Pfizer Inc. and BioNTech SE have submitted a request to amend the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for a booster dose of their COVID 19 vaccine to include all individuals 18 years of age and older.
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The amendment request is based on results from a Phase 3 randomized, controlled trial evaluating the efficacy and safety of a 30 µg booster dose of the vaccine, which enrolled more than 10,000 participants during a period when the Delta variant was the prevalent strain.
In October, the companies announced positive topline results from the trial showing that a booster dose administered to individuals 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, with no new safety concerns identified.
A booster dose of the Pfizer BioNTech COVID 19 Vaccine is currently 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.
Booster eligibility and schedule are based on the labeling information of the vaccine used for the primary series.
Data from the Phase 3 booster trial have been shared with the European Medicines Agency (EMA) and other regulatory authorities.
A booster dose of the vaccine is approved in the European Union and authorized approved in other countries for individuals 18 years of age and older based on previously submitted safety, tolerability and immunogenicity data, with recommendations for populations varying based on local health authority guidance. ■