Pfizer, BioNTech Ask FDA for Full Approval of Covid-19 Vaccine
By Joseph Walker
Pfizer Inc. and BioNTech SE have asked the U.S. Food and Drug
Administration to grant full approval for their Covid-19 vaccine,
which would ease restrictions on distribution and advertising and
give the vaccine the imprimatur of one of the world's most
influential regulatory bodies.
The vaccine was cleared for use by the FDA in December under an
emergency-use authorization, which allows for products to be
distributed during public-health emergencies based on the best
available evidence at the time. The authorization was granted
following a review by FDA scientists and physicians and a
recommendation by an external group of expert advisers.
The FDA typically has 60 days to accept the approval application
and up to 10 months to conduct a standard review before issuing its
decision. Pfizer and BioNTech said they have requested a priority
review for the vaccine, which should shorten the deadline for a
decision to six months.
Pfizer and BioNTech said their approval application includes
longer-term clinical trial data from more than 46,000 volunteers
that showed the vaccine was 91.3% effective up to six months after
the second of two doses. The emergency-use authorization issued
last year was based on data from about 38,000 volunteers who were
followed for a median of two months after the second dose.
Under conditions of the authorization, the vaccine only can be
distributed at the direction of the U.S. government and agencies
such as the Centers for Disease Control and Prevention. The FDA
also is permitted to restrict advertising and communications
related to the vaccine.
Pfizer and BioNTech won emergency approval from the FDA by
showing their vaccine was 95% effective in preventing symptomatic
disease after two months. The vaccine surpassed the agency's
standard that Covid-19 vaccines be at least 50% effective at
preventing disease in a placebo-controlled trial to receive an
emergency-use authorization, the same bar that must be cleared for
full approval. Emergency approval requires compelling evidence from
a large clinical trial with two months of patient data, while six
months of evidence is needed for full approval.
The emergency-use guidelines were created to allay concerns that
the agency would rush vaccines to the market under political
A Pfizer spokesman didn't immediately respond to a request for
comment on any plans the company has to sell the vaccine directly
to customers such as pharmacies and hospitals if it receives full
Pfizer executives have said that the emergency-use authorization
limits what they can do to raise awareness about the benefits of
the vaccine and instill confidence in its safety and effectiveness,
amid hesitancy by many Americans. The company said it plans to
increase its public outreach should its approval request, known as
a Biologics License Application, be granted.
"We are in a period where we are operating under an EUA....So,
there are guardrails as it pertains to that and what it is that we
can do" to drive awareness and demand, Angela Hwang, Pfizer group
president for biopharmaceuticals, said during the company's
February earnings call with analysts.
"We'll be able to do even more...once we receive [the] BLA.
We're working towards that and we will build on the education
initiatives that we already have in place, but we'll be able to
amplify that even more," she said.
Write to Joseph Walker at firstname.lastname@example.org
(END) Dow Jones Newswires
May 07, 2021 15:43 ET (19:43 GMT)
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