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CHMP Adopts Positive Opinion Recommending Approval of KOSTAIVE®, a Self-Amplifying mRNA Vaccine against COVID-19

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CHMP Adopts Positive Opinion Recommending Approval of KOSTAIVE®, a Self-Amplifying mRNA Vaccine against COVID-19

CHMP Adopts Positive Opinion Recommending Approval of KOSTAIVE®, a Self-Amplifying mRNA Vaccine against COVID-19

December 16, 2024

Meiji Seika Pharma Co., Ltd. (Headquarters: Tokyo, Japan, President and Representative Director: Daikichiro Kobayashi) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of KOSTAIVE, a self-amplifying mRNA (sa-mRNA) vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years and older.

The European Commission is expected to make a final decision on the marketing authorization based on this approval recommendation, subsequently.

About sa-mRNA

mRNA vaccines help protect against infectious diseases by providing a blueprint for cells in the body to make a protein to help our immune systems recognize and fight the disease. Unlike standard mRNA vaccines, self-amplifying mRNA vaccines instruct the body to make more mRNA and protein to boost the immune response.

About Meiji Seika Pharma

Meiji Seika Pharma, since it launched penicillin in 1946, has been providing efficacious and high-quality pharmaceutical products including therapeutics and vaccines for infectious diseases, therapeutics for central nervous system diseases and generic drugs, to meet various medical needs. https://www.meiji.com/global/pharmaceuticals/

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