Vaccine Victory: FDA grants full approval to Pfizer BioNTech COVID-19 Vaccine

On Monday, August 23, the Food and Drug Administration (FDA) granted full approval to Pfizer-BioNTech’s COVID-19 vaccine for people 16 and older. This is the first COVID-19 vaccine to receive full approval in the United States. The FDA ruling should help overcome vaccine-hesitancy in some unvaccinated people who have stated this as their primary concern.

According to the FDA, the approved vaccine will now be marketed as Comirnaty to prevent COVID-19 disease in individuals 16 years of age and older. The vaccine will continue to be available to individuals ages 12-15 under emergency use authorization (EUA) granted on May 10, 2021. Recently recommended by the CDC, a third-dose booster for certain immunocompromised individuals will remain available under the EUA.

The FDA uses emergency use authorizations during public health emergencies to provide access to medical products that effectively treat, prevent, or diagnose a disease. The FDA website states it must determine whether the known and potential benefits of a product outweigh any risks.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 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,” said Acting FDA Commissioner Janet Woodcock, M.D. “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. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

The Comirnaty vaccine contains messenger RNA (mRNA), a type of genetic material. The mRNA is used to mimic the COVID-19 virus’ protein responsible for the infection. The mRNA is only present in the vaccinated body for a short time to allow the body to produce a defense against natural COVID-19 protein. It is not incorporated into an individual’s genetic material, nor does it alter any genetic material. The newly named Cominraty has the same formulation as the Pfizer-BioNTech’s vaccine used under the EUA.

Before granting full approval, the FDA reviewed data from a clinical trial that supported the original EUA findings earlier this year. The approval review included data from a longer duration of follow-up in a larger clinical trial population.

According to the website, 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.

Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.

The FDA will continue to monitor as safety concerns continue to be identified and evaluated. The agency is also requiring post-marketing studies to assess the risks of myocarditis and pericarditis following vaccination.

It is important to remember that no vaccine will 100% prevent infection from COVID-19. The protection from any of the vaccines is to reduce infection and hospitalization rates significantly. The current surge in hospitalizations shows vaccinations are effective in prevention and hospitalization as most COVID-19 patients are unvaccinated.