The United States Food and Drug Administration (FDA) on Monday granted full approval to Pfizer-BioNTech’s COVID-19 vaccine for use among patients 16 years and older, making it the first of the disease’s vaccines to cross beyond conditional use.
Since Dec. 11, 2020, the mRNA-based vaccine had been operating under an Emergency Use Authorization (EUA) for those age brackets, but now, it will be able to be marketed as Comirnaty. The EUA still is in effect for those of ages 12 to 15, and for third doses marked for immunocompromised individuals, until separate approval processes certify the drug’s use for those patients.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” Dr. Janet Woodcock, Acting FDA Commissioner, said. “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. 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.”
Approval followed nearly a year of review of preclinical and clinical data, the manufacturing process, and other information related to quality, safety and efficacy of the Pfizer-BioNTech vaccine. Inspectors also consulted the sites where the vaccine was produced, so the FDA – rather than the companies and their researchers – could assess the capabilities of the end result.
An mRNA-based vaccine, like this one, essentially helps the body to mimic a protein in SARS-CoV-2, the virus that causes COVID-19. This spurs recipients’ immune systems to react defensively when confronted by SARS-CoV-2. Comirnaty has the same formulation as the former EUA vaccine. Like its forebear, it will be distributed via two doses, spaced three weeks apart.
“We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines,” Dr. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, said. “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.”
Specifically, the FDA reviewed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients at least 16 years old and older, who produced no signs of COVID-19 virus infection within a week of their second dose. Another 22,000 or so people in each category were evaluated for safety details. Based on the trial results, the vaccine was deemed to be 91 percent effective in preventing COVID-19. The most common side effects include pain, redness and swelling at the injection site, fatigue, headache, muscle and joint pain, chills and fever.
Even with approval, the vaccine will continue to undergo voluntary post-marketing safety studies.