Novavax said it expects the Phase 3 clinical trial for its SARS-CoV-2 vaccine candidate, NVX‑CoV2373, to begin in the coming weeks in the United States and Mexico. More than 100 trial sites have been selected with some alternate sites in place, should they be needed, the company said in a press release.
NVX‑CoV2373 is a stable, prefusion protein antigen derived from the genetic sequence of the SARS-CoV-2 coronavirus spike (S) protein and adjuvanted with the company’s’ proprietary Matrix‑M.
Preliminary blinded data on NVX-CoV2373 in older adults needed to proceed to Phase 3 has previously been reviewed by the U.S. Food and Drug Administration (FDA), the company said. Additional clinical data from the Phase 2 trial conducted in the United States and Australia are expected to be unblinded in Q1 and will be targeted for publication.
Novavax will use vaccine material produced at commercial scale for this trial. Therefore, the company said it has been working closely with the FDA to complete trial-initiation gating activities related to its commercial-scale production at FUJIFILM Diosynth Biotechnologies in Research Triangle Park, NC.
Novavax was awarded $1.6 billion in funding from the U.S. government to meet its Operation Warp Speed goals to expedite the delivery of millions of doses of safe, effective vaccines for COVID-19. The award is funding the Phase 3 trial in the United States and Mexico and manufacturing scale-up.
Meanwhile, Novavax completed enrollment of 15,000 participants in a Phase 3 clinical trial being conducted in the United Kingdom. to determine efficacy and safety of NVX-CoV2373. The U.K. Vaccines Taskforce and National Institute for Health Research played pivotal roles in the rapid recruitment and enrollment of volunteers, the company said.
Interim data in this event-driven trial are expected as soon as early first quarter 2021, although the timing depends on the overall COVID-19 rate in the region. These data are expected to serve as the basis for licensure application in the United Kingdom, European Union and other countries. More than 25 percent of enrollees in the trial are over the age of 65, while a large proportion of volunteers had underlying co-morbid medical conditions generally representative of the population.
