other shoe dropping.
And then if you could, finally, speak to, briefly, the
efficacy of the Chinese and the Russian vaccines. Have they
performed well?
And I do have other questions, but I would like to get to
those first.
Dr. Soon-Shiong. Thank you. I think the first question
about long-haul COVID, it has been underappreciated. And I
think we really should be concerned about that. And the whole
idea, as I believe, this is because of the viral load, what is
happening with this virus, that actually because it enters
through the blood vessels, it causes inflammation of the blood
vessels, so now you have myocarditis and heart attacks, young
people. You now have strokes. I have young people--a colleague
who is 44 years old had a stroke. You have people with high
incidence of diabetes.
So this is unlike any other virus. It has the capacity
almost to act like cancer, where when it gets into you, it
actually has a way to immunosuppress your body. So it is
critical that now we take a different strategy of not having
just an antibody-based vaccine that covers the outer part of
the virus called spike. There is an inner part of the virus
called nucleocapsid, the inside of the virus that allows it to
replicate. And for some reason, we are the only organization,
one of maybe few, going after both the outer spike and the
inner nucleocapsid.
So all of the vaccines, including in China, including in
Russia, including United States, have gone after the spike
vaccine to try and block it because that is the general regular
dogmatic way of going after vaccines. But if you treat cancer
and you treat this kind of virus, you need to generate a
different kind of strategy, and that is what we have been
doing.
With regard to support from the NIH and even broader,
Chairman Bass asked us the real direct question. One of the
tragedies is we went way into clinical trials prior to COVID
for cancer without vaccine, as well as then when COVID hit, we
reverted the DPAS letter, which apparently only went to people
that received funds from BARDA. We were denied. So other supply
chain dried up. We had no access to simple things like bags,
media to this very day. So we had to ration between our cancer
program and the COVID program, which drove us then to find ways
to create mitigation or supply chain strategy, and that was the
blessing where we had recombinant protein as--from Texas. And
we developed the sRNA and as well as our adenoviruses.
The other question I think you asked--I am sorry, I forget
the other question.
Mr. Smith. Well, it really was whether or not about
therapeutics, but above all whether that the CDC and especially
NIH were cooperating with, you know, your vision, which seems
to have been somewhat bypassed.
Dr. Soon-Shiong. Yes. I think, with all due respect, we
have tried. We have gone to BARDA, NIH and made multiple
presentations. And I think, you know, the--even during the Warp
Speed era our pleas were not answered.
Mr. Smith. Missed opportunity. Thank you so much for that
leadership. And I hope, you know, Chairwoman Bass and I can
further take that vision. Because, I mean, you make excellent
points and now it is being borne out with this long-haul COVID
that--I mean, I know many people who are suffering exactly what
you just talked about, strokes that you would never expect it
among young people. And they are in my district, and they have
got to be in Africa as well, and we probably do not know enough
about.
So thank you so much, Doctor. Really appreciate it.
Dr. Soon-Shiong. Thank you.
Ms. Bass. Representative Bera.
Mr. Bera. Thank you, Chairwoman.
I have the privilege of being a doctor as well as someone
who has spent a lot of time thinking about pandemics, and
certainly was in Africa post-Ebola and Sierra Leone, and
chaired the first hearing on COVID-19--or at that time we did
not have the novel coronavirus back in February 2020. Now it
seems we are losing track of time.
And, Dr. Bottazzi, also had the pleasure in March 2020
having your colleague, Peter Hotez, as one of our witnesses in
the committee I chaired.
At that time when we were learning about this, many of us
were very concerned that, you know, what we were seeing in New
York, when the virus got to Africa, would be devastating. Yet
given, I think as Dr. Soon-Shiong already pointed out, you
know, the comorbidities of tuberculosis, HIV, et cetera. And we
did not quite see it play out the way we thought it might.
And, you know, I guess I would ask the panelists--and I was
reading a New York Times article last week, I think, that was
looking at Sierra Leone. And I was in Sierra Leone in West
Africa a month ago. And it is not that COVID wasn't there,
because when you look at serologic studies and, you know,
antibody studies of the population, a lot of the population is
showing antibodies. But it does not seem as though the number
of fatalities were what we would have expected
epidemiologically.
And I would just be curious if any of the panelists have
any thoughts on that. Is it just that people are dying but they
are just not being taken to hospitals, given the healthcare
system in Africa, or is it something else that we should be
thinking about studying, if there is something unique?
Dr. Bottazzi, if you want to----
Dr. Bottazzi. Thank you very much, Congressman. I think you
are right. I think it has been challenging overall, because we
knew that we were seeing how COVID-19 and the access to all
these possible solutions, right? Vaccines and, you know,
therapeutics, and understanding the clinical management was not
trickling down to the countries that we could have prepared
better seeing the experience from countries that already were
suffering, right? You know, certainly starting from not only
Italy, where I was born, and you know, my family really
suffered through. And, you know, then later, certainly United
States and other high-income countries.
And I think it is because we did not recognize, as our
representative here from Africa CDC, that, you know, we have to
continually strengthen the health systems. And certainly enable
that not only there is an access to when these solutions arrive
to those countries can be deployed, but that we can empower
them--because the capability is there, we can empower them to
produce them in their own way.
Thank you.
Mr. Bera. Right. Yes. No. And obviously, again, from
epidemiological perspective, lots of theories, younger
population that still got infected but did not suffer the
mortality that, you know, older populations as in Italy or in
New York City and across the United States.
Dr.--yes, please.
Dr. Soon-Shiong. Maybe I just sort of react to maybe the
science behind some of the immunology of patients in Africa. It
is interesting, what we have now discovered, there is a thing
called cross-reactive T cells; meaning that if you had previous
infections even of coronaviruses, you may have T cells that
actually recognize this COVID and actually ablate them.
The other thing is that the patients in Africa have BCG
vaccinations from TB. There is now evidence that BCG in its own
right generates these cross-reactive protectivity. So it is
still unproven science, but what is interesting as was being
very clear is that there is a cross-reactivity of T cells that
can protect, and maybe that can account for some of the
difference in death rates in Africa.
Mr. Bera. Certainly that was something, you know, the BCG
argument, I have talked to folks at UCF and others, because
there was a case to be made, we did not see it early on in
India and other--in countries where you have folks with high
rates of BCG and then in places like Italy or the United States
where we do not use BCG. But there is speculation there.
And on the cross-immunity piece, again, early on, we would
have expected to see high rates in Japan where you have an
older population, et cetera, which has never really panned out.
So I do think that there is more research to understand this
virus from the epidemiology perspective.
Dr. Soon-Shiong has laid out a novel approach that, you
know, just from my medical background makes some sense. As a
virologist and someone who is an expert in vaccine development,
I would ask your thoughts on the approach.
