Health

EMA recommends BioNTech, Pfizer's Omicron vaccine for approval

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BioNTech (NASDAQ:BNTX) and Pfizer have announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for their Omicron KP.2-adapted COVID-19 vaccine, COMIRNATY® KP.2.

The vaccine is designed for active immunization against COVID-19 caused by SARS-CoV-2 for individuals aged six months and older.

The CHMP recommendation, dated September 19, 2024, is supported by non-clinical data and clinical evidence demonstrating improved response to multiple Omicron sublineages.

Both companies emphasized that the KP.2-adapted vaccine has shown a "substantially improved response" compared to previous formulations.

The European Commission's decision is anticipated soon, after which the vaccine will be shipped to EU countries that have specifically ordered this formulation.

 

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