Pfizer, BioNTech seek full FDA approval for COVID vaccine
Pharmaceutical giants Pfizer/BioNTech announced Friday that they have initiated their application to the US Food and Drug Administration for full FDA approval of their COVID-19 vaccine for people ages 16 and older, according to CNN.
At present, Pfizer's mRNA two-shot vaccine is approved in the U.S. under emergency use authorization (EUA) by the FDA.
The process of applying for full FDA approval involves submitting a Biologics License Application, known as a BLA.
The FDA requires vaccine manufacturers to provide them with data related to manufacturing processes, facilities and additional information that proves the vaccine can be produced reliably and consistently.
They must also submit all pre-clinical and clinical trial data.
Pfizer/BioNTech plan to submit this information to the FDA over the next few weeks on a rolling basis. After this, a goal date will be set for a decision by the FDA.
According to CNN, Pfizer/BioNTech has requested priority review, which requests that the FDA take action within 6 months, instead of within the standard 10 months timeframe.Though this current application to the FDA is only intended for adults 16 and older, Pfizer/BioNTech is also working to expand its EUA to include children ages 12 to 15.
The companies hope to submit an additional BLA to cover this younger age group once the essential data has been collected six months after administering second doses.
Pfizer/BioNTech say 170 million doses of the vaccine have been distributed across the US to date.
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