GAITHERSBURG, Md. — Americans may soon have a new COVID-19 vaccine option — shots made with more proven technology than current versions. The big question: why should they care?
After long delays, the Food and Drug Administration is expected to decide on whether to approve Nova vax’s vaccine within weeks. It’s late in the pandemic for a new choice, with about three-quarters of American adults already vaccinated.
But the company hopes to find a niche among some of the unvaccinated millions who may agree to a more traditional type of injection — a protein vaccine — and also become a top choice for boosters, no matter what kind of people got it first. Only about half of vaccinated adults have received a supporter.
The Novavax vaccine is already being used in parts of Europe and several other countries, but FDA approval is a major hurdle. And health experts are keeping a close eye on whether a new tool offers any benefits, either in baiting vaccinations or perhaps even offering a broader range of immunity.
“I’ve seen so far from the Novavax data that it’s a really impressive protein vaccine,” said immunologist E. John Wherry of the University of Pennsylvania.
The Novavax vaccine trains the body to fight the coronavirus by releasing copies of the outer layer, the spike protein. Those spike copies are grown in insect cells, purified, and packaged in nanoparticles that resemble a virus to the immune system, said study lead author Dr. Gregory Glenn of Novavax.
Then an immune-boosting ingredient, or excipient, made from the bark of a South American tree, is added that acts as a red flag to make those particles look suspicious enough to trigger a strong reaction.
“It’s actually a bubble. It’s made from things you find in root beer,” Glenn said. “When an immune cell sees this, it is activated quite a bit. … We boost the immune response.”
Protein vaccines have been used for years to prevent hepatitis B, shingles, and other diseases.
A third American option, from Johnson & Johnson, is not widely used. It’s a very different approach from the Pfizer and Moderna shots. Those so-called mRNA vaccines have saved countless lives and changed the course of the pandemic, yet some people are uncomfortable with the new technology that gives the body genetic instructions to make its own spike copies.
WHY SO LATE?
Manufacturing issues have held back the vaccine worldwide, but Novavax CEO Stanley Erck said those issues have been resolved and are “far behind us.” The company said more than 40 million doses had been distributed to countries in Asia, Europe, and elsewhere by March.
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 injections.
Erck said the Serum Institute recently passed an FDA inspection, paving the way for the agency to complete its vaccine evaluation.
HOW WELL DO THE SHOTS WORK?
Earlier in the pandemic, large studies in the U.S., Mexico, and the U.K. found that two doses of the Novavax vaccine were safe and about 90% effective in preventing symptomatic COVID-19. When the delta variant showed up last summer, Novavax reported that a booster dose ramped up the virus-fighting antibodies that could target that mutant.
An even more contagious branch of the coronavirus family tree dominates the omicron mutant and its relatives. While none of the world’s COVID-19 vaccines are as strong against omicron, Glenn said lab tests show that Novavax injections produce cross-protective antibodies.
Like other vaccine makers, Novavax brews shots that have been updated to better target omicron. It opened a study in Australia to test how well an omicron-targeted booster boosts immunity in people initially given Pfizer or Moderna doses.
And in flasks full of insect cells at the company’s Maryland-based research lab, scientists are designing spike proteins to match even newer omicron siblings, just in case they’re needed.
On June 7, the FDA’s scientific advisors will publicly review the evidence for the Novavax vaccine for adults — and almost certainly discuss when and how it can be used as a booster. If the FDA approves the vaccine, the next step would be recommendations from the Centers for Disease Control and Prevention on its use.
European regulators are considering extending Novavax injections to teens based on a U.S. survey of youth ages 12 and up during last summer’s delta wave. The company plans further testing in younger children soon.
The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute’s Department of Science Education. The A.P. is solely responsible for all content.