merican 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 shot are used worldwide in Australia and Canada. The U.S. clearance hurdle is however a major obstacle for the Maryland-based business.
FDA’s vaccine chief Dr. Peter Marks said another choice in the U.S. may entice at least some vaccine holdouts—whatever their reason—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. There are only 27 million adults in the United States who have not been vaccinated. Eventually, Novavax hopes also to become a choice for the millions more who haven’t yet had a booster dose of today’s vaccines. In addition to being used for booster purposes, shots may also be given elsewhere depending on which vaccine is being used.
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Tuesday’s question: Do the benefits of two primary doses of the Novavax vaccine outweigh any risks? They did, according to the FDA advisory panel.
Two doses of Novavax were found to be safe in large studies done in Britain, Mexico, and the U.S. They also proved about 90% effective in preventing symptoms like COVID-19. One complication: Those studies were done far earlier in the pandemic, well before more contagious coronavirus variants emerged—including the omicron mutant and its relatives.
Novavax chief medical officer Dr. Filip Dubovsky said the company 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 told the FDA advisory panel.
The FDA noted that the vast majority of patients experienced mild side effects, like fatigue and pain at the injection site. However, there was one concern. There were six cases, or myocarditis in, heart disease, among those who had received the vaccine.
After the rare link between the Moderna and Pfizer shots, vaccines have been under scrutiny.
Novavax suggested that other possible causes could have been involved in the trials. COVID-19 can lead to heart inflammation, along with other infections. The company said more than 744,000 vaccinations in other countries so far support the shots’ safety.
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Novavax is made from copies of coronavirus spike protein, which are packaged in nanoparticles to look like viruses. Then an immune-boosting ingredient, or adjuvant, that’s made from the bark of a South American tree is added that acts as a red flag to ensure those particles look suspicious enough to spark a strong immune response.
For years, protein vaccines were used to protect against hepatitis B and shingles.
That’s very different than the vaccines currently used in the U.S. Moderna and Pfizer are two of the most well-known vaccines. These provide instructions genetically to allow the body’s production of spike protein. J&J uses a cold virus to deliver those instructions.
Manufacturing problems held up Novavax’s vaccine but the company said those problems have been resolved. Novavax, a small biotech company, created the vaccine in its research lab, but the Serum Institute of India, the world’s largest vaccine maker, produces most of its shots including those slated for the U.S.
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