US FDA Warns Johnson and Johnson Vaccine Triggers Severe Cases of Guillain- Barré Including Death

US FDA Warns Johnson and Johnson Vaccine Triggers Severe Cases of Guillain- Barré Including Death

The U.S. Food and Drug Administration (FDA) recently shared with the public that the Johnson and Johnson COVID-19 vaccine is associated with what is apparently a small number of Guillain-Barré cases but the agency maintains that benefits outweigh the risks at this point. While the incidence is only 100 out of 12 million, there was a death. Many of the patients that were impacted were males in the 50s and above. Disturbingly, 95% of the cases were severe, requiring hospitalization. TrialSite monitors these signals carefully.

What follows is a TrialSite breakdown of this situation as reported recently by the Washington Post.

What is Guillain-Barré?

Occurring in about 2 per 100,000 people annually, the condition includes rapid-onset muscle weakness triggered by the immune system damaging the peripheral nervous system. Most often, the condition impacts both sides of the body, and the first symptoms can morph to start in the feet and hands and spread to other parts of the body. During the acute phase, this condition can be life-threatening, as, in about 15% of the cases, an individual can develop weakness of the breathing muscles and thus require mechanical...

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