Pfizer-BioNTech COVID-19 Vaccine Receives Full Approval by FDA

Today, Aug. 23, 2021, the U.S. Food and Drug Administration approved the Pfizer-BioNTech COVID-19 vaccine for prevention of COVID-19 disease in people ages 16 and older. This mRNA vaccine will now be marketed as Comirnaty. The vaccine continues to be available for people ages 12-15 under emergency use authorization (EUA). Read more in the news release at FDA Approves First COVID-19 Vaccine.

COVID-19 vaccine providers should continue to vaccinate and use Pfizer COVID-19 vaccine as you have been. The full license does not impact current recommendations. CDC’s Advisory Committee on Immunization Practices (ACIP) will be meeting on Monday, Aug. 30, 2021, to discuss updating its recommendation for this vaccine.

While we wait for a vaccine to be authorized in children younger than age 12, it is important that everyone who is eligible now get the vaccine. The Delta variant has led to significant increases in the number of children and adults infected with COVID-19. Vaccination of eligible groups will help reduce the spread of the virus and protect those who are too young to be vaccinated. The American Academic of Pediatrics strongly discourages providers from administering the vaccine off-label for children ages 11 and younger. Off-labels actions are also a violation of section 1 of the COVID-19 Vaccination Program Provider Agreement. Clinical trials are underway for this age group and more data will hopefully be available soon. Read more at American Academy of Pediatrics Cautions Against Off-Label Use of COVID-19 Vaccines in Children Under 12.

In the coming days, we will update our provider materials to reflect the full licensure of the Comirnaty/Pfizer COVID-19 vaccine product, and will let providers know when a vaccine information statement (VIS) is available to use in place of an EUA fact sheet. Stay tuned to our provider bulletin and subscribe if you have not already at COVID-19 Vaccine Provider Updates.