The U.S. Food and Drug Administration announced Aug. 23 the first COVID-19 vaccine approval for the Pfizer-BioNTech COVID-19 vaccine. Moving forward, the vaccine will be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine is still under emergency use authorization for individuals ages 12-15 and for the administration of a third dose in certain immunocompromised people, according to the FDA.
Comirnaty contains messenger RNA, which according to the FDA, is a kind of genetic material the body uses to make a copy of one of the proteins in the virus that causes COVID-19. For those who receive the vaccine, their immune system defends against the virus that causes COVID-19. An FDA study on Comirnaty found out of 22,000 people who received the vaccine and 22,000 people who received a placebo, approximately 91% of participants found it was effective in preventing COVID-19, according to the news release.
“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a statement. “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.”
Acting FDA Commissioner Janet Woodcock said the approval may decrease hesitancy among individuals to get vaccinated, and she believes this milestone could shift the pandemic in a different direction.
Pfizer's vaccine has been under emergency use authorization for individuals 16 and older since Dec. 11 and has included ages 12-15 since May 10. Emergency use authorizations can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose or treat the disease, outweigh the known and potential risks of the product, according to the FDA.
“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,” Woodcock said.