Novavax COVID-19 Vaccine Backed by FDA Advisors
OneUnvaccinated American adults against COVID-19 may soon receive another choice, as Food and Drug Administration advisories on Tuesday advocated a more traditional shot.
Next, FDA must decide whether to allow latecomers to produce vaccines Novavaxa protein vaccine produced using more conventional technology than current U.S. options.
Novavax’s photo already in use in Australia, Canada, parts of Europe, and dozens of other countries. But US clearance is a major obstacle for the Maryland-based company.
The FDA’s director of vaccines, Dr. Peter Marks, said another choice in the US could lead at least some vaccine holders — whatever the reason — to consider rolling up their sleeves.
“We have very serious vaccine uptake problems in the United States,” says Marks. “Anything we can do to make people more comfortable accepting these potentially life-saving products is something we feel compelled to do.”
If the FDA does authorize Novavax as the nation’s fourth vaccine, it’s still unclear how widely it will be used — at least immediately. Only about 27 million adults in the US remain unvaccinated. Ultimately, Novavax also hopes to become the choice of choice for millions of others who have not yet received the booster dose of today’s vaccine. These shots are used elsewhere as a booster, regardless of which vaccine was given initially.
Read more: Here’s what to know about COVID-19 Booster Shots for kids
Question three: Do the benefits of the two main doses of Novavax vaccine outweigh any risks? The FDA advisory board voted that it do so, by a 21-0 vote with one abstention.
Large studies in the US, Mexico and the UK show that two doses of the Novavax vaccine are safe and about 90% effective in preventing symptomatic COVID-19. One complication: Those studies were done much earlier in the pandemic, before more contagious coronavirus variants emerged — including the omicron mutant and its relatives.
Novavax’s chief medical officer, Dr. Filip Dubovsky, says the company has tested a booster dose — and it has developed antibodies against the virus that can tackle that type of mutation.
He told the FDA advisory panel.
And while trials have shown people typically experience only mild reactions like pain or fatigue at the injection site, the FDA has highlighted a possible concern: six cases of inflammation of the heart, known as myositis. heart disease, was found among the 40,000 people vaccinated in the studies.
Vaccines are being closely monitored for the potential for heart inflammation following Pfizer and Moderna . injections related to that rare risk.
Novavax argued that there were other potential causes for some of the cases in its tests. COVID-19, like other infections, can also cause inflammation of the heart. The company says more than 744,000 vaccinations in other countries to date have supported the safety of vaccinations.
Read more: At least 20% of people who receive COVID-19 develop lingering conditions, CDC study says
The Novavax vaccine is made from copies of the spike protein that covers the coronavirus, packaged into nanoparticles for the immune system like a virus. Then an immune-boosting ingredient, or adjuvant, made from the bark of a South American tree is added, which acts as a red flag to make sure those seeds look suspicious enough to cause infection. strong immune response.
Protein vaccines have been used for many years to prevent hepatitis B, shingles, and other diseases.
That is very different from the vaccines currently used in the US. Most widely used Pfizer and Moderna Vaccines provide genetic instructions for the body to make copies of the mutated protein. J&J uses a cold virus to provide those instructions.
Manufacturing issues affected Novavax’s vaccine, but the company says those issues have been resolved. Novavax, a small biotech company, created the vaccine in its research lab, but Serum Institute of Indialargest vaccine manufacturer in the world, producing most injections including those scheduled for the United States
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