Springfield News-Sun

FDA advisers back Novavax COVID-19 shots as new option

- By Lauran Neergaard

American adults who haven’t yet gotten vaccinated against COVID-19 may soon get another choice, as advisers to the Food and Drug Administra­tion on Tuesday backed a more traditiona­l type of shot.

Next, the FDA must decide whether to authorize the vaccine made by latecomer Novavax, a protein vaccine that’s made with a more convention­al technology than today’s U.S. options.

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

FDA’S vaccine chief Dr. Peter Marks said another choice in the U.S. may entice at least some vaccine holdouts to consider rolling up their sleeves.

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

If the FDA authorizes Novavax as the nation’s fourth vaccine, it’s not clear how widely it would be used — at least right away. Only about 27 million U.S. adults remain unvaccinat­ed. Eventually, Novavax hopes also to become a choice for the millions more who haven’t yet had a booster dose of today’s vaccines. The shots are used elsewhere as a booster, regardless of which vaccine people got originally.

Tuesday’s question: Do the benefits of two primary doses of the Novavax vaccine outweigh any risks? The FDA advisory panel voted that they do, by a 21-0 vote with one abstention.

Studies in the U.S., Mexico and Britain found two doses of the Novavax vaccine were safe and about 90% effective at preventing symptomati­c COVID-19. One complicati­on: Those studies were done far earlier in the pandemic, well before more contagious coronaviru­s variants emerged.

Novavax chief medical officer Dr. Filip Dubovsky said they already has tested a booster dose — and it revved up virus-fighting antibodies that could tackle that mutant.

This type of vaccine “we think generates a broad immune response against a broad array of variants,” he said.

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