Dr. Soon-Shiong. Sorry, Congressman. Are you asking me that
question?
Mr. Bera. I was going to ask your colleague from--Dr.
Bottazzi, to give your opinion on the novel approach to go
after the nucleotides as well as the spike proteins.
Dr. Bottazzi. So we also are firm believers, like Dr. Soon-
Shiong mentioned, that you really have to tackle this
immunologically from many aspects. In our case, which we focus,
of course, on recombinant protein technologies, we address this
through formulation science, right; through, what do you pair
the vaccine protein antigen with? And we have seen now from
work that we have done, not only with Dr. Soon-Shiong, but also
with our partners from AAHI, or IDRI, that toll-like receptors
from the class of agonists of TLR 4, TLR 7/8, TLR 9 really
complement really well with very conventional adjuvants such as
aluminum. And then by doing also the strategies of prime
boosting and--primary immunization and then boosting, like, you
know what we are doing, again, with Dr. Soon-Shiong, which is
bringing RNA with protein, viral vectors with protein. Those
are the strategies that probably will really accelerate, as
well as bring solutions.
And, again, we do not know what works in what situation
based on what microbe we are dealing with. So we need to be
able to be very flexible and really adapt and use the
technologies in a way where rapidly you can collaborate and
fold in different scientific tools to be able to address what
works well and in what moment in time during a given emergency
or pandemic.
Thank you.
Mr. Bera. I----
Ms. Bass. Thank you.
Representative Issa.
Oh, I am sorry, Dr. Bera, but we will come back on another
round.
Mr. Bera. No, I was just--I was yielding back. Thank you.
Ms. Bass. OK.
Representative Issa.
You are muted.
Mr. Issa. OK. Here we go.
Dr. Bottazzi, your organization, your boss actually, has
commented that the CDC and Operation Warp Speed could care less
about the work that you are doing and that is why you had to go
and get all of your funding from philanthropy. Is that an
accurate statement, from what I understand, or
characterization?
Dr. Bottazzi. So we--thank you so much, Congressman Issa.
We have engaged in conversations with multiple stakeholders in
the U.S. Government: the White House COVID Task Force, the
State Department, USAID, you know, even the Development Finance
Corporation, certainly NIH, BARDA, you name it. Very generally
supportive, always telling us how we are doing wonderful work.
But the reality is that it really hasn't led to any substantial
financial support for our center.
In parallel, we have seen that the Quad summit has been
quite supportive of Biological E. So I think that it is really
how--how we haven't been given the opportunity of raising the
visibility that--you know, a lot of the work that enabled a
vaccine such as Corbevax really started in Houston, and in
Texas, and in the United States. And I think that it really
should be, you know, an honor, of course, of highlighting that
we are really contributing to also, you know, the work that,
you know, can come and close the gap overseas and globally.
Mr. Issa. And I appreciate that. One question I have: What
was the total philanthropy dollars that it took to develop this
vaccine? Do you have a number?
Dr. Bottazzi. Yes. Thank you for your question. And we were
actually reviewing those numbers the other day. And for the
COVID-19 program, we received approximately $5 million in
philanthropy, direct philanthropy. And then maybe a couple, $2
or $3 million more. So a total of $8 million in grants, but
that came from philanthropic foundation organizations. A small
bridging fund we got from the National Institutes of Health,
approximately $500,000.
Mr. Issa. I do not want to call this an indictment on NIH,
but you developed a lot for very little money. And as other
committees are reviewing those organizations, perhaps this is a
good piece to transfer from this committee to the committees
that have to look at whether or not NIH stands for not invented
here or whether CDC was really giving a fair allocation of
massive resources that Congress gave them.
Do you have any intellectual property protection on this
vaccine? Have you applied for patents?
Dr. Bottazzi. No, Congressman, we have not. It really came
from a philosophy of the fact that we had been working on
neglected diseases for, you know, 20 years, and we want to
remove barriers. The fact that we use a technology that it is,
to be quite honest, relatively generic, right? Even though we
do create these seed banks and this genetic engineer that does
have intellectual property because our scientists are the
creators, we prefer to not patent it because our mission is to
really then share our knowledge and enable others to be able to
learn from it.
Mr. Issa. Now, if we are going to see this vaccine used
more broadly outside of India, it is going to require both the
WHO and other organizations to test it. Who is funding the
testing of that? And is there anything we should be doing to
expedite that?
Dr. Bottazzi. Yes, very good question. And, in fact, when I
was mentioning of how much we are--vaccine center was able to
fundraise, we also agreed amongst our partners that we would
delink the way that how the vaccine program would move forward.
So, for example, BioE did not have to fund us, nor we had to,
of course, fund them. But each of us had that ownership or
accountability. And BioE, fortunately, for the Quad summit,
they did receive some help from the U.S. Government, but they
also had to tap into other global sources and their own country
and their own internal moneys.
So I think that, you know, it is again that there are many
ways that probably you can break this paradigm. But it is clear
that the inequity also on who decides where the funding should
go to diversify a portfolio of solutions is where we struggled
a little bit.
Mr. Issa. Well, I want to thank you for the work you have
done, because most of Africa has had to put up with Sputnik and
other untested comparatively and questionable vaccines. So the
fact that there is one that has American confidence behind it
is welcomed.
And, Madam Chair, I appreciate this hearing, and yield
back.
Ms. Bass. Well, Mr. Issa, before I move on to Mr. Phillips,
let me just suggest that since we are in appropriation season,
maybe it would be an opportunity for us to do a bipartisan
letter calling on you--know, calling out these issues.
Mr. Issa. It would be most welcome. Consider me signed on.
Let me know where.
Ms. Bass. OK. Wonderful, wonderful.
Mr. Phillips.
Mr. Phillips. Thank you, Madam Chairwoman. And greetings to
our wonderful witnesses. So grateful to all of you. I was
hoping to compliment President Masisi on Botswana's remarkable
vaccination rate, which is unique amongst African countries, of
course.
But I will direct my first question to you, Dr. Ogwell. How
did Botswana become so successful vis--vis its neighbors in
administering the vaccines? What tactics and techniques and
strategies could we all learn from?
Dr. Ogwell. Thank you, Representative Phillips.
Botswana did three things, which may be not so unique, but
they did them well.
One is they used very effectively their traditional
systems. They have communities that have chiefs, and they live
within relatively well-defined areas. So using those
traditional mechanisms, they could reach out to literally every
Botswana, wherever it is that they were. So they used this
system very effectively.
Second is Botswana started the vaccination drive very
early. They did not wait to have loads of vaccines to be able
to go out and do very effective community engagement. So the
public was sort of waiting for the vaccines to be able to come,
and this made uptake much faster than if the public had not
been engaged.
