FDA Fully Approves Pfizer-BioNTech COVID-19 Vaccine

Comirnaty approval is a "milestone" in the COVID-19 pandemic.

The US Food and Drug Administration (FDA) today fully approved the Pfizer-BioNTech COVID-19 vaccine for use in persons aged ≥16 years, marking the first COVID-19 vaccine to receive such approval.

The vaccine will now be marketed as Comirnaty, according to the FDA’s Monday morning announcement.

“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. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.,” said Acting FDA Commissioner Janet Woodcock, MD, in the press release.

Comirnaty is still available under emergency use authorization (EUA), including for adolescents aged 12-15 years and for the administration of a third dose in certain immunocompromised persons.

The FDA issued the first EUA back in December 2020 for the Pfizer-BioNTech COVID-19 vaccine for individuals aged ≥16 years. The FDA’s decision was based on safety and effectiveness data from a large randomized, controlled, blinded ongoing clinical trial.

The FDA reviewed updated data from the same clinical trial to support its approval decision today, which included a longer duration of follow-up in a larger clinical trial population.

Specifically, the agency analyzed effectiveness data from approximately 20 000 vaccine and 20 000 placebo recipients aged ≥16 years who did not have evidence of COVID-19 infection within a week of receiving the second dose. Vaccine safety was evaluated in approximately 22 000 individuals who received the vaccine and 22 000 placebo recipients all aged ≥16 years.

The results showed that Comirnaty was 91% effective in preventing COVID-19 disease, according to the FDA. Over half of participants were followed for safety outcomes for at least 4 months after the second dose. Overall, nearly 12 000 recipients were followed for at least 6 months.

Comirnaty was also found effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death, according to the FDA.

The most commonly reported side effects by participants who received the vaccine were pain, redness, and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever.

The study also found higher risk of myocarditis and pericarditis, especially within 7 days of receiving the second dose. The observed risk was also higher for men younger than age 40 years compared to women and older men. The observed risk was highest in men aged 12-17 years.

Although some cases required intensive care support, available data from short-term follow-up suggested that most individuals had resolution of symptoms. Information is not yet available regarding potential long-term health outcomes, but the prescribing information includes a warning about these risks.

“We have not lost sight that…the public is counting on safe and effective vaccines,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”