The US Food and Drug Administration (FDA) has announced a new warning about the J&J Covid vaccine related to a rare autoimmune disorder, according to a report.

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A box of Janssen COVID-19 vaccine doses from Johnson & Johnson is pictured at Grubb’s Pharmacy on Capitol Hill on Monday, April 12, 2021.

Tom Williams | CQ-Roll Call, Inc. | Getty Images

The Food and Drug Administration is expected to announce a new Covid-19 vaccine warning from Johnson & Johnson, saying the vaccine is linked to a serious but rare autoimmune disorder, The Washington Post reported Monday, citing four unnamed sources.

About 100 initial reports of Guillain-Barré syndrome were discovered after 12.8 million doses of the J&J vaccine were administered, the Centers for Disease Control and Prevention said in a statement to NBC News. Guillain-Barre is a rare neurological disorder in which the body’s immune system mistakenly attacks part of the nervous system.

It is estimated that it affects 1 in 100,000 people each year, and most people eventually recover from the disorder, according to the National Institute of Neurological Disorders and Stroke.

Cases reported after receiving the J&J injection largely occurred about two weeks after vaccination and are mostly in males, many of whom are 50 and older, according to the CDC. The agency said that the available data do not show a similar pattern with Pfizer or Moderna vaccines.

US regulators are expected to stress that the J&J vaccine is safe and that its benefits clearly outweigh the potential risks, the newspaper reported, citing people familiar with the situation.

The Food and Drug Administration and Jammu Johnson did not immediately respond to CNBC’s request for comment.

“Reports of GBS after receiving the J&J/Janssen COVID-19 vaccine in the Vaccine Adverse Event Reporting System (VAERS) are rare, but likely indicate a small potential risk for this side effect after this vaccine,” the CDC said in a statement NBC News.

The expected new warning is just a recent setback for J&J, which has struggled with problems producing its vaccine as well as public concerns about a rare, potentially life-threatening blood clotting disorder linked to its dose.

After the vaccine was approved in late February, the vaccine was touted as a boon because it can be stored at refrigerator temperatures for months and only takes a single dose — unlike Pfizer and Modern, which require more complex transportation methods and are two doses.

More than 12 million J&J shots have been taken in the United States, according to data collected by the Centers for Disease Control and Prevention.

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