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

LONDON, June 17 (Reuters) – The European Medicines Agency (EMA) started a rolling review on Friday of a variant-adapted COVID-19 vaccine from Moderna (MRNA.O), as coronavirus cases linked to Omicron sub-variants see an uptick in the region.

A pharmacist holds a vial of the Moderna coronavirus disease (COVID-19) vaccine in West Haven, Connecticut, U.S., February 17, 2021. REUTERS/Mike Segar

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. read more

On Wednesday, the EMA also launched a rolling review of a competing mRNA variant-adapted vaccine made by the partnership between Pfizer (PFE.N) and BioNTech (22UAy.DE). read more

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.

Reporting by Natalie Grover in London Editing by Mark Heinrich and Frances Kerry

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Source: Reuters