American adults who haven’t been vaccinated against COVID-19 may soon have another option, as Food and Drug Administration advisories on Tuesday advocated a more traditional shot.
Next, the FDA must decide whether to allow latecomer Novavax’s protein vaccine as the nation’s fourth coronavirus vaccine for adults. It’s made with more conventional technology than today’s dominant Pfizer and Moderna snapshots, and the Johnson & Johnson option is less commonly used.
Novavax shots are available in Australia, Canada, parts of Europe and many other countries, for primary immunization or for combination immunization. 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 prompt at least some vaccine owners – whatever their reasons – 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.”
The FDA’s final decision is not expected immediately, as the agency completes its review of the data.
Nor is it clear how widely the Novavax vaccine will be used, at least immediately. According to the Centers for Disease Control and Prevention, only about 27 million adults in the US have not been immunized. Eventually, Novavax also hopes to become the choice of choice for millions of other people who have not received the booster dose of today’s vaccine, regardless of which shot they received initially.
The FDA’s advisory panel voted that the benefits of the two main doses of Novavax outweigh its risks – but they have a lot of questions about the role of the shots at this point in the pandemic.
“This vaccine really fills some unmet need,” such as an option for people with allergies to competitive shots, said Dr Michael Nelson at the University of Virginia.
But the FDA is currently looking at two doses for adults, when a third COVID-19 vaccine is needed, he said.
And while “this vaccine has incredible potential,” there is still no clear evidence of how well it works against the more contagious omicron variant and its siblings, Dr. Bruce Gellin of the Rockefeller Foundation adds.
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.
Novavax chief medical officer Dr. Filip Dubovsky said the booster dose tests have raised antibodies against the virus that can address the omicron mutation, data that the FDA will have to review later.
He told the FDA advisory panel.
Trial participants typically experience only mild reactions such as pain or fatigue at the injection site, but the FDA has highlighted a possible concern: six cases of inflammation of the heart, known as myocarditis, was found among 40,000 people vaccinated in studies.
The COVID-19 vaccine is being closely monitored for possible heart inflammation after injections of Pfizer and Moderna are associated with that rare risk.
Novavax argued that there were other potential causes for the reports. Other infections including COVID-19 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.
Several FDA advisors said the Novavax vaccine should be given a warning until more information is known, but cautioned against the estimated incidence of rare side effects of the Pfizer and Moderna shots.
Dr Cody Meissner of Tufts University said: “I don’t want to inappropriately stigmatize this vaccine.
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 United States. The most widely used Pfizer and Moderna vaccines provide genetic instructions for the body to make its own copy 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 this vaccine in its research lab. But the Serum Institute of India, the world’s largest vaccine producer, produces most of the shots including those scheduled for the US.
