US Issues New Warning for Johnson & Johnson COVID-19 Vaccine

The U.S. Food and Drug Administration is adding a new warning to Johnson & Johnson’s COVID-19 vaccine because of a link to a rare neurological condition.

The federal oversight agency issued a statement Monday saying it had received preliminary reports of 100 people who developed Guillain-Barré syndrome after receiving the single-shot vaccine. According to the FDA, Guillain-Barré syndrome occurs when the immune system damages nerve cells, causing muscle weakness and occasional paralysis.  Between 3,000 and 6,000 people are diagnosed each year with the condition in the United States. The FDA said of the 100 vaccine recipients who developed Guillain-Barré syndrome, one person died and 95 were hospitalized. Most of the cases were reported in men 50 years old and older, and usually two weeks after being inoculated. The numbers are a small fraction of the 12.8 million people who have received the Johnson and Johnson vaccine, which makes up a small proportion of the U.S. vaccine supply.  The FDA said after evaluating the information it has determined that “the known and potential benefits” of the vaccine “clearly outweigh the known and potential risks.”