Pfizer: positive CHMP opinion for COVID-19 vaccine

(CercleFinance.com) - Pfizer and BioNTech have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for the two companies' monovalent vaccine adapted to Omicron KP.
2 COVID-19 vaccine (COMIRNATY KP.2) to prevent COVID-19 caused by SARS-CoV-2 in people aged 6 months and over.

The European Commission will examine the CHMP's recommendation and is expected to take a final decision shortly. Following the EC decision, Pfizer and BioNTech's Omicron KP.2-adapted COVID-19 vaccine will be shipped to European Union (EU) member states.

The CHMP recommendation dated September 19, 2024 is based on non-clinical and manufacturing data for the Omicron KP.2-adapted vaccine, and on clinical and real-world evidence supporting the safety and efficacy of previous formulations of COVID-19 vaccines by Pfizer and BioNTech.

Non-clinical data showed that the KP.2-adapted vaccine generated a significantly improved response against several currently circulating Omicron JN.1 sublineages, including KP.2, LB.1, KP.3 and KP.3.1.1, compared to the companies' Omicron XBB.1.5-adapted COVID-19 vaccine.

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