The third thing they did and they did very well is they
constantly were seeking out vaccines. Even when vaccines were
not very easy to come by, Botswana was out there engaging with
the Africa CDC, the African Union to try and get as many doses
as was possible. So they invested their own money in getting
extra vaccines.
The final thing I must add is that they utilized public
health systems that were already in play. As you know, Botswana
has a very relatively high prevalence of HIV during the time
that it was very divided to the continent, and they utilized
those mechanisms and that infrastructure to be able to get the
vaccines out to the public.
So this is some of the things that they did and they did
very well, and I think it is a good example not just for
Africa, but for elsewhere as well.
Mr. Phillips. Absolutely. Thank you.
And which brings me to my next question, which is about
youth. You did not mention the engagement of the young people
to be Ambassadors in their own communities. Are there examples
of youth being engaged to become Ambassadors and advocates for
vaccinations, considering their influence in so many
communities?
Dr. Ogwell. Absolutely. In fact, we have just launched what
we call the Bingwa Initiative. Bingwa in Swahili means
``champion,'' and this is purely for the youth. And we are
rolling this out across the continent, getting the youth to
speak to the youth, and getting champions within the youth to
be able to drive that agenda.
One example that I would like to mention here is more
local, where they used the youth and technology very
effectively to get them out to get vaccinated, and they did
this very early in the vaccination rollout, and the numbers
that they are showing for vaccination are very good, and we are
trying to adopt that onto the whole continent.
The youth are the least vaccinated on the continent, and
they are the next target that we are aiming at in improving the
vaccination rate on the continent here.
Mr. Phillips. Wonderful, and I appreciate that.
Before my time expires, I would also like to question you
about food insecurity. Of course, the war in Ukraine is
affecting food supplies, surely will affect them around the
world. How is it doing so right now in Africa? Anything you
might share with us, either what is occurring now or what you
might be concerned about because of the war?
Dr. Ogwell. We are already seeing the effects of
interrupted supply, and across the continent, for example, the
price of staple things like bread and wheat products are
suddenly just going up. Oil, vegetable oils, those are just
going up, and this is expected to become worse in the coming
days, certainly very much and directly related to the conflict
that is going on in Eastern Europe.
Mr. Phillips. And is there anything that we, the United
States, can do to ensure that our aid dollars are directed to
the places that need it most and for the reasons most needed?
Dr. Ogwell. Yes. And I mean, my--being from Africa CDC, I
will say that we need to bring the pandemic under quick
control----
Mr. Phillips. Yes.
Dr. Ogwell [continuing]. So that the health issues do not
bog down economic recovery, and this will be a very good place
to invest. As I was saying, the idea of the vaccination rollout
and us strengthening infrastructure that is going to support
not just this pandemic, but any other epidemic that may be able
to come in the future, these are very good areas to invest and
ensure that people are healthy enough to go out and do their
economic activities devoid of any health challenges.
Mr. Phillips. Thank you, sir.
And with that, Madam Chair, I yield back.
Ms. Bass. Thank you.
And I will call on Representative Omar in 1 second. But,
Representative Phillips, maybe one thing that we could do would
be to help more African countries grow wheat.
Mr. Phillips. Yes, exactly.
Ms. Bass. So that African countries do not have to import.
Mr. Phillips. And representing a State and district that
does a lot of that, I am happy to make some connections.
Ms. Bass. All right. Thank you.
Representative Omar.
Ms. Omar. Thank you, Chairwoman.
And I cosign on helping Africa grow more wheat. Countries
like Sudan import 50 percent of their wheat from Ukraine and
Russia, and they are going to feel the impact of this war.
Again, I want to thank you so much, Chairwoman, for holding
this important hearing and thank our witnesses for their
incredible testimoneys.
I would like to direct this question to Dr. Ogwell. I would
like to ask you about how the pace and delivery of vaccine
donations is impacting the public rollout. Last year the AU and
the Africa CDC and COVAX criticized the pace and manner in
which vaccine donations have been provided to Africa.
As I understand it, the unpredictability of shipment,
coupled with extremely complicated but necessary storing and
delivery processes, isn't allowing communities enough time to
operate the needed outreach and public campaigns to reach those
that need the vaccines. As a result, the supply chain can
become extremely backlogged, the cold chain equipment strained
to capacity, and worst-case scenarios, some of the vaccines
could actually go unused because of expiration. In fact, the
Africa CDC requested a month-long pass in February of this
year.
Dr. Ogwell, could you speak to some of these challenges and
to what extent they can be remedied?
And how do you think these issues have impacted vaccine
hesitancy?
I am really interested in seeing how the U.S. Government
and international partners can help with these issues.
Dr. Ogwell. Thank you, Representative Omar.
And let me start with the last question around hesitancy.
We are not seeing high levels of hesitancy on the continent. It
is not the problem. The problem is the vaccines need to get to
the public, and the public are not coming to the static health
facilities. So we need new strategies that get the vaccines to
where members of the public are. And that is one very opportune
area of investment of getting the vaccination rollout
initiative that we are rolling out at the Africa CDC to reach
the public where they are, whether that is in the marketplaces,
in the schools, in the religious institutions, CDC. Wherever
the public will be, that is where we go.
Now, when we look at acquisition of vaccines during this
period when vaccines have been available, right from the
beginning, sometime in the middle of last year when we were
really urging availability of vaccines early on the continent,
it was difficult to come across those. And, unfortunately, we
saw a situation where, by the end of the year last year, we
were still getting trickles of vaccines.
Now, the flood came early this year, where we were getting
donations and where we were going to purchase the vaccines were
becoming more available, and the system of absorbing those
vaccines are not strong on the continent.
So you end up with a situation where you have donations
coming in. The vaccines that African companies have purchased
are coming in. And at the same time, the system is not
absorbing enough, so you end up with a lot of idle capacity in
as far as vaccines are concerned.
So what we need to do, and what we are working very hard at
Africa CDC to do is, one, to encourage a pause in the
donations, because we need the vaccines, but we do not need
them now. We need them later on, probably in the second quarter
of the year, because of fixing the vaccination rollout
capacity. We are not saying do not donate; we are saying donate
a bit later so that we fix what we have already.
And if we do that, then we can be able to ensure that we
reach members of the public where they are, we get the
information over to the members of the public that the vaccine
is still safe and they are still useful, and also to get those
who have been vaccinated to get boosted.
So we see the investment earlier is the one of vaccination
rollout, and sent to the health systems so that any future
vaccines that will come we will also be able to easily get to
the public.
Thank you.
