EU regulator begins review of Pfizer-BioNTech's variant-adapted COVID shot
9/8/2022 19:28
The European Medicines Agency (EMA) 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 Europe.
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.
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