Canadian vaccine manufacturer hoping its COVID-19 shot will win over the FDA and vaccine holdouts
Manufacturing problems held up the vaccine globally, but Novavax CEO Stanley Erck said those problems have been resolved and "are well behind us."
Americans may soon get a new COVID-19 vaccine option — shots made with a more tried-and-true technology than today’s versions. The big question remains: Why should they care?
After long delays, the Food and Drug Administration is expected to decide within weeks whether to authorize Novavax’s vaccine. It’s late in the pandemic for a new choice, with about three-quarters of U.S. adults already vaccinated.
But the company is hoping to find a niche among some of the unvaccinated millions who might agree to a more traditional kind of shot — a protein vaccine — and also to become a top choice for boosters, regardless of which type people got first. Only about half of vaccinated adults have gotten a booster.
The Novavax vaccine already is used in parts of Europe and multiple other countries, but FDA clearance is a key hurdle. And health experts are closely watching to see if a new tool offers advantages, either in enticing vaccine holdouts or maybe even offering somewhat broader immunity.
“What I’ve seen of the Novavax data so far is it’s a really impressive protein vaccine,” said University of Pennsylvania immunologist E. John Wherry.
Manufacturing problems held up the vaccine globally, but Novavax CEO Stanley Erck said those problems have been resolved and “are well behind us.” The company said more than 40 million doses had been distributed by March to countries in Asia, Europe and elsewhere.
Novavax, a small biotech company, created the vaccine in its research lab, but the Serum Institute of India, the world’s largest vaccine maker and other factories produce the shots.
Erck said the Serum Institute recently passed an FDA inspection, clearing the way for the agency to finish evaluating the vaccine.
Earlier in the pandemic, large studies in the U.S., Mexico and Britain found two doses of the Novavax vaccine were safe and about 90% effective at preventing symptomatic COVID-19. When the delta variant emerged last summer, Novavax reported a booster dose revved up virus-fighting antibodies that could tackle that mutant.
On June 7, the FDA’s scientific advisers will publicly evaluate evidence backing the Novavax vaccine for adults — and almost certainly will debate when and how it might be used as a booster. If the FDA authorizes the vaccine, the next step would be recommendations from the Centers for Disease Control and Prevention on how to use it.
European regulators are considering expanding Novavax shots to teenagers based on a U.S. study of those as young as 12 during last summer’s delta wave. The company plans further tests in younger children soon.