The European Medicines Agency (EMA) on Wednesday listed Guillain-Barre Syndrome—a neurological disorder that can cause temporary paralysis—as a “very rare” side effect of the AstraZeneca Covid-19, a move that comes just weeks after the nerve disorder was listed as a possible side effect for another adenovirus-based vaccine made by Johnson & Johnson.
- In an update published on Wednesday, EMA said a causal relationship between the adenovirus-based vaccine and Guillain-Barre Syndrome (GBS) was “considered at least a reasonable possibility.”
- The agency said therefore the condition should be added to the product information as a side effect of the vaccine.
- The EMA also recommended a warning should be added to inform the vaccine’s recipients to seek medical attention if they develop weakness and paralysis in the extremities that can progress to the chest and face.
- The incidence of the side effect remains extremely rare, with only 833 cases reported worldwide from about 592 million administered doses of the AstraZeneca vaccine, as of July 25.
- GBS is a disorder where the body’s immune system attacks the nerves, causing temporary paralysis and breathing difficulties and it has been reported in several patients who have been infected with Covid-19.
In July, the drug regulator listed GBS as a “very rare” side effect of the Johnson & Johnson single-dose vaccine, which is built on the same adenovirus technology as the AstraZeneca shot. The U.S. Food and Drug Administration also issued a warning in July of an increased risk of developing the neurological disorder with the Johnson & Johnson vaccine. But both agencies noted that the incidence of such cases was extremely rare and the benefits of the vaccines still outweighed the risks. A study published last month in the British Medical Journal showed that people infected with Covid-19 faced a much greater risk of developing dangerous blood clots—another rare vaccine side effect—compared to people who have received a Pfizer or AstraZeneca coronavirus vaccine.