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|Articles|July 23, 2021
EMA’s CHMP Adopts Positive Opinion for Moderna COVID-19 Vaccine Use in Adolescents
Author(s)BioPharm International Editors
The EMA’s CHMP has adopted a positive opinion recommending marketing authorization for Moderna’s COVID-19 vaccine (Spikevax) to include adolescents 12 years of age and older.
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The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for Moderna’s COVID-19 vaccine, Spikevax, to include adolescents 12 years of age and older, Moderna announced in a
Moderna announced data from the ongoing Phase II/III study on June 10, 2021, which enrolled more than 3,500 participants ages 12–18 years in the United States. After two doses of the Moderna COVID-19 vaccine, no cases of COVID-19 were observed in the vaccine group, and the study met its primary endpoint. The vaccine was generally well tolerated with a safety and tolerability profile consistent with the previous Phase III study in adults.
Most of the adverse events were mild or moderate in severity. Injection site pain was the most common local adverse event, while the most common systemic adverse events after the second dose of mRNA-1273 were headache, fatigue, myalgia, and chills.
The European Commission will consider authorizing the use of the Moderna COVID-19 vaccine in adolescents younger than 12 years of age.
Moderna is also conducting the KidCOVE study, a Phase II/III study, of mRNA-1273 in children ages six months to 12 years.
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