Research & Development
Pfizer Inc and BioNTech announces FDA's first authorization of COVID-19 vaccine booster
23 September 2021 -

Healthcare company Pfizer Inc (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) reported on Wednesday the receipt of the US Food and Drug Administration's (FDA) emergency use for the booster dose of the Pfizer-BioNTech COVID-19 Vaccine.

The Pfizer-BioNTech COVID-19 Vaccine is approved for 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 whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.

According to the company, 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.

A booster dose of the vaccine elicited higher neutralizing antibody titers against the initial SARS-CoV-2 virus (wild type), as well as the Beta and Delta variants, when compared with the levels observed after the two-dose primary series, following scientific evidence from the Pfizer-BioNTech clinical programme evaluating the safety, tolerability and immunogenicity of a booster dose of the COVID-19 vaccine.

In conjunction, the US Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) will meet to discuss a potential recommendation for the use and rollout of boosters to Americans.

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