The US Food and Drug Administration (FDA) has fully approved Pfizer and BioNTech’s biologics license application (BLA) for their Covid-19 vaccine, Comirnaty, for individuals aged 16 years and above.
Since December last year, the vaccine has been available in the US under emergency use authorization (EUA) for people aged 16 years and older.
This was expanded to include adolescents aged 12 to 15 years in May this year.
Comirnaty, which is based on BioNTech’s messenger RNA (mRNA) technology, is claimed to be the first Covid-19 vaccine to be granted complete approval by the FDA.
mRNA is used to make a mimic of one of the proteins in the virus that causes Covid-19.
The FDA approval is based on a comprehensive data package submitted by the companies that include six-month efficacy and safety data from the Phase III trial after second dose.
Pfizer stated that the BLA submission package also includes the manufacturing and facilities data required for licensure.
Pfizer chairman and CEO Albert Bourla said: “Based on the longer-term follow-up data that we submitted, today’s decision by the FDA affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed.
“About 60% of eligible Americans are fully vaccinated, and infection, hospitalization and death rates continue to rise rapidly among unvaccinated populations across the country.”
The companies have delivered more than 1.2 billion Covid-19 vaccine doses to over 120 countries or territories across the world since last December.
In a separate development, Pfizer has signed a definitive agreement to acquire Trillium Therapeutics in a deal valued at about $2.26bn.
Recently, the company and its partner BioNTech have submitted the first phase of a three-part clinical trial programme to FDA to authorise a third, or booster dose of their Covid-19 vaccine.
They are also planning to seek licensure of the third dose of Comirnaty in the US through a supplemental BLA for people aged 16 years and above.