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Summary
- Novavax to commence a late-stage clinical study of its COVID-19 vaccine, NVX-CoV2373.
- The pivotal Phase 3 study (PREVENT-19) is being conducted with the support from Operation Warp Speed collaborators.
- The trial to enrol up to almost 30K subjects across 115 sites in Mexico and the US.
Late-stage biotechnology player developing next-generation vaccines Novavax Inc (Nasdaq:NVAX) revealed that it would start its late-stage clinical trial. The trial will evaluate the efficacy, safety, as well as immunogenicity of COVID-19 vaccine candidate of Novavax- NVX-CoV2373.
On 28 December 2020, the share price of NVAX last quoted at US$119.49, up by 2.26% on Nasdaq.
Let us discuss in detail-
Novavax’s NVX-CoV2373 pivotal Phase 3 study
On 28 December 2020, Novavax disclosed the initiation of its pivotal Phase 3 study, PREVENT-19, in Mexico and the US. The Phase 3 clinical trial builds on the previous investigation from Phase 1/2 clinical studies indicating that the vaccine was generally well-tolerated, triggered a strong immune response, and produced highly neutralising antibodies against the novel coronavirus.
©Kalkine Group 2020
PREVENT-19 is being carried out with Operation Warp Speed (OWS) partners’ assistance including the Department of Defense and the NIAID, part of the NIH, and BARDA.
Moreover, BARDA is also providing up to almost US$1.6 billion under an agreement with the Department of Defense.
Additionally, the Company is currently performing a large pivotal Phase 3 clinical study in the UK, along with a safety and efficacy (Phase 2b) study in South Africa and an ongoing Phase1/2 clinical study in Australia and the US.
Novavax disclosed that data from these clinical studies are anticipated as soon as the early first quarter of 2021. The Company has notified that the timing of the clinical trial depends on the rate of transmission in the regions.
President & CEO of Novavax Stanley C. Erck commented-
Earlier, two COVID-19 vaccines made by Pfizer Inc (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) and the other by Moderna Inc (Nasdaq:MRNA), had received emergency use authorisation (EUA) in the US.
PREVENT-19 Phase 3 Study in a Nutshell
The PREVENT-19 clinical study is an observer-blinded, placebo-controlled, randomised study for evaluating the efficacy, safety, as well as immunogenicity of NVX-CoV2373 in up to 30K subjects across 115 sites in Mexico and the US.
PREVENT-19 trial design has been harmonised to align with other Phase 3 clinical trials conducted under the sponsorships of the OWS. Moreover, the study also includes the usage of a single external independent Data and Safety Monitoring Board (DSMB) for the evaluation of safety and perform a non-blinded review once predetermined interim assessment events are made.
Novavax stated that the primary efficacy analysis for the late-stage clinical trial is event-driven. It is based on the number of participants having symptomatic mild, moderate, or severe symptoms of COVID-19. Subjects of the study will be monitored for 24 months after the administration of the second dose.
