Philadelphia Medicine Fall 2020 - 17

p h i l a m e d s o c .o rg

End of pandemic
In the end, health-care providers will make all the difference if
and when the pandemic will end.
Health care providers are the lynchpin, critically, in the successful
COVID-19 vaccination program, Cohn said.
Vaccine misinformation has been shared with pamphlets or
other paper-based methods throughout history, Cohn said. "What
is different now is the rapidity at which information can become viral
and spread beyond a single community. A small group of individuals
can really expand anti-vaccine or vaccine misinformation."

been shortcutted and that "the vaccine's been studied and these are
the results. And those are messages that we will release, for certain."
"We at FDA are very committed to doing whatever we can to
gain back the public's trust in vaccines," Marks said. "For us, that
means doing our job, which is making sure that whatever comes
out of this process is safe and effective and is of a tremendously high
quality, and that there is very good transparency into what we've
done so that doctors and the American public can see we have done
our job correctly." *

Individuals and group influences can also inform decisions
about vaccination.
"How do we reassure the public?" Johnson said. "It's very important.
People are fearful, the general public, are fearful of a vaccine that's
being released under Operation Warp Speed, which makes me
nervous, too. Because it sounds like everything's been shortcutted
and we don't know that it is really safe."
The health department's job, Johnson said, is to counter some
of that information and to reassure people that things have not

candidates from the BNT162 program.
We decided to advance our BNT162b2
vaccine candidate into the Phase 2/3 study
after review of the preclinical and clinical
data from our Phase 1/2 clinical trials and in
consultation with the U.S. Food and Drug
Administration. BNT162b2, which received
Fast Track designation from the FDA, encodes
the spike protein that makes up the corona
or crown you have all seen in images of the
SARS-CoV-2 virus.

As with all our work to advance investigational vaccines, we will work closely with
clinical trial sites and experienced investigators
and regulatory agencies worldwide to ensure
high quality and safety standards are rigorously
applied to our development program. In
addition, an independent Data Monitoring
Committee is in place to evaluate the safety
of our vaccine candidate on an ongoing basis.
If regulatory approval or authorization
is obtained, Pfizer and BioNTech expect
to manufacture globally up to 100 million
doses by the end of 2020 and potentially
approximately 1.3 billion doses by the end
of 2021.

h regulatory authorities, including the FDA,
to progress our program while ensuring that
safety and maintaining the highest standards
in our development process is our top
priority. We will never cut corners in our
research, development, or manufacturing
efforts. Science has overcome disease before,
and it will again. It is our hope that mRNA
vaccines become one of the tools in the fight
against COVID-19.
What is your projected date for public
availability?

The trial is designed to demonstrate that
the vaccine prevents COVID-19 disease
We cannot speculate if and when our
in those who have not been infected by
candidate vaccine may receive regulatory
SARS-CoV-2 prior to immunization and
approval. Right now, our focus remains on
in all persons regardless of whether they had What are the steps involved in the release developing a safe and effective vaccine to help
previously been infected by SARS-CoV-2. of the vaccine?
end the global COVID-19 pandemic. We
Secondary endpoints include prevention of
Right now, the world is looking to science are committed to upholding the integrity of
severe COVID-19 disease in those groups. - and specifically to vaccines - to bring us the data-driven, scientific review process set
Approximately 120 clinical investigational to the other side of this pandemic. With out by global regulatory agencies, including
sites in four countries (U.S., Brazil, Argentina, increasing levels of public concern about the FDA, and are continuing to work with
and South Africa) and 39 U.S. states are the scientific and regulatory processes for agencies as our clinical trials progress. Our
participating in the Phase 3 study. Clinical evaluating potential COVID-19 vaccines, objective is to ensure rapid uptake and
investigational sites in two more countries we must recognize that safe, effective, and access for patients who will need a vaccine,
- Germany and Turkey- may be added in high-quality vaccines are important; and by ensuring early allocation of needed doses.
the near future. The latest information on now more urgent than ever to provide pro- Pfizer is committed to bringing this vaccine
the trial's progress can be found at www.bit. tection against COVID-19. Time is of the to help meet the global public health need. *
ly/PfizerTesting.
essence but we have been working closely wit

Fall 2020 : Philadelphia Medicine 17
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Philadelphia Medicine Fall 2020

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