FDA Approves Pfizer’s COVID Vaccine

The FDA approved the Pfizer/BioNTech COVID-19 vaccine on Monday, the first vaccine against the novel coronavirus to receive full approval.

The vaccine will be marketed as Comirnaty, and can be used for individuals ages 16 and older to prevent COVID-19. However, the vaccine is still under emergency use authorization (EUA) for adolescents ages 12-15, the agency said.

FDA Acting Commissioner, Janet Woodcock, MD, characterized the approval as a “milestone” in the pandemic.

“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 in a statement.

The vaccine has been under an EUA since Dec. 11, 2020 for individuals ages 16 and older, but the full approval comes from expanded safety and efficacy data released by the manufacturer this April. An analysis of 927 confirmed cases found that the vaccine had 91.3% efficacy against symptomatic disease up through 6 months after the second dose.

In addition, the vaccine was 100% effective in preventing severe disease, as defined by the CDC, Pfizer said.

Safety data from 12,000 people followed up through 6 months found injection site pain, fatigue, headache, muscle or joint pain, and fever were the most common adverse events. However, the FDA noted an increased risk of myocarditis and pericarditis in the 7 days following the second dose, particularly among males ages 12-17. However, short-term follow-up data suggest most symptoms resolved completely, the agency added.

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research, in a statement.