Moderna submits for marketing approval of COVID-19 vaccine in adolescents in Europe

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Shares of Moderna Inc. MRNA, +5.56% rose 0.5% in premarket trading Monday, after the biotechnology company said it had submitted for conditional market approval (CMA) with the European Medicines Agency (EMA) for its COVID-19 vaccine in adolescents, ages 12 to less than 18. In May, the company said the Phase 2/3 study of its vaccine in adolescents met its primary immunogenicity endpoint. "We are encouraged that the Moderna COVID-19 vaccine was highly effective at preventing COVID-19 and SARS-CoV-2 infection in adolescents," said Chief Executive Stéphane Bancel. "We have filed for authorization with Health Canada and we will file for an Emergency Use Authorization with the U.S. FDA and regulatory agencies around the world for this important younger age population." Moderna's stock has soared 97.3% year to date through Friday, while the S&P 500 SPX, +0.88% has gained 12.6%.

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