FDA Authorizes Novavax as New Alternative to mRNA COVID-19 Vaccines

On Wednesday, the Food and Drug Administration approved Novavax’s protein-based Covid vaccination for adults, giving Americans an alternative to Pfizer-BioNTech and Moderna’s mRNA-based doses.

Novavax is a COVID-19 vaccine that uses a more typical protein-based technology, in contrast to the other vaccines now available in the United States: Pfizer-BioNTech, Moderna, and Johnson & Johnson all use mRNA technology, and Johnson & Johnson is a viral-vector vaccine.

The Novavax primary series is provided in two doses, 21 days apart. In a clinical trial against older COVID-19 variants (mainly alpha), the Novavax vaccine was 90% effective against symptomatic COVID-19. However, additional research is required to assess its efficiency against omicron.

Know About Novavax

Novavax expects that its vaccine will appeal to individuals who have rejected Pfizer-BioNTech and Moderna’s messenger RNA-based vaccines. About 22 percent of Americans haven’t had a single dose of the COVID vaccine.

The Novavax vaccine, administered in two doses three weeks apart, functions differently than mRNA vaccinations. Nanoparticles are composed of proteins from the surface of the coronavirus that cause Covid-19 to induce an immunological response. Similar vaccinations based on proteins have been used extensively throughout the world for decades.

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The late addition of Novavax’s vaccine to the medical arsenal is not anticipated to have a significant impact on the coronavirus’s progression. Two-thirds of Americans have received at least their initial series of vaccinations, and doses of vaccines manufactured by other businesses are abundant.

After two years of research and development, the vaccine has finally conquered manufacturing issues to become the fourth shot to receive approval in the United States. The Centers for Disease Control and Prevention will have a meeting next week to talk about who should get the Novavax vaccine.

The two-dose vaccination was approved as a primary immunisation series for adults rather than a booster, which may limit its initial availability.The Biden administration announced earlier this week that it would purchase 3.2 million pills, enough to immunise 1,6 million Americans. In its announcement of the purchase, the government said that Novavax was expected to finish quality testing “in the coming weeks.” This was an important step before the dosages could be given out.

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FDA Evaluation of Available Safety Data

In the long run, the executives of Novavax believe that their vaccine could play a crucial role in regulating the virus as a seasonal booster. The FDA has already asked companies to change their fall booster shots, and scientists at Novavax are working on a new shot that will target the BA.4 and BA.5 subvariants that are circulating.

Initial data on Novavax’s novel variant booster targeting the BA.4 and BA.5 subvariants is anticipated in late summer or fall, and the company anticipates being able to provide an updated booster shot in the fourth quarter.

Executives from Novavax recently gave evidence that piqued the interest of several FDA advisors and showed that the original formulation of the vaccine may be able to withstand the spread of hard versions.

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