This is the New Warning to Be Announced by the FDA on J&J’s Covid Vaccine
According to a newly expected Food and Drug Association (FDA) announcement, there is anew warning on J&J’s Covid vaccine that is related to a rare
autoimmune disorder.
The Washington Post has reported that the FDA is expected to announce a new warning for the Johnson & Johnson Covid vaccine, saying the shot has been linked to a serious but rare autoimmune disorder.
Roughly 100 preliminary reports of Guillain-Barre syndrome have been detected after 12.8 million doses of the J&J vaccine were administered, the CDC said.
The Post has also assured that U.S. regulators are expected to emphasize that the J&J vaccine is safe and that its benefits clearly outweigh the potential risks. The news outlet had cited unnamed people familiar with the situation.
Guillain-Barre is a rare neurological disorder in which the body’s immune system mistakenly attacks part of the nervous system. The National Institute of Neurological Disorders and Stroke have found that it is estimated to affect roughly one persin in 100,000 a year.
The cases that had been reported after receiving the J&J shot mostly happened about two weeks after vaccination and mostly in males. Many were 50 years and older, according to the CDC. Available data do not show a similar pattern with Pfizer’s or Moderna’s vaccine, the agency also noted.
“Reports of GBS after receipt of the J&J/Janssen COVID-19 Vaccine in the Vaccine Adverse Event Reporting System (VAERS) are rare, but do likely indicate a small possible risk of this side effect following this vaccine,” the CDC saif to NBC News.
J&J said on Monday that it was in discussions with the FDA and other regulators about the disorder.
“The chance of having this occur is very low, and the rate of reported cases exceeds the background rate by a small degree,” the company said. “We strongly support raising awareness of the signs and symptoms of rare events to ensure they can be quickly identified and effectively treated.”
Disclaimer: We have no position in any of the companies mentioned and have not been compensated for this article.