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

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  • 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 PFEBioNTech 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.
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Posted In: BiotechNewsHealth CareFDAGeneralBriefsCOVID-19 Vaccine
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