The FDA is expected to approve updated COVID-19 vaccines as early as next week

The U.S. Food and Drug Administration (FDA) is preparing to approve updated COVID-19 vaccines that target newer strains of the virus, potentially as soon as next week, according to sources familiar with the situation. This comes as the country faces its most significant summer surge in two years. The FDA is expected to approve new mRNA vaccines from Moderna and Pfizer/BioNTech, which focus on a strain known as KP.2. It remains unclear if Novavax's updated vaccine, which targets the JN.1 strain, will be authorized simultaneously.

The FDA is expected to approve updated COVID-19 vaccines as early as next week
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This approval would be earlier than last year’s version, which was greenlit on September 11. Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, emphasized the importance of getting vaccinated during this surge and noted that he recently received last season’s vaccine to boost his immunity. The U.S. Centers for Disease Control and Prevention (CDC) recommended in June that everyone over six months old should get both an updated COVID-19 vaccine and a flu shot this year.

Representatives from Pfizer and Moderna confirmed they have sufficient supplies of the updated vaccines and are ready to distribute them upon approval, with Moderna expecting availability in stores within days of FDA authorization. Novavax’s vaccine, based on protein technology, takes longer to produce, but the company anticipates its updated vaccine will be ready for distribution once authorized.

The CDC's data indicates that the levels of the SARS-CoV-2 virus in wastewater are at "very high" levels nationally, marking the highest summer peak since July 2022. Although severe disease measures like hospitalization and death rates are rising, they remain significantly lower than in previous years. The current dominant strain in the U.S. is KP.3.1.1, which has tripled in prevalence over the past month. Both KP.3.1.1 and KP.2, included in the updated mRNA vaccines, are offshoots of the JN.1 strain targeted by Novavax’s vaccine, all of which are variants of Omicron.

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