Full Approval Granted PfizerBioNTech COVID19 Vaccine

Today, the Food and Drug Administration (FDA) announced full approval of the Pfizer-BioNTech mRNA COVID-19 vaccine in individuals 16 years and older. This is the first COVID-19 vaccine reviewed and fully approved through its Biologics License Application (BLA) process. 

“Final FDA approval should further assure people that the Pfizer-BioNTech vaccine is safe and effective," said ASHP Chief Executive Officer Paul W. Abramowitz. "After FDA’s thorough and transparent review, it is clear that the benefits of this vaccine in helping to prevent COVID-19 far outweigh the risks. Anyone who still has concerns or questions about the vaccine should consult a pharmacist, physician, nurse, or another trusted healthcare professional to discuss their personal risks and benefits.”

The BLA included data from the pivotal Phase 3 clinical trial of the vaccine demonstrating the vaccine’s efficacy and favorable safety profile up to six months after the second dose.

On Dec. 11, 2020, the FDA issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine, the first available in the U.S.  As of Aug. 22, 2021, over 200 million Americans have received at least one dose of a vaccine and at least 170 million have completed a vaccination regimen. This equates to over 362 million doses having been administered in the U.S. with over 204 million doses administered being the Pfizer-BioNTech COVID-19 vaccine.

In May 2021, the FDA expanded the EUA of the Pfizer-BioNTech COVID-19 vaccine to include adolescents 12 through 15 years of age. The company intends to submit a supplemental BLA to support licensure of the vaccine in this age group once data are available after the required six months following administration of the second dose.

Separately, public health and medical experts from the Department of Health and Human Services announced on Aug. 18, 2021, the administration's plan to provide booster doses of mRNA COVID-19 vaccines to anyone previously fully immunized starting eight months after their second dose of either mRNA vaccine. The administration announced the plan before formal FDA authorization and Centers for Disease Control and Prevention Advisory Committee on Immunization Practices (ACIP) recommendation of booster shots. The ACIP is expected to meet again on Aug. 30-31, 2021. 

For additional resources, visit the ASHP COVID-19 Resource Center vaccine webpage, review our COVID-19 Vaccine Confidence Toolkit, view the ASHP-supported Vaccination from the Misinformation Virus PBS documentary, and visit SafeMedication.com for a patient-friendly article and graphics on understanding COVID-19 variants.