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"There has to be substantial evidence of efficacy for adequate
and well-controlled clinical trials. That means at least one large,
well-controlled, randomized, Phase 3 trial.
"If we all want to get back to our lives as we would like them to
be, we're going to have a vaccine that probably has somewhere on
the order of 70% to 80% efficacy. I'd love it if it had more, but if
it has at least 70% or 80% efficacy - and we can get 70% to 80%
of people to take it - we might be in a place of herd immunity.
"We spend a lot of time making sure we do not let history
repeat itself and we care a lot about manufacturing quality, we care
about safety and efficacy, and in this case, post-market surveillance,
important for vaccines, will take on a heightened importance for a
COVID-19 vaccine."
Operation Warp Speed
Messonier: "Our partners in Operation Warp Speed assure us
that some vaccine will be available this calendar year in 2020. But
we expect the quantities of vaccine will be limited."
Cohn: "The manufacturers have been contracted by Operation
Warp Speed to produce up to 100 million doses each of vaccine. We
are also contracting out putting together ancillary supplies, which
include PPE, sent to a centralized distributor, so that when vaccine
shows up to your office, it includes all of the ancillary materials, such
as needles and syringes you will need to administer the vaccines."
Johnson: "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, etc.
"And that's the health department's job: counter some of that
information to reassure people that things have not been shortcutted,
the vaccine's been studied and these are the results. And those are
messages that we will release, for certain."
Steps before the vaccine can be released to the public
Tsou: "The committee has to make recommendations on who will
get the vaccine first when scarce supplies are available. The Philadelphia
Health Department is making preliminary recommendations to the
CDC, according to what I understand. I do not know what they will
be recommending. The rest of the state, beyond Philadelphia, will
be following the recommendations from the Pennsylvania Health
Department. There is an entire communication effort on getting
the vaccine out when it becomes available. It is likely that health
care workers will be a top priority, especially those working with
COVID-19 patients and in the ER.
Johnson: "How do we reassure the public? It's very important. I
think those are the kinds of messages to send as soon as the vaccine
is available.
"I think that having the best strategy overall is to just help the

12 Philadelphia Medicine : Fall 2020

public understand how beneficial the vaccines are generally. Reaffirm
faith that we don't have measles epidemics, at least we don't have
them in Philadelphia, because everybody's vaccinated. We don't
have complications of the vaccine and we don't have deaths from
measles. We just need to keep reminding people about the proven
safety and efficacy of vaccines.
"The best predictor to getting a person to accept a vaccine is to
have a strong recommendation from the medical providers."
Marks: "We at FDA are very committed to doing whatever we
can to gain back the public's trust in vaccines. For us, that means
doing our job, which is making sure that whatever comes out of
this process is safe and effective and has 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."
Barriers to the release of a vaccine
Tsou: "The vaccine manufacturers have said that they will not
apply for FDA approval until Phase 3 trials show safety and efficacy."
Bailey: "In the process of the pandemic and in the search for
therapeutics and vaccines, unfortunately the FDA and the CDC
have really taken some hits and the public has lost confidence in
the credibility of the FDA and the CDC. How do we get this back
and how do we convince our colleagues as well as our patients to
take the vaccine, which we hope will be very safe and effective in
this type of skeptical, doubting climate?"
Marks: "We don't look from side to side, we look straight ahead
at public health. We are here to make sure that our greater American
family gets the same quality, safe, effective vaccine that we want for
our own families. We will do this in as public a manner as we can."
Vaccine released to the public
Tsou: "I don't think anyone knows the answer. The President
hoped it would be before Nov. 3, but most experts think it will be
December or later."
Johnson: "I think that we will probably see some vaccines in
December with small amounts for the highest priority groups. There
will not be a public release of vaccine, for the more general public,
until 2021."
Marks: "I agree with Dr. Tony Faucci, it is probably more likely
we will see something in the November-December timeframe.
"Barring some safety concerns that we don't know about, I would
be hoping that we start to see something - I don't know for sure - but
I would think the probability increases to a reasonable likelihood that
we will have something before the end of the year. It's speculation and
a bit of wishful thinking, but I think it is informed speculation." *
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