FDA = US Food and Drug Administration warns product information on the 12th that a person who received the new coronavirus vaccine of pharmaceutical giant Johnson & Johnson reported "Guillain-Barré syndrome" that causes paralysis of limbs. Added.
The FDA has not changed its recommendations, saying that "the benefits of vaccination continue to outweigh the risks."
On the 12th, the FDA added a warning to the product information of the new coronavirus vaccine of pharmaceutical giant Johnson & Johnson that the person who received the vaccine reported "Guillain-Barré syndrome".
Guillain-Barré Syndrome is a disease in which immunity attacks one's nerve cells, causing paralysis of the limbs, and the FDA estimates that it affects 3,000 to 6,000 people in the United States each year. I will.
According to the FDA, in the United States, when the Johnson & Johnson vaccine is given approximately 12.5 million times, the provisional "Guillain-Barré syndrome" is tentative through a system that voluntarily reports on post-vaccination health effects. It means that there were 100 reports.
"Current evidence suggests an association with this vaccine, but it's not enough to prove a causal link," the FDA said.
On top of that, we have not changed the recommendation of vaccination, saying that "the benefits of vaccination continue to outweigh the risks".
The FDA and the CDC = Centers for Disease Control and Prevention will monitor for similar reports and proceed with expert analysis.