The U.S. FDA has expanded the emergency use authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine to include individuals 18 years and older. The booster dose is to be administered at least six months after completion of the primary series, and is the same dosage strength as the doses in the primary series.
In October, the companies announced positive results from a trial showing that a booster dose administered to those who previously received the Pfizer-BioNTech primary two-dose series demonstrated a relative vaccine Efficacy of 95% when compared to those who did not receive a booster. Thus far, these are the first and only efficacy data disclosed from any randomized, controlled COVID-19 vaccine booster trial. The adverse event profile was generally consistent with other clinical safety data for the vaccine.
A booster dose of the Pfizer-BioNTech COVID-19 Vaccine was previously authorized by the FDA for emergency use after completion of a primary series in individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19, and individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2, as well as eligible individuals who have completed primary vaccination with a different authorized COVID-19 vaccine.
Pfizer and BioNTech continue to supply the vaccine, including sufficient volume for boosters, under their existing Supply Agreement with the U.S. government, which continues through April 2022.