HOW WELL DO THE SHOTS WORK?

The Novavax vaccine trains the body to fight the coronavirus by delivering copies of its outer coating, the spike protein. Those spike copies are grown in insect cells, purified and packaged into nanoparticles that to the immune system resemble a virus, said Novavax research chief Dr. Gregory Glenn.

Then an immune-boosting ingredient, or adjuvant, that’s made from the bark of a South American tree is added that acts as a red flag to ensure those particles look suspicious enough to spark a strong response.

“It’s basically a soap bubble. It’s made of stuff that you find in root beer,” Glenn said. “When an immune cell sees that, it becomes quite activated . ... We supercharge the immune response.”

Protein vaccines have been used for years to prevent hepatitis B, shingles and other diseases.

It’s a very different approach than the Pfizer and

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 percent 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.