The US Food and Drug Administration (FDA) has approved the biologics license application (BLA) of Pfizer and BioNTech for their Covid-19 messenger ribonucleic acid (mRNA) vaccine, Comirnaty, to prevent the disease in individuals aged 16 years or above.
The vaccine is co-developed by BioNTech and Pfizer and is based on the former’s mRNA technology.
The companies noted that Comirnaty is the first Covid-19 vaccine to receive FDA approval.
Based on preliminary results from the pivotal Phase III clinical trial, the vaccine has been available under emergency use authorization (EUA) since last year in the US.
Under updated EUA, the vaccine is available for use in individuals aged 12 to 15 years as well as for the inoculation of a third dose in some immunocompromised people.
To obtain full FDA approval, the companies submitted a complete data package, including longer-term follow-up data from the Phase III trial.
In the Phase III trial, the vaccine demonstrated increased efficacy and a favourable safety profile up to six months after the second shot.
Furthermore, the BLA submission package comprised the manufacturing and site data needed to obtain licensure.
In May this year, the companies concluded BLA submission, which received priority review from the FDA in July.
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.
“Hundreds of millions of doses of our vaccine already have been administered in the US since December 2020, and we look forward to continuing to work with the US government to reach more Americans now that we have FDA approval.”
Pfizer and BioNTech intend to obtain licensure of a third or booster shot of Comirnaty in people aged 16 years or above through a supplemental BLA.
Separately, the UK Government has signed a contract to procure 35 million additional doses of Pfizer and BioNTech’s vaccine.
As per the deal, the Covid-19 vaccine doses will be supplied from the second half of next year.