Ms. Omar. Yes. I recently learned about the Kitengela, the
national vaccine depot in Kenya which operates a very complex,
cold storage facility and delivers vaccines to people across
nine counties. Yet, during the rainy season, one road leading
to the depot is often washed out, shutting down these critical
and crucial efforts. And when I was just in Liberia, the CDC
director there was talking about some of these infrastructure
challenges, and I know that we cannot have a comprehensive
discussion about these issues without talking about some of the
infrastructure challenges that exist.
What are some that you have noticed and ways that we can
help some of these African countries address their
infrastructure issues?
Dr. Ogwell. Two that are very much related to vaccination
rollout are, one, the cold chain system. We have very good cold
chain facilities in the capitals when the vaccines arrive, but
then getting the vaccines to a storage facility outside into
the rural areas becomes a challenge.
So it means that small doses, small numbers of doses are
being sent to the rural areas, and that leaves people out to
queue to get the small doses, while the facility in the capital
is having a lot of doses. So fixing that cold chain is
extremely valuable and one area of investment.
Second is ensuring that we can be able to get the
communities to understand the importance of vaccination within
their own context. A lot of the messages that we are having now
are very, very broad, and addressed relatively well-educated
populations. But if you get the community health workers to be
out in the communities, engaging with members of the public,
then they would be able to translate that message in their own
local context, using their own cultural idioms and imagery, and
that would be able to encourage more people to get out and get
vaccinated.
So these are two really big areas for partnership and
investment that would really help vaccination rollout very
rapidly.
Let me add one thing that----
Ms. Bass. Let me move on to one other person, but we will
come back around, OK?
Dr. Ogwell. That's fine.
Ms. Bass. We are past time.
Ms. Omar. Thank you, Chairwoman. I yield back.
Ms. Bass. Sure. Absolutely.
Representative Jacobs.
Ms. Jacobs. Well, thank you, Madam Chair.
So, Dr. Ogwell, I would actually like to followup on some
of the questions from my colleague, Congresswoman Omar. I know
that, you know, she talked about a lot of the challenges
related to vaccine distribution and delivery, and one of the
starkest issues being supplies and logistics. And you just
spoke about the logistical and supply challenges different
countries have faced, but I was wondering if you could talk
about the flip side.
Can you speak to the infrastructure and cold chain systems
some countries have built over the past 2 years? Representative
Omar mentioned Kenya, who has made remarkable process in
training its health workers in vaccination and cold chain
systems. So which countries have been able to do this, and what
do those countries need to make sure they can make the best use
of the infrastructure they have spent 2 years building?
Dr. Ogwell. Thank you, Representative Jacobs.
And I will give three countries--many more have done a lot,
but there is three standouts. One is Uganda, second is Zambia,
and third is Rwanda. They have utilized the existing
infrastructure for different public health and primary
healthcare programs that they have in the country, and upgraded
them with a cold chain infrastructure that has enabled vaccines
to be able to reach the rural areas. And the result has been a
jump in the number--the percentage of vaccinations. Uganda, for
example, was in the 6--7 percent, but right now it is above 25.
So the utilization of existing infrastructure and revamping
it has resulted in the cold chain industry in these countries
really going up in a very fast way.
So a very easy way of trying to get the cold chain system
up and running would be to check what is already in existence,
because you already have immunization programs in each and
every country. It is just that now they are not being used.
They are laying idle while we are trying to fix a new system
for COVID-19. We need to use infrastructure that we already
have, and that has been shown in those three countries that I
have given an example of.
Ms. Jacobs. Well, thank you very much.
Dr. Soon-Shiong, I want to talk a little about the CorbeVax
vaccine. Obviously, if this can be widely manufactured and
distributed among low-income countries across the African
continent, it would be transformational as I think we've heard
you talk about today. But which countries do you expect would
be prepared to take this new vaccine on and what would that
timeline look like?
Dr. Soon-Shiong. Well, first of all, thank you for the
question.
The answer is every country could take this on, including
our own country, and what has happened as you heard in terms of
who was funding the trials, I think the question that Dr. Issa,
Congressman Issa asked, we are funding the trials actually.
And so, not only the CorbeVax vaccine, which is the RBD
plus an adjuvant, we are funding the next generation COVID
vaccine where the adjuvant is actually from 3M, which is a
better adjuvant even.
So not only are we funding those trials, we actually are
funding--we actually have both GMP manufacturing in the United
States and soon you will have full GMP manufacturing in
Botswana, and also in South Africa, so the ability to actually
create this is not only very real.
Let me just speak, however, to this whole conversation that
has been happening in the last 30 minutes about the cold chain.
I think that is actually the wrong root cause. The root cause
is not the cold chain. I do not think fixing cold chain with
the electricity issues and the power and the infrastructure is
the answer actually. It is actually fixing the vaccine that
does not require cold chain is the root cause, and that is the
problem. And we need to solve that, not only with this current
CorbeVax vaccine, but the vaccines coming along with the saRNA
which is actually stable at room temperature. I think that is
the root cause, and this idea of thinking that Africa with its
power, electricity, coal-generating plant problem can actually
have cold chain is actually the wrong way of actually putting
resources together.
The second thing, with regard to the opportunity here is
exactly as was spoken, we need to bring it to the community.
And in South Africa, I am working with 67 mobile vans in the
South African government bringing the vaccines to where the
community is, and we are developing that.
The third thing, with regard to the food insecurity, is not
just the food insecurity, but water. So I am already working
with South Africa developing, actually, ways of extricating
water from the atmosphere to actually generate the water.
So these are what I call root solutions to root causes, and
I think what I am concerned about is we look in the wrong
direction. The vaccines should be T cell-based vaccines, not
antibody-based vaccines. The vaccines should be room
temperature-based vaccines, not minus 80-degree vaccines. And
then in regard to the food insecurity, we need water.
So these are the things that we are developing, and I am
pleased to say the reason we brought Pula Corbevax to Botswana,
President Masisi asked me to be his health advisor. And one of
the things we brought to Botswana was not only the
manufacturing, but working with Biological E and Texas Health
and, you know,
[inaudible], we developed this program. And now the next
generation of this RBD we will be using a 3M product, and,
again, now manufactured fully in Botswana.
So all of these products are fully manufacturable in Africa
for Africa by Africans, and then gives themselves self-
reliance.
Ms. Jacobs. Thank you so much.
Madam Chair, I yield back.
Ms. Bass. Thank you, Representative Jacobs.
Now let me invite Representative Jackson Lee.
Ms. Jackson Lee. Madam Chair, let me thank you so very much
to you and the ranking member, Congressman Smith, for--with a
little bit of humor, bringing me back.
Ms. Bass. You are always welcome here.
