EU Drugs Watchdog Begins Review of Modernas Variant COVID Vaccine

LONDON (Reuters) – 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 sublineages see an uptick in the region.

U.S.-based Moderna’s bivalent vaccine targets two strains of the SARS-CoV-2 virus behind COVID, an early version of 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 as a booster shot than the original vaccine.

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

In a rolling review, 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 sooner, citing the spread of particularly contagious Omicron sublineages, BA.4 and BA.5.

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