This sBLA submission is supported by clinical, pre-clinical, and manufacturing data demonstrating the safety, tolerability, and immunogenicity of the bivalent vaccine.
Both vaccine candidates demonstrated a favorable safety and tolerability profile similar to the Pfizer-BioNTech COVID-19 Vaccine
The manufacture of finished doses will commence in 2022 and at full operational capacity, the annual production is expected to exceed 100 million doses annually
The submission to the US FDA has been initiated and they intend to file these data with the European Medicines Agency and other regulatory bodies in the coming weeks
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