FDA announces new warning for Johnson & Johnson vaccine

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The U.S. Food and Drug Administration announced this week revisions to the vaccine recipient and vaccination provider fact sheets for the Johnson & Johnson novel coronavirus (COVID-19) vaccination, which will now include information pertaining to an observed increased risk of Guillain-Barré Syndrome (GBS) following vaccination.

GBS  is a neurological disorder in which the body’s immune system damages nerve cells, causing muscle weakness, or in the most severe cases, paralysis. Based on an analysis of Vaccine Adverse Event Reporting (VAERS) data, there have been 100 preliminary reports of GBS following vaccination with the Janssen vaccine after approximately 12.5 million doses administered, FDA officials said in a statement.

Of these reports, 95 of them were serious and required hospitalization. There was one reported death.

The Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine has been revised to include a warning about GBS and the Fact Sheet for Recipients and Caregivers has been revised to include information about GBS. The warning in the Fact Sheet for Healthcare Providers Administering Vaccine notes that reports of adverse events suggest an increased risk of GBS. Additionally, the Fact Sheet for Recipients and Caregivers notes that vaccine recipients should seek medical attention right away if they develop symptoms.

Each year in the United States, an estimated 3,000 to 6,000 people develop GBS. Most people fully recover from the disorder. 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 Johnson & Johnson 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, officials said.

FDA representatives said the agency continues to work with the U.S. Centers for Disease Control and Prevention (CDC) to monitor reports of GBS following vaccination with the Johnson & Johnson vaccine. Additionally, the FDA has evaluated the available information for the vaccine and continues to find the known and potential benefits clearly outweigh the known and potential risks.

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