Pfizer COVID-19 Vaccine Receives Full FDA Approval

On August 23, 2021, the FDA announced Pfizer BioNTech’s COVID-19 vaccine has received full approval for ages 16 and older. Full FDA approval requires review of 6 months of post-vaccine data instead of the 2 months required for Emergency Use Authorization (EUA). Full approval also allows for manufacturers to market directly to consumers and gives more flexibility to physicians in the usage of the drug or vaccine.

At this time the Pfizer vaccine for ages 12-15 and the Moderna and Johnson & Johnson vaccines continue to be under EUA approval. All three approved vaccines went through the same trials that other drugs do in a more traditional approval process just on a different track than is commonly used by the FDA. Hundreds of millions of COVID-19 vaccination doses have now been given in the United States and the data shows that these vaccines continue to be safe, effective, and our best protection against COVID-19 and newer, more contagious variants.