FDA Grants Full Approval to First COVID-19 Vaccine

On Monday, the U.S. Food and Drug Administration (FDA) approved the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine became the first in the nation to receive full FDA approval. The Pfizer-BioNTech vaccine continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised persons.

According to the FDA, approved vaccines must undergo the agency’s standard process for reviewing the quality, safety, and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). The Pfizer-BioNTech COVID-19 Vaccine BLA approved by the FDA this week builds on extensive data and information previously submitted as part of the manufacturer’s EUA and includes other information such as clinical data and vaccine testing results. The FDA then conducts its own analyses of information provided in the BLA to ensure the vaccine’s safety and effectiveness.

Following the FDA’s approval, California Governor Gavin Newsom issued a statement confirming the safety and efficacy of the vaccine. California Department of Public Health (CDPH) Director and State Public Health Officer Dr. Tomás Aragón also issued a statement acknowledging the full federal approval and urging residents to receive the COVID-19 vaccine to protect themselves and help end the pandemic.

The full FDA announcement is available here.