Nov 9 (Reuters) – Moderna Inc (MRNA.O) filed Tuesday for European authorization of its COVID-19 vaccine in children ages 6-11, weeks after it delayed a similar application to US regulators.
The European Union had approved the vaccine in July for use in teenagers ages 12 to 17, but several countries, including Sweden, have discontinued use for people age 30 and younger due to rare heart-related side effects. read more
Moderna said in late October that the US drug regulatory agency needed more time to complete its assessment for use in the 12-17 age group as it studies the risk of a type of heart infection called myocarditis after vaccination. read more
The drugmaker delayed the U.S. application for children ages 6 to 11, while the FDA completes its assessment for use of the vaccine in the 12-17 age group.
Earlier in October, the company said its vaccine elicited a strong immune response in children ages six to 11 and plans to submit the data to global regulators soon.
Moderna said on Tuesday it had applied to the European Medicines Agency for a 50 microgram dose of the vaccine in children, half the strength used in its adult vaccines.
Reporting by Manojna Maddipatla and Manas Mishra in Bengaluru; Editing by Arun Koyyur
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