Pfizer, BioNTech request FDA full approval of their Covid-19 vaccine

Pfizer, BioNTech ask FDA for full approval of Covid-19 vaccine If granted, the Pfizer vaccine would be the first in the U.S. to be fully approved. NBC News

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.

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. ...

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 auth ..orization for its Covid-19 vaccine for children ages 12 to 15 within the coming week.