Vaccine maker Novavax has completed enrollment of the Phase 3 trial for its Covid-19 vaccine in the UK, and a large-scale clinical trial in the United States and Mexico will begin “in the coming weeks,” the company announced Monday.
The UK trial enrolled 15,000 participants, and will determine the efficacy and safety of Novavax’s experimental vaccine, called NVX-CoV2373. Interim results from that Phase 3 trial are expected “as soon as early first quarter 2021,” depending on how fast Covid-19 is spreading in the region, the company said.
Novavax also announced it has fully enrolled its Phase 2b vaccine trial in South Africa, with more than 4,400 participants. Among its trials, more than 20,000 participants have been dosed to date.
The Phase 3 clinical trial in the United States and Mexico will begin “in the coming weeks” -- later than it had previously suggested. The vaccine maker said earlier in November that this trial would likely begin by the end of the month.
It would be the fifth coronavirus vaccine to enter late-stage clinical trials in the United States. The Maryland-based company was awarded $1.6 billion from the federal government’s Operation Warp Speed to fund its Phase 3 trial in the US and Mexico and to scale-up manufacturing.
Novavax's vaccine is made by growing synthetic versions of the coronavirus spike protein in armyworm moth cells. The vaccine combines these particles with the company’s adjuvant – a plant-based compound that helps boost the immune response to the vaccine.