Pfizer Inc. and BioNTech SE announced that the FDA has expanded the Emergency Use Authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine to include individuals 16 years of age and older. The booster dose is to be administered at least six months after completion of the primary series and is the same formulation and dosage strength as the doses in the primary series.

“Today’s decision by the FDA to further expand the Emergency Use Authorization of a booster dose of our COVID-19 vaccine is a critical milestone as we continue to stay vigilant in addressing the virus,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “From the beginning, we aimed to provide strong, safe protection to as many people as possible in an effort to end this pandemic. While new variants, including Omicron, emerge across the globe, we believe that the best way to minimize the spread of COVID-19 and any future variants is getting all eligible people fully vaccinated with the first two-dose series and a booster dose as recommended.”

“The booster vaccination increases the level of immunity and dramatically improves protection against COVID-19 in all age groups studied so far,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “In the current situation, it is important to offer everyone a booster, particularly against the background of the newly-emerging variants such as Omicron.”

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 18 years of age and older, as well as for eligible individuals who have completed primary vaccination with a different authorized COVID-19 vaccine.

Pfizer and BioNTech plan to submit a supplemental Biologics License Application (sBLA) for approval of a booster dose of their COVID-19 vaccine in individuals 16 years of age and older. The sBLA will include efficacy and safety data from a Phase 3 trial showing that a 30-μg booster dose administered to individuals 16 years and older 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. These are the first 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, with a favorable safety profile.