Novavax initiates Phase I/II trial of COVID-19 vaccine candidate NVX‑CoV2373

Novavax on Monday announced that it has enrolled the first participants in a Phase I/II trial of its coronavirus vaccine candidate NVX‑CoV2373, with preliminary results expected in July. The news follows the Coalition for Epidemic Preparedness Innovations (CEPI) recently awarding up to $384 million in additional funding to Novavax to advance development for NVX-CoV2373 against SARS-CoV-2.

Novavax CEO Stanley Erck said "we look forward to sharing the clinical results in July and, if promising, quickly initiating the Phase II portion of the trial."

The Phase I portion is recruiting approximately 130 healthy participants 18 to 59 years of age at two sites in Australia. The randomised, placebo-controlled study will evaluate the immunogenicity and safety of NVX‑CoV2373, a stable prefusion protein that will incorporate Novavax's Matrix-M adjuvant, as well as a non-adjuvanted form of the vaccine. Novavax said the Phase II portion of the trial is expected to be conducted in multiple countries, including the US, and will assess immunity, safety and COVID‑19 disease reduction in a broader age range.

The company has indicated that the CEPI funding would allow manufacturing of up to 100 million doses by the end of 2020, and also permit it to gain access to large-scale manufacturing capacity in several countries, with the aim of potentially producing over 1 billion doses next year.

Richard Hatchett, chief executive at CEPI, said "our investment in Novavax allows us to focus on manufacturing in parallel with the clinical development of the vaccine, so that if the vaccine is proven to be safe and effective, we can make doses available to those who need them without delay."

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