Novavax’s COVID-19 Shot Finally Authorized In US, But Could Miss Out Again On Bivalent Booster
Still Hoping To Hit $4bn Revenues Despite Slow Start
A protein-based vaccine for COVID-19 reaches the US at last, but Novavax looks set miss out once again as the fall deadline for BA.4/5 variant-targeting vaccines approaches.
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FDA Commissioner says the new shots will skip advisory committee review after June meeting on reformulation. ‘As we know from prior experience, strain changes can be made without affecting safety.’
Under FDA guidance, the companies submitted clinical data for BA.1-targeting bivalent vaccines together with BA.4/BA.5 preclinical data. Novavax got a nod for its COVID-19 vaccine in adolescents, but its own Omicron development efforts remain behind the two mRNA heavyweights.
Moderna takes the next step in the in the development of COVID-19 vaccines, with the first approval of the first bivalent vaccine that can produce a broader immune response to new SARS-CoV-2 variants.