Novavax announced on Monday that it initiated the Phase III PREVENT-19 trial of its experimental coronavirus vaccine NVX-CoV2373 in the US and Mexico following earlier delays. The study, which is being conducted in collaboration with Operation Warp Speed (OWS), will enrol approximately 30,000 people aged 18 years and older who will be randomised to receive the protein-based vaccine or placebo.
In late October, Novavax explained that the start of PREVENT-19 had been pushed back by about a month as it worked to scale up the manufacturing process, although it noted at the time that it had made "significant progress" on that front. Meanwhile, the company indicated last month that the trial would get under way in "in the coming weeks."
According to Novavax, two thirds of the study's participants will receive two intramuscular injections of NVX-CoV2373, administered 21 days apart, while the remainder will be given placebo. The trial's primary endpoint is the prevention of PCR-confirmed, symptomatic COVID-19, while the key secondary goal is the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. The drugmaker said that both endpoints will be assessed at least seven days after the second study vaccination in volunteers who have not been previously infected with SARS-CoV-2.
Novavax added that it plans to recruit a diverse population into the study, with at least 25% of participants expected to be 65 years or older. Gregory Glenn, the company's president of R&D, remarked "we recognise that volunteers considering our trial may have questions about the potential impact on their ability to receive an authorised vaccine when it becomes available to them. We wish to reassure participants that we are working to ensure that their involvement in our trial does not negatively impact their ability to be vaccinated at the appropriate time."
Novavax is also currently conducting a pivotal Phase III trial in the UK, a Phase IIb safety and efficacy study in South Africa, and an ongoing Phase I/II trial in the US and Australia. "Data from these trials are expected as soon as early first-quarter 2021, although timing depends on transmission rates in the regions," the company said. Novavax has previously reported data from Phase I/II trials demonstrating that NVX-CoV2373 provoked a robust immune response, generated highly neutralising antibodies against the virus and was generally well tolerated.
Novavax is preparing to deliver 100 million doses of NVX-CoV2373 to the US, possibly as early as year-end, as part of a $1.6-billion contract with the federal government. The vaccine comprises a stable perfusion protein antigen derived from the SARS-CoV-2 spike protein and contains Novavax's Matrix‑M adjuvant.
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