Pfizer takes first steps to apply for full FDA approval of its COVID-19 vaccine

Vaccine currently only approved for emergency use
Posted at 7:20 AM, May 07, 2021

Pfizer and BioNTech have taken the first steps with the Food and Drug Administration to seek full approval of their COVID-19 vaccine in the U.S. for people 16 and older.

Currently, the Pfizer vaccine — and all other COVID-19 vaccines — are only being administered under emergency use authorization. Pfizer is the first company to seek full approval from the FDA.

In its press release Friday, Pfizer and BioNTech said that more than 170 million doses of its two-shot vaccine have been distributed in the U.S.

“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,” Albert Bourla, Pfizer’s chairman and CEO said. “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.”

According to the press release, Pfizer and BioNTech initiated a Biologics License Application with the FDA on Friday. The FDA's website says that a BLA “is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce.”

According to CNN, the companies will submit information to the FDA over the next few weeks on a rolling basis. Once the FDA has the required information, it will set a goal date for a decision. Pfizer has asked that a decision be expedited to six months rather than the typical 10-month time period.

Pfizer also said Friday that it had submitted an application to the FDA seeking to have its COVID-19 vaccine made available by emergency use for kids aged 12 to 15.

Pfizer’s vaccine was the first to be cleared for emergency use by the FDA and the CDC. Studies published Wednesday show that the Pfizer vaccine is extraordinarily efficient in protecting against severe cases of two common COVID-19 variants, the B.1.1.7 variant and the B.1.351 variant.