On Oct. 25, 2021, Moderna announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had concluded that a booster dose of Spikevax, the Company’s vaccine against COVID-19, at the 50 ﾵg dose level may be considered in people aged 18 years and older at least six months after completion of the primary series.

The EMA based this positive opinion on scientific evidence shared by the company, including a data analysis from the Phase 2 clinical study of mRNA-1273, which was amended to offer a booster dose of mRNA-1273 at the 50 µg dose level to interested participants 6-8 months following their second dose.

Neutralizing antibody titers had waned prior to boosting, particularly against variants of concern, at approximately 6 months. Notably, a booster dose of mRNA-1273 at the 50 µg dose level boosted neutralizing titers significantly above the Phase 3 benchmark. After a booster dose, a similar level of neutralizing titers was achieved across age groups including in older adults (ages 65 and above). The safety profile following the booster dose was similar to that observed previously for dose 2 of mRNA-1273.