New Coronavirus Vaccine Candidate: Novavax Starting Clinical Trials Of NVX-COV2373 To Fight Pandemic

Novavax Inc. on Tuesday announced a phase 1/2 trial of its coronavirus vaccine, NVX-CoV2373, one of at least eight potential vaccines being tested against the pandemic that has caused some 347,000 deaths worldwide.

Novavax (NVAX), a late-stage biotechnology company, said results from its phase 1 trial were expected to be released in July. The vaccine is a prefusion protein that uses nanoparticle technology and a substance to enhance the body’s immune response.

“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,” said Dr. Richard Hatchet, CEO of the Coalition for Epidemic Preparedness Innovations, which is funding the trial.

Earlier this month, Moderna announced promising results from its mRNA-1273 vaccine, originally developed to treat SARS, and announced phase 2 trials to begin in July. Pfizer and BioNTech SE also are among the companies testing vaccines, as is the University of Oxford in England and a Chinese group. An estimated 110 vaccines are being explored but have yet to make it to clinical trials.

Dr. Anthony Fauci, director of the U.S. National Institute of Allergies and Infectious Diseases, has said it would be at least a year before an effective vaccine can be identified but there was no guarantee a vaccine actually would be developed, a sentiment echoed by World Health Organization officials, who have said we just may have to learn to live with the virus, much like HIV/AIDS.

Novavax said the first phase of its trial would be randomized, observer blind and placebo controlled. Approximately 130 healthy individuals ages 18 to 59 were to be enrolled. The trial is to be conducted at two sites in Australia as winter approaches. Two doses of the vaccine will be administered, both with and without the enhancing agent.

The phase 2 trial is to be conducted in multiple countries and broaden the age range.

NVX-CoV2373 showed promise in preclinical testing, producing high levels of antibodies and prompting immune responses, Novavax said.

“These results provide strong evidence that the vaccine candidate will be highly immunogenic in humans, potentially leading to protection from COVID ‑ 19 and thus helping to control the spread of this disease,” Novavax 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,” Hatchett said.

Novavax shares were up 13% on the news.