CDC advisers endorse more traditional Novavax COVID shot

By LAURAN NEERGAARD
AP Medical Writer

American adults who have not yet received COVID-19 vaccines should consider a new option from Novavax – a more traditional type of vaccine, influential government advisers said Tuesday.

Regulators authorized the nation’s first so-called protein vaccine against COVID-19 last week, but injections of Novavax cannot begin until the Centers for Disease Control and Prevention recommends their use.

Most Americans have already received at least their first COVID-19 vaccines, but CDC officials said between 26 million and 37 million adults have not received a single dose — the population Novavax will target for the moment.

“We really need to focus on this population,” said CDC adviser Dr. Oliver Brooks, former president of the National Medical Association. Hopefully the vaccine will “turn them from unvaccinated to vaccinated.”

While it’s unclear how many will be convinced by a more conventional option, “I’m really positive about this vaccine,” agreed fellow adviser Dr. Pablo Sanchez of Ohio State University.

THE NOVAVAX DIFFERENCE

All of the vaccines used in the United States train the body to fight off the coronavirus by recognizing its outer coating, the spike protein — and the first three options essentially turn people’s cells into a temporary vaccine factory. The Pfizer and Moderna vaccines provide genetic instructions for the body to make copies of the spike protein. Johnson & Johnson’s less used option uses a cold virus to provide these instructions.

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

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

HOW IT WORKS WELL

Large studies in the United States, Mexico and Britain have found two doses of the Novavax vaccine to be approximately 90% safe and effective in preventing symptomatic COVID-19. When the delta variant emerged last summer, Novavax reported that a booster dose accelerated anti-virus antibodies that could attack this mutant.

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

But early manufacturing issues delayed the Novavax vaccine – meaning the vaccines were studied long before the omicron variant hit, so it’s unclear how well they hold up to the system-evading mutant immune.

Yet Novavax points to lab tests that show the first two hits stimulate the production of anti-virus antibodies that offer cross-protection against the omicron, including the BA.5 subtype that is currently the main threat. from the country. A booster dose further accelerated the cross-protecting antibodies.

HOW TO USE NOVAVAX PHOTOGRAPHS

CDC advisers unanimously approved the two-shot primary series. But several noted that it was important that regulators allow a booster when, about five months after their last dose, Novavax recipients will need it.

Also, the two doses are usually given three weeks apart. But CDC officials said that, like other COVID-19 vaccines, you can wait up to eight weeks for the second dose — except for those most at risk, who need protection. rapidly.

WHAT HAPPENS NEXT

CDC Director Dr. Rochelle Walensky must sign off on the advisory committee’s recommendations for adults to receive the first two doses of Novavax. In its first purchase, the US government purchased 3.2 million doses.

The Novavax vaccine is also used in Europe, Canada, Australia, South Korea and other countries. Many allow booster doses, and European regulators recently allowed injections to be given from the age of 12.

The Maryland-based company also expects US clearance for a booster dose and adolescent vaccination to follow fairly quickly.

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

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The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute Department of Science Education. The AP is solely responsible for all content.