Pfizer and BioNTech seek U.S. authorization for omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine

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Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) have filed paperwork with the FDA requesting Emergency Use Authorization (EUA) for an updated COVID-19 vaccine booster.

Specifically, the request relates to an omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine.

In late June, FDA recommended including an omicron BA.4/5 component for COVID-19 vaccine boosters.

Last week, the UK approved Moderna’s bivalent COVID-19 vaccine based on the original omicron lineage BA.1.

Pfizer and BioNTech are seeking authorization for a booster vaccine targeting the more recent sublineages omicron BA.4/BA.5.

If granted, the booster would be available for individuals at least 12 years old.

Pfizer and BioNTech note that the vaccine, if authorized, is available for immediate shipment.

The companies note that they plan on beginning a clinical trial focused o…

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