Pfizer and BioNTech’s Omicron JN.1-adapted COVID-19 vaccine (COMIRNATY® JN.1) has received a positive recommendation for marketing authorization from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). The vaccine is intended for active immunization against COVID-19 caused by SARS-CoV-2 in individuals six months and older.
The vaccine adaptation aligns with recommendations from the World Health Organization and the European Medicines Agency, which suggest targeting the SARS-CoV-2 variant JN.1 in COVID-19 vaccination campaigns for the 2024-2025 season.
Clinical and non-clinical evidence supports the safety and efficacy of Pfizer and BioNTech’s COVID-19 vaccines, including the JN.1-adapted version. Pre-clinical data indicates that the JN.1-adapted vaccine generates an enhanced response against Omicron JN.1 sublineages, including KP.2, KP.3, and others, compared to the companies’ Omicron XBB.1.5-adapted vaccine.
The European Commission is expected to review the CHMP’s recommendation and make a final decision soon. The updated vaccine will be available for distribution to EU member states upon approval.
Pfizer and BioNTech have proactively manufactured the Omicron JN.1-adapted vaccine to ensure supply before the fall and winter season when demand for COVID-19 vaccination is anticipated to rise. The companies are also submitting rolling applications to the U.S. Food and Drug Administration to approve their Omicron KP.2-adapted COVID-19 vaccines for individuals six months and older.
Pfizer and BioNTech continue to monitor the evolving epidemiology of COVID-19 and are committed to meeting global public health needs through developing and distributing vaccines.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
