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FDA updates label of J&J Covid-19 vaccine to warn of potential Guillain-Barre syndrome
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The US Food and Drug Administration updated the label for Johnson & Johnson’s coronavirus vaccine Monday, saying there may be an increased risk of a rare neurological condition called Guillain-Barré Syndrome among people who have been recently vaccinated.
The FDA said it was not yet clear if the vaccine causes the condition, but noted an increase in reports of the sometimes paralyzing syndrome.
“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 (GBS) following vaccination,” it said in a statement sent to CNN.
“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.
“Based on an analysis of Vaccine Adverse Event Reporting (VAERS) data, there have been 100 preliminary reports following vaccination with the Janssen vaccine after approximately 12.5 million doses administered,” the FDA said in the statement.
“Of these reports, 95 of them were serious and required hospitalization. There was one reported death. Each year in the United States, an estimated 3,000 to 6,000 people develop GBS. Most people fully recover from the disorder,” the agency added.
“GBS has also been observed at an increased rate associated with certain vaccines, including certain seasonal influenza vaccines and a vaccine to prevent shingles. Although the available evidence suggests an association between the Janssen vaccine and increased risk of GBS, it is insufficient to establish a causal relationship. No similar signal has been identified with the Moderna and Pfizer-BioNTech COVID-19 vaccines.” ...
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