(CercleFinance.com) – Pfizer and BioNTech 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 Omicron KP.2 adapted COVID-19 Vaccine (COMIRNATY KP.2) to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 6 months and older.
The European Commission will review the CHMP recommendation and is expected to make a final decision shortly. Following the EC decision, the COVID-19 vaccine adapted to Omicron KP.2 from Pfizer and BioNTech will be shipped to the European Union (EU) Member States.
The CHMP recommendation dated 19 September 2024 is based on non-clinical and manufacturing data of the vaccine adapted to Omicron KP.2 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 generates 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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