Novavax hopes its COVID shot wins over FDA, vaccine holdouts

Jun 1, 2022, 9:31 PM | Updated: Jun 2, 2022, 3:28 pm
Novovax COVID-19 vaccine's incubate in flasks at the company research laboratory in Gaithersburg, M...

Novovax COVID-19 vaccine's incubate in flasks at the company research laboratory in Gaithersburg, Md., on May 24, 2022. The company is hoping to find a niche among some of the unvaccinated millions who might agree to their more traditional protein vaccine as a shot. (AP Photo/Angie Wang)

(AP Photo/Angie Wang)

              In this image provided by the Serum Institute of India, vials of freshly manufactured Novavax COVID-19 vaccines wait to be labeled in 2022, in Pune, India. The U.S. Food and Drug Administration is evaluating a more traditional kind of vaccine made by Novavax, which the company hopes can win over unvaccinated people and become a top choice for boosters. (Serum Institute of India for Novavax via AP)
            
              Novavax research chief Dr. Gregory Glenn discusses the company’s COVID-19 vaccine in Gaithersburg, Md., on May 24, 2022. The U.S. Food and Drug Administration is evaluating a more traditional kind of vaccine made by Novavax, which the company hopes can win over unvaccinated people and become a top choice for boosters. (AP Photo/Angie Wang)
            
              Scientists examine a step in the vaccine purification process as they design updates to the Novavax's COVID-19 shots in the company's research laboratory on May 24, 2022, in Gaithersburg, Md. The U.S. Food and Drug Administration is deciding whether to authorize use of Novavax’s more traditional kind of COVID-19 vaccine, which the company hopes can win over unvaccinated people and become a top choice for boosters. (AP Photo/Angie Wang)
            
              Scientists work on the vaccine purification process as they design updates to the Novavax's COVID-19 shots in the company's research laboratory on May 24, 2022, in Gaithersburg, Md. The U.S. Food and Drug Administration is deciding whether to authorize use of Novavax’s more traditional kind of COVID-19 vaccine, which the company hopes can win over unvaccinated people and become a top choice for boosters. (AP Photo/Angie Wang)
            
              Novovax COVID-19 vaccine's incubate in flasks at the company research laboratory in Gaithersburg, Md., on May 24, 2022. The company is hoping to find a niche among some of the unvaccinated millions who might agree to their more traditional protein vaccine as a shot. (AP Photo/Angie Wang)

GAITHERSBURG, Md. (AP) — 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: 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.

WHAT’S DIFFERENT?

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 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. A third U.S. option, from Johnson & Johnson, isn’t as widely used.

WHY SO LATE?

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. When the delta variant emerged last summer, Novavax reported a booster dose revved up virus-fighting antibodies that could tackle that mutant.

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.

Like other vaccine makers, Novavax is brewing shots updated to better target 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.

And in flasks full of insect cells in the company’s Maryland-based research lab, scientists are designing spike proteins to match even newer omicron siblings, in case they’re needed.

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. The company plans further tests in younger children soon.

___

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.

Copyright © The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

AP

File - People shop at an Apple store in the Westfield Garden State Plaza mall in Paramus, New Jerse...
Associated Press

A key inflation gauge tracked by the Fed slowed in February

The Federal Reserve's favored inflation gauge slowed sharply last month, an encouraging sign in the Fed's yearlong effort to cool price pressures through steadily higher interest rates.
9 hours ago
FILE - The OpenAI logo is seen on a mobile phone in front of a computer screen displaying output fr...
Associated Press

Musk, scientists call for halt to AI race sparked by ChatGPT

Are tech companies moving too fast in rolling out powerful artificial intelligence technology that could one day outsmart humans?
1 day ago
starbucks...
Associated Press

Starbucks leader grilled by Senate over anti-union actions

Longtime Starbucks CEO Howard Schultz faced sharp questioning Wednesday before the Senate Health, Education, Labor and Pensions Committee
2 days ago
FILE - The overdose-reversal drug Narcan is displayed during training for employees of the Public H...
Associated Press

FDA approves over-the-counter Narcan; here’s what it means

The U.S. Food and Drug Administration on Wednesday approved selling naloxone without a prescription, the first over-the-counter opioid treatment.
2 days ago
FILE - A Seattle police officer walks past tents used by people experiencing homelessness, March 11...
Associated Press

Seattle, feds seek to end most oversight of city’s police

  SEATTLE (AP) — The U.S. Justice Department and Seattle officials asked a judge Tuesday to end most federal oversight of the city’s police department, saying its sustained, decade-long reform efforts are a model for other cities whose law enforcement agencies face federal civil rights investigations. Seattle has overhauled virtually all aspects of its police […]
3 days ago
capital gains tax budgets...
Associated Press

Washington moves to end child sex abuse lawsuit time limits

People who were sexually abused as children in Washington state may soon be able to bring lawsuits against the state, schools or other institutions for failing to stop the abuse, no matter when it happened.
3 days ago

Sponsored Articles

Compassion International...

Brock Huard and Friends Rally Around The Fight for First Campaign

Professional athletes are teaming up to prevent infant mortality and empower women at risk in communities facing severe poverty.
Emergency Preparedness...

Prepare for the next disaster at the Emergency Preparedness Conference

Being prepared before the next emergency arrives is key to preserving businesses and organizations of many kinds.
SHIBA volunteer...

Volunteer to help people understand their Medicare options!

If you’re retired or getting ready to retire and looking for new ways to stay active, becoming a SHIBA volunteer could be for you!
safety from crime...

As crime increases, our safety measures must too

It's easy to be accused of fearmongering regarding crime, but Seattle residents might have good reason to be concerned for their safety.
Comcast Ready for Business Fund...
Ilona Lohrey | President and CEO, GSBA

GSBA is closing the disparity gap with Ready for Business Fund

GSBA, Comcast, and other partners are working to address disparities in access to financial resources with the Ready for Business fund.
SHIBA WA...

Medicare open enrollment is here and SHIBA can help!

The SHIBA program – part of the Office of the Insurance Commissioner – is ready to help with your Medicare open enrollment decisions.
Novavax hopes its COVID shot wins over FDA, vaccine holdouts