Pfizer/BioNTech initiate application with EU regulator for updated COVID-19 vaccine

Pfizer and partner BioNTech said on Friday they have initiated an application to the European Medicines Agency (EMA) for authorization of an updated COVID-19 vaccine targeting Omicron subvariant XBB.1.5. 

Earlier in June, Europe's medicine regulators backed the World Health Organization's recommendation to update the antigen composition of COVID-19 shots to target one of the currently dominant XBB variants ahead of the upcoming autumn vaccination campaign.

Pfizer/BioNTech said they expect to be ready to ship XBB.1.5-adapted monovalent vaccines to member states of the European Union immediately following regulatory approval.