Novavax hopes its injection from COVID will defeat the FDA, vaccine supporters

It is expected that after long delays, the Food and Drug Administration will decide within a few weeks whether to allow the Novavax vaccine. In a pandemic for a new choice, it’s too late, with about three-quarters of adults in the U.S. already vaccinated.

Soon, Americans may receive a new version of the vaccine against COVID-19 – pictures taken with more proven technology than modern versions. The big question is: why should they care?

It is expected that after long delays, the Food and Drug Administration will decide within a few weeks whether to allow the Novavax vaccine. In a pandemic for a new choice, it’s too late, with about three-quarters of adults in the U.S. already vaccinated.

But the company hopes to find a niche among some of the millions of unvaccinated who could agree to a more traditional type of vaccine – the protein vaccine – and become the best choice for boosters, no matter what type of people get it first. Only about half of the vaccinated adults received revaccination.

The Novavax vaccine is already used in some European countries and many other countries, but FDA approval is a key hurdle. And health experts are watching closely to see if the new tool offers benefits, either in luring vaccines, or perhaps even offering broader immunity.

“What I’ve seen in Novavax data so far is a really impressive protein vaccine,” said Pennsylvania University immunologist E. John Wery.

WHAT ARE DIFFERENT?

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

An immune-boosting component, or an adjuvant made from the bark of a South American tree that then acts as a red flag, is then added to ensure that these particles look suspicious enough to cause a strong reaction.

“Essentially, it’s a bubble. It’s made from materials you’ll find in root beer, ”Glenn said. “When an immune cell sees this, it is fully activated. … We boost the immune response. ”

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

This is a completely different approach than shooting Pfizer and Moderna. These so-called mRNA vaccines have saved countless lives and changed the course of the pandemic, but still some people do not like the new technology that gives genetic instructions to the body to make their own copies. The third U.S. option, from Johnson & Johnson, is not as widely used.

WHY IS IT SO LATE?

Problems with production have held back the vaccine worldwide, but Novavax CEO Stanley Erk said the problems have been resolved and “beyond us”. The company said that by March, more than 40 million doses had been distributed to Asia, Europe and other countries.

Novavax, a small biotech company, has created the vaccine in its research lab, but India’s Serum Institute, the world’s largest vaccine maker, and other factories produce injections.

Erk said the Serum Institute recently passed an FDA audit, clearing the agency of a path to completing vaccine evaluations.

HOW GOOD ARE SHOTS?

Earlier during the pandemic, large studies in the US, Mexico and the UK found that two doses of Novavax vaccine were safe and about 90% effective in preventing symptomatic COVID-19. When the delta variant appeared last summer, Novavax reported that the booster dose activated antibodies that fight viruses that could fight the mutant.

Now dominated by an even more contagious branch of the coronavirus family tree, the mutant Omicron and its relatives. Although none of the world’s vaccines against COVID-19 have proven to be as potent against omicron, Glenn said laboratory tests show that Novavax injections do cause cross-antibody protection.

Like other vaccine manufacturers, Novavax is preparing images that have been updated to better target the omicron. He opened a study in Australia to test how well-targeted the omicron booster boosts immunity in people who originally received doses of Pfizer or Moderna.

And in flasks full of insect cells, at the company’s research lab in Maryland, scientists are developing spike proteins that match even new native omicrons when needed.

WHAT’S NEXT?

On June 7, FDA scientific advisers will publicly evaluate the evidence of the Novavax vaccine for adults – and will almost certainly discuss when and how it can be used as a booster. If the FDA authorizes the vaccine, the next step will be recommendations from the Centers for Disease Control and Prevention on how to use it.

European regulators are considering expanding Novavax intake for teens based on a U.S. study of those aged 12 during a delta wave last summer. In the near future, the company plans to conduct additional tests on young children.

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