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Friday, March 5th, 2021

Novavax begins clinical trials of COVID-19 vaccine candidate

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A COVID-19 vaccine candidate created by Novavax, Inc. and supported by the Coalition for Epidemic Preparedness Innovations (CEPI) began clinical trials this week, with the enrollment of participants in a Phase 1/2 study.

The vaccine in question is called NVX-CoV2373, a stable, prefusion protein made from the genetic sequence of SARS-CoV-2 — the virus that causes COVID-19 — with nanoparticle technology. It has shown some success in preclinical trials, demonstrating the ability to bind with receptors targeted by the virus. Those results showed high immunogenicity and high levels of neutralizing antibodies, meaning the candidate could be highly protective for humans.

“Administering our vaccine in the first participants of this clinical trial is a significant achievement, bringing us one step closer toward addressing the fundamental need for a vaccine in the fight against the global COVID‑19 pandemic,” Stanley Erck, president and CEO of Novavax, said. “We look forward to sharing the clinical results in July and, if promising, quickly initiating the Phase 2 portion of the trial.”

That clinical data would include preliminary immunogenicity and safety results. That first trial will be randomized, observer-blinded, and placebo-controlled. It will take place at two sites in Australia, enrolling approximately 130 healthy patients between 18 and 59 years old. That second phase would be spread across multiple countries and focus on assessing immunity, safety, and capability to counter COVID-19 in a broader age range. Manufacturing capacity will be scaled up in parallel.

CEPI will invest up to $388 million into clinical development of the candidate. This marks the fourth COVID-19 vaccine candidate to enter clinical trials.

“Entering clinical trials is an important step on the path to delivering a safe, effective, and globally accessible vaccine against COVID-19,” CEPI CEO Richard Hatchett said. “Vaccines provide our best hope of permanently defeating this pandemic, so it is encouraging to see rapid progress being made in the development of Novavax’ vaccine candidate. CEPI’s priority in building our portfolio has been to focus on vaccine candidates with the potential to be developed at speed and scale and made globally accessible. 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.”