Ms. Jackson Lee. I am warmed by the work of this committee,
and have great respect for your work and you, and as you well
know, we have done this over the years, and I am glad to now,
after the pandemic, join you on a very, very important issue.
Let me acknowledge all of the witnesses that are here, and
particularly welcome Dr. Bottazzi, who is the codirector of the
Baylor Children's Hospital dealing with vaccine technology. And
I would like to just put a little bit on the record that that
facility is very, very unique because it has dealt with
poverty-related neglected tropical diseases which find
themselves both on the continent of Africa and other developing
communities. The diseases are such as hookworm, and now this
team has created a low-cost vegan vaccine, effective COVID-19
vaccine for low-income countries.
So Dr. Bottazzi's partner, as I understand it, is Dr.
Hotez, who I have worked with for many, many years, and this
has been something that he has spearheaded, joined by Dr.
Bottazzi, and they are now in India, and it is produced by
Biological E where it is known as CorbeVax, and CorbeVax now
has been given to more than 15 million children and adolescents
in India for its first 2 weeks of a rollout campaign. And now
the leadership of Botswana plants are underway for 100 million
doses, and the hope is more than 1 billion doses will be made
to address global vaccine inequity.
I wanted the committee to know that, and I wanted to
acknowledge Dr. Bottazzi for her presence here. She and Dr.
Peter Hotez make a very powerful team.
I had the privilege of meeting the President of Botswana in
Houston as he was being introduced to this unique vaccine which
there is a commitment to produce it in Botswana, and I think it
can be one of the first steps, among many, to deal with this
issue.
So let me ask, Dr. Ahmed Ogwell, your view of vaccines
being produced on the continent, and the importance of being
able to have access in any number of countries to treat and to
vaccinate Africans with the produced vaccine already there.
Dr. Ogwell. Thank you, Representative Jackson Lee.
Local production of vaccines, indeed any other health
product that we need in an emergency response, is a very high
priority for the African continent. And this is a lesson we
have learned because of the disruption of supply chain when you
have something as big as a pandemic happening across the globe.
Our local production is an ambition that we have made into
action, and as you have heard, there are many countries that
are now in the process of setting up facilities to produce
vaccines on the continent because right now we only have 1
percent being produced. We import 99 percent. Our ambition is
that by 2040, we will be manufacturing 60 percent on the
continent and only importing a maximum of 40.
So the local production will ensure that we can be able to
have the vaccines and other products more easily available
because it is within the continent. If anything is happening
elsewhere in the world, it does not disrupt that supply chain.
The only thing that we need to fix is how do we get the
markets to actually purchase the vaccines here on the
continent, because a lot of the vaccines are being purchased
through facilities that----
Ms. Jackson Lee. Thank you so very much.
Let me quickly ask Dr. Bottazzi and Dr. Soon-Shiong, if I
pronounced the last name right, are your vaccines mutually
exclusive, or do they find a way of complementing each other,
one blocking, as I understand--attacking the T cell, if I
understand, and the other one blocking?
Dr. Bottazzi?
Dr. Bottazzi. Sure. Thank you.
Ms. Jackson Lee. And if I could get Dr. Soon-Shiong to
answer as well.
Dr. Bottazzi.
Dr. Bottazzi. Thank you. And thanks, Representative Jackson
Lee, for being here.
It is very complementary. I think Dr. Soon-Shiong already
mentioned that we are even having to continue improving our
vaccine technology, complementing it to look for, you know,
temperature stability, including additional adjuvants,
including additional strategies that could potentially even
combine different technologies. So I think it is the way to go.
It is the future of vaccine development.
Ms. Jackson Lee. Dr. Soon-Shiong.
Dr. Soon-Shiong. Well, we have actually published this,
what we call mix and match, so the opportunity to take an
antibody-based vaccine added to a T-cell vaccine as a prime and
a boost has shown potent antibodies, potent T cells and, most
importantly, memory T cells and memory B cells. So this has now
been shown pre-clinically, and we are in trials.
What is exciting is if you combine that with room
temperature and maybe even nasally administered, you now find
the holy grail where you can have a durable vaccine, a mix-and-
match vaccine, room temperature vaccine, and durable long-term
protection as universal COVID.
We are there, I think, very much there from a science
perspective. What we need now is to have the vision and
leadership and funding and support to make this available to
the world.
Ms. Jackson Lee. Madam Chair, thank you so very much. I
hope you will count me as trying to encourage our government to
jump and leap into the funding partnership that can help both
of these scientists to go even further to help our friends on
the continent and elsewhere.
Just a personal note to congratulate Dr. Bottazzi and Dr.
Hotez for being nominated for a Nobel Prize for their work, and
I think that should be on the record. They are a team, Dr.
Peter Hotez and Dr. Bottazzi, and I hope that we will be able
to have him as a witness in the near future to complement his
outstanding and excellent partner.
With that, Madam Chair, I will yield back with the many,
many questions I still have, but thank you.
Ms. Bass. And you are welcome to stay because we are going
to do another round. So with what you shared, I guess we will
come back looking for you for your signature.
Ms. Jackson Lee. Yes, you will.
Ms. Bass. Dr. Soon-Shiong, just a quick question, and then
I am going to go to Mr. Smith.
If an individual has had four shots, which I guess we are
on our fourth shot now, of Pfizer or Moderna--I understand that
the vaccine that you are proposing acts differently on the
body, so I am assuming that there would not be a problem to go
from Pfizer to the vaccine that you are proposing--I guess that
you are developing?
Dr. Soon-Shiong. Thank you, Madam Chair.
On the contrary, frankly. We have actually looked at the
blood of patients or subjects or healthy volunteers that
receive just the current approved vaccines and look at the T
cell--what you call T cells in the blood. There is a test
called the ELISpot. We find very little T cells.
When we have looked then at subjects who have received both
the Pfizer and our vaccine, we see not only the antibodies, but
we see potent T cells and potent T cells to both the outside of
the virus as well as inside of the virus called the
nucleocapsid. What is exciting is that that portion of the
virus on the image of the virus does not mutate because if it
does mutate, it cannot replicate.
So by having T cells as well as antibodies, and what we
call this mix-and-match opportunity of a prime and boost, we
really can now answer basically long-term durable protection,
rather than having four shots of an antibody vaccine that
continues to wane, and really almost chasing your tail with the
variant. So, yes, the answer is the combination of a boost is a
reality.
Ms. Bass. Thank you.
Mr. Smith.
Mr. Smith. Thank you very much, Madam Chair.
You know, the idea of a monopoly of thought by, whether it
be CDC or NIH, often precludes wonderful ideas like what you
are talking about, Dr. Soon-Shiong, and I find that to be very
disturbing.
