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 Friday. 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 (BLA), which is "a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce," according to the FDA website. 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.
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The vaccine, named BNT162b2, was the first Covid-19 vaccine to be awarded emergency use authorization in December. It was also the first Covid-19 vaccine to receive regulatory clearance in the US, after the company applied to the FDA for emergency use authorization in December. As a condition of the EUA, the companies were expected to work towards full approval from the FDA.
Clinical trials and recently published real-word data show the vaccine is up to 95% effective at preventing infection, severe illness and hospitalization. Pfizer/BioNTech reported last month that trial results show the vaccine remains more than 91% effective against disease with any symptoms for six months.
Recent research suggests the vaccine is effective against some worrying virus variants, and Pfizer/BioNtech is currently testing booster and variant-specific vaccines.
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