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The agency is evaluating Moderna’s application for use of Spikevax in children aged 6 to 11.
Then European Medicines Agency (EMA) announced on Nov. 10, 2021 that it has begun evaluating Moderna’s application to extend the use of its COVID-19 vaccine, Spikevax, to children ages 6–11. The agency’s Committee for Medicinal Products for Human Use (CHMP) will review vaccine data and results from an ongoing clinical study that includes children aged 6–11. EMA anticipates the evaluation to take two months, approximately. Once the CHMP reaches an outcome from the review, its opinion will be forwarded to the European Commission for a final decision.
Spikevax is currently authorized in the European Union for use in people 12 years and older.