FDA Expands Pfizer’s COVID-19 Vaccine Booster Authorization

November 19, 2021 - FDA recently expanded the emergency use authorization (EUA) for a booster dose of the Pfizer-BioNTech COVID-19 vaccine to include individuals 18 years of age and older.

Caregivers can administer the booster dose at least six months following completion of the primary series. The booster shot is the same dosage strength as the doses in the primary series.

“As we near the two-year mark in our fight against COVID-19, we have reached another critical milestone with the expanded authorization of a booster dose of our COVID-19 vaccine in individuals 18 years and older,” Albert Bourla, chairman and CEO of Pfizer, said in the announcement.

“With boosters, more adults will now have the opportunity to help preserve a high-level of protection against this disease. We are grateful to the FDA for their rigorous review, and the action taken today that we hope will help accelerate our path out of this pandemic,” Bourla continued.

In September, FDA authorized Pfizer’s booster dose six months after completing the primary series for individuals 65 years of age and older and individuals 18 to 64 years at high risk of severe virus or with frequent institutional or occupational exposure to SARS-CoV-2.

And in October, Pfizer and BioNTech announced that their booster was 95.6 percent effective in individuals compared to placebo.

The randomized, controlled Phase 3 trial enrolled over 10,000 individuals 16 years of age and older. In the trial, all patients completed the primary two-dose series of the Pfizer- BioNTech vaccine and then received a 30 microgram booster dose of the vaccine or placebo.  

There were five cases of COVID-19 in the booster group and 109 cases in the placebo group during the study period. 

The companies will continue to supply their vaccine, including sufficient volume for boosters, under their existing supply agreement with the government ends in April 2022.