Novavax hopes its COVID shot wins over FDA, vaccine holdouts

Novavax hopes its COVID shot wins over FDA, vaccine holdouts

GAITHERSBURG, Md. — Americans may soon get a new COVID-19 vaccine option — shots made with a more tried-and-true technology than today’s versions. What is the big question?

After long delays, Novavax will be approved by the Food and Drug Administration within weeks. With about three quarters of U.S. adult population already being vaccinated, it’s too late to offer a better choice.

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. About half of adults who have been vaccinated have received a booster.

The Novavax vaccine is already available in many countries across Europe, and other nations. FDA approval is however a major hurdle. Health experts will be closely monitoring to determine if the new tool has any advantages in appealing vaccine-rejectants or offering a wider range of 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.

WHAT’S DIFFERENT?

The Novavax vaccine trains your body to combat the coronavirus. It delivers copies of the outer layer, called 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.

Next, an adjuvant (an immune-boosting agent) is added. This acts as a red alert to make sure that the particles are not suspicious and elicit strong reactions.

“It is 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 Moderna shots. Those so-called mRNA vaccines have saved countless lives and changed the course of the pandemic but still, some people are uncomfortable with the new technology that delivers genetic instructions for the body to make its own spike copies. Johnson & Johnson’s third U.S. option is not as popular.

WHY IS IT SO DISTANT?

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.

HOW WELL DO THE SHOTS WORK?

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. Novavax announced that a booster dose of virus-fighting antibody that was able to combat the mutant’s emergence last summer had been approved.

Now an even more contagious branch of the coronavirus family tree is dominant, the omicron mutant and its relatives. While none of the world’s COVID-19 vaccines have proved as strong against omicron, Glenn said lab tests show Novavax shots do trigger cross-protective antibodies.

Novavax, like other vaccine manufacturers, is making shots that better target the omicron. It opened a study in Australia to test how well an omicron-targeted booster revs up immunity in people who initially got Pfizer or Moderna doses.

Scientists are creating spike proteins from insect cells found in the Maryland-based company’s research laboratory to match newer omicron sibling compounds, just in case.

WHAT’S NEXT?

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. Further tests are planned for younger children.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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