Johnson & Johnson was in talks with the U.S. Food and Drug Administration and Centers for Disease Control and Prevention about the matter.
Johnson & Johnson is in another setback with the regulators from the United States. This comes as their coronavirus vaccines are found to have links to a rare neurological disorder.
The reports emerged on Monday, stating that the Food and Drug Administration would update its label for the vaccine. Later that day, the federal agency released the fact sheet, detailing the warnings for the potential increased risk of the Guillain-Barré syndrome.
Speaking to CNN, the FDA said that they were announcing revisions to the label on the Janssen vaccines. As noted, they included “information pertaining to an observed increased risk” of the disorder following a vaccination.
The warning from the U.S. FDA
The agency did not establish that the Johnson & Johnson vaccine could cause the syndrome. It is reportedly “insufficient to establish a causal relationship” between the two. It did note, however, an “increase in reports” of the condition, which sometimes causes paralyzation.
In the updated label, it says that the accounts of adverse events “suggest an increased risk of Guillain-Barré syndrome” within 42 days after vaccination.
Meanwhile, they have not identified the “similar signal” with the other COVID-19 vaccines. They referenced the jabs from Moderna and Pfizer/BioNTech in this dynamic.
Johnson & Johnson vaccine and Guillain-Barré syndrome
In the same fact sheets for patients and caregivers, the FDA shared some of the details of the data, as well as the warning. As noted, the Guillain-Barré syndrome is a neurological disorder wherein the immune system damages nerve cells. This causes muscle weakness and paralysis, at times.
The agency added that the disorder “has occurred in some people” who have taken the Janssen jabs. Out of the 12.8 million doses administered, 100 preliminary reports of the syndrome had been reportedly filed.
95 cases out of the hundred also involved people who needed hospitalization. The FDA, then, said that the chance of having this is “very low.” Unfortunately, though, one person died, as per reports.
In the end, the federal agency urged individuals to seek medical attention upon noticing certain symptoms. These include difficulty in walking, speaking, chewing or swallowing, bowel or bladder control problems, double visions, and “weakness or tingling in the arms and legs, especially if it spreads, after receiving a vaccine.”
Benefits outweigh “minute risk of complications”
This was not the first time that the vaccine maker ran into a “significant” regulatory issue. Forbes recalled that the federal government recommended a pause on the Janssen vaccinations on April 13. This came as health officials “investigated a handful of rare but serious blood clotting issues.”
Ten days later, though, the regulators lifted the pause. As stated, the benefits of taking the Johnson & Johnson COVID-19 vaccine “far outweighed the minute risk of complications.”
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