On August 23, the COVID-19 Vaccine produced by Pfizer-BioNTech became the first vaccine of its kind to be fully approved by the us Food And Drug Administration (FDA). The vaccine will now be known as Comirnaty and will be available to people who are 16 years of age or older. It also has Emergency Use Authorization (EUA) for children in the 12-15 years age group.
FDA Commissioner Janet Woodcock, M.D., 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.”
In a statement released, the FDA explained, “Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19.” Addressing concerns related to vaccine hesitancy, it further clarified, “The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into – nor does it alter – an individual’s genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.”
Further allaying fears, Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research, said, “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.”
The FDA further explained that “in the FDA’s review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.” It concluded, “Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.” It is noteworthy that Pfizer-BioNTech’s vaccine was the first among COVID-19 vaccines to be granted EUA on December 11, 2020. On May 10, the authorization was extended to the 12-15 years old age group.
Feature Image: DoD photo by Lisa Ferdinando via Wikimedia Commons