Moderna files CMA to EMA for mRNA 1273 booster dose in COVID-19

Moderna announced it has submitted for a conditional marketing approval (CMA) with the European Medicines Agency (EMA) for the evaluation of a booster dose of the Moderna COVID-19 vaccine (mRNA-1273) at the 50 µg dose level. The Phase II study of mRNA 1273 was amended to offer a booster dose of mRNA 1273 at the 50 µg dose level to interested participants 6 months following their second dose (n=344).

Neutralizing antibody titers had waned significantly prior to boosting at approximately 6 months. A booster dose of mRNA 1273 at the 50 µg dose level boosted neutralizing titers significantly above the Phase III benchmark. After a third dose, a similar level of neutralizing titers was achieved across age groups, notably in older adults (ages 65 and above). The safety profile following dose 3 was similar to that observed previously for dose 2 of mRNA-1273. These data will be submitted to a peer-reviewed publication.

An additional analysis showed that a booster dose of mRNA 1273 at the 50 µg dose level induced robust antibody responses and significantly increased geometric mean titers (GMT) for all variants of concern including Beta (B.1.351) by 32- fold, Gamma (P.1) by 43.6-fold and Delta (B.1.617.2) by 42.3-fold.