FDA adds warning of rare reaction risk to J&J vaccine
US regulators on Monday added a new warning to Johnson & Johnson's COVID-19 vaccine about links to a rare and potentially dangerous neurological reaction but said it's not entirely clear the shot caused the problem. The Food and Drug Administration announced the new warning, flagging reports of Guillain-Barre syndrome, an immune system disorder that can cause muscle weakness and occasionally paralysis.
About 100 people developed the syndrome after receiving the vaccine
Health officials described the side effect as a small "possible risk" for those getting the shot. The action comes after the FDA and the Centers for Disease Control and Prevention reviewed reports of about 100 people developing the syndrome after receiving the one-dose vaccine. Almost all of them required hospitalization and one person died, the FDA said.
Around 3K-6K people develop the syndrome each year: CDC
Guillain-Barre syndrome occurs when the body's immune system mistakenly attacks some of its nerve cells, causing 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.
Reported cases a tiny fraction of those vaccinated with it
The number of cases reported in connection with J&J's vaccine represents a tiny fraction of the nearly 13 million Americans who have received the one-dose shot. Most cases were reported in men, many 50 years old and up and usually about two weeks after vaccination. J&J said in a statement it has been discussing the reports with the FDA and other health regulators globally.
'Most vaccines used in US show no risk of disorder'
The government said the vaccines most used in the US, made by Pfizer and Moderna, show no risk of the disorder. The new warning will be included in pamphlets given to people getting the J&J shot. They should seek medical attention if they experience any symptoms, which include tingling sensations, trouble walking, and double vision, the FDA said.
Guillain-Barre can be triggered by several infections
The CDC and the FDA have been monitoring side effect reports submitted by physicians, drugmakers, and patients to a federal vaccine safety database. Guillain-Barre can be triggered by a number of infections, including flu, cytomegalovirus, and Zika virus. But there have been rare cases in which people develop the disorder days or weeks after receiving certain vaccines.