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

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

The FDA then has to decide whether to approve the protein vaccine made by the late Novavax as the country’s fourth adult coronavirus vaccine. It is made with more conventional technology than the current dominant Pfizer and Moderna shots 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 combination and matching enhancers. However, the US license is a major hurdle for the Maryland-based company.

The head of FDA vaccines, Dr. Peter Marks said another option in the US could entice at least some vaccines – whatever their reason – to consider rolling up their sleeves.

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

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

The FDA’s final decision is not expected immediately, as the agency completes its review of the data.

Nor is it clear how widely a Novavax vaccine will be used, at least immediately. About 27 million adults in the United States alone remain unvaccinated, according to the Centers for Disease Control and Prevention. Eventually, Novavax also hopes to become a choice for the millions more who have not yet received a booster dose of today’s vaccines, regardless of which vaccine humans originally received.

The FDA advisory committee voted that the benefits of two major doses of Novavax outweighed its risks – but had many questions about the role of the pistons in this area of ​​the pandemic.

“This vaccine does meet some unmet needs,” such as a choice for people with allergies to competing vaccines, said Dr. Michael Nelson of the University of Virginia.

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

And while “this vaccine has incredible potential”, there is still no clear evidence of how well it works against the most contagious variant of the micron and its siblings, added fellow counselor Dr. Bruce Gelin of the Rockefeller Foundation.

Large studies in the United States, Mexico, and the United Kingdom have found that two doses of the Novavax vaccine were safe and approximately 90% effective in preventing symptomatic COVID-19. One complication: These studies were done much earlier in the pandemic.

The Chief Medical Officer of Novavax, Dr. Filip Dubovsky said tests of a booster dose revived anti-virus antibodies that could fight the mutated micron, data that the FDA should consider later.

This type of vaccine “we think triggers a broad immune response to a wide range of variants,” he told the FDA advisory team.

The test participants generally had only mild reactions, such as pain at the injection site or fatigue, but the FDA highlighted a potential concern: Six cases of heart inflammation, known as myocarditis, were found in the 40,000 people who received the vaccine in the study.

COVID-19 vaccines are being closely monitored for the possibility of heart inflammation after the Pfizer and Moderna vaccines were linked to this rare risk.

Novavax claimed that there were other possible causes for the reports. Other infections, including COVID-19, can also cause inflammation of the heart. The company said more than 744,000 vaccinations in other countries so far support vaccine safety.

Several FDA advisers said the Novavax vaccine should be accompanied by a warning until more is known, but warned of comparisons with the estimated rate of rare side effects from the Pfizer and Moderna vaccines.

“I do not want to stigmatize this vaccine,” said Dr. Cody Meisner of Tufts University.

The Novavax vaccine consists of copies of the coronavirus-coated spike protein, packaged in nanoparticles that look like a virus to the immune system. Then an immune-boosting ingredient or adjuvant is made from the bark of a South American tree, which 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 US The most widely used vaccines, Pfizer and Moderna, provide genetic instructions to the body to make its own copies of the spike protein. J&J uses a cold virus to deliver these instructions.

Production problems have hampered the Novavax vaccine, but the company says those problems have been resolved. Novavax, a small biotechnology company, developed the vaccine in its research lab. But the Serum Institute of India, the world’s largest vaccine maker, produces most of its vaccines, including those for the United States.

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The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Education Department. The AP is solely responsible for all content.

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

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

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