Novavax slips after COVID-19 vaccine update

 

• Novavax (NASDAQ:NVAX) provides an update on its COVID-19 vaccine program. 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 Matrix‑M.
• Two of the three planned late-stage efficacy trials for NVX-CoV2373 are fully enrolled, and more than 20,000 participants have been dosed to-date.
• Novavax completed enrollment of 15,000 participants in a Phase 3 U.K. trial. Interim data are expected in early Q1 2021.
• These data are expected to serve as the basis for licensure application in the U.K., European Union and other countries.
• The Phase 2b trial taking place in South Africa is now fully enrolled. A total of 4,422 volunteers are taking part.
• This trial is expected to increase the body of efficacy data of NVX-CoV2373 in racially and geographically diverse populations as well as in older adults, with efficacy data expected to be available in Q1 2021.
• Novavax expects its pivotal Phase 3 trial in the U.S. and Mexico to begin in the coming weeks.
• Preliminary blinded data on NVX-CoV2373 in older adults has previously been positively reviewed by the FDA.
• Additional clinical data from the Phase 2 trial conducted in the U.S. and Australia are expected to be unblinded in Q1 2021.
• Novavax was awarded $1.6B in funding from the U.S. government to meet its Operation Warp Speed goals to expedite the delivery of millions of COVID-19 vaccine doses and scale-up manufacturing.
• https://seekingalpha.com/news/3639860-novavax-slips-6-after-covidminus-19-vaccine-update