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EMA Committee Adopts Positive Opinion For Moderna COVID-19 Vaccine In Adolescents

The European Medicines Agency's or EMA Committee for Medicinal Products for Human Use or CHMP adopted a positive opinion recommending marketing authorization for Moderna Inc.'s (MRNA) COVID-19 vaccine, Spikevax, to include adolescents 12 years of age and older, the company said in a statement.

"The CHMP recommendation of the authorization of our COVID-19 vaccine for use in individuals 12 years of age and older in the European Union is a positive step forward toward authorization of our vaccine in this age group," said Stéphane Bancel, Chief Executive Officer of Moderna.

Moderna said it is also conducting a Phase 2/3 study, called the KidCOVE study, of mRNA-1273 in children ages 6 months to less than 12 years.

On December 18, 2020, the U.S. FDA authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18 years of age or older. Moderna has received emergency or other conditional, interim or provisional authorization for use of its COVID-19 vaccine in adults from health agencies in more than 50 countries and an Emergency Use Listing from the World Health Organization (WHO).

Moderna has filed for emergency or other conditional, interim or provisional authorization for use of its COVID-19 vaccine in adolescents with global health agencies.

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