The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation for Pfizer and BioNTech’s Omicron JN 1-adapted monovalent Covid-19 vaccine, COMIRNATY JN 1.
The vaccine is intended for active immunisation against the infection in people aged six months and above.
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The World Health Organization’s Technical Advisory Group on COVID-19 Vaccine Composition and the European Medicines Agency’s Emergency Task Force (ETF) recently advised updating vaccines to address the JN 1 variant for the 2024 to 2025 vaccination campaign.
The ETF highlighted that “evidence indicates that targeting JN 1 will help maintain the effectiveness of the vaccines as SARS-CoV-2 continues to evolve.”
The European Commission (EC) is set to review the CHMP’s positive opinion and issue a final decision.
Post the receipt of EC approval, the updated vaccine will be made available across European Union member states.
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By GlobalDataPfizer and BioNTech proactively produced the Omicron JN 1-adapted vaccine to ensure immediate availability for the anticipated higher demand during the autumn and winter seasons of 2024 to 2025.
The CHMP’s endorsement is based on comprehensive clinical, non-clinical and real-world data supporting the efficacy and safety of Pfizer-BioNTech’s Covid-19 vaccines.
The application comprised data demonstrating the JN 1-adapted vaccine’s potential to elicit a significantly enhanced response against Omicron JN 1 sublineages, surpassing the response from their Omicron XBB.1.5-adapted vaccine.
The companies are initiating rolling submissions with the US Food and Drug Administration seeking approval for Omicron KP.2-adapted vaccines in people aged six months and above.
BioNTech is the marketing authorisation holder of the COMIRNATY vaccine and its variants in regions including the US, the EU and the UK.
