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Moderna Says Updated COVID-19 Vaccine Receives EMA Backing for EU Approval
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Moderna Says Updated COVID-19 Vaccine Receives EMA Backing for EU Approval
Sep 6, 2024 12:58 PM

08:53 AM EDT, 09/05/2024 (MT Newswires) -- Moderna ( MRNA ) said Thursday that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of the updated Spikevax COVID-19 vaccine for SARS-CoV-2 variant JN.1 in individuals aged at least six months.

The company said the availability of the vaccine for the 2024 to 2025 fall and winter seasons depends on the final decision from the European Commission.

The positive recommendation from the EMA follows guidance from the agency's Emergency Task Force to update vaccines to target the JN.1 Omicron subvariant, Moderna ( MRNA ) said.

The company said it has received approvals for the updated vaccine in Japan, Taiwan, and the UK, with similar regulatory applications under review in other regions.

Moderna ( MRNA ) is also taking part in a European Commission tender for COVID-19 mRNA vaccines, it added.

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