Trial results for the COVID-19 vaccine developed by Novavax show more than 90% efficacy among the nearly 30,000 people in the U.S. and Mexico who participated in the trials. But because it wouldn’t be available for emergency use authorization until late September 2021 at the earliest—and possibly won’t even be granted that status—it’s possible that the vaccine may not be used in the U.S. for the current wave of vaccinations.
As the New York Times reported, it’s possible the Food and Drug Administration would tell Novavax not to apply for emergency status because there are plenty of other vaccines in use. Instead, Novavax would have to apply for a full license, which would be an even longer process.
And even though Stanley Erck, the CEO of the Maryland biotechnology company, admitted that the Novavax vaccine may first win approval elsewhere, he’s buoyed by the results of the efficacy trials.
“I think the good news is that the data are so compelling that it gives everybody an incentive to pay attention to our filings,” Erck said.
Dr. Gregory Glenn, president of research and development for Novavax, told CNN that the trial did well in two very different North American nations, though he incorrectly pegged Mexico and the U.S. as being on separate continents.
“Different continent, different population, different viruses floating around, and yet, we still see really good efficacy,” Glenn said. “This is what you want to have.”
The trial, which began in December 2020, employed 29,960 adults across 113 sites in the United States and six sites in Mexico. The study involved some participants who received two doses of the Novavax vaccine 21 days apart and others who received a placebo.
While there were 77 coronavirus cases during the study, only 14 were from the vaccine group, and all of those were mild. That contrasted with 63 total placebo cases, including 10 moderate and four severe cases; Novavax concluded the vaccine showed 100% efficacy against moderate or severe disease based on those trial results.
While the Novavax vaccine might not be part of this current wave of vaccinations, its protein-based technology and its comparatively easy storage could make it ideal for booster shots down the line.
In the meantime, as the Washington Post reported, the vaccine could potentially be deployed in other nations where doses are in demand.
“A lot of our vaccine is going to be targeted in the early stages for Covax,” Erck said, referring to the World Health Organization’s Covax initiative, “and so a lot of those doses are going to get into the low- and middle-income countries first, which is a good thing.”
One of the questions that Novavax is presenting in the COVID-19 vaccine equation is how the U.S. FDA emergency use authorizations—which allowed the Pfizer/BioNTech, Moderna, and Johnson & Johnson vaccines to be relatively fast-tracked—will be utilized going forward.
The Post noted that the agency might be changing its approach to vaccine approvals based on something that happened earlier in June: Ocugen had been seeking emergency authorization for Covaxin, a COVID-19 vaccine currently utilized in India. But on June 10, the company announced that the FDA has instead recommended the company use a biologics license application—the typical route for a vaccine to go to market, which adds a number of months to the authorization process.
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