You know, over the course of my career, I have been in
Congress 42 years. The first amendment I offered in Congress
with Tom Daschle was to make Agent Orange and its contaminants
[inaudible] Compensating service connection disabled so the
people receive some compensation and some help. It failed
because there was a consensus at DOD and IOM and elsewhere that
it was not causing the deleterious effects in veterans that we
said. Ten years later it was all accepted.
I offered the Persian Gulf Illness Bill, and we were being
told it was just anxiety that was producing these symptoms, and
so, my bill did become law, but you keep learning that we push
aside something that does not fit a narrative and good ideas
are lost.
So I want to thank you for what you are doing, Dr. Soon-
Shiong. If you could provide all of us--I think it would be
helpful for the record--how BARDA and others precluded your
participation, and you said it went right back to warp speed,
so it is right from the start, I think that is very important
for us to know that and also to have a lessons learned. And I
do appreciate the great work you are doing there.
Let me also say, even on Lyme disease, I chaired a Lyme
disease caucus--in 1998, I had a bill that wanted to bring Lyme
literate doctors into the equation because people were saying
take 1 month of Doxycyline and you are cured, and that is not
true. We finally got it a few years ago, and everyone said,
Oops, we missed that. But there was a monopoly on the thought,
and even Dr. Fauci was a part of that back then.
So I thank you if you could make that available to us.
Second, your views--and this would go to all three of our
very distinguished witnesses and experts--on the Administration
of vaccines to children, which seems to be somewhat open-ended
as to how safe and efficacious it is, how young--I would and I
think my colleagues would love to know what your expert
opinions are. And, very briefly, Chinese and Russian vaccines,
do they compare? Are they as good, equivalent to those like
from Pfizer, Moderna, AstraZeneca? And I do have a letter--
thank you.
Dr. Soon-Shiong. Thank you, Congressman. I certainly will
provide that information.
Mr. Smith. Thank you.
Dr. Soon-Shiong. With regard to children, I think it is
very important--you know, we begin to see, unfortunately, even
unvaccinated children and deaths in young children. So I think,
like every other vaccine, it is really, really important that
once demonstrated to be safe in children that children get
vaccinated.
The good news, the CorbeVax vaccine at least I know now has
been put into, as I said, 15 of 16 million children, but, more
importantly, just been approved I think from 5 to 11 years.
With regard to the Chinese vaccines and the Russian
vaccines, the Sputnik vaccine, unfortunately, there is very
little publication to really--for me to as a scientist to give
you a definitive idea. The hearsay is, unfortunately, it is
less effective because, one, it is first generation, what we
would call adenovirus, which you and I have antibodies against
first-generation adenovirus.
And then, second, it is, again, the spike vaccine against
the antibodies that wane. So, unfortunately, the material that
is being sent to Africa has been a lot of the Sputnik, as well
as the Chinese vaccines, which has not been as effective.
Mr. Smith. Would the other experts, witnesses, like to
answer or weigh in on vaccines for children and the efficacy of
the Russian and Chinese?
Dr. Bottazzi. If possible, Congressman, I can comment just
to expand on what Dr. Soon-Shiong mentioned about CorbeVax
that, indeed, we know Biological E, it is advancing with
studies from 5 years of age and above. We, of course, behind
the scenes, have seen the data. I think the regulators are
doing their final review in India to extend then the
authorization, which I think is wonderful news because it will,
of course, you know, also benefit that age range of population.
Indeed, they are going to be evaluating them below the 5-year
of age. I think it is also important to recognize that we can
look at below the 5-year age to evaluate their safety.
And I think I concur with Dr. Soon-Shiong that, you know,
as scientists, we do not have a lot of data with regards to the
other vaccines, but it is clear that we are seeing, based on
how Omicron has taken over, how reinfections and infections are
going on in areas where we know primarily were being vaccinated
with these poorlyactivated vaccines that, clearly, vaccines
such as CorbeVax and other strategies have to come in and
rescue, and rescue them as certainly boosters, and ideally to
also confer more durable and long-term protection, both as Dr.
Soon-Shiong mentioned in the not only humoral antibody but also
cellular responses.
Thank you.
Mr. Smith. Thank you so much.
Dr. Ogwell?
Ms. Bass. How about I move on?
Mr. Smith. OK.
Ms. Bass. Thank you, Ranking Member.
Dr. Bera.
Mr. Bera. Thank you, Madam Chairwoman.
Dr. Bottazzi, for the CorbeVax, what price point--what is
the cost to produce?
Dr. Bottazzi. Thank you for that question.
So we, based on certainly ourselves' experience of seeing
how much hepatitis B vaccines cost around the world, and
because of the type of supply chain and components that
recombinant protein vaccines have, they usually range below the
$2 per dose. Now we know that Biological E which, of course,
you know, established those price points with their own
governments and on the basis of their negotiations, have now
also shown that CorbeVax in India is less than $2 per dose.
So I think that it is something that is very aligned to the
platform that it uses. We could possibly go even lower, but as
you know, adjuvants, especially new proprietary adjuvants, may
be the ones that are increasing the cost. But for the most
part, all of the components are not only widely available, the
cost of production uses reagents that are usually very
affordable, and that is inherent in the way that we designed
the technology to ensure that we minimize by using very
standard industry, you know, procedures that we know that they
would have access. Therefore, we do see the cost of the goods.
Mr. Bera. In your clinical trial data, what was the
efficacy--and, obviously, the safety profile was good, in terms
of efficacy?
Dr. Bottazzi. Yes. So I can speak for what--now we know
there is a couple of publications that Biological E has already
uploaded in the med archives while they are being peer-
reviewed, but the clinical strategy that they did ultimately
ended up in a phase 3 trial as a superiority trial comparing
CorbeVax with Covishield. Covishield is the AstraZeneca vaccine
produced in India, and it showed superiority, so it met the
superiority standards. And based on the correlates of
protection that Moderna and Pfizer uses with regards to
neutralizing antibodies, it showed greater than 90 percent
efficacy against the original Wuhan virus, but more than 80
percent protections against Alpha, Beta, and Delta. And now we
know also behind the scenes that it is still holding up pretty
nicely against Omicron, and I think that Dr. Soon-Shiong can
attest to that because he has seen some of this data.
The great news is that it also was superior in safety. It
showed, again, as comparison that 50 percent less adverse
reactions were observed when CorbeVax was used with regards to
safety signals. So we are very confident that it is superior.
Mr. Bera. And for CorbeVax, for manufacturing capacity, it
is older technology, so you can tap into global manufacturing
fairly easy, as compared to mRNA vaccines?
