The US Food and Drug Administration (FDA) has approved the Biologics License Application for the Pfizer-BioNTech Covid-19 vaccine. It will now be marketed as Comirnaty for the prevention of Covid-19 disease in individuals 16 years of age and older. It is the first COVID-19 vaccine to be granted approval by the FDA.
The vaccine continues to be available under emergency use authorisation (EUA), including for individuals 12 to 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
“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 authorisation, 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,” said Acting FDA Commissioner Janet Woodcock.
For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the 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 conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.
Comirnaty contains mRNA, which is used by the body to mimic one of the proteins in the virus that causes Covid-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes Covid-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into – nor does it alter – an individual’s genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.
To support the FDA’s approval decision, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population. Specifically, in the FDA’s review for approval, the agency analysed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older 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 16 years of age and older. Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.
More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least six months.
Additionally, the FDA conducted an evaluation of the post-authorisation safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech Covid-19 vaccine and has determined 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 to 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. The Comirnaty Prescribing Information includes a warning about these risks.
Image credit: Jan Felix Christiansen