Novavax’s Pending EUA Likely Less Important Than Future Updates
Upcoming booster, adolescent data may be more commercially significant for the vaccine, which would enter a US market with few willing adults still unvaccinated. The tough prospects for one of the first COVID vaccines in development is a lesson in the importance of avoiding regulatory delays.
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The agency also includes a myocarditis warning in the fact sheet for the first protein-based COVID-19 vaccine to reach the US market.
The bivalent vaccine is likely to get regulatory support, along with government contracts, but competitors, notably Moderna, will also step into the ring.
Phase III data from two studies of the adjuvanted recombinant vaccine candidate showed increases in neutralizing antibody titers against the original SARS-CoV-2 strain and variants of concern.