Philadelphia Medicine Fall 2020 - 10

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

cover story continued

COVID-19 VACCINE: WHAT DO HEALTH-CARE
PROFESSIONALS HAVE TO SAY?
By Andy Andrews, Editor
In October, according to Bloomberg magazine, the coronavirus
crisis reached a grim milestone, with deaths surpassing 1 million
worldwide. The chief epidemiologist of China, where the pathogen
originated at the end of 2019, warned that the global pandemic is
unlikely to be contained in the near future.
Emergency authorization could grant vaccines first to health-care
workers, first responders or the elderly.

the vaccine correlates with the clinical outcomes. We don't yet know
that for the coronavirus.
"For our first few vaccines, we will have to rely on what we see in
terms of clinical outcomes. That means that we'll expect these first
couple of vaccines that come through to reach clinical endpoints as
opposed to just reaching immunological endpoints."

Messonnier: "Despite all the uncertainty, we are going to be
In a recent Pew Research Center poll, about half of U.S. adults relying on the systems that we always rely on to ensure that the
(51%) say they would definitely or probably get a vaccine to prevent vaccines that are being recommended are safe and effective, and
COVID-19 if it were available today; nearly as many (49%) say that oversight on those vaccines is vigorous and also transparent.
they definitely or probably would not get vaccinated at this time. We hope that by talking this through, we will build your confidence,
Intent to get a COVID-19 vaccine has fallen from 72% in May, a not only in these vaccines, but in the systems that are in place. Your
21% point drop.
confidence is crucial, I understand, if you're going to be able to talk
confidently to your patients about these vaccines."
When will the vaccine be released?
Here is information provided by several experts in the field who
are following vaccine development.
They are:
* Dr. Walter Tsou, interim executive director of Philadelphia
Physicians for Social Responsibility
* American Medical Association President Dr. Susan R. Bailey
* Dr. Peter Marks, director of the Center for Biologics Evaluation
and Research at the Food and Drug Administration
* Dr. Nancy Messonnier, director of the National Center for
Immunization and Respiratory Diseases, or NCIRD, for the
Centers for Disease Control and Prevention, or CDC.
* Dr. Amanda Cohn, acting chief medical officer at NCIRD and
executive secretary for the Advisory Committee on Immunization
Practices, or ACIP, for CDC.
* Dr. Caroline Johnson, acting deputy health commissioner,
Philadelphia Department of Public Health
Role in vaccine development
Marks and his team are tasked with ensuring that the COVID-19
vaccine that's ultimately produced is both safe and effective and
that it has gone through a rigorous evidence-based and transparent
process, despite the accelerated timeline.
Marks: "We at FDA are able to facilitate rapid vaccine development; for instance, for influenza vaccine, because we understand
the immune correlates for protection. What marker can we use,
be it antibody formation or some other property, be it T-cells or
others, that we can see that we know that the immune response to

10 Philadelphia Medicine : Fall 2020

Cohn: "The ACIP advises the CDC director, and upon CDC
approval, they become CDC recommendations."

Criteria for vaccine efficacy and safety
Johnson: "Mostly the frontrunners are two-dose vaccines,
particularly for the first round of immunization.
"If they're released two weeks apart, boy, does that put us in a
pickle. Because if one is better than another, what do you do with
the one product that's sitting in a freezer someplace and everybody
wants the product with the better efficacy? There are a lot of issues
that come up with having multiple products released at the same time.
"The problem right now is we don't know which vaccine we are
talking about and we actually haven't seen the safety and efficacy
data. I don't think it will be smart for us to go ahead and say, we
haven't seen any of the study results, but we're sure it's safe. We're
not going to do that."
Marks: "Based upon careful consideration and discussion, we
felt that an effective vaccine should be at least 50% more effective
than a placebo with a coronavirus infection.
"This combination ramps up the size of these trials so that they
will be robust in terms of giving us hopefully clear and compelling
efficacy data at the end of the day.
"We're allowing interim and final efficacy analysis. All trials have
interim analyses.
"For the general safety evaluation, we asked for these trials to
at least be the size of other safety data sets that we have. That is at
least several thousand people: a minimum of 3,000 for preventative
vaccines, but we usually like many more than that, if we can. And
we wanted it to have enough follow-up for safety.
continued on page 12

https://philamedsoc.org/

Philadelphia Medicine Fall 2020

Table of Contents for the Digital Edition of Philadelphia Medicine Fall 2020