FDA Limits Use of J&J Vaccine, Citing Security Considerations

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The US Meals and Drug Administration has restricted the usage of Johnson & Johnson’s single-shot coronavirus vaccine as a result of small threat of growing a uncommon and probably life-threatening blood clotting dysfunction. 

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In a statement launched yesterday (Might 5), the FDA mentioned it’s limiting the emergency use authorization of the vaccine. Now, adults can solely take the Johnson & Johnson shot if different vaccines aren’t available or medically applicable—for instance, if they’ve had allergic reactions to different coronavirus vaccines. Sufferers may additionally obtain the J&J vaccine in the event that they refuse to take one other shot. (The shot was by no means licensed for adolescents or kids.)

The J&J vaccine is associated with a generally deadly situation referred to as thrombosis with thrombocytopenia syndrome (TTS). In response to the FDA assertion, an up to date evaluation of security information by way of March 18 discovered that there have been 60 confirmed circumstances of TTS after J&J vaccinations, with 9 leading to demise. That’s out of roughly 17 million individuals who have gotten the J&J vaccine, in line with The Washington Post, for a price of about three circumstances for each million doses administered. When it happens, this facet impact normally manifests inside one to 2 weeks of vaccination and is usually handled with heparin, an anti-clotting agent that may trigger extreme bleeding. 

“If we see deaths and there may be an alternate vaccine that’s not related to deaths however is related to comparable efficacy . . . we felt it was time at this level to make an announcement on the [product’s] truth sheet that this was not a first-line vaccine,” Peter Marks, director of the FDA’s Middle for Biologics Analysis and Analysis, tells STATThe ninth TTS demise related to the J&J shot occurred within the first quarter of this yr, prompting the FDA to restrict the vaccine’s use, reviews STAT.

Marks notes that different, safer vaccines can proceed for use to inoculate individuals in opposition to the coronavirus. Already, greater than 202 million have obtained two doses of the licensed COVID-19 vaccines from Pfizer-BioNTech and Moderna, in line with the Put up. 

The J&J vaccine, initially conceived as a one-shot various to those mRNA vaccines, was authorized in February of final yr. However the usage of the vaccine has slumped as a result of threat of blood clots, manufacturing points, and decrease efficacy than the Moderna and Pfizer choices, reviews Reuters. US well being authorities paused the usage of the shot in April 2021 as a result of potential threat of blood clots however resumed its use 10 days later, saying that the advantages of the vaccine outweighed the dangers. In December, the Facilities for Illness Management and Prevention recommended that different vaccines be used as an alternative of J&J.

J&J has up to date its personal fact sheet for the vaccine as properly. “Knowledge proceed to assist a positive benefit-risk profile for the Johnson & Johnson Covid-19 vaccine in adults, when put next with no vaccine,” the corporate writes.

See “Blood Clot Risk from COVID-19 Higher than After Vaccines: Study

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