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Novavax asks FDA for emergency authorization of its COVID-19 booster

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(NEW YORK) — Novavax has submitted an application to the Food and Drug Administration for Emergency Use Authorization of its COVID-19 vaccine as a booster in adults that can be used on top of the its primary vaccine series or to mix and match with a different primary series, the company announced.

“It’s important for people to have a choice as they evaluate how to stay protected against COVID-19, and boosters are an invaluable tool to build upon immunity obtained from previous vaccinations,” Stanley C. Erck, President and Chief Executive Officer of Novavax, said in a statement on Monday.

“Based on the data presented to the FDA’s VRBPAC and the CDC ACIP, we believe our vaccine offers a broad, long-lasting immune response against a range of variants,” Erck said.

Although half a million doses of Novavax’s vaccine have now been distributed to states, following its authorization last month, just 9,700 doses of Novavax’s COVID-19 vaccine have been administered across the country, according to federal data.

The sluggish start may be, in part, due to the fact that the vaccines were not immediately made available after authorization, and thus, there could be some reporting delays.

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Last month, officials from the Centers for Disease Control and Prevention signed off on the use of Novavax’s COVID-19 vaccine for Americans ages 18 years and older, making it the fourth COVID-19 vaccine to be made available to the American public.

The Biden administration secured 3.2 million doses of Novavax’s COVID-19 vaccine.

A number of health experts had expressed their hope that some of the individuals, who are still hesitant to be vaccinated, would be more inclined to get the Novavax vaccine, because it is based on a more traditional protein-based technology, one already used for the flu vaccine and other shots, while Pfizer and Moderna vaccine platforms tapped a new genetic technology — with messenger RNA — to produce their vaccines.

Early indicators suggest that the authorization has yet to convince a large swath of the 26 million unvaccinated American adults to get the shot.

However, experts say that although overall uptake may still be limited, there some Americans who have been vaccinated with Moderna, Pfizer, or Johnson & Johnson’s COVID-19 vaccines, may feel more inclined to receive Novavax’s booster.

“Having vaccine options likely plays role in improving vaccination coverage. Given so many Americans have yet to receive their boosters despite the clear indication of their impact on reducing risk of severe complication from COVID-19, that improvement in vaccine uptake may be somewhat limited,” said John Brownstein, Ph.D., an epidemiologist at Boston Children’s Hospital and an ABC News contributor.

Across the country, 110 million Americans — or more than half of those eligible to be boosted — have yet to receive their first booster shot, according to data from the CDC.

Similarly, although over 61 million people, over the age of 50, are eligible to receive their second COVID-19 booster shot, just a third of people have actually done so.

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