FDA to Announce New J&J Covid Vaccine Warning Linked to Rare Autoimmune Disease, Report Says – .

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FDA to Announce New J&J Covid Vaccine Warning Linked to Rare Autoimmune Disease, Report Says – .


A box of Janssen COVID-19 vaccine doses from Johnson & Johnson is pictured at the Grubb Pharmacy in Capitol Hill on Monday, April 12, 2021.
Tom Williams | CQ-Roll Call, Inc. | Getty Images
The Food and Drug Administration is expected to issue a new warning for Johnson & Johnson’s Covid-19 vaccine, saying the vaccine was linked to a serious but rare autoimmune disease, the Washington Post reported on Monday, citing four anonymous sources.
About 100 preliminary reports of Guillain-Barre syndrome have been detected 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 to affect about one 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 vaccine largely occurred around two weeks after vaccination and mostly in men, many of whom are 50 years of age and older, according to the CDC. Available data does not show a similar pattern with Pfizer’s or Moderna’s vaccine, the agency said.

U.S. regulators should stress that the J&J vaccine is safe and that its benefits clearly outweigh any potential risks, the Post reported, citing people familiar with the situation.

The FDA and J&J did not immediately respond to CNBC’s request for comment.

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

The awaited new warning is just the latest setback for J&J, which has suffered from problems with its vaccine production as well as public concerns about a rare, life-threatening blood clotting disorder linked to its injections.
After its clearance at the end of February, the vaccine was touted as a blessing because it could be stored at refrigerator temperature for months and only required a single dose, unlike those from Pfizer and Moderna, which require methods of more complicated transport and are in two doses.

More than 12 million shots of J&J have been administered in the United States, according to data compiled by the CDC.

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