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Benzinga
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Pfizer (PFE), BioNTech Seek EU Nod For Omicron-Based COVID Jab

Pfizer BioNTech Omicron EMA Vaccine European Medicines Agency Moderna Covid-19 Pfizer Inc Merck

Pfizer (NYSE:PFE) and its partner, BioNTech (NASDAQ:BNTX) announced that they have completed the submission of a regulatory application to the European Medicines Agency (EMA), which seeks authorization for their Omicron-adapted bivalent COVID-19 vaccine candidate in individuals aged 12 years and older.

The bivalent vaccine is a combination of Pfizer/BioNTech's currently marketed COVID-19 vaccine, Comirnaty and a vaccine candidate targeting the spike protein of the Omicron BA.1 subvariant. The regulatory filing by Pfizer and BioNTech follows the guidelines laid down by both the EMA and the International Coalition of Medicines Regulatory Authorities to develop Omicron-specific vaccines for tackling the problem of new and evolving COVID-19 variants.

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