Washington: In yet another warning related to Covid-19 vaccine, the US regulators on Monday raised alarm on Johnson & Johnson’s vaccine about links to a rare and potentially dangerous neurological reaction, but also noted it’s not completely known if the shot caused the problem.


What’s the FDA warning?


On Monday, the Food and Drug Administration shared the new findings flagging the concerns related to Guillain-Barre syndrome, an immune system disorder that can cause muscle weakness and paralysis at times. On the other hand, health officials mentioned the side effect as a “small possible risk” for those taking the jab, according to AP report.


The warning comes after the FDA and the Centers for Disease Control and Prevention analysed reports of about 100 people developing the syndrome after taking the jab.


According to the FDA observation, almost all of them who took the dose required hospitalisation and one person also passed away after taking the dosage. Most cases were reported in men — many 50 years old and up — and usually about two weeks after vaccination, as per the report.


What’s Guillain-Barre syndrome?


Guillain-Barre syndrome happens when the body’s immune system ends up attacking some of its nerve cells by mistake leading to muscle weakness and sometimes paralysis that typically is temporary. An estimated 3,000 to 6,000 people develop the syndrome each year, according to the CDC.


Although the number of cases reported in connection with J&J’s vaccine exhibits only a tiny fraction of the nearly 13 million Americans who have received the one-dose shot.


The pharma company has been discussing the reports with the FDA and other health regulators around the world. The CDC said it would ask its panel of outside vaccine experts to review the issue at an upcoming meeting.


Meanwhile, the government said the most vaccines used in the US made by Pfizer and Moderna have not exhiited any risk of the disorder after more than 320 million doses have been administered.


The FDA insisted on adding the new warning in pamphlets given to people getting the J&J shot. Bsides that seek medical attention if they experience any symptoms, which include tingling sensations, trouble walking and double vision, the FDA said.