Comirnaty is said to be the first Covid-19 vaccine to receive full FDA approval and is indicated to prevent Covid-19 in people aged 16 years and above
The US Food and Drug Administration (FDA) has approved the Pfizer and BioNTech’s Biologics License Application (BLA) for their Covid-19 vaccine, to be marketed as Comirnaty.
Comirnaty was approved to prevent Covid-19 in people aged 16 years and above and marks the first Covid-19 vaccine to receive full regulatory approval by the FDA.
In December 2020, the Pfizer-BioNTech Covid-19 Vaccine was granted Emergency Use Authorisation (EUA) for active immunisation in people aged 16 years and above.
The EUA was expanded to include individuals aged 12 to 15 years in May this year.
The US regulator said that the vaccine will be available under EUA for people aged 12 to 15 years and for the administration of the third dose in immunocompromised individuals.
US FDA acting commissioner Janet Woodcock said: “The FDA’s approval of this vaccine is a milestone as we continue to battle the Covid-19 pandemic.
“While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved Covid-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product.”
The FDA approval was based on a complete data package submitted for the BLA, which includes long-term follow-up data from the Phase 3 trial.
Pfizer and BioNTech completed the BLA submission in May this year, and have received the Priority Review for their submission in July 2021.
In the Phase 3 study, the vaccine demonstrated high efficacy of 91% and a favourable safety profile, for up to six months after the administration of the second dose.
The data package for BLA submission also includes the manufacturing and facilities data, which is essential for licensure.
Pfizer and BioNTech intend to seek licensure of a third, booster dose of Comirnaty in people aged 16 years and above, through a supplemental BLA.
Also, the companies plan to submit a supplemental BLA for potential full FDA approval of Comirnaty in individuals aged 12 to 15 years, once the required data is available.
Pfizer chairman and chief executive officer 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, hospitalisation and death rates continue to rise rapidly among unvaccinated populations across the country.
“I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity.”
In a separate development, the US government is set to issue updated guidance to require all US service personnel to be vaccinated, reported Reuters citing Pentagon spokesman John Kirby.