[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
        
        
        
        
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Available: http://www.foreignaffairs.house.gov/, http://docs.house.gov, 

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                        ______                       


             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:]
    
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    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.
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    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:]
    
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    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
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                   OPENING REMARKS FROM CHAIRMAN BASS
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