FDA Advisors Back Novavax COVID Shot

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A U.S. Food and Drug Administration vaccine advisory panel on Tuesday recommended that Novavax’s COVID-19 shots be added to the vaccine arsenal that Americans have at their disposal.

Twenty-one panel members voted to approve the vaccine, while one person abstained. Next, the FDA will have to decide whether to authorize the shot for emergency use, which would make it the fourth coronavirus vaccine available in this country. The FDA typically follows the recommendations of its panels, although a decision isn’t expected immediately.

The Novavax shot is based on the traditional vaccine technology used to fight influenza and shingles, offering a distinctly different option to Americans who may be wary of the mRNA vaccines made by Pfizer and Moderna. Many experts are also eager to add another type of vaccine to the nation’s offerings.

“It’s important to have choices in vaccine platforms in a pandemic that is constantly evolving,” Gregory Poland, director of the Mayo Clinic’s Vaccine Research Group and a paid consultant to Novavax, told the Washington Post.

Meanwhile, Dr. Peter Marks, who heads up vaccine development at the FDA, said the Novavax shots could appeal to vaccine holdouts, the Associated Press reported.

“We do have a problem with vaccine uptake that is very serious in the United States,” Marks noted. “Anything we can do to get people more comfortable to accept these potentially lifesaving products is something that we feel we are compelled to do.”

Still, Novavax’s two-shot regimen arrives more than a year after other highly effective vaccines became available. And most of those eligible for the shot — people 18 and older — are already vaccinated. About 27 million adults in the United States have not received any shot, the Post reported.

The panel’s decision was based on clinical trial data the company released before the Omicron variant took over the country. The vaccine was shown to be 90 percent effective, but its development has repeatedly been delayed by manufacturing challenges, the Post reported.

“It is disappointing … that we don’t have more updated information, because we’re looking at the efficacy against strains that don’t exist anymore,” noted advisory committee member Eric Rubin, an infectious disease specialist at Brigham and Women’s Hospital in Boston. Even so, he said the case for the vaccine was “pretty compelling,” considering some people who have avoided mRNA vaccines have shown interest in Novavax.

“The messenger RNA vaccines are truly remarkable. They are a great gift to humanity, and they were the first to cross the finish line. But whether or not they will turn out to be the optimal vaccine for these viruses is not clear,” H. Cody Meissner, a pediatric infectious diseases specialist at Tufts University School of Medicine in Boston, told the Post. “I don’t think we want to rest on what we have at this point because there’s always an opportunity to improve a vaccine.”

Still, the ultimate use of the Novavax vaccine is probably as a booster, the Post reported. Going forward, the company plans to seek authorization for the shot as a booster and for use in adolescents and children.

The vaccine contains nanoparticles composed of proteins from the surface of the coronavirus, making it different from the vaccines developed by Pfizer, Moderna and Johnson & Johnson.

“We remain committed to ensuring that any American who wants a vaccine can get one, including those that prefer a non-mRNA option,” Jorge Silva, a spokesman for the U.S. Department of Health and Human Services, told The New York Times.

But in a number of countries where the Novavax vaccine is already available, uptake has been low, according to the Times.

The Biden administration is working with Novavax to receive “a limited quantity of vaccine” if it gets the green light, Silva said.

More information

Visit the U.S. Food and Drug Administration for more on COVID vaccines.

Source: HealthDay

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