FDA Fully Approves Pfizer-BioNTech COVID-19 Vaccine

In a historic first, officials with the FDA have approved Pfizer and BioNTech’s COVID-19 vaccine, which will be marketed as Comirnaty, for the prevention of COVID-19 in individuals 16 years of age and older.¹

“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,” said Acting FDA Commissioner Janet Woodcock, MD, in a press release. “Today’s milestone puts us one step closer to altering the course of this pandemic in the US.”¹

The vaccine will continue to be available under emergency use authorization (EUA), including for children 12 to 15 years of age and for the administration of a third dose in certain immunocompromised individuals, according to a press release. The vaccine was originally authorized under EUA on December 11, 2020, and the authorization was expanded to include individuals 12 through 15 years of age on May 10, 2021.¹

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” Woodcock said in the press release. “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 confidence that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product.”¹

In order to receive full FDA approval, vaccines must undergo the agency’s process for reviewing the quality, safety, and efficacy of the products. Officials with the FDA evaluate data and information included in the biologics license application, which expanded on the extensive information previously submitted for the EUA.¹

This data included vaccine efficacy findings in approximately 20,000 vaccine recipients and 20,000 placebo recipients aged 16 years and older who did not have evidence of COVID-19 virus infection within a week of receiving the second dose. The vaccine’s safety was evaluated in approximately 22,000 individuals who received the vaccine and 22,000 who received a placebo. According to the press release, the vaccine was 91% effective in preventing COVID-19 infection.¹

The most commonly reported adverse effects by clinical trial participants who received the vaccine included pain, redness, swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. Approximately 12,000 recipients have been followed for at least 6 months for the safety assessments.¹

Officials also conducted an evaluation of the post-authorization safety surveillance data regarding myocarditis and pericarditis following administration of the vaccine, and determined that the data demonstrate increased risks, especially within 7 days following the second dose. This risk is higher among men less than 40 years of age, with the highest risks in male adolescents 12 through 17 years of age. Short-term follow-up data suggest that most individuals’ symptoms resolved, although some required intensive care.¹

“We have not lost sight that the COVID-19 public health crisis continues in the US and that the public is counting on safe and effective vaccines,” said Peter Marks, MD, PhD, director of the FDA Center for Biologics Evaluation and Research, in the press release. “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 US.”¹

The FDA and CDC will continue to monitor for safety concerns, and the FDA is requiring Pfizer and BioNTech to conduct post-marketing studies assessing the risks of myocarditis and pericarditis. The studies will include an evaluation of long-term outcomes among individuals who develop myocarditis following vaccination.¹

“Final FDA approval should further assure people that the Pfizer-BioNTech COVID-19 vaccine is safe and effective,” said Paul W. Abramowitz, PharmD, Sc.D. (Hon), FASHP, chief executive officer of the American Society of Health-System Pharmacists, in a statement. “After FDA’s thorough and transparent review, it is clear that the benefits of this vaccine in helping to prevent COVID-19 far outweigh the risks.”²

REFERENCE

1. FDA Approves First COVID-19 Vaccine. News release. FDA; August 23, 2021. Accessed August 23, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine

2. ASHP Statement. Email; August 23, 2021. Accessed August 23, 2021.