EU drugs watchdog begins review of Moderna’s variant COVID vaccine

The European Medicines Agency (EMA) started a rolling review recently of a variant-adapted COVID-19 vaccine from Moderna, as corona virus cases linked to Omicron sub-variants see an uptick in the region.

The US-based Moderna’s so-called bivalent vaccine targets two strains of the SARS-CoV-2 virus behind COVID, the original strain first identified in China, and the Omicron variant.

Last week, Moderna said its bivalent vaccine produced a better immune response against Omicron than the original shot.

Earlier, the EMA also launched a rolling review of a competing mRNA variant-adapted vaccine made by the partnership between Pfizer and BioNTech.

A rolling review means the regulator assesses the data as it becomes available, and the process continues until there is enough data for a formal marketing application.

While a new Omicron-driven wave of infections has been widely anticipated in the northern hemisphere this autumn and winter, a European disease monitoring agency has already warned cases could surge soon, citing the spread of particularly contagious Omicron sub-variants.