The European Union’s drug regulator listed a rare nerve disorder known as Guillain-Barré syndrome (GBS) as a possible AstraZeneca COVID-19 vaccine side effect, according to the watchdog in a Wednesday update.
The European Medicines Agency (EMA) said the AstraZeneca shot, known as Vaxzevria, was associated with 833 GBS cases as of July 31. That’s out of 592 million doses administered, the EMA said (pdf).
Reported cases of GBS concern “suspected side effects” such as “medical events that have been observed after vaccination, but which are not necessarily related to or caused by the vaccine,” said the agency. “Pain in legs and arms or stomach and influenza-like symptoms have also been included in the product information as side effects,” it added.
In another update this week (pdf), the EMA said that potential side-effects to Johnson & Johnson’s single-dose shot include “swollen lymph nodes, unusual or decreased feeling in the skin, tinnitus, diarrhea, and vomiting.” GBS was not associated with the J&J vaccine.
Both AstraZeneca’s and Johnson & Johnson’s vaccines will include updated product information to reflect their respective side-effects, according to the EMA.
Deployment of the AstraZeneca vaccine was put on hold in March of this year in several European countries after reports emerged that the shot could be associated with rare blood clots that were developed after individuals received it. Most countries that placed a pause on the vaccine resumed its usage during the same month.
AstraZeneca’s vaccine, which uses an adenovirus vector, has not been authorized for emergency use by the Food and Drug Administration in the United States. Johnson & Johnson’s vaccine, which uses similar technology, was authorized for emergency use earlier this year. Vaccines made by Moderna and Pfizer use different technology based on mRNA and require two doses.
The FDA also has warned that GBS is a rare but possible side effect of the J&J vaccine.
COVID-19 is the illness caused by the CCP (Chinese Communist Party) virus.
According to the Mayo Clinic, GBS is a condition where the body’s immune system attacks the nerves, potentially causing paralysis.
“In its most severe form Guillain-Barre syndrome is a medical emergency. Most people with the condition must be hospitalized to receive treatment,” the clinic says, noting that there is no known cure. “The exact cause of Guillain-Barre syndrome is unknown” although “two-thirds of patients report symptoms of an infection in the six weeks preceding.”
AstraZeneca and J&J have not responded yet for a comment on the EMA’s update.