Philadelphia Medicine Fall 2020 - 13

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Vaccine technologies
According to the FDA, vaccine technologies that have been used
include DNA vaccines and RNA vaccines. The two most advanced
candidates in the U.S. are RNA vaccines, Marks said. There are
protein subunit vaccines coming up quickly in development.
Outside of the U.S., in both China and Europe, there are
inactivated virus vaccines being developed, the FDA noted.
"We asked for these trials to at least be the size of other safety
data sets that we have," Marks said. "That is at least several thousand
people: a minimum of 3,000 (patients) 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."

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Trying to figure out what roles that multiple vaccine programs
will have is uncharted territory for the FDA and other organizations.
"What are we going to do after the first effective vaccine becomes
available?" Marks said. "What do we do for the second one? How
do we try to keep getting safety data in a robust manner? How
do we go about the best way of collecting that post-deployment
safety data?"

Keep politics out
During the AMA webinar, Bailey noted that, during the first
Presidential debate in September, President Trump said a vaccine
would be ready and available in a few weeks.
"We've heard in the past that he said it would be ready by
election day, and of course this is at odds with what we hear from
the scientific community," Bailey said. She asked Marks: "Who is
ultimately driving the vaccine approval process? How can physicians
be assured that politics don't impact the approval process, and how
do we assure our patients about this?"
Marks said the FDA commissioner is committed to keeping
politics out of the process.
"The secretary of health and human services testified before
Congress that politics will stay out of this," Marks said. "You have
my word, to the extent that anyone will listen to me, that politics
is going to stay out of this process.
"We have an incredible staff of career scientists who are infectious
diseases physicians, with a statistician along with risk communicators
who are all working on this. By necessity, they need to be the ones
to look at this and who make this determination about whether the
vaccine is safe and effective. They will do that in conjunction with
our manufacturing experts who come from a variety of different
disciplines, who will make sure this vaccine, whatever it is, is of
very high quality.
"If I can ask for anything, it would be that everyone would take
a pledge to stop politicizing vaccines. This is just too important
for all of us."
In fact, Messonnier of the CDC believes all are looking forward
"to having a vaccine soon that will be available for kids."
Will the FDA adopt a fast-track process for vaccines in the future?
"That question keeps me up at night," Marks said. "It's not quite

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a 24/7 shop, but we are at 20- to 22-hour-a-day shifts. We couldn't
continue this breakneck pace after COVID-19. But there will be
elements we will continue on with."

Co-immunization
Johnson noted there is very little information about whether an
individual can receive a COVID-19 immunization at the same time
a regular flu shot is administered.
But she believes that both are important.
"For the most part, vaccinations do not seem to have contraindications
for other vaccines," Johnson said. "There are some rules about vaccines
that can be given simultaneously. I know that you usually do not give
a lot of virus vaccines together. I don't think that we know right now
whether we'll be approved that you give the flu vaccine at the same
time that you give the COVID-19 vaccine. There is no information
because there is no vaccine out there for COVID-19. There is no
information about the timing of flu vaccines and COVID-19 vaccines."
She said that the worst-case scenario is that you'd separate them
by a couple of weeks.
Johnson said: "I would not give medical providers any guidance.
Right now we don't know."
"This is not just like the flu vaccine," Johnson said. "And of course
there is a second dose, so we have to set up a callback mechanism.
It's not just about how much vaccine shows up. It's also about how
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Philadelphia Medicine Fall 2020

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