EU regulator begins review of Pfizer-BioNTech's variant-adapted COVID shot

The European Medicines Agency has started a rolling review of a variant-adapted COVID-19 vaccine from Pfizer and BioNTech, it said on Tuesday.

The 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 offshoots BA.4/5 that are currently behind most cases in the region.

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