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    FDA says Novavax Covid-19 vaccine is effective, but also raises concerns


    Scientists on the Meals and Drug Administration mentioned the Covid-19 vaccine developed by the biotech Novavax was efficient at stopping illness however questioned how efficient it’s towards at present circulating strains — and raised considerations concerning the potential for a uncommon aspect impact.

    Their evaluation, specified by briefing documents launched Friday forward of an advisory committee assembly on the vaccine, despatched Novavax shares down greater than 16%.

    The FDA’s scientists raised considerations, specifically, concerning the threat of myocarditis and pericarditis related to the vaccines. Each are forms of irritation of the center or surrounding tissue which have additionally been related to the mRNA-based Covid vaccines developed by Pfizer and its accomplice BioNTech and Moderna.


    The FDA’s Vaccines and Associated Organic Merchandise Advisory Committee will meet on June 7 to think about whether or not the Novavax vaccine must be licensed as one other Covid vaccine choice within the U.S. The company is just not certain by the suggestions of its outdoors advisory committees, however tends to observe them.

    There was curiosity within the Novavax vaccine as a result of it’s produced on a extra conventional vaccine platform than the newer mRNA vaccines, which could persuade some individuals who haven’t acquired a Covid vaccine to get one. The Novavax vaccine consists of a key protein from the SARS-CoV-2 virus that’s produced in insect cells and bolstered with one other chemical, referred to as an adjuvant, meant to provide an immune response. Comparable applied sciences are utilized in some influenza vaccines.


    However the FDA paperwork elevate questions on how the vaccine, often called NVX-CoV2373, can be positioned whether it is licensed.

    “Related information to evaluate effectiveness of NVX-CoV2373 towards the Omicron variant and sublineages, together with observational information from use in different international locations the place the vaccine has been deployed, are at present unavailable,” the FDA wrote. “Nonetheless, primarily based on the efficacy estimate within the medical trial of this vaccine, it’s extra seemingly than not that the vaccine will present some significant stage of safety towards COVID-19 attributable to Omicron, specifically towards extra extreme illness.”

    Additionally it is not clear how a lot a booster dose of the vaccine, at present given as a two-dose sequence, would enhance safety.

    5 of the instances of myocarditis and pericarditis within the Novavax path have been reported inside two weeks of vaccination. One case could have been attributable to Covid, not the vaccine, however there have been no clear various explanations for the opposite instances. 4 instances of coronary heart irritation occurred in younger males, mirroring what’s seen with the mRNA vaccines.

    What’s extra, the FDA scientists mentioned, the identification of a number of vaccine-associated instances in a the protection database with the Novavax vaccine “raises concern that if causally related, the chance of myocarditis following NVX-CoV2373 could possibly be greater than reported throughout post-authorization use of mRNA COVID-19 vaccines.” The FDA scientists famous that myocarditis was not recognized earlier than the mRNA vaccines have been licensed.

    The FDA additionally mentioned that an authorization of the Novavax vaccine would depend upon details about the corporate’s manufacturing processes.

    “Testing and submission of producing and product info for the NVX-CoV2373 product supposed to be used below EUA have been nonetheless in course of on the time of this evaluation,” the FDA scientists wrote.

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