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"And it may not be off. I haven't heard anything about the illness
or reaction, so I don't know," Johnson said. "They're being very
conservative with these vaccines as far as watching the outcome. So
that study may be restarted very soon."
What company will be first to have a vaccine in distribution?
And if it's a two-dose immunization, how many days apart will that
mean it will be administered?
"One of the frontrunners is the Pfizer product, and I think that
one is a 21-day and then the Moderna product is a 28-day," she said.
"But they're not going to be less than 21 days. You can't go any sooner
than that but you can go later (for the second dose)."
Pfizer and Moderna companies are the frontrunners. Johnson
believes Pfizer will be first.
In October, the FDA, according to its website, issued guidance
to provide sponsors of requests for Emergency Use Authorization,
or EUA, for COVID-19 vaccines with recommendations regarding
the data and information needed to support the issuance of an EUA
under section 564 of the FD&C Act (21 U.S.C. 360bbb-3) for an
investigational vaccine to prevent COVID-19 for the duration of
the COVID-19 public health emergency.
This guidance reiterates that any assessment regarding an EUA
will be made on a case-by-case basis considering the target population,
the characteristics of the product, the preclinical and human clinical
study data on the product, and the totality of the available scientific
evidence relevant to the product.
"Moderna has already told us they are not going to be ready for
According to Marks, the FDA has asked for a median of two
any release until December," she said. "The Pfizer vaccine could be months of safety follow-up after the final vaccination in the population
on target to release anytime in November. So that's the way it looks that's enrolled in the trials. The rationale for that, when you look
now, that Pfizer might be the first one and then Moderna the second." at other events with other vaccines, is they tend to occur within a
median of two months or before.
'Free of cost'
"The vaccine will be free of cost," Cohn said. "The product will
be sent at no charge. Providers will be able to bill for reimbursement
for the administration of the vaccine. Additional information will
be available in the next couple of weeks."
Infection control and social distancing and ultra-cold storage for
vaccines will have to be in place.
That includes areas with the least amount of good health-care access.
"We are aware that it is communities that have
the least access to health care that have been overly
impacted by the COVID-19 outbreak," Cohn said.
One clear message the CDC wants to tell
providers is that "we don't need people to stockpile
needles," Cohn said. "The needles and syringes for
all of these doses have been secured.
"Communicating about our safety monitoring
to providers, health care workers and to the public
is one of the things we recognize. We need to start
now and it needs to happen regularly and often to
assure the public we are doing everything we can to
monitor the safety of these vaccines, even after use."
"We can't compound the devastating impact of
COVID-19 by rushing in an unsafe or ineffective
vaccine to market," said American Medical Association President Dr. Susan R. Bailey.
In his role as director, 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.
"That seems like a reasonable compromise," Marks said." We are
asking the manufacturers to come in and speak with us early on and
to plan that 'pharmacovigilance.'"
Marks said the data set the FDA will need "has to be large enough
that we make sure we don't have problems that could be associated
with vaccination in this area.
"We know from viruses, like the coronavirus family, this issue of
enhanced respiratory disease could be a problem, at least theoretically,"
he said. "We need to make sure that by giving a vaccine, we're not
going to cause more problems than we started off with."
The FDA's guidance strongly recommended that
as the companies go about enrolling in these trials,
they make sure that they enroll the populations that
are really in need of a coronavirus vaccine, "because
otherwise we're not really going to be serving those
in need," Marks said.
"We ask that an adequate number of older individuals and individuals with medical co-morbidity
get enrolled in these trials, that potentially pregnant
women and women of childbearing potential be
enrolled in clinical trials. Although pregnant women
may come in a second wave, certainly women of
childbearing potential are being enrolled. We need to
have pediatric population plans and they may come
also as a second wave as we develop more confidence
in the adult population that's vaccinated."
If any possible risk is identified, it's important that vaccine
developers do additional targeted studies on vaccine candidates,
according to Marks.
"Accelerated approval will be done for a vaccine using an immune
correlative protection based on the immune response," he said.
"Now that's no easy task," Bailey said. "The work of Dr. Marks
"Until we have a better handle on how those immune correlates
and his team could not be more important than it is right now."
correspond to clinical outcomes, we're going to need to base things
on our traditional clinical end-points."
continued on page 13
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Philadelphia Medicine Fall 2020
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