The UK trial has enrolled more than 5,500 participants since it started at the end of September; and will expand to 15,000 (up from an initial target of 10,000) with enrolment expected to be completed by the end of November. Interim data from this trial is currently expected in the first quarter of 2021.
Gregory M. Glenn, M.D., President of Research and Development at Novavax, said: “We are grateful for the support of the U.K. Government’s Vaccines Taskforce (VTF) and the National Institute for Health Research (NIHR) for our pivotal trial. Recognizing the recent, large increase in the number of COVID-19 cases in the UK, as well as the rapid progress in participant enrollment for our trial, in consultation with the VTF and NIHR, we adjusted our plans and increased enrollment.”
Novavax intends to start a Phase 3 clinical trial in the US and Mexico by the end of next month. This trial will be conducted with support from the US government through Operation Warp Speed: and will enrol up to 30,000 patients across the US and Mexico.
Novavax commits to publishing the protocol for the US trial in the same way as other vaccine developers.
Protein subunit vaccine
NVX‑CoV2373 is a stable, prefusion protein made using Novavax’ nanoparticle technology and includes Novavax’ proprietary Matrix‑M adjuvant.
In preclinical trials, NVX-CoV2373 demonstrated induction of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection.
In the Phase 1 portion of its Phase 1/2 clinical trial, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in a Phase 3 trial in the UK and two ongoing Phase 2 studies that began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the US and Australia.
Novavax has secured $2bn in funding for its global coronavirus vaccine program, including up to $388m in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).