FDA advisers back Novavax COVID-19 vaccine as 4th option for US adults


American adults who have not yet been vaccinated against COVID-19 may soon have another choice, as Food and Drug Administration advisers backed a more traditional type of vaccine on Tuesday.

Next, the FDA must decide whether or not to authorize the protein vaccine made by latecomer Novavax as the nation’s fourth coronavirus vaccine for adults. It’s made with more conventional technology than today’s dominant Pfizer and Moderna plans and the less-used Johnson & Johnson option.

Novavax vaccines are already available in Australia, Canada, parts of Europe and many other countries, either for initial vaccinations or as mixed boosters. But US customs clearance is a major hurdle for the Maryland-based company.

FDA vaccine chief Dr. Peter Marks said another choice in the United States could make at least some vaccine holders — whatever their reason — consider rolling up their sleeves.

“We have a vaccination problem that is very serious in the United States,” Marks said. “Anything we can do to make it easier for people to accept these potentially life-saving products is something we feel compelled to do.”

SEE ALSO: Meet a couple from North Carolina who took part in the Novavax vaccine trial

A final decision from the FDA is not expected immediately as the agency finishes sifting through the data.

It’s also unclear to what extent a Novavax vaccine would be used, at least in the immediate future. Only about 27 million American adults are still unvaccinated, according to the Centers for Disease Control and Prevention. Eventually, Novavax also hopes to become a choice for the millions of others who have yet to receive a booster dose of today’s vaccines, regardless of which vaccine people originally received.

The FDA advisory committee voted that the benefits of two primary doses of Novavax outweigh its risks – but they had many questions about the injections’ role at this stage of the pandemic.

“This vaccine does indeed fill some unmet need,” as an option for people allergic to competing injections, said Dr. Michael Nelson of the University of Virginia.

But the FDA is currently considering two doses for adults, when other COVID-19 vaccines have needed a third dose, he said.

And although “this vaccine has incredible potential”, there is not yet clear evidence of its effectiveness against the more contagious variant of omicron and its siblings, added Dr. Bruce Gellin, adviser to the Rockefeller Foundation.

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. A complication: these studies were carried out much earlier in the pandemic.

Novavax chief medical officer Dr. Filip Dubovsky said testing of a booster dose accelerated anti-virus antibodies that could attack the omicron mutant, data the FDA will have to review later.

This type of vaccine “we believe generates a broad immune response against a wide range of variants,” he told the FDA advisory committee.

Trial participants generally experienced only mild reactions such as pain or fatigue at the injection site, but the FDA highlighted one possible concern: six cases of heart inflammation, known as name myocarditis, were found among the 40,000 people who received the vaccine in the studies.

COVID-19 vaccines are under scrutiny for the possibility of heart inflammation after injections from Pfizer and Moderna were linked to this rare risk.

Novavax argued that there were other potential causes for the reports. Other infections, including COVID-19, can also cause heart inflammation. The company said more than 744,000 vaccinations in other countries to date support vaccine safety.

Several FDA advisers said the Novavax vaccine should come with a warning until more is known, but cautioned against comparisons with the estimated rare side effect rate of Pfizer vaccines and Moderna.

“I don’t want to stigmatize this vaccine inappropriately,” said Dr. Cody Meissner of Tufts University.

The Novavax vaccine is made up of copies of the spike protein that coats the coronavirus, packaged in nanoparticles that to the immune system look like a virus. Then an immune-boosting ingredient, or adjuvant, made from the bark of a South American tree is added and acts as a red flag to ensure that these particles look suspicious enough to trigger a strong immune response.

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

This is very different from the vaccines currently used in the United States. The most widely used Pfizer and Moderna vaccines provide genetic instructions for the body to produce its own copies of the spike protein. J&J uses a cold virus to provide these instructions.

Manufacturing issues delayed Novavax’s vaccine, but the company said those issues have been resolved. Novavax, a small biotech company, created the vaccine in its research lab. But the Serum Institute of India, the world’s largest vaccine maker, produces most of its shots, including those planned for the United States.

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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.

Copyright © 2022 by The Associated Press. All rights reserved.



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