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Johnson & Johnson's (NYSE: JNJ) COVID-19 vaccine has been linked to a second rare but severe side effect.
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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.
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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.
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"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.
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The FDA said that there were 100 preliminary reports of the syndrome out of the 12.5 million people who received the vaccine.
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However, no such relationship was seen between the Moderna Inc (NASDAQ: MRNA) or Pfizer Inc (NYSE: PFE) - BioNTech SE (NASDAQ: BNTX) vaccines and the autoimmune condition.
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Of those 100 cases, 95 were serious and required hospitalization, and that there was one reported death.
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The agency noted that most people with Guillain-Barré syndrome recover and said there was insufficient data to establish a causal relationship.
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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.
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Price Action: JNJ shares are down 0.93% at $167.91 premarket on the last check Tuesday.
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