J&J Vaccine Gets Additional Warning For Neurological Syndrome Risk
Guillain-Barré syndrome is rare in the general population, and most people eventually recover. As some reports link cases to side effects from Johnson & Johnson's covid vaccine, the FDA is adding a warning to the shot label.
The Washington Post:
FDA Adds New Warning On Johnson & Johnson Vaccine Related To Rare Autoimmune Disorder
The Food and Drug Administration announced a new warning for the Johnson & Johnson coronavirus vaccine on Monday, saying the shot has been linked to a serious but rare side effect called Guillain-Barré syndrome, in which the immune system attacks the nerves. About 100 preliminary reports of Guillain-Barré have been detected in vaccine recipients after the administration of 12.8 million doses of the Johnson & Johnson vaccine in the United States, according to a companion statement from the Centers for Disease Control and Prevention, which monitors vaccine safety systems with the FDA. Of these reports, 95 were serious and required hospitalization, the FDA statement said. There was one death. Neither agency provided details about the death. (McGinley and Sun, 7/12)
CNBC:
J&J Covid Vaccine: FDA To Announce New Warning Related To A Rare Autoimmune Disorder, Report Says
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 person in 100,000 each year, and most people eventually recover from the disorder, according to the National Institute of Neurological Disorders and Stroke. The cases reported after receiving the J&J shot largely occurred about two weeks after vaccination and mostly in males, many aged 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 said. (Lovelace Jr., 7/12)
Stat:
J&J Covid-19 Vaccine May Trigger Neurological Condition In Rare Cases
Most are older males, which fits with the known pattern of GBS, said John Moore, an immunologist at Weill Cornell Medicine. “A rare, but very probably real consequence of the vaccine,” said Paul Offit, a vaccine expert from Children’s Hospital of Philadelphia. “Again, the benefits of the vaccine clearly and definitely outweigh its very rare risks.” The FDA’s statement comes after a similar signal of GBS was identified with AstraZeneca’s Covid vaccine. (Branswell, 7/12)
The New York Times:
Guillain-Barré Syndrome And The Johnson & Johnson Vaccine: What To Know
The risk appears to be very small. So far, there have been 100 reports of the syndrome in people who had received the Johnson & Johnson vaccine. Nearly 13 million doses of the vaccine have been administered in the United States. Here are answers to some common questions about the syndrome and its connection to vaccination. (Anthes, 7/12)
