Booster dose for adolescents 12-17 years

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a favorable opinion recommending that the conditional marketing authorization for the COVID-19 vaccine Spikevax by Moderna be changed to a booster dose of 50 µg, for adolescents (12-17 years), at least three months after the end of the core series.

The CHMP based its favorable opinion on the scientific evidence provided by the manufacturer, including comprehensive safety data. A 50 µg booster at least three months after the end of the baseline series is expected to significantly increase the immune response against variants of concern, including Omicron, compared to pre-boost levels.

Spikevax (containing elasomeran mRNA) has been given a conditional marketing authorization by the European Commission (EC) based on a recommendation from the European Medicines Agency (EMA) and is indicated for active immunization to prevent coronavirus disease (COVID-19) caused by SARS-CoV-2 virus in people 6 years of age and older. A booster dose may be given at least three months after the second dose in adults 12 years of age and older.

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