The European Medicines Agency (EMA) listed Guillain-Barré syndrome on Wednesday, a rare neurological damage, as a “very rare” side effect of the AstraZeneca vaccine. According to the EMA, 833 cases of the neurological syndrome have been reported worldwide as of July 31, out of 592 million doses administered.
“The EMA Pharmacovigilance Risk Assessment Committee (PRAC) concluded that a causal relationship between Vaxzevria and Guillain-Barré syndrome is considered at least a reasonable possibility”, the European regulator said in a statement. “Guillain-Barré syndrome should therefore be added to the product information as a side effect of Vaxzevria”, is it specified.
The frequency category assigned is “very rare”, that is, occurring in less than 1 in 10,000 people.
What is Guillain-Barré syndrome?
Guillain-Barré syndrome is a rare disease: in France, its incidence (ie the number of new cases recorded each year) is estimated to be around 1 in 10,000.
It is a disease qualified as autoimmune: in fact, in patients with Guillain-Barré syndrome, the peripheral nerves (these are the nerve fibers that transmit information from the brain and the spinal cord to muscles and organs) are attacked by the immune system.
Symptoms of varying severity result: abnormal sensations (pins and needles, tingling, electrical sensations … especially in the hands and feet), muscle weakness (which can lead to paralysis of a limb), pain intense similar to cramps (in the thighs, buttocks, back …), difficulty speaking, swallowing, breathing, digesting …
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