FDA Head Defends Covid-19 Vaccine-Approval Process
By Thomas M. Burton
WASHINGTON -- Food and Drug Administration Commissioner Stephen
M. Hahn defended his agency's vetting process for Pfizer Inc.'s
Covid-19 vaccine, saying a thorough and meticulous review is needed
to assure a skeptical public of the vaccine's safety and
In an interview with The Wall Street Journal, Dr. Hahn said his
agency has had 150 people working days, nights and weekends in
parallel teams to review the test data submitted by Pfizer and
German partner BioNTech SE.
The FDA has also scheduled a meeting of an outside advisory
committee for Dec. 10 to review the test data, which Dr. Hahn said
was another step taken to assure the public amid concerns that the
FDA might rush approval.
"We realize there is an issue in the U.S. around vaccine
hesitancy. There have been concerns raised about the speed with
which Covid-19 vaccines have been developed," Dr. Hahn said. "This
will meet our gold standard of safety and efficacy that the
American people have come to trust."
Dr. Hahn's comments came on the day that British regulators
cleared the Pfizer vaccine for general distribution. A day before,
Dr. Hahn had been summoned to the White House by President Trump's
chief of staff, Mark Meadows, to explain why the FDA wasn't acting
as quickly as the British.
Both men declined to discuss their conversation, but in the
interview Dr. Hahn said the FDA was working as fast as it could to
confirm that Pfizer's vaccine is as safe and effective as the
company has claimed.
Since Pfizer submitted its application for FDA vaccine
authorization on Nov. 20, agency vaccine analysts have been looking
at questions such as whether there are differences in how different
ethnic and age groups respond. The agency has been looking at the
results of about 44,000 study patients.
Even though the FDA has sped the authorization process because
the Covid-19 pandemic has already killed more than 250,000
Americans, that faster process still will require "clear and
compelling evidence of safety and efficacy in at least one Phase 3
[late-stage] clinical trial, " he said.
The companies have said the vaccine is about 95% effective in
preventing the coronavirus-caused disease.
The FDA staff have been looking at individual patient data to
ask whether its statisticians come to the same conclusions as the
companies did. The process is one that "typically would take us
months," Dr. Hahn said.
Groups have been working in shifts, nights and weekends, looking
in parallel at issues of clinical effectiveness and safety, and of
levels of antibodies to confirm the way the vaccine is working.
In addition to its own analysis, the FDA has scheduled the Dec.
10 meeting of the advisory committee of medical experts, and agency
officials have said they expect to reach a decision within three to
four days after the meeting.
Preparing the agency's analysis and documents to be made public
before the meeting has been time-consuming, Dr. Hahn said, but he
added that "we felt it was important to have that independent body
take a look at it."
Such advisory committees' advice normally is followed by the
FDA, though not always. In this case, with efficacy of about 95%
and a disease rampant among the public, it would appear unlikely
that the FDA wouldn't authorize a vaccine.
A second vaccine from Moderna Inc. also is already under review
by teams at the FDA. The advisory panel is scheduled to evaluate
that application Dec. 17.
Write to Thomas M. Burton at email@example.com
(END) Dow Jones Newswires
December 02, 2020 19:24 ET (00:24 GMT)
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