Pfizer, BioNTech ask FDA for full approval of Covid-19 vaccine


Pfizer and BioNTech asked the Food and Drug Administration Friday for full approval of the companies’ Covid-19 vaccine. If approved, it would be the first Covid-19 vaccine in the United States to hold that distinction.

The vaccine was the first to be granted an emergency use authorization, or EUA, in December, for use in the U.S.

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Vaccines can only be authorized in this manner during public health emergencies — in this case, the Covid-19 pandemic. Indeed, all Covid-19 vaccines currently in use in the U.S. are being administered through EUAs.

Last year, the FDA said that in order to apply for an EUA for a Covid-19 vaccine, a drugmaker needed to provide two months of safety and efficacy data.

A biologics license application — needed for full approval of a drug or vaccine — requires six months of data.

“We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S. Government,” Pfizer chairman and CEO Albert Bourla said in a statement Friday announcing the application.

“We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months,” he added.

If the FDA signs off, Pfizer will be able to market the vaccine.

Full approval may also make vaccine mandates “a little more feasible,” said John Grabenstein, a former executive director of medical affairs for vaccines at Merck and a former Department of Defense immunologist. An approval could help employers decide, for example, whether to require employees get vaccinated before going back into the workplace.

The FDA is expected to take several weeks to review the application.

“Someone needs to read through all of that data,” Grabenstein said. “I think a month or two would be about right.”

To grant full approval would mean “the FDA has looked at a longer period of time after vaccination and is fully satisfied that all the I’s are dotted and that all the T’s are crossed,” he added.

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“We’re at a point where there is enormous safety data for mRNA vaccines,” said Dr. Arnold Monto, who leads the FDA’s committee of independent experts, called the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, which is often called upon by the FDA for guidance.

The Pfizer vaccine, along with that of Moderna, relies on mRNA technology, which uses bits of genetic code to teach the immune system to recognize and fight off SARS-CoV-2, the virus that causes Covid-19.

In March, the Centers for Disease Control and Prevention published real-world study data that found both mRNA vaccines reduced infections by 90 percent in fully vaccinated people. And there’s increasing evidence that the Pfizervaccine is effective against variants, including the ones first identified in the United Kingdom and South Africa.

More 132 million doses of the Pfizer vaccine have been administered in the U.S., according to the CDC.

The FDA is not required to call upon its VRBPAC members before giving full approval. Once the FDA acts, the CDC is expected to follow by saying which groups should or should not be given the vaccine.

At this point, Pfizer is only applying for full approval for people ages 16 and up.

Separately, the company is waiting on the FDA to grant emergency use authorization for its Covid-19 vaccine for children ages 12 to 15 within the coming week.

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Akshay Syal contributed.





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