FDA Warns Johnson & Johnson Vaccine Linked to Risk of Guillain-Barré Syndrome
Headline Roundup July 12th, 2021
On Monday the U.S. Food and Drug Administration (FDA) added a warning to the Johnson & Johnson coronavirus vaccine after data suggested the vaccine led to an increased risk of a disorder called Guillain-Barré syndrome. The Washington Post reported that after 12.8 million people were inoculated, approximately 100 people developed the neurological condition, which causes the immune system to attack the nerves and sometimes has a paralyzing effect. The FDA said no data has shown a similar link between the disorder and the Moderna or Pfizer-BioNTech COVID-19 vaccines. This comes after distribution of Johnson & Johnson's vaccine was paused earlier this year after a link to blood clot development in younger recipients.
The story received coverage from across the spectrum.
The U.S. Food and Drug Administration on Monday added a warning to the fact sheet for Johnson & Johnson's (JNJ.N) COVID-19 vaccine saying that data suggests there is an increased risk of a rare neurological disorder in the six weeks after inoculation.
In a letter to the company, the FDA classified the chances of getting Guillain-Barré syndrome (GBS) after vaccination as being "very low." Still, it said J&J vaccine recipients should seek medical attention if they have symptoms including weakness or tingling sensations, difficulty walking or difficulty with facial movements.
The Johnson & Johnson vaccine will soon have a new warning from the Food and Drug Administration after the shot was linked to a rare but serious side effect in a handful of patients, it was revealed Monday.
The side effect, Guillain-Barré syndrome — a condition that occurs when the immune system attacks the body’s nerves — has been detected in about 100 people after 12.8 million jabs of the single-dose shot were administered, the Centers for Disease Control and Prevention told the Washington Post.
The US Food and Drug Administration updated the label on Johnson & Johnson's coronavirus vaccine Monday to warn of the possible increased risk of a rare neurological complication known as Guillain-Barré syndrome.
While the FDA said it had not established the vaccine could cause the syndrome, it noted an increase in reports of the sometimes paralyzing condition.
"Today, the FDA is announcing revisions to the vaccine recipient and vaccination provider fact sheets for the Johnson & Johnson (Janssen) COVID-19 Vaccine to include information pertaining to an observed increased risk of Guillain-Barré Syndrome...