FDA adds new warning to J&J COVID-19 vaccine

The Food and Drug Administration (FDA) is adding a label to Johnson & Johnson’s COVID-19 vaccine, warning that it has been linked to rare cases of Guillain-Barré syndrome (GBS), a neurological disorder in which the body’s immune system mistakenly attacks part of its nervous system.

There have been 100 preliminary reports following vaccination after approximately 12.5 million doses administered, FDA said in a statement. Of these reports, 95 of them were serious and required hospitalization. There was one reported death.

The cases have largely occurred about two weeks after vaccination and mostly in men, many aged 50 and older, the CDC said in a statement. The cases are rare, “but do likely indicate a small possible risk of this side effect following this vaccine,” the CDC said.

Notably, CDC added that they did not see a similar pattern with mRNA vaccines, after over 321 million doses administered in the United States. The agency said its vaccine advisory committee will discuss the issue at an upcoming meeting.

The FDA noted that the vaccine is still safe and effective, and the known and potential benefits clearly outweigh the known and potential risks.

J&J problems: The warning is the latest blow to the Johnson & Johnson vaccine, which was supposed to be an important part of the U.S. vaccination effort. But usage has lagged and the vaccine has been plagued by problems.  The CDC and FDA paused use of the vaccine for more than a week in April after it was linked to rare and potentially life-threatening blood clots.

The company has also suffered from serious production problems at its only U.S. manufacturing plant.