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FDA Grants Expanded EUA To Pfizer, BioNTech COVID-19 Vaccine Booster To Include 18 Yrs And Older

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Pfizer Inc. (PFE) and BioNTech SE (BNTX) announced Friday that the U.S. Food and Drug Administration (FDA) has expanded the emergency use authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine to include individuals 18 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 dosage strength as the doses in the primary series.

The FDA decision is supported by clinical data showing robust immune responses following a booster dose of the vaccine, exceeding what has been seen even after the completion of the highly-effective two-dose primary schedule.

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.

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 people aged 65 and older as well as adults aged 18 to 64 who are at high risk of severe COVID-19; and people aged 18 to 64 with frequent institutional or occupational exposure to SARS-CoV-2.

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