Dr. Bottazzi. Absolutely. And, in fact, what we did, we
evaluated the entire world ecosystem of who makes hepatitis B
vaccines, and that is how, in addition, of course, of working
with Biological E, we are working with Biofarma in Indonesia,
who is, right now, finishing up their clinical development, and
hopefully they will have their Halal approval this summer. We
are working with groups like Incepta in Bangladesh. And as we
mentioned, we are also now working with Botswana and the group
from ImmunityBio and Nant to also then bring that capacity to
the African continent. In addition, we are in conversations
with Argentina, with Mexico, with Panama, with Colombia, with
Vietnam.
So this is, you know, not only those who can make it, but
those who want to learn how to make it. Protein-based vaccines
can really serve as the base because if you learn how to make
that conventional traditional platform, then they can bounce
off and collaborate among vaccine manufacturers. You know, I
think it is a good way to certainly start building the
capacity.
Mr. Bera. So we in the United States have been using the
COVAX facility as a mechanism to get vaccine distribution. Has
COVAX taken a look at your vaccine?
Dr. Bottazzi. That is a very good question.
And so all of the manufacturers that we work with have an
aspiration and certainly have prior track records of having
their vaccines pre-qualified, which is one of the requirements,
of course, to be able to be then received by COVAX and then
COVAX distributed.
So all of these manufacturers are working with the World
Health Organization through their systems of how to get them to
the process. At the same time, they are working with stringent
regulatory agencies. For example, Biological E is working with
the Australian regulatory body, TGA, mostly also because it is
part of the Quad Summit Agreement that Australia was going to
support the regulatory framework to, you know, enable CorbeVax
to also reach other countries, such as the small Asian
countries supported by financiers like the Asian Development
Bank, for example.
So there are parallel mechanisms that would also enable the
quality stamp so that it can be much better received by not
only the end consumer but certainly the countries that, you
know, are aspiring to receive the vaccine.
Mr. Bera. Madam Chairwoman, thank you for indulging. If I
could last one last question?
Ms. Bass. Go right ahead.
Mr. Bera. Given, let's say, at a $2 price point--and I am
guessing that Pfizer is at--the mRNA vaccines are at about the
$20 price point in purchasing?
Dr. Bottazzi. I believe that based on what I have seen in
the UNICEF tracker, that is approximately--you are correct.
Mr. Bera. So we--and efficacy is very similar, and we as
the stewards of the American taxpayer are to make a decision on
how we can purchase and ramp up as much as possible. And it
would be very difficult for other countries to quickly stand up
and run production facilities that they will be starting from
scratch. We, as the U.S. Government, ought to be looking at,
you know, CorbeVax and others. Would that be an accurate
statement?
Dr. Bottazzi. We would be honored to find a partner within
the United States that could--similar to what we are working
already with Nant and ImmunityBio, could enable possibly the
access of producing more vaccines that could even be eventually
then evaluated within the regulatory framework of the United
States. I think it will come and certainly address the
hesitancy gap that we are seeing in the U.S. It may increase
the access, especially for pediatric vaccinations, and give an
option also for booster strategies within not only the U.S.,
but maybe even other countries like Canada or even European
countries that may find a value of bringing an alternative
technology.
We just need to, of course, not only--our priority,
Congressman, is low-, middle-income countries, right, that we
need to bridge that gap. That is the ultimate, you know,
essential because we want to really block this virus to
continue mutating. But there is a huge value of also being able
to do this with partners here in the United States and other
countries.
Mr. Bera. Dr. Soon-Shiong, it looks like you had a
question.
Dr. Soon-Shiong. Yes, I just want to react to that. You
now, quietly behind the scenes, we have actually built that GMP
facility both now in Colorado, and now just acquired a massive
facility in Dunkirk, Buffalo, New York, so that this CorbeVax-
type recombinant protein, together with the next generation
adjuvant can be made.
So that is a reality now. We are doing this, again, without
any support, without any financial support, and the opportunity
for us to create this national preparedness and, as you heard,
100 million doses per month is a real easily scalable
opportunity here.
I have then taken that same opportunity and gone into
Capetown and gone into Gaborone, and the two plants are already
there now in which we are doing the same thing.
So I think you are right. I think we are--the Congressman
talked about, you know, the dogma of thought, and the absence
of, you know, looking beyond the opportunity is really
frustrating from our perspective. But the good news is we have
taken action, and we have now both a large scale GMP facility
in the West Coast as well as the East Coast of the United
States.
Ms. Bass. I am going to go to Representative Jackson Lee,
and then we will wrap up with the ranking member.
Ms. Jackson Lee.
Ms. Jackson Lee. Thank you, Madam Chair.
And the previous discussion was insightful and inciting,
almost got a medical school tutorial there. It was extremely
informative.
But let me pose the questions to, again, our scientists,
Dr. Soon-Shiong and Dr. Bottazzi. How important--I am reminded
of the efforts that we made in Houston with Dr. Peter Hotez and
your team, Dr. Bottazzi, to reach out to the
[inaudible] Construct in the past Administration, and it
was extremely difficult and nonresponsive. Seemingly, over and
over again, we attempted to get them to understand the
importance of the work being done.
But let me say to both of you how important is it for there
to be some governmental, Federal Governmental partnerships in
the work that you are doing?
Dr. Bottazzi?
Dr. Bottazzi. Thank you, Representative Jackson Lee.
I think it is very important. It is very important because,
ultimately, it really brings the sustainability, you know, and
the shared responsibility and accountability of enabling that
these types of solutions eventually reach the people that are
in need. And we are very appreciative and very excited to be
working with groups such as the group from Dr. Soon-Shiong.
But, ultimately, you know, it is all leaving the responsibility
to the private sector, and I think we need to break the
paradigm where if we want to see progress, we need to not only
bring the government, bring certainly the research academic
institutions, bring all of the different stakeholders to
diversify and balance the way that we do science, and really
change this paradigm and look at it where not only the big
multinationals have the capacity or the interest, but, clearly,
even from the roots of, you know, a research center in a
children's hospital in Texas is able to play in the big
leagues, right? And then partnering, you know, doing very
unique but, at the same time, very selective partnerships,
transparent and certainly open that we are like-minded, we have
been able to advance this work where, as you said, maybe we did
not get the recognition nor the support as we should have.
Thank you.
Ms. Jackson Lee. Thank you. Thank you so much.
Dr. Ogwell--and I do not know if Dr. Soon-Shiong is still
there or had to depart. But we are expecting in the United
States another Omicron surge about mid-April as my facts seem
to indicate.
I would like you to comment on the impact of a surge or a
spread in one continent that can ultimately impact Africa. And
can you tell me, do you think the numbers of infection and
mortality may not have been accounted for and that you may have
had more deaths on the continent and more infection on the
continent than have been accounted for just because of the
largeness and other difficulties in getting reporting?
