On Dec. 16, 2022, Moderna announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had adopted a positive opinion recommending a variation to the marketing authorization to include a booster dose of Spikevax bivalent Original/Omicron BA.1 (mRNA-1273.214), at the dose level for children (6-11 years) of 12.5mcg/12.5mcg (0.25 mL) at least three months after the last prior dose of a COVID-19 vaccine.

The pediatric application was based on clinical trial booster data for Moderna’s original vaccine, Spikevax, which was administered to over a thousand participants. The application described data from a 25 μg booster dose administered to children ages 6 to 11 years old following a completed primary series of the Moderna COVID-19 vaccine. In addition, the application included clinical trial data from a Phase 2/3 studying mRNA-1273.214.