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April 21 (Reuters) - Moderna said on Tuesday the European Commission had approved its combination vaccine for the prevention of influenza and COVID-19 in adults 50 years of age and older.
Here are the details:
• The approval follows a positive recommendation from the European Medicines Agency, making mCombriax the first authorised combined flu and COVID‑19 vaccine.
• Shares of the vaccine maker rose nearly 2% in morning trading.
• The EU's decision is based on a study of 8,000 participants that showed those who received mCombriax generated more antibodies than those who received separate shots against the viruses.
• People needed two separate shots for COVID-19 and influenza until now and the vaccines were updated regularly to match the viral strains in circulation.
• Moderna's combination shot will be available in all 27 European Union member states, as well as Iceland, Liechtenstein and Norway, the company said.
• In February, Moderna said mCombriax could be available in certain EU markets for the 2026-2027 season.
• The company last year withdrew its U.S. application for its COVID-flu combination shot to wait for efficacy data from a late-stage trial of its influenza vaccine.
• Moderna said in February it was waiting for guidance from the U.S. Food and Drug Administration on refiling the application.
(Reporting by Siddhi Mahatole in Bengaluru; Editing by Shreya Biswas)
