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FDA to Announce New Warning for J&J Vaccine As Cases of Rare Autoimmune Disorder Spike

The Food and Drug Administration (FDA) is expected to announce a new warning for Johnson & Johnson’s COVID-19 vaccine, following preliminary reports of a rare nerve condition developed in a few people who received the shot. Through a symptom monitoring system called the Vaccine Adverse Event Reporting System, regulators have found 100 suspected cases of Guillain-Barré syndrome, but the reports are considered preliminary. The cases were mainly reported about two weeks after vaccination and mainly among males ages 50 and older.

However, the regulators say that the risks of developing this rare condition, known as Guillain-Barré syndrome, are very low. The benefits of receiving the vaccine still greatly outweigh the risks.

Guillain-Barré syndrome can cause muscle weakness and sometimes paralysis, and symptoms typically last for a few weeks to a couple of years. While Guillain-Barré has led to deaths and permanent nerve damage in some, most people fully recover.

More than 12.8 million people in the US have been vaccinated with Johnson & Johnson’s COVID-19 vaccine; still, the risk of developing the condition maybe about three to five times higher in those who received the Johnson & Johnson vaccine as compared with the general U.S. population. The warning will likely be added to the fact sheets given to health care providers and patients. According to the CDC, viruses, and bacteria are typically the culprits in triggering the syndrome, but rarely, certain vaccines have also started it.

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