FDA Advisory Panel Recommends Novavax COVID-19 Vaccine for Emergency Use

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A U.S. Food and Drug Administration (FDA) vaccine advisory panel voted on Tuesday to recommend the emergency use of Novavax’s COVID-19 vaccine.

The advisory voted 21–0 with one abstention, after seven hours of discussion, agreeing that the benefits of a two-dose Novavax vaccine outweighed its risk for use in adults aged 18 and older.

Dr. Michael Nelson, professor of medicine at the Division of Asthma, Allergy, and Clinical Immunology at the University of Virginia School of Medicine, said that the Novavax vaccine is another tool for people who are not able to get the mRNA shots.

“I do feel that it does offer something for fulfilling unmet needs including those populations who have hesitancy with regards to the messenger RNA vaccines,” Nelson said. “As an allergist, that offers me an additional tool for individuals who have hypersensitivity responses to initial doses of the messenger RNA vaccine.”

About 22 percent of Americans have not received a single dose of the COVID-19 shot, with 78 percent who have gotten at least one dose, as of June 7, according to the Centers for Disease Control and Prevention (CDC).

While the Johnson & Johnson COVID-19 shot is available, the FDA restricted its use in May 2022 due to the risk of developing potentially life-threatening blood clots with low levels of platelets.

Dr. Cody Meissner, chief of Pediatric Infectious Diseases at Tufts Children’s Hospital, said that more vaccine options are needed as it’s not clear whether the mRNA COVID-19 injections “will turn out being optimal vaccines for these viruses.”

“I think we still need new vaccines,” Meissner said. “I don’t think we want to rest on just what we have at this point because there’s always an opportunity to improve on a vaccine … such as sterilizing immunity and the duration of the immune response and the breadth of the immune response.”

Studies have shown that the effectiveness of the Pfizer, Moderna, and Johnson & Johnson COVID-19 vaccines administered in the United States wanes significantly after three months. In addition, the harmful effects of these vaccines are being observed by physicians like Dr. Ryan Cole and Dr. Richard Urso, among other doctors and medical scientists.

By Meiling Lee

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