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Novavax non-mRNA COVID vaccine gets CDC approval : NPR


A kidney dish with a syringe containing the Novavax COVID-19 vaccine is refrigerated ready for use in February at a vaccination center in Prisdorf, Germany.

Georg Wendt / AP


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Georg Wendt / AP


A kidney dish with a syringe containing the Novavax COVID-19 vaccine is refrigerated ready for use in February at a vaccination center in Prisdorf, Germany.

Georg Wendt / AP

U.S. adults who haven’t had any COVID-19 shots should consider a new option from Novavax — a more traditional vaccine, health officials said Tuesday.

Regulators authorized the nation’s first protein vaccine against COVID-19 last week, but the final hurdle was a recommendation from the Centers for Disease Control and Prevention.

Dr Rochelle Walensky, director of the CDC, said: “If you’ve been waiting for a COVID-19 vaccine to be built on a different technology from those previously available, now is the time to get involved. join millions of Americans who have been immunized,” said Dr. Rochelle Walensky, director of the CDC, in a statement. , endorsed an earlier decision from an influential advisory board.

Most Americans have had at least their primary COVID-19 vaccine to date, but CDC officials say between 26 million and 37 million adults have not received a single dose — subjects that Novavax, currently at, will target.

“We really need to focus on that population,” said CDC advisor Dr. Oliver Brooks, president of the National Medical Association. The hope is that the vaccine “will change them from unvaccinated to vaccinated.”

While it’s unclear how many people would be convinced by a more conventional option, “I’m really positive about this vaccine,” said co-advisor, Ohio State University’s Dr. agree.

The Novavax difference

All vaccines used in the US train the body to fight the coronavirus by recognizing its outer coating, spike protein – and the first three choices essentially turn human cells into a makeshift vaccine factory. The Pfizer and Moderna vaccines provide genetic instructions for the body to make copies of the mutant protein. The less commonly used Johnson & Johnson option uses the cold virus to provide those instructions.

In contrast, the Novavax vaccine injects copies of a mutant protein that is grown in a lab and packaged into nanoparticles for the immune system to resemble a virus. Another difference: An ingredient called an adjuvant, made from the bark of a South American tree, is added to help boost that immune response.

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

How well does it work?

Large studies in the US, Mexico and the UK show that two doses of the Novavax vaccine are safe and about 90% effective in preventing symptomatic COVID-19. When the delta variant emerged last summer, Novavax reported that a booster dose that raised antibodies against the virus could address that mutation.

Reactions to vaccines are typically mild, including arm pain and fatigue, but regulators have warned of the possibility of a rare risk, heart inflammation, which has also happened with vaccines Pfizer and Moderna, mainly in young men or young men.

But in the first place, manufacturing problems delayed the Novavax vaccine – meaning the shots were studied long before the omicron variant hit the market, so it’s unclear. how well they fight immune mutations.

However, Novavax points to laboratory testing showing that the first two injections promote the production of virus-fighting antibodies that are able to cross-protect against omicrons, including the BA.5 subtype, which is currently the the nation’s top threat. A booster dose further increases cross-protective antibodies.

How to use Novavax snapshots

CDC advisors unanimously endorsed the two-player primary series. But some people note that it is important for regulators to clear a booster by the time, five or so after their last dose, that people receiving Novavax will need a dose.

In addition, the two doses are usually given three weeks apart. But CDC officials say that, like other COVID-19 vaccines, it’s possible to wait up to eight weeks for a second dose — with the exception of those most at risk, who need protection quickly.

What happens next?

Walensky signed the recommendation for adults to take the first two doses of Novavax. In the first purchase, the US government purchased 3.2 million doses, and vaccinations are expected to begin in the next few weeks.

The Novavax vaccine is also used in Europe, Canada, Australia, South Korea and other countries. Many allow booster doses, and European regulators recently removed injections for children as young as 12 years old.

The Maryland-based company also expects US approval of the booster dose and youth vaccinations to be available soon.

And like other vaccine makers, Novavax is testing updated injections to better accommodate the latest omicron subtypes – in anticipation of another round of boosters in the fall and winter. this.



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