FDA advisers back Novavax COVID-19 shots as new US option
American adults who haven’t but gotten vaccinated in opposition to COVID-19 could quickly get one other selection, as advisers to the Food and Drug Administration on Tuesday backed a extra conventional sort of shot.
Next, the FDA should resolve whether or not to authorize the vaccine made by latecomer Novavax, a protein vaccine that’s made with a extra typical technology than immediately’s U.S. choices.
Novavax shots are already utilized in Australia, Canada, elements of Europe and dozens of different international locations. But U.S. clearance is a key hurdle for the Maryland-based company.
FDA’s vaccine chief Dr. Peter Marks stated one other selection within the U.S. could entice at the least some vaccine holdouts — no matter their purpose — to think about rolling up their sleeves.
“We do have a problem with vaccine uptake that is very serious in the United States,” Marks stated. “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 extensively it might be used — at the least instantly. Only about 27 million U.S. adults stay unvaccinated. Eventually, Novavax hopes additionally to turn out to be a selection for the hundreds of thousands extra who haven’t but had a booster dose of immediately’s vaccines. The shots are used elsewhere as a booster, no matter which vaccine folks bought initially.
Tuesday’s question: Do the advantages of two main doses of the Novavax vaccine outweigh any dangers? The FDA advisory panel voted that they do, by a 21-0 vote with one abstention.
Large research within the U.S., Mexico and Britain discovered two doses of the Novavax vaccine had been secure and about 90% efficient at stopping symptomatic COVID-19. One complication: Those research had been executed far earlier within the pandemic, nicely earlier than extra contagious coronavirus variants emerged — together with the omicron mutant and its kinfolk.
Novavax chief medical officer Dr. Filip Dubovsky stated the company already has examined a booster dose — and it revved up virus-fighting antibodies that would deal with that mutant.
This sort of vaccine “we think generates a broad immune response against a broad array of variants,” he advised the FDA advisory panel.
And whereas the trials confirmed usually folks skilled solely gentle reactions such as injection-site ache or fatigue, the FDA did spotlight a attainable concern: six circumstances of coronary heart irritation, recognized as myocarditis, discovered among the many 40,000 individuals who acquired the vaccine in research.
Vaccines are coming below shut scrutiny for the potential for that coronary heart irritation after the Pfizer and Moderna shots had been linked to that uncommon threat.
Novavax argued there have been different potential causes for among the circumstances in its trials. COVID-19, as nicely as different infections, can also trigger coronary heart irritation. The company stated greater than 744,000 vaccinations in different international locations thus far assist the shots’ security.
The Novavax vaccine is made from copies of the spike protein that coats the coronavirus, packaged into nanoparticles that to the immune system resemble a virus. Then an immune-boosting ingredient, or adjuvant, that’s created from the bark of a South American tree is added that acts as a purple flag to make sure these particles look suspicious sufficient to spark a powerful immune response.
Protein vaccines have been used for years to stop hepatitis B, shingles and different ailments.
That’s very completely different than the vaccines presently used within the U.S. The most generally used Pfizer and Moderna vaccines ship genetic directions for the physique to provide its personal copies of the spike protein. J&J makes use of a chilly virus to ship these directions.
Manufacturing issues held up Novavax’s vaccine however the company stated these issues have been resolved. Novavax, a small biotech company, created the vaccine in its analysis lab, however the Serum Institute of India, the world’s largest vaccine maker, produces most of its shots together with these slated for the U.S.
The Associated Press Health and Science Department receives assist from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely chargeable for all content material.