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A fourth Covid vaccine is cleared for use in the United States.

July 20, 2022
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The Centers for Disease Control and Prevention on Tuesday really useful {that a} newly licensed vaccine from Novavax be used as an choice for adults searching for a main immunization in opposition to the coronavirus.

Dr. Rochelle Walensky, the C.D.C.’s director, signed off on the suggestion of a panel of vaccine consultants that had unanimously endorsed the vaccine on Tuesday afternoon. The resolution removes the closing regulatory hurdle for the fourth Covid-19 shot licensed in the United States.

The Novavax vaccine is anticipated to play a restricted position in the nation’s immunization marketing campaign, not less than initially. Last week, the Food and Drug Administration licensed it as a main immunization for adults, however has not but thought of it for a booster shot.

Novavax, a Maryland pharmaceutical firm, obtained vital federal funding to develop its shot however fell far behind in the vaccine race. Even so, it is hoping the shot will enchantment to Americans who’ve to this point declined to be vaccinated.

Somewhere between 26 and 37 million adults in the United States haven’t but obtained a coronavirus vaccine, in keeping with survey information offered at the assembly by Dr. Katherine Fleming-Dutra of the C.D.C.

But in the nations the place it has been out there for months, Novavax’s shot has but to have a big impact on vaccination charges. Novavax stated in its presentation to the panel on Tuesday that simply over 1 million doses of its vaccine had been administered worldwide via the finish of June, solely a tiny fraction in comparison with the attain of competing pictures.

The Biden administration stated final week that it might purchase 3.2 million doses of Novavax’s two-shot vaccine, sufficient to totally vaccinate 1.6 million individuals in the United States. The vaccine is not but out there in pharmacies and different clinics that administer pictures. Novavax stated in a information launch after the vote that the F.D.A. had signed off on the first doses supposed for the United States and that the firm expects to ship its vaccine to a distribution middle “in the coming days.”

With two doses spaced three weeks aside, the vaccine was discovered to be extremely protecting in opposition to an infection and extreme illness from the coronavirus in scientific trials. But these have been carried out earlier than the emergence of the Omicron variant, which has sharply decreased the effectiveness of different licensed vaccines in stopping infections.

Novavax’s vaccine works in a different way from the three Covid vaccines beforehand licensed in the United States. It provokes an immune response with nanoparticles made up of proteins from the floor of the coronavirus that causes Covid-19. Similar protein-based vaccines have been used globally for many years.

Dr. Evelyn Twentyman of the C.D.C. offered outcomes from a survey suggesting that comparatively few unvaccinated Americans would select Novavax. Just 16 % of unvaccinated respondents stated they “probably” or “definitely” would get a protein-based Covid vaccine, and 50 % of unvaccinated respondents stated they “probably” or “definitely” wouldn’t.

At the assembly on Tuesday, C.D.C. officers reviewed scientific trial information that has linked the vaccine to an elevated however small danger of creating types of coronary heart irritation often known as myocarditis and pericarditis.

Dr. Filip Dubovsky, the chief medical officer at Novavax, stated at the assembly that the firm has been monitoring instances of coronary heart irritation in nations the place the vaccine was already licensed. Surveying simply over 1 million doses, the firm has recognized 17 particular or possible instances of myocarditis and pericarditis, he stated.



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