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 pressure.

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 approval.

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 joseph.walker@wsj.com

(END) Dow Jones Newswires

May 07, 2021 15:43 ET (19:43 GMT)

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