Pfizer-BioNTech requests federal authorization for Omicron-adapted booster

Biotech partners Pfizer and BioNTech announced on Monday that they have requested Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for their new Omicron-adapted booster vaccine.

In order to address the ongoing evolution of SARS-CoV-2, the application complies with FDA guidelines and includes data from the companies’ Omicron-adapted booster shots, including pre-clinical and manufacturing data from the Omicron BA.4/BA.5-adapted vaccine as well as clinical data from their bivalent Omicron BA.1-adapted vaccine.

The Omicron BA.4/BA.5-adapted bivalent vaccination will be available for shipping right away, pending permission, Pfizer said in a press release.

“Given the ongoing evolution of SARS-CoV-2 and its variants, it’s of great importance that vaccines can be rapidly adapted to the major circulating Omicron lineages,” said Professor Ugur Sahin, M.D., CEO and Co-Founder of BioNTech.

Per Reuters, “Pfizer said it was ready to deliver doses for September under a $3.2 billion deal in place with the U.S. government for 105 million doses,” including the booster dose adapted for the Omicron variants.

“In less than three months after the FDA provided its guidance for adapted vaccines in the U.S., we are ready to ship the first doses of our Omicron BA.4/BA.5-adapted bivalent vaccine, pending regulatory authorization, to provide people in the U.S. with the possibility to get a booster adapted to the currently most dominant strain of the virus,” Professor Sahin adds.

This month, a clinical study examining the Omicron BA.4/BA.5-adapted bivalent vaccine’s immunogenicity, safety, and tolerability in people 12 years of age and older is set to kick off.

In a previous announcement, the companies confirmed that Phase 2/3 trial of a 30-µg booster dose of their Omicron BA.1-adapted bivalent vaccine candidate proved safety, tolerability, and immunogenicity against the Omicron BA.1 variant spike protein.

As Bio.News previously reported, the FDA is calling for fall boosters to specifically address the Omicron variants.

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