Novavax has officially hit go on advanced trials of its coronavirus vaccine candidate in the U.S. and Mexico, working with up to 114 sites in this country to enroll up to 30,000 total participants.
These latest trials follow late-stage trials already underway in the U.K., as well as phase 2 trials in South Africa and phase 1/2 trials in U.S. and Australia. The company said it hopes to get data from those clinical tests as soon as the first quarter of 2021, depending on enrollment and transmission rates.
As for the newest trials in U.S. and Mexico, they were originally slated for mid-October, then by the end of November, but Novavax has said that scaling up its manufacturing efforts has taken time. It’s working with testing sites across the country where there are higher transmission rates, though the only ones in this vicinity thus far — one slated for Baltimore and another for D.C. — haven’t started enrolling participants yet. Another in Newport News, Virginia, has begun recruiting for this trial.
Novavax received fast-track status for this candidate from federal regulators and aims to have more than 25% of participants be at least 65 years old, more than 15% be Black, 10% to 20% be Latinx and 1% to 2% be American Indian to test its vaccine candidate on a diversity of adults and those most affected by the virus. Enrollment information is here, while the full testing protocol can be found here.
Novavax said its product, called NVX-CoV2373, can be stored at 2 to 8 degrees Celsius and is shipped in liquid form. As part of the U.S. and Mexico tests, it said it's aiming for this product to prevent confirmed, symptomatic cases of Covid, as well as particularly severe and moderate cases. Two-thirds of the participants in these new studies will receive dual vaccine injections, each 21 days apart, while the remaining one-third will receive a placebo. In its first phase of trials, Novavax previously reported that its vaccine was found to be generally well-tolerated and elicit “robust antibody responses,” adding that it showed the potential to reduce the disease’s transmission and didn't result in any "severe" side effects.
“We recognize that volunteers considering our trial may have questions about the potential impact on their ability to receive an authorized vaccine when it becomes available to them," Gregory Glenn, Novavax's president of research and development, said in a statement. "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.”
The local biotech is one of a handful of companies working to develop a coronavirus vaccine — two are already being disseminated to recipients after the Food and Drug Administration approved their emergency use, one by Moderna Inc. (NASDAQ: MRNA) and another by Pfizer Inc. (NYSE: PFE) and BioNTech. Several other companies have initiated their own trials for their experimental vaccines aimed at curbing coronavirus.
Novavax has racked up a cumulative $2 billion in funding for development of NVX-CoV2373, including $1.6 billion from the federal government’s Operation Warp Speed, $60 million from the Department of Defense and up to $388 million from the Coalition for Epidemic Preparedness Innovations, or CEPI.
It's raised another nearly $650 million, much of it from stock sales, and has registered another 5.37 million shares worth up to $500 million to potentially sell should it need additional funding. This all comes as the company has shuffled its leadership team to fill its chief commercial officer role and brought on two new board members in the last two months: Gilead Sciences alum Gregg Alton and International AIDS Vaccine Initiative and Merck alum Margaret McGlynn, both of whom have years of experience in bringing drugs to the commercial market.
As of 2 p.m. Monday, Novavax's stock price had dipped more than 7% to $119.39 per share.
