Facts About COVID-19 Vaccines From the FDA
Learn about the evidence supporting FDA-approval of Comirnaty and FDA emergency use authorization of COVID-19 vaccines
The U.S. Food and Drug Administration approved Comirnaty for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older. The vaccine has the same formulation as the Pfizer-BioNTech COVID-19 Vaccine that continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age, for the administration of a third dose in certain immunocompromised individuals, and for a single booster dose in certain populations.
Three COVID-19 vaccines are authorized for emergency use. The vaccines are:
- Pfizer BioNTech COVID-19 Vaccine
- Moderna COVID-19 Vaccine
- Janssen (sometimes called Johnson & Johnson) COVID-19 Vaccine
Who authorizes COVID-19 vaccines for emergency use?
The FDA is the regulatory authority with oversight of the safety, effectiveness and quality of vaccines that are used in the U.S., including COVID-19 vaccines. Career scientists and doctors at the FDA determine whether to approve or authorize COVID-19 vaccines after they thoroughly analyze and evaluate the data submitted by the manufacturer related to safety, effectiveness and manufacturing quality.
During a public health emergency like the current COVID-19 pandemic, the FDA may issue an EUA when the agency’s scientific experts have determined, among other things, that the known and potential benefits of the vaccine outweigh its known and potential risks.
For Comirnaty, the company submitted a Biologics License application (BLA) to FDA which built on the extensive data and information previously submitted that supported the EUA. This included preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections at the sites at which the vaccine is made.
FDA employees are also fathers, mothers, daughters, sons, sisters, brothers and more. They and their families are directly impacted by the work they do.
- FDA Approves First COVID-19 Vaccine Pfizer-BioNTech
- FDA Statement on Johnson – Johnson COVID-19 Vaccine
- FDA Approved Drugs in 2020