Pfizer and BioNTech have received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for Comirnaty JN.1, an Omicron JN.1-adapted monovalent Covid-19 vaccine.
The CHMP has recommended marketing authorisation for Comirnaty JN.1 for active immunisation against Covid-19 caused by SARS-CoV-2 in individuals aged six months and above.
The adaptation of the positive opinion by CHMP has been driven by recommendation from the World Health Organization (WHO) Technical Advisory Group on Covid-19 Vaccine Composition and the European Medicines Agency’s Emergency Task Force (ETF).
Both organisations recommended revising Covid-19 vaccines for the 2024-2025 vaccination campaign, focusing on targeting the SARS-CoV-2 variant JN.1.
ETF said that evidence shows that targeting the JN.1 variant will help sustain the vaccines’ effectiveness as SARS-CoV-2 continues to evolve.
The CHMP’s recommendation is based on the full body of previous clinical, non-clinical, and real-world evidence that back the safety and efficacy of Pfizer and BioNTech’s Covid-19 vaccines.
The application also included manufacturing and pre-clinical data demonstrating that the JN.1-adapted monovalent Covid-19 vaccine elicits a significantly enhanced immune response.
The vaccine showed superior results against various Omicron JN.1 sublineages, such as KP.2, KP.3, and other currently circulating sublineages, in comparison to the companies’ Omicron XBB.1.5-adapted monovalent Covid-19 vaccine.
The European Commission (EC) will assess the CHMP’s recommendation and is anticipated to reach a final decision shortly.
Once approved by the EC, the updated vaccine is expected to be promptly shipped to eligible European Union (EU) member states.
Pfizer and BioNTech are said to have proactively manufactured the Omicron JN.1-adapted monovalent Covid-19 vaccine at risk to ensure readiness for the upcoming season.
Both companies are commencing rolling applications to the US Food and Drug Administration (FDA) for vaccine approval.
Comirnaty utilise BioNTech’s proprietary mRNA technology which was jointly developed by the companies.
BioNTech holds the marketing authorisation for the vaccine and its adapted versions like Comirnaty Original/Omicron BA.4/5; and Comirnaty Omicron XBB.1.5 in the US, the EU, the UK, and other countries.
