EMA to hold Sept. 1 meeting on Moderna and Pfizer/BioNTech COVID Omicron vaccines
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The European Medicines Agency (EMA) has scheduled a meeting on Sept. 1 to discuss applications from Moderna (NASDAQ:MRNA) and Pfizer (NYSE:PFE)/BioNTech (NASDAQ:BNTX) on their modified COVID-19 vaccines with Omicron protection.
The shots are bivalent, meaning they provide protection against the original COVID strain as well as the BA.1 Omicron subvariant.
Earlier this month, the EMA said it began a rolling review of the Pfizer (PFE)/BioNTech (BNTX) adapted vaccine.
On Monday, the two companies submitted an application for an Emergency Use Authorization for a bivalent COVID vaccine to the US FDA.