Dr. Ogwell.
Dr. Ogwell. Thanks. Thank you, Representative Jackson Lee.
The facts on the last question, if there is a surge
anywhere in the world, due to the way in which goods and,
particularly, human beings travel, it really easily will be
able to cross borders, and even continents to another part of
the world. So any site anywhere becomes a risk for anywhere
else, including Africa.
You know, as far as the unaccounted for numbers are
concerned, sero surveys are showing us that the testing,
testing numbers are certainly not giving us the exact figure.
We have seen testing numbers that are lower than the reality of
the sero surveys.
As far as deaths are concerned, this is something that we
are still looking at to see what the excess deaths actual rate
is. We do not have those figures yet. But, clearly, looking at
the testing figures being lower than the actual, we expect that
the death rates also will be able to be different, but we do
not think it will be by a huge amount. It will not necessarily
change the fact that Africa has seen there to be lower deaths
during this pandemic.
Thank you.
Ms. Jackson Lee. Dr. Soon-Shiong, you are here, and so let
me give to you the issue or the question of the importance of
government collaboration on some of the work that you and Dr.
Bottazzi are doing. But I also want you to comment on the
reality of the fact of this new Omicron. This infectious
disease, this COVID-19, is this here to stay with us? Is this
going to be--even though your technology suggests that it can
be obliterated, but in any event, it seems that it is a growing
phenomenon that it goes from one continent to the next in terms
of intensity.
Doctor?
Dr. Soon-Shiong. Sorry. I think I lost connection for a
second.
Ms. Jackson Lee. Did you hear my question?
Dr. Soon-Shiong. Sorry. Go ahead. Sorry. I just lost
connection for a second. If you could repeat the question.
Ms. Jackson Lee. No problem, with the chairwoman's
indulgence.
I asked the question, the importance of governmental
collaboration between your work and, of course, Dr. Bottazzi's
work. I know the difficulty we had in the last Administration
to get any intention on some of these research reproaches, but
the importance of that.
And then, can you give us an assessment about Omicron's
seemingly long-lasting ability to thrive and grow? You do have
research that suggests that you have an approach to that, but
it does seem to reinvent itself because we are expecting a
surge of Omicron here in the United States which, obviously,
will impact the rest of the world.
Dr. Soon-Shiong. Thank you, Congresswoman. It is a really
important question with regard to the importance of the
government participation.
We suffered from the absence of that because, frankly, it
is a catch-22. Without any support, we were then denied access
to the thing called the DPAS. Without the DPAS, we couldn't
even get supplies, even if we paid for it ourselves. So, yes,
it is really critical for both of us to have government support
and participation.
With regard to the Omicron, it is really very real. The
Omicron B2 now is--what is very scary is if the recombination
of what we call the Delta together with the Omicron, on the one
hand, you get an increase in effectivity (ph); on the other
one, you get increased diving into the lungs and increased
toxicity.
So very much like AIDS, I worry that this virus then will
hide. And, again, very much like with AIDS, unless you have a T
cell--again, I sound like a broken record. We, in our body,
have two cells, one called a natural killer cell; the other one
called a T cell--that we were born with, God-given protection
against viruses and infection. If we can activate those,
educate those, which is exactly the strategy we have taken for
cancer, as well as for COVID and HIV, we have a way to actually
rid ourselves, rid our bodies of this virus, rather than it
hiding.
So, yes, both of those are important questions. And my
level of frustration is I think there are scientific answers to
this problem.
Ms. Jackson Lee. Let's hope we have given you a glimmer of
hope. Again, let me express my appreciation to all of the
witnesses and the chair for--this is a vital hearing, and I
think we cannot move soon enough on our letters, and maybe an
approach to the Administration, that I know is very eager to do
what is right with their COVID-19 task force, to see some of
this brilliant work that is being done, that maybe we can move
that aspect as well, Madam Chair, in terms of their interface
with government collaboration and support as we face what it
looks to be a long journey with COVID, with Omicron, with the
Delta variant, and something that we need to get in front of.
Thank you so very much.
Ms. Bass. Absolutely.
And let me just mention that although President Masisi was
not able to be with us, I would like to, without objection,
include into the record his testimony and make sure that all of
the witnesses have his testimony as well.
Mr. Smith.
[The prepared statement of Mr. Masisi follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Ms. Jackson Lee. May I just thank--may I just give a
special appreciation to President Masisi, since he was in my
community and has been a leader in these issues?
Ms. Bass. Sure.
Ms. Jackson Lee. Thank you so much.
Ms. Bass. OK.
Mr. Smith.
Mr. Smith. Thank you so much, Madam Chair. Thank you for
another great hearing. I think this was very insightful, gives
us items to work on and to expand.
And, you know, I would just say to Dr. Bottazzi, thank you
for your tremendous work. You know, I have had Dr. Hotez at two
of my hearings previously on neglected tropical diseases. When
I read his book--I actually read it twice--it just blew me away
with his expertise, but also the incidents, the prevalence of
worms and everything else here, all the neglected tropical
diseases that are out there.
And Karen and I actually authored a law. We tried to get it
passed through the normal route, couldn't do it, for whatever
reason, the Senate, but we added it to a must-pass bill, and it
is now law to further expand the efforts on neglected tropical
diseases. But it was all inspired by Dr. Hotez, so I do thank
him for that.
And, again, I would like unanimous consent--ask unanimous
consent to a letter to President Biden signed by 14 members of
the Texas delegation asking that the CorbeVax be looked at. You
know, it points out 300 of that vaccine have been purchased by
the Indian Government, pre-purchased, and I would ask that it
be made part of the record.
But, again, thank you, Karen. Thank you, Madam Chair, for
another great hearing.
I yield back.
[The information referred to follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Ms. Bass. Absolutely.
Well, let me just thank our witnesses, one, for bearing
with us. We went over time, but I think that this hearing was
so rich that we needed to spend a little extra time and give
members extra time to ask questions. But we will followup with
you because you have raised several points and I think you have
provided a little bit of a roadmap for us, and so, we will
followup with each of you to get your specific recommendations
quantified a bit more.
So with this, I would like to call the hearing adjourned.
[Whereupon, at 4:19 p.m., the subcommittee was adjourned.]
APPENDIX
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
OPENING REMARKS FROM CHAIRMAN BASS
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
RESPONSES TO QUESTIONS SUBMITTED FOR THE RECORD
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
[GRAPHIC] [TIFF OMITTED] T7168.035
[GRAPHIC] [TIFF OMITTED] T7168.036
[GRAPHIC] [TIFF OMITTED] T7168.037
[GRAPHIC] [TIFF OMITTED] T7168.038