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FDA Advisors Support Novavax COVID-19 Shots as a New US Option

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

Next, the FDA must decide whether to approve latecomer Novavax’s vaccine, a protein vaccine made with more conventional technology than today’s US options.

Novavax shots are already being used in Australia, Canada, parts of Europe and dozens of other countries. But US clearance is a key hurdle for the Maryland-based company.

FDA vaccine chief Dr. Peter Marks said another election in the US could tempt at least some vaccine holdouts — for whatever reason — to roll up their sleeves.

“We have a vaccine uptake problem that is very serious in the United States,” Marks said. “Anything we can do to make people feel more comfortable accepting these potentially life-saving products is something we are committed to.”

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If the FDA approves Novavax as the country’s fourth vaccine, it’s not clear how widely it would be used — at least immediately. Only about 27 million US adults remain unvaccinated. Ultimately, Novavax hopes to also become a choice for millions of people who have not yet received a booster dose of today’s vaccines. The shots are used elsewhere as a booster shot, regardless of what vaccine people were originally given.

Tuesday’s Question: Do the benefits of two primary doses of the Novavax vaccine outweigh the risks? The FDA Advisory Panel voted 21-0, with one abstention.

Large studies in the US, Mexico and the UK found that two doses of the Novavax vaccine were safe and about 90% effective in preventing symptomatic COVID-19. A complication: These studies were conducted much earlier in the pandemic, well before more contagious coronavirus variants emerged — including the omicron mutant and its relatives.

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dr Filip Dubovsky, Novavax’s chief medical officer, said the company had already tested a booster dose – and she had developed virus-fighting antibodies that could target this mutant.

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

And while the studies showed that people generally had only mild reactions, such as pain at the injection site or fatigue, the FDA highlighted a potential problem: Six cases of heart inflammation, known as myocarditis, were found among the 40,000 people who took the vaccine in studies received.

Vaccines are being closely scrutinized for the possibility of heart inflammation after the Pfizer and Moderna vaccines were linked to this rare risk.

Novavax argued there were other possible causes for some of the cases in its court cases. COVID-19, as well as other infections, can also cause heart inflammation. The company said that so far more than 744,000 vaccinations in other countries support vaccination safety.

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The Novavax vaccine consists of copies of the spike protein that coats the coronavirus, packaged in nanoparticles that resemble a virus to the immune system. An immune-boosting ingredient, or adjuvant, made from the bark of a South American tree is then added, which acts as a warning signal to ensure 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 US. The most widely used vaccines, from Pfizer and Moderna, provide genetic instructions for the body to make its own copies of the spike protein. J&J uses a cold virus to deliver these instructions.

Manufacturing issues held up Novavax’s vaccine, but the company said those issues have been resolved. Novavax, a small biotech, developed the vaccine in its research lab, but the Serum Institute of India, the world’s largest vaccine maker, produces most of its recordings, including those slated for the US

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https://www.local10.com/health/2022/06/07/fda-advisers-back-novavax-covid-19-shots-as-new-us-option/ FDA Advisors Support Novavax COVID-19 Shots as a New US Option

Sarah Y. Kim

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