Tag Archive for: Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine

Moderna Inc. on Tuesday sought U.S. authorization for its COVID-19 booster shot tailored against the BA.4 and BA.5 subvariants of Omicron and said if cleared it would be ready to deliver the doses in September.

The European Medicines Agency (EMA) will hold an extraordinary meeting on Sept. 1 to discuss applications from Moderna and Pfizer for vaccine boosters modified to target the Omicron variant, the regulator said on Tuesday.

Pending authorization, the Omicron BA.4/BA.5-adapted bivalent vaccine will be available to ship immediately. A conditional marketing authorization application has also been initiated with the European Medicines Agency (EMA) for the Omicron BA.4/BA.5-adapted bivalent vaccine and is expected to be completed in the coming days.