FDA Adds Rare Nerve Condition As Second Warning To Johnson & Johnson's COVID-19 Vaccine

Johnson & Johnson's JNJ COVID-19 vaccine has been linked to a second rare but severe side effect.
The FDA issued a warning that there are data "connecting the shot to an increased risk" of Guillain-Barré syndrome, a rare condition where the body's immune system attacks its nerves.
In April, the FDA and CDC paused the rollout of the vaccine after data linked it to a rare blood clotting disorder. The agencies lifted the hold ten days later, arguing that the benefits still outweighed the risks.
"Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination," the updated label reads.
The FDA said that there were 100 preliminary reports of the syndrome out of the 12.5 million people who received the vaccine.
However, no such relationship was seen between the Moderna Inc MRNA or Pfizer Inc PFE - BioNTech SE BNTX vaccines and the autoimmune condition.
Of those 100 cases, 95 were serious and required hospitalization, and that there was one reported death.
The agency noted that most people with Guillain-Barré syndrome recover and said there was insufficient data to establish a causal relationship.
Recently, the FDA added a warning to patient and provider fact sheets for the Pfizer and Moderna COVID-19 vaccines to indicate a rare risk of heart inflammation.
Price Action: JNJ shares are down 0.93% at $167.91 premarket on the last check Tuesday.