Today, the U.S. Food and Drug Administration (FDA) granted full approval to the Pfizer-BioNTech mRNA COVID-19 Vaccine, which will be marketed as “Comirnaty.”
Under the newly granted FDA approval, Comirnaty will be available to all people ages 16 and older to prevent COVID-19 disease. Under Emergency Use Authorization, the vaccine will continue to be available to all individuals ages 12 and older, and a third dose will be available to immunocompromised people.
“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. in an Aug. 23 media statement. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
In Comirnaty’s journey to FDA approval, the agency reviewed vaccine effectiveness data from roughly 40,000 individuals ages 16 and older — half of whom received placebos — who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose.
Based on this analysis, the agency determined Comirnaty was 91% effective in preventing COVID-19 disease.
In addition to reviewing vaccine effectiveness data, the FDA also reviewed vaccine safety data. More than half of the clinical trial participants from the vaccine effectiveness study were monitored for safety outcomes for at least four months after their second dose of Comirnaty. An additional 12,000 recipients were followed for at least six months following their second dose.
Based on this study, the FDA determined that the most common side effects included:
- Pain, redness and swelling at the injection site
- Muscle or joint pain
The FDA also evaluated the risks related to myocarditis and pericarditis following the administration of Comirnaty. After a thorough review, the agency determined:
- Risk is highest among men ages 12 to 17.
- The symptoms appear within seven days of the second dose of Comirnaty.
- Most symptoms clear up.
The FDA and the Centers for Disease Control and Prevention (CDC) will continue to monitor the safety of Comirnaty, specifically as it relates to long-term outcomes, through the robust vaccine safety monitoring systems in place in the US.
Because Comirnaty has now received full FDA approval, the vaccine will not require additional review from the Western States Scientific Safety Review Workgroup or the ACIP.
As such, Comirnaty is now available for fully approved use in Oregon.
Even with full approval, health care providers must administer COVID-19 vaccines in accordance with all program requirements and recommendations of CDC, the Advisory Committee on Immunization Practices (ACIP) and the FDA. Therefore, off-label use of Comirnaty is not recommended.
Here is a brief timeline of Comirnaty’s (Pfizer vaccine) journey to becoming a fully approved vaccine in the US:
- Dec. 11, 2020: FDA authorizes Pfizer-BioNTech two-dose COVID-19 vaccine for emergency use in the US for individuals ages 16 and older.
- May 10, 2021: FDA authorizes Pfizer-BioNTech two-dose COVID-19 vaccine for emergency use in the US for individuals ages 12 and older.
- Aug. 12, 2021: FDA authorizes additional mRNA vaccine dose for certain immunocompromised individuals
- Aug. 23, 2021: FDA approves Pfizer-BioNTech COVID-19 vaccine (Comirnaty) for individuals ages 16 and older.
- Vaccine Information Fact Sheet for Recipients and Caregivers About Comirnaty
- FDA, CDC and Western States recommend additional vaccine dose for immunocompromised individuals
- Western states workgroup approves vaccinations for individuals 12 and older
- Vaccine 101: What’s an mRNA vaccine?
- Myocarditis and Pericarditis Following mRNA COVID-19 Vaccination
- Approval versus Emergency Use Authorization (EUA): What’s the difference?