Health
FDA Approves Updated Moderna, Pfizer COVID Vaccines
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Topline
The Food and Drug Administration approved new COVID-19 vaccines from Pfizer and Moderna on Thursday, with both drugmakers saying their shots will be available in the coming days ahead of the fall and winter surge of respiratory viruses.
A healthcare worker holding a Covid vaccine.
Key facts
Both shots target the KP.2 COVID-19 variant – a descendant of the omicron subvariant – which was the dominant strain circulating in the US earlier this year.
The FDA has granted accelerated use authorization to the updated shots from Moderna and Pfizer to “better target currently circulating variants and provide better protection against the severe outcomes of COVID-19,” the FDA said in its report. announcement.
Moderna told Forbes it expects its vaccine to be available “within the next few days,” while Pfizer does said the vaccine “will ship immediately and will be available in pharmacies, hospitals and clinics across the U.S. starting in the coming days.”
The FDA asked vaccine makers in June to make shots that target 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 — which has applied for approval for a vaccine targeting the JN.1 variant — failed to receive FDA approval on Thursday, saying in a statement it is working “productively” with the FDA as it completes the review, and expects approval to occur “in time for the peak vaccination season.”
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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 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 is eligible and more (Forbes)
COVID’s new ‘FLiRT’ variants – what you need to know as experts fear summer surge (Forbes)