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 Peter Marks, director of the Food and Drug Administration's Center
for Biologics Evaluation and Research, made the statement in
response to concerns raised on a conference call late last week of
government officials, pharmaceutical executives and academics who
serve on a vaccine working group organized by the National
Institutes of Health, according to three sources familiar with the
matter.
When contacted by Reuters, Marks confirmed the account.
Scientists, public health officials and lawmakers are worried that
the Trump administration will pressure the FDA to authorize a
COVID-19 vaccine in advance of the November presidential election,
even if data from clinical trials do not support its widespread use.
Marks told Reuters he has not faced any political pressure and that
the FDA would be guided by science alone. Should that change, "I
could not stand by and see something that was unsafe or ineffective
that was being put through," Marks said.
"You have to decide where your red line is, and that's my red line,"
he said. "I would feel obligated (to resign) because in doing so, I
would indicate to the American public that there's something wrong."
He added that he would equally object if someone sought political
gain by holding up approval of a vaccine that was shown to work, and
that was safe.
Michael Caputo, assistant secretary for public affairs at the
Department of Health and Human Services, which oversees FDA and NIH,
said the government aims to identify a safe and effective vaccine by
January 2021.
Speculation about the FDA approving a vaccine under political
pressure "only undermines confidence in the public health system,"
Caputo said in a statement. "I've never met one FDA regulator who
wouldn't resign over improper pressure, and that's how America knows
their seal of approval is the gold standard."
The FDA declined to comment on the meeting.
President Donald Trump's approval ratings have fallen sharply in the
wake of a pandemic that has killed more than 173,000 Americans and
infected over 5.5 million. The race to produce a vaccine has become
the centerpiece of his administration's response.
Earlier this month, Trump said a vaccine was possible before the
Nov. 3 vote.
In a statement on Thursday, FDA Commissioner Stephen Hahn said that
under Marks' leadership, the agency's scientists are monitoring the
COVID-19 vaccine trials, "the data from which will be the deciding
factor for any FDA approval."
Anthony Fauci, the nation's leading infectious disease expert, has
also said publicly that political considerations will not influence
any decision on a coronavirus vaccine.
OCTOBER SURPRISE?
Large-scale clinical trials of the leading vaccine candidates from
Moderna Inc <MRNA.O>, Pfizer Inc <PFE.N> and AstraZeneca Plc <AZN.L>
were launched in recent weeks.
The FDA has scheduled a meeting of its advisory committee of outside
experts on coronavirus vaccines on Oct. 22.
Marks said the trials were enrolling volunteers "reasonably well"
and that it was "possible" data could be available to interpret as
early as October. If not, the committee could still discuss broader
regulatory issues regarding a vaccine, he said.
On the NIH call with members of its vaccine working group on Aug.
14, some participants asked whether it was realistic to expect
sufficient safety and efficacy data from those trials before the
election, the sources familiar with the matter said.
The discussion then turned to concerns about a so-called October
surprise announcement, in which the Trump administration rushes to
unveil a vaccine candidate, the sources said.
At that point, they said, Marks told participants on the call that
if the FDA were pressured to approve a vaccine without enough
evidence of it being safe and effective, he would resign.
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"It was pretty dramatic," one of the sources said. "It was a bold statement."
EMERGENCY USE
The U.S. government has invested nearly $11 billion to help develop and
manufacture more than half a dozen coronavirus vaccine candidates. Fauci has
said the project, dubbed Operation Warp Speed, could identify a successful
vaccine by January 2021 and provide tens of millions of doses early in the year.
Marks, a hematologist, has worked at FDA since 2012 and oversees a division
responsible for regulating cutting-edge biotech treatments, vaccines and gene
therapies.
The agency's commissioner Hahn, a political appointee, typically has the power
to issue an emergency authorization for a vaccine, expediting the traditional
approval process in situations like the current pandemic.
Marks is the top FDA scientist involved in the process, charged with making a
recommendation on any potential vaccine candidate. The Health and Human Services
secretary could also overrule any FDA decision, Marks said.
Earlier this year, the FDA gave emergency authorization for hospitals to use
malaria drug hydroxychloroquine as a COVID-19 treatment after it had been touted
by Trump. The agency later withdrew the authorization after data showed
hydroxychloroquine was of no benefit and could harm some patients.
Hahn, Marks and another FDA official penned an article in the Journal of the
American Medical Association this month acknowledging public anxiety about
lowering regulatory standards to approve a coronavirus vaccine.
"FDA is committed to ensuring that any vaccine is manufactured in accordance
with all of FDA's quality standards and that its safety and effectiveness are
verified before being authorized or licensed," they wrote.
The officials also pledged that the FDA's vaccine advisory committee would
conduct a "transparent discussion" in advance of any vaccine authorization or
license.
It is unclear whether any of the vaccine trials will enroll enough subjects and
yield meaningful data for the FDA to review ahead of the U.S. election.
AstraZeneca could supply the first doses of its vaccine to the United States as
soon as October, "assuming FDA approval of safety and efficacy or emergency use
authorization of the vaccine," a company spokesman said in a statement to
Reuters. He declined to address whether AstraZeneca would have sufficient data
to submit to the FDA by then.
"It is important to remember that -- while the data so far is certainly
encouraging -- there is no guarantee that this vaccine will ultimately be
approved or granted an emergency use authorization," the spokesman said.
Pfizer said in a statement that it expects to file with the FDA for emergency
authorization or "some form of regulatory approval" as early as October. Moderna
did not immediately respond to a request for comment.
Kathryn Edwards, former chairwoman of the FDA's vaccine advisory committee and
scientific director at the Vanderbilt Vaccine Research Program, said she does
not believe the group would allow itself to be strong-armed into recommending a
candidate if the data is inadequate. "If it is not done right, there will be
such a hue and cry from the scientific community that it will be clearly heard,"
she said.
(Reporting by Dan Levine in San Francisco and Marisa Taylor in Washington;
Editing by Michele Gershberg and Daniel Wallis)
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