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Pfizer and BioNTech Initiate Application to European Medicines Agency for Omicron XBB.1.5-Adapted Monovalent COVID-19 Vaccine •The application reflects guidance from EMA and other major health authorities to pr.

United kingdomUnited statesFosun pharmaWorld health organizationCommittee for medicinal products human useEuropean commissionEuropean medicines agencyRoche groupDrug administrationExchange commissionEuropean unionPfizer incInitiate applicationAdapted monovalentMarketing authorization holderBiologics license holder