A major public health milestone was reached on Monday as the U.S. Food and Drug Administration (FDA) approved the first COVID-19 vaccine. The Pfizer-BioNTech vaccine has become the first vaccine to be approved by the FDA.
“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 (EUA), 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,” Acting FDA Commissioner Janet Woodcock, M.D. said.
“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.,” continued Woodcock.
Governor Tim Walz echoed Woodcock’s sentiment in a statement released Monday afternoon. “The FDA’s approval of Pfizer’s COVID-19 vaccine is exciting news. This vaccine is safe, it’s saving lives, and now it’s fully approved,” Walz said.
“Today’s action gives Minnesotans additional assurance that the Pfizer vaccine is safe and effective. Along with vaccines from Moderna and Johnson & Johnson, these are the best tools we have in our fight against COVID-19. If you haven’t yet, now is the time to roll up your sleeves and get your shot,” Walz said.
Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021.
Now that the Pfizer-BioNTech vaccine has been approved by the FDA, it will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older.
Comirnaty (Pfizer vaccine) 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. 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.
FDA evaluation of safety and effectiveness data for approval for 16 years of age and older
To support the FDA’s approval decision, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population.
Specifically, 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 FDA’s clinical trial, the vaccine was 91% effective in preventing COVID-19 disease. More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.
Going forward, the FDA and Centers for Disease Control and Prevention (CDC) have monitoring systems in place to ensure that any safety concerns continue to be identified and evaluated in a timely manner.
Comirnaty (Pfizer vaccine) is now approved for Americans 16 years of age and older. The vaccine continues to be available to Americans between 12 and 15 years of age under an Emergency Use Authorization (EUA). Two other vaccines—the single-dose Johnson & Johnson vaccine and the two-dose Moderna vaccine—are authorized for Americans 18 years of age and older.
The FDA is continuing its review and approval process for these two vaccines as well as for use of Pfizer in people younger than 16.
All COVID-19 vaccines are free, and readily available at hospitals, pharmacies, clinics, and other health care providers around Minnesota. Visit vaccines.gov to find a vaccine location near you and to sort by vaccine type.