mRNA-free Novavax COVID vaccine receives CDC approval: NPR


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The kidney cup with syringes containing Novavax COVID-19 vaccine is in the refrigerator and ready for use in February at the vaccination center in Priesdorf, Germany.

Georg Wendt/AP

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Georg Wendt/AP

The kidney cup with syringes containing Novavax COVID-19 vaccine is in the refrigerator and ready for use in February at the vaccination center in Priesdorf, Germany.

Georg Wendt/AP

American adults who have not yet been vaccinated against COVID-19 should consider a new option from Novavax, a more traditional type of vaccine, health officials said Tuesday.

Last week, regulators approved the country’s first so-called protein-based COVID-19 vaccine, but the latest hurdle was a recommendation from the Centers for Disease Control and Prevention.

“If you have been waiting for a COVID-19 vaccine based on technology other than what was previously available, now is the time to join the millions of vaccinated Americans,” CDC Director Dr. Rochelle Walensky said in a statement. , endorsing the earlier decision of the influential advisory group.

By now, most Americans have received at least their primary COVID-19 shots, but CDC officials said between 26 million and 37 million adults have not received a single dose — a population that Novavax will target for now.

“We really need to focus on this population,” said CDC adviser Dr. Oliver Brooks, former president of the National Medical Association. Let’s hope the vaccine “turns them from unvaccinated to vaccinated.”

While it’s unclear who the more traditional option will convince, “I do have confidence in this vaccine,” agreed fellow consultant Dr. Pablo Sanchez of Ohio State University.

Difference from Novavax

All vaccines used in the US train the body to fight the coronavirus by recognizing its outer shell, the spike protein, and the first three options actually turn human cells into a makeshift vaccine factory. The Pfizer and Moderna vaccines provide the body with the genetic instructions for making copies of the spike protein. A lesser used variant of Johnson & Johnson uses the common cold virus to deliver these instructions.

In contrast, the Novavax vaccine injects copies of the spike protein that are lab-grown and packaged into nanoparticles that resemble a virus to the immune system. Another difference: An ingredient called an adjuvant, made from the bark of a South American tree, is added to boost the 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 showed that two doses of the Novavax vaccine were safe and about 90% effective in preventing symptomatic COVID-19. When the delta variant appeared last summer, Novavax reported that a booster dose activated virus-fighting antibodies that could fight this mutant.

Typical vaccine reactions were mild, including arm pain and fatigue, but regulators warned of a rare risk of heart inflammation, which has also been seen with Pfizer and Moderna vaccines, mostly in teenage boys or young men.

But early on, manufacturing issues delayed the release of the Novavax vaccine — meaning vaccines were studied long before the omicron variant, so it’s not clear how well they do against the immune-evading mutant.

However, Novavax points to lab tests that show the first two injections do stimulate the production of virus-fighting antibodies that provide cross-protection against omicrons, including the BA.5 subtype, which is currently the top threat in the country. The booster dose further activated cross-protective antibodies.

How to use Novavax vaccinations

Advisers from the Centers for Disease Control and Prevention (CDC) unanimously approved an initial series of two shots. But some pointed out that it was important for regulators to allow a booster by the time, five or so months after the last dose, that Novavax recipients needed it.

In addition, two doses are usually administered three weeks apart. But CDC officials said that, as with other COVID-19 vaccines, a second dose could be expected for up to eight weeks, except for people at the highest risk who need rapid protection.

What happens next

Walensky has signed recommendations for adults to get their first two doses of Novavax. In the first purchase, the US government purchased 3.2 million doses and vaccination is 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 recently European regulators have allowed vaccinations at 12 years of age.

The Maryland-based company also expects U.S. approval for a booster dose and teen vaccinations to follow fairly soon.

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

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