The US Medicines Agency warned on Monday of an "increased risk" of developing Guillain-Barré syndrome, a rare neurological disorder, associated with the Covid-19 vaccine from Johnson & Johnson.
What to rejoice the most fierce "anti-vax" this Monday while Emmanuel Macron wants to vaccinate at all costs in France.
US health authorities have identified 100 reported cases of people having developed Guillain-Barré syndrome, out of nearly 12.5 million doses of this vaccine administered.
Of these 100 cases, 95 were serious and required hospitalization.
One person died.
The statement follows a Washington Post article on Monday that the FDA was to announce a new warning on J & J's coronavirus vaccine linked to rare autoimmune disease.
Guillain-Barré syndrome is a rare neurological disease in which the body's immune system mistakenly attacks part of the peripheral nervous system, which is the network of nerves outside the brain and spinal cord. spinal.
France is counting on this vaccine to accelerate its vaccination campaign
Last April, the European Medicines Agency (EMA) had already announced that blood clots should be added to the "very rare side effects" of the Johnson & Johnson vaccine against Covid-19. The announcement was made during a virtual press conference "on the conclusions about the safety assessment" on Tuesday. However, the EMA considers that the benefit / risk balance of this serum remains “positive”. This decision is all the more important as several European countries, including France, are counting on this vaccine to speed up their immunization campaign.
To reach its conclusions, the European Medicines Agency says it relied in particular on eight reports made on the subject in the United States, a country where more than seven million people have already been vaccinated with the Johnson & Johnson vaccine. "All cases have occurred in people under the age of 60 within three weeks of vaccination, the majority in women," writes the EMA in its press release. Based on the available evidence, no specific risk factors could be confirmed at the time.