The vaccine had previously been offered in the US under Emergency Use Authorization (EUA) since December; and has now become the first COVID-19 vaccine approved in the US.
The approval is for people aged 16+, with use of the vaccine in adolescents aged 12-15 and the administration of a third booster shot in certain immunocompromised individuals remaining under EUA.
Under the Biologics License, granted to BioNTech Manufacturing GmbH, the vaccine will now be marketed as Comirnaty (a name that has been in use in other markets such as the EU since December).
Boosting vaccination rates
In total, around 60% of eligible Americans are fully vaccinated at the moment. FDA Commissioner Janet Woodcock, M.D., alongside Pfizer and BioNTech, says she hopes the full approval will encourage more people to get vaccinated.
“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,” she said.
“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. This milestone puts us one step closer to altering the course of this pandemic in the US.”
The Pfizer/BioNTech vaccine was granted EUA in the US on December 11, 2020. The companies then completed a rolling submission for a BLA in May 2021: and gained priority review from the FDA in July.
Comirnaty’s BLA builds on the data and information previously submitted for EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made.
The agency then conducted its own analyses of the information in the BLA to ensure the vaccine met its standards for approval.
It also assessed updated data from clinical trials, which included a longer duration of follow-up than the EUA.
The agency analyzed effectiveness data from around 20,000 vaccine and 20,000 placebo recipients, aged 16+, who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo.
Around 12,000 recipients were followed for safety outcomes for at least six months after the second dose; while data was available for around half the clinical trial participants for a duration of at least four months after the second dose.
The updated data from the clinical trials say the vaccine is 91% effective in preventing COVID-19 disease.
Myocarditis and pericarditis
The FDA also addressed concerns related to myocarditis and pericarditis and concluded that the data ‘demonstrate increased risks, particularly within the seven days following the second dose’.
“The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes.”
Prescribing information was updated to include a warning about these risks in June.
As announced earlier this month, Pfizer and BioNTech plan to seek licensure of a booster dose of Comirnaty in individuals 16 years of age and older via a supplemental BLA.
The companies also intend to submit a supplemental BLA to support potential full FDA approval of Comirnaty in teenagers 12 - 15 years old once the required data (six months after second dose) are available. In the meantime, the vaccine remains available to 12- to 15-year-olds under the EUA granted by the FDA in May.
For individuals at least 12 years of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise, a third dose of the vaccine also remains available under EUA following an amendment by the FDA on August 12.