Pfizer, BioNTech Get Positive CHMP Opinion for New Covid-19 Vaccine
By Chris Wack
Pfizer and BioNTech said the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended marketing authorization for their Omicron JN.1-adapted monovalent Covid-19 vaccine.
The updated vaccine for JN.1 would be used for active immunization to prevent Covid-19 caused by SARS-CoV-2 in individuals 6 months of age and older.
The adaptation is based on the recommendation from the World Health Organization Technical Advisory Group on Covid-19 Vaccine Composition and the European Medicines Agency's Emergency Task Force to update Covid-19 vaccines to target the SARS-CoV-2 variant JN.1 for the 2024-2025 vaccination campaign.
The companies said the ETF stated 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 will review the CHMP's recommendation and is expected to make a final decision soon. Following the EC decision, the updated vaccine will be available to ship to applicable European Union member states immediately.
Pfizer and BioNTech have been manufacturing the Omicron JN.1-adapted monovalent Covid-19 vaccine at risk to ensure supply readiness ahead of the upcoming fall and winter season when the demand for Covid-19 vaccination is expected to increase.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
June 27, 2024 11:08 ET (15:08 GMT)
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