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FDA Approves Updated Novavax COVID Vaccine Week After Approving Moderna and Pfizer Shots

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FDA Approves Updated Novavax COVID Vaccine Week After Approving Moderna and Pfizer Shots

Topline

The Food and Drug Administration approved Novavax’s new COVID-19 vaccine on Friday, a week after Pfizer and Moderna authorized their shots, though all drugmakers say their shots will be available in the coming days ahead of the fall and winter breathing. virus wave.

Key facts

The Novavax vaccine goals the JN.1 COVID-19 variant, which was the dominant strain circulating in the US earlier this year but now makes up less than 1% of cases.

Both Pfizer and Moderna’s shots target the KP.2 COVID-19 variant: JN.1 is the parent variant of KP.2.

The FDA asked vaccine makers in June to make shots targeting the JN.1 variant of the coronavirus, but later changed this recommendation to advise manufacturers to focus on the KP.2 strain of the JN line after reviewing updated case data; Novavax said production for JN.1-specific shots was already underway and could make KP.2 shots.

Novavax told Forbes that its vaccines will be available in “thousands of locations” once the FDA’s Center for Biologics Evaluation and Research releases the vaccine batches.

Moderna told Forbes it expects its vaccine to be available “within the next few days,” while Pfizer said the vaccine “will ship immediately and will be available in pharmacies, hospitals and clinics across the U.S. in the coming days.”

The FDA said it granted accelerated use authorization to Moderna and Pfizer’s updated shots on August 22 to “better target currently circulating variants and provide better protection against the severe outcomes of COVID-19,” the agency said in his report. announcement.

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Important background

The new vaccines are monovalent, meaning they target one specific COVID-19 variant, although they provide some protection against other strains. KP.2 is a descendant of JN.1, and both strains are descendants of the omicron variant. Although KP.2 was the most dominant variant earlier this summer, it has now been knocked down sixth place while its descendants currently dominate. Research has shown that all three updated vaccines are more effective at protecting against the JN lineage than the currently available XBB vaccines, which were approved last year. Compared to its XBB vaccine, Pfizer’s KP.2 COVID-19 vaccine provided a 7.3 times stronger response in mice infected with KP.2 and several other JN variants, according trial data. Moderna’s KP.2 vaccine was fine eight times more effective at protecting mice against JN variants than the XBB.1.5 vaccine. Novavax scientists gave mice an XBB.1.5 vaccine and administered the JN.1 shot 11 months later. The JN.1 vaccine was fine 48 times more effective at protecting against the JN lineage than the first XBB.1.5 shot.

Tangent

The Centers for Disease Control and Prevention recommends everyone six months and older should receive an updated vaccine, regardless of whether they have been vaccinated before. Modern And Pfizer’s vaccines will be available to people six months and older Novavax’s The shot will be aimed at people aged 12 and over.

Read more

FDA Approves Updated COVID Vaccines: Effectiveness, Who’s Eligible and More (Forbes)

COVID’s new ‘FLiRT’ variants – what you need to know as experts fear summer surge (Forbes)