February 22, 2021 -- Novavax announced a memorandum of understanding with Gavi, the Vaccine Alliance, to provide 1.1 billion cumulative doses of its COVID-19 vaccine candidate, NVX-CoV2373, to the Covax facility. The company has also fully enrolled participants in its pivotal phase III clinical trial of NVX-CoV2373.
Covax was established by public health agencies, including the World Health Organization, to provide governments with early access to a large portfolio of COVID-19 vaccines.
The vaccine will be manufactured and distributed globally by Novavax and the Serum Institute of India (SII). Novavax licensed its vaccine to SII with no upfront, milestone, or technology transfer payments. Novavax and SII are jointly committed to deliver 1.1 billion doses to the Covax facility.
Gavi will work with Novavax to finalize an advance purchase agreement for vaccine supply and global distribution allocation via the Covax facility and its partners.
The company also announced that it has completed enrollment of its Prevent-19 phase III study in the U.S. and Mexico to evaluate the efficacy, safety, and immunogenicity of NVX-CoV2373. The study has enrolled 30,000 individuals from diverse populations. Two-thirds of the participants are assigned to randomly receive two intramuscular injections of the vaccine, administered 21 days apart, while one-third of the trial participants receive a placebo. Prevent-19 is being conducted with support from the U.S. government partnership.