The vaccine is a stable, prefusion protein antigen derived from the genetic sequence of the SARS-CoV-2 coronavirus spike (S) protein and adjuvanted with Novavax's proprietary Matrix‑M.
The firm has fully enrolled two of the three planned late-stage efficacy trials for NVX-CoV2373 with more than 20,000 participants dosed to date. The primary efficacy endpoints for the trials have been harmonized and reviewed by global regulatory agencies.
Novavax has completed enrollment of 15,000 participants in the U.K. phase III clinical trial with interim data expected as soon as the first quarter of 2021, but the timing will depend on the overall COVID-19 rate in the region. The data is expected to serve as the foundation for licensure in the U.K. and other countries.
The firm has also completed enrollment of the phase IIB trial taking place in South Africa. A total of 4,422 volunteers are taking part and the participants include 245 medically stable, HIV-positive participants. The trial is expected to add to the body of evidence regarding the vaccine and its effect on racially and geographically diverse populations.
The phase III trial taking place in the U.S. and Mexico will begin in the coming weeks, Novavax said. More than 100 trial sites have been selected with some alternates on the list as well. The firm will use vaccine material produced at commercial scale for the trial and thus has been working with the U.S. Food and Drug Administration to complete trial-initiation gating activities.
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