The Hague (AFP)
The European Medicines Agency (EMA) on Wednesday listed Guillain-Barré syndrome, a rare neurological impairment, as a "very rare" side effect of AstraZeneca's Covid-19 vaccine.
According to the EMA, 833 cases of the neurological syndrome have been reported worldwide as of July 31, while more than 592 million doses of Vaxzevria serum, from the AstraZeneca laboratory, have been administered worldwide as of July 25. July.
"The EMA Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that a causal relationship between Vaxzevria and Guillain-Barré syndrome is considered at least a reasonable possibility," said the European regulator in a press release.
"Guillain-Barré syndrome should therefore be added to the product information as a side effect of Vaxzevria," said the agency, headquartered in Amsterdam.
The assigned frequency category is "very rare", that is, occurring in less than 1 in 10,000 people.
Guillain-Barré syndrome is an attack on the peripheral nerves characterized by weakness or even progressive paralysis, most often starting in the legs and sometimes going up to reach the breathing muscles then the nerves of the head and neck. .
The EMA has recommended an update of a warning included since July in the product information to raise awareness of the risks among healthcare professionals and those receiving the vaccine.
The warning also reminds patients to seek medical attention immediately if they develop weakness and paralysis of the extremities that may progress to the chest and face.
The European regulator had listed Guillain-Barré syndrome in July as a "very rare" side effect of the Johnson & Johnson anti-Covid-19 vaccine, using the same adenovirus technology as the Vaxzevria serum.
The US Medicines Agency also warned in July of an "increased risk" of developing neurological syndrome with Johnson & Johnson's serum.
Both regulators had clarified that the vaccine's benefits outweighed the potential risks.
© 2021 AFP