2023.02.23 - Response Letter

Steve Bjornson Pfizer Inc
Vice President & COO 235 E. 42nd St.

Vaccine Research & Development New York, NY 10017
February 23, 2023
The Honorable Ronny Jackson

446 Cannon House Office Building
Washington, D.C. 20515
Dear Representative Jackson:

Thank you for your recent letter regarding the research and development of our COVID-
19 products. We appreciate the opportunity to discuss our COVID-19 research.
The research work we do at Pfizer is done to develop the safest and most effective
medicines and vaccines to help protect people. As part of standard scientific practice,
Pfizer adapts viruses to ensure the ongoing effectiveness of our vaccines and medicines
as new variants emerge. We urgently try to understand how the virus has and could adapt
naturally and the impact this could have on the effectiveness of vaccines and medicines.
This work is done in a well-controlled and restricted research environment. These studies
are required or recommended as part of the development of COVID-19 vaccines and
medicines by FDA, European Medicines Agency, Japanese Medicines Agency, and other
global regulatory authorities. Many other companies and academic institutions do this
work and have for over a century – dating back to the work of Pasteur – for the
development of vaccines and medicines.
As a global company whose mission is developing breakthroughs that improve patients’
lives, Pfizer conducts our research following stringent safety standards, including
requirements for working with SARS-CoV-2. To be clear, we do not, and never would,
engage in research to create or adapt viruses with the intention of making them more
contagious or harmful to people.
* * *
Our Vaccine and Oral Treatment Research Related To Naturally Emerging Variants
In the ongoing development of the Pfizer-BioNTech COVID-19 vaccine, Pfizer has not
conducted gain-of-function research with SARS-CoV-2 for any potential use in humans,
laboratory animals or to use as a vaccine. When a new SARS-CoV-2 variant of interest
or concern emerges and is identified by public surveillance systems and health
authorities, Pfizer studies any changes in the spike protein to understand whether an
update to the vaccine might be required. We do this by adapting the virus in a highly
secure lab so that the spike protein matches the newly identified circulating variants. This
is done to mimic viruses that are already circulating in nature. This type of work is scientific
best practice and is commonly conducted by other companies, institutions and public
health authorities. It is necessary both for assessing the effectiveness of existing vaccines
and new vaccine candidates targeted at currently circulating variants. In fact, we
developed the current bivalent vaccine as a result of this research. We submit key results
of our variant research to government agencies and publish them for the scientific
community.
We also evaluate variants circulating in the real world to assess the effectiveness of our
COVID-19 oral treatment, Paxlovid. The concern for antiviral medicines is that resistance
will develop, making the medicine ineffective. We have seen this resistance previously in
HIV and Hepatitis C, and most recently with COVID-19 antibodies. Part of our medical
responsibility is to continually assess the possibility of Paxlovid resistance. This is
required by global regulatory agencies—including the FDA, European Medicines Agency,
Japanese Medicines Agency among others. We appropriately submit data from these
assessments to these agencies and publish key results for the scientific community. We
undertake these assessments by adding the active ingredient in Paxlovid to cells infected
with COVID-19 virus in a laboratory culture dish and then testing to see what changes
emerge in the main protease of the virus (the target of Paxlovid). As we have previously
indicated, we then isolate the new viruses from these studies, or adapt viruses with
targeted changes in the main protease, and test to see whether Paxlovid is still effective.
All of this work is done in highly secure laboratories, and we have not studied these
adapted COVID-19 viruses in animals. To date, there is no evidence of clinical resistance
to Paxlovid. Again, these studies are required by global regulatory agencies and follow
well-established protocols under strict safety conditions and are used by other institutions
and companies around the world.
Our Commitment to Safety
Pfizer strictly adheres to policies at the institutional, state, federal and global levels that
help ensure that virus research is conducted ethically, safely and securely. The research
we described above is conducted in Pfizer’s highly secure Biosafety level 3 laboratory,
whose operations have oversight by the CDC. It is carried out by highly trained
professionals who comply with strict physical containment procedures to ensure physical
containment of all pathogens.
Pfizer is dedicated to conducting research in an ethical and responsible manner. We have
an unwavering commitment to keeping high standards of safety, quality, and compliance
at the forefront of all we do. The pharmaceutical industry is one of the most stringently
regulated industries in the world and rightly so as patient safety is key. All Pfizer products,
including our COVID-19 products, underwent rigorous regulatory agency review prior to
authorization.
Our Continued Investments in the Fight Against COVID-19
Pfizer has a deeply held belief that it is our responsibility to rapidly develop and deploy
vaccines against emerging viruses that might lead to future pandemics.
Pfizer did not receive government funding for the development of the COVID-19 vaccine
or Paxlovid. The funds received by Pfizer from the U.S. government were payments for
products that the government procured. Any suggestion that these payments represent
government support of the development and production of our COVID-19 products is
simply incorrect. We have invested from our own resources at risk and we plan to continue
the development and manufacture of COVID vaccines and therapeutics.
* * *
Thank you again for your letter. 1 Pfizer is dedicated to conducting research in an ethical
and responsible manner. We have an unwavering commitment to keeping high standards
of safety, quality, and compliance at the forefront of all we do. We appreciate the
opportunity to engage with you on these important issues.
Sincerely,
Vice President & COO

Worldwide Research, Development & Medical
Vaccine Research & Development
Pfizer
1
In responding to your letter, Pfizer has used its best efforts to be as accurate and responsive as possible
based on our understanding of the terms used in your letter. The representations herein are based on
Pfizer’s current information and belief. In providing information in response to your letter, neither Pfizer,
nor any of its affiliates, waive, nor intend to waive, any rights or privileges with respect to your letter,
including any applicable attorney-client, work product or other evidentiary privilege, or any objection to
your letter’s requests.

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Steve Bjornson Pfizer Inc

Vice President & COO 235 E. 42nd St.

February 23, 2023

The Honorable Ronny Jackson

Dear Representative Jackson:

Vice President & COO

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