On Jul. 22, 2022, Moderna announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had adopted a positive opinion recommending a variation to the conditional marketing authorization (CMA) to include a booster dose of Spikevax, the Company’s COVID-19 vaccine, at the 50 µg dose level for adolescents (12-17 years) at least three months after completion of the primary series.

The CHMP based this positive opinion on scientific evidence shared by the company, including comprehensive safety data. The administration of a booster dose of 50 µg at least three months after administration of completion of the primary series is predicted to substantially increase the immune responses against variants of concern, including Omicron compared to pre-boost levels.