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


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 its primary vaccine series or to mix and match with a different primary series. can be done for. Company announced.

Stanley C. Erk, President and CEO of Novavax, said, “It is important for people to have a choice as they evaluate how to stay safe against COVID-19, and boosters to build up immunity gained from previous vaccinations. An invaluable tool.” said in a statement on Monday.

“Based on the data presented to the FDA’s VRBPAC and CDC ACIP, we believe that our vaccine provides a broad, long-lasting immune response against a wide variety of forms,” ​​Erck said.

A box of Novavax Covid-19 vaccine, arranged at a pharmacy in Schwanksville, Pennsylvania, on August 1, 2022.

Hannah Baer/Bloomberg via Getty Images, FILE

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 nationwide, according to federal data.

The slow onset may be due, in part, to the fact that vaccines were not provided immediately after authorization, and thus, there may have been some reporting delay.

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

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

Many health experts expressed their hope that some individuals, who are still hesitant to vaccinate, would be more inclined to receive the Novavax vaccine, as it is based on a more traditional protein-based technology that already has is being used. flu vaccine and other shots, while Pfizer and the Moderna Vaccine Platform tapped a new genetic technology — along with messenger RNA — to produce their vaccines.

Early indicators suggest that authority has yet to persuade 26 million non-vaccinated American adults to get the shot.

Photo: A vial of the Novavax Covid-19 vaccine is arranged at a pharmacy on August 1, 2022 in Schwanksville, Pennsylvania.
A vial of Novavax Covid-19 vaccine is arranged at a pharmacy in Schwanksville, Pennsylvania, on August 1, 2022.

Hannah Baer/Bloomberg via Getty Images, FILE

However, experts say that although the overall uptake may still be limited, there are some Americans who have been vaccinated by Moderna, Pfizer or Johnson. And Johnson’s COVID-19 vaccine, Novavax’s booster.

“Having vaccine options likely plays a role in improving vaccination coverage. Given that so many Americans have not yet received their boosters, their impact on reducing the risk of a serious complication from COVID-19 is significant. Despite clear indications of cancer, 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 to be promoted — have yet to receive their first booster shot, according to CDC data.

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


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