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The U.S. Food and Drug Administration is poised next week to sign off on an improved Covid-19 vaccine that targets recently circulating strains of the virus, according to two sources familiar with the matter, two sources familiar with the matter said. Summer wave In two years.
The agency is expected to greenlight modern RNA vaccines targeting a strain of the virus called KP.2 from Moderna and Pfizer/BioNTech, said the sources, who declined to be named because the timing was not public. It was unclear whether the agency would simultaneously approve an updated shot of Novavax that targets the JN.1 strain.
The move will be several weeks earlier than last year's version of the vaccine; FDA termination On September 11.
Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, told : “It's time to scale up with this surgery.”
Osterholm spoke on it Podcast At a time when the virus is circulating at a high level and it is not certain when new vaccines will be available, it will be remembered that last week, the vaccination dose of the previous season was received to increase the immunity.
He added that he now expects to receive the updated in four months, which is the gap Recommended Health officials.
In June, the US Centers for Disease Control and Prevention Recommended Everyone over 6 months of age should get both an updated Covid-19 vaccine and a flu shot this year.
Representatives for Pfizer and Moderna told that the companies had sufficient supplies of the updated Covid vaccines and would be ready to ship the doses when approved. A Moderna spokeswoman said they expect the vaccine to be in stores within days of the FDA closure.
The Novavax vaccine is based on protein technology, which takes longer than mRNA vaccines. Officials of the company to investors in A Conference call The vaccine, which was updated last week, is expected to arrive in warehouses this month and be ready for distribution when approved. A spokeswoman for Novavax did not immediately respond to a request for comment Friday.
An FDA spokeswoman said the agency could not comment on the timing of product applications, but “expected to take timely action to approve or disapprove updated Covid-19 vaccines to provide vaccines this fall.”
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Levels of the SARS-CoV-2 virus that causes Covid-19 are measured Waste water According to the CDC, they are at “very high” levels nationally DataIt triggered the highest summer peak in the US since July 2022. Monitoring the amount of virus in wastewater is a test of how widespread the virus is and other forms of monitoring have failed.
Measurements A serious diseaseAccording to the CDC, hospitalizations and deaths, including hospitalizations, are on the rise, but nowhere near the levels seen in previous years.
Experts say the wave of the virus is driven by declining immunity and new variants. According to CDC data, the prevalence in the US is KP.3.1.1. Estimate Covers 37% of cases in the last two weeks. This has tripled the level from a month ago.
KP.3.1.1 and KP.2 – the strain included in the updated mRNA vaccines – both of J.N.1Novavax shot target, and they are all Versions A variant of Omicron.
's Brenda Goodman contributed to this report.