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


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

U.S.-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.

On Wednesday, 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.

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