The US Food and Drug Administration (FDA) warned Monday evening of a possible link between the Johnson & Johnson coronavirus vaccine and the Guillain-Barre syndrome, in which the immune system attacks the nervous system.
“Although the available evidence suggests an association between the Janssen vaccine and increased risk of GBS, it is insufficient to establish a causal relationship,” the FDA statement said, according to news outlets. It added, “Importantly, the FDA has evaluated the available information for the Janssen COVID-19 Vaccine and continues to find the known and potential benefits clearly outweigh the known and potential risks.”
On its part, Johnson & Johnson said in a statement, “We have been in discussions with the US Food and Drug Administration and other regulators about rare cases of the neurological disorder, Guillain-Barre syndrome, that has been reported following vaccination with the Janssen COVID-19 vaccine. “The chance of having this occur is very low, and the rate of reported cases exceeds the background rate by a small degree,” it added.
The Washington Post reported that about 100 cases of GBS syndrome were recorded within the 12.8 million Johnson & Johnson doses administered in the US. The FDA updated the label of the vaccine that includes a new warning that reads, “Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of Guillain-Barrأ ©syndrome during the 42 days following vaccination.”
Source- KUNA