Pfizer, BioNTech Apply for FDA Emergency Use Authorization for Omicron Booster

The makers of the Comirnaty COVID-19 vaccine have applied to the US Food and Drug Administration (FDA) for an emergency use authorization for their new Omicron BA.4 and BA.5 booster shots. The new version of Pfizer and BioNTech’s vaccine is bivalent, containing spike protein mRNA from the original SARS-CoV-2 and Omicron BA.4/BA.5.

According to Phil Taylor, “According to Pfizer/BioNTech, preclinical data has shown that a booster dose with the BA.4/BA.5-adapted bivalent vaccine generated a strong neutralising antibody response against Omicron BA.1, BA.2 and BA.4/BA.5 variants, as well as the original wild-type strain. Pfizer and Moderna have both filed a bivalent COVID-19 vaccine based on wild-type SARS-CoV-2, as well as the BA.1 subvariant in Europe, and earlier this month, Moderna secured the first approval for its bivalent shot in the UK.”

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(Source: PharmaPhorum, August 23rd, 2022)