EU CONFIRMS NEW RARE SIDE EFFECT FOR J&J VACCINE
(Reuters) – The European Medicines Agency (EMA) announced in a statement Thursday that Guillain-Barré syndrome – an autoimmune disease targeting certain nerves – will be added to the list of rare side effects of the COVID vaccine -19 from Janssen, a subsidiary of Johnson & Johnson.
After reviewing all the available data, the agency’s Pharmacovigilance Risk Assessment Committee estimated that a “cause and effect relationship between the COVID-Janssen vaccine and Guillain syndrome -Barré was possible “.
The EMA, which reaffirms the favorable benefit-risk balance of this vaccine, specifies that while the cases of occurrence of this syndrome are extremely rare, recently vaccinated people who develop suggestive signs such as weakness or tingling at the extremities of the limbs or vision disturbances should seek medical attention immediately.
Guillain-Barré syndrome is a rare autoimmune condition in which the immune system attacks peripheral nerves, which can cause pain, numbness, muscle weakness, or difficulty walking.
In France, the J&J vaccine is only used for people over the age of 55.
(Pushkala Aripaka report in Bengalore, with the contribution of Myriam Rivet in Paris, edited by Sophie Louet)