On Friday, Pfizer/BioNTech has initiated its application to the US Food and Drug Administration for full FDA approval of its Covid-19 vaccine for people ages 16 and older, the companies said.
This is the first Covid-19 vaccine in the United States to be assessed for full approval from the FDA.Pfizer’s mRNA two-shot vaccine is currently being used in the US under emergency use authorization (EUA) from the FDA. The companies say 170 million doses of the vaccine have been distributed across the US to date.
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, chairman and chief executive officer of Pfizer, said in a statement.
“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.
“To apply for full FDA approval Pfizer/BioNTech submitted a Biologics License Application, known as a BLA. The FDA requires vaccine manufacturers submit data on manufacturing processes, facilities and additional information that demonstrates that the vaccine can be produced reliably and consistently. They are also required to submit all pre-clinical and clinical trial data.
Pfizer/BioNTech will submit that information to the FDA over the next few weeks on a rolling basis. Once all the required information is submitted, a goal date will be set for a decision by the FDA.
Pfizer/BioNTech has requested priority review, which asks the FDA to take action within 6 months, compared to the 10 months designated under standard review.The application to the FDA is only intended for adults 16 and older. Pfizer/BioNTech is simultaneously applying to expand its EUA to include children ages 12 to 15.
The companies then plan to submit an additional BLA to cover this younger age group once the essential data has been collected six months after administering second doses.