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

Reuters
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FILE PHOTO: A woman holds a medical syringe and a small bottle labelled "Coronavirus COVID-19 Vaccine

(Reuters) - Pfizer and partner BioNTech said on Friday they have initiated an application to the European Medicines Agency (EMA) for authorization of 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 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.

The companies added they also plan to file an application with the U.S. drug regulator in the coming days.

Moderna said on Thursday it had completed a submission to the U.S. Food and Drug Administration seeking authorization for its updated COVID-19 vaccine targeting XBB.1.5.

(Reporting by Raghav Mahobe in Bengaluru; Editing by Krishna Chandra Eluri)