Moderna, Inc. plans to file for US Food and Drug Administration authorization of its bivalent, Omicron-specific COVID-19 vaccine candidate in the coming weeks and is hoping by late summer to be ready to start shipments in time for the fall.
The company announced positive data on 8 June from the Phase II/III study of mRNA-1273.214, showing superiority against the Omicron variant compared with the FDA-approved Spikevax vaccine, originally known as mRNA-1273
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