According to the EMA, 108 cases of the neurological syndrome have been reported worldwide as of June 30, when more than 21 million people have been administered the Janssen vaccine, from the American laboratory Johnson & Johnson. One person died.
“The benefits of the vaccine continue to outweigh the risks”
“After evaluating the available data, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) considered that a causal relationship between the COVID-19 Janssen vaccine and Guillain-Barré syndrome is possible”, the European regulator said in a statement.
“EMA confirms that the benefits of the Covid-19 Janssen vaccine continue to outweigh the risks of the vaccine”, however, underlined the agency located in Amsterdam.
A warning to healthcare professionals
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. .
Although cases have been reported very rarely, healthcare professionals should be alert to the signs and symptoms of the neurological syndrome in order to “Allow early diagnosis, supportive care and treatment”, stressed the EMA. A warning will be included in the product information to educate healthcare professionals and those receiving the vaccine of the risks.
This Guillain-Barré syndrome warning is also included in the information for the AstraZeneca anti-Covid vaccine, using the same adenovirus technology as the Janssen serum.
An “increased risk” for the US drug agency
No link has been established between the syndrome and the Comirnaty (Pfizer / BioNTech) and Spikevax (Moderna) vaccines, using messenger RNA technology, the EMA said.
The US Medicines Agency this month also warned against a “Increased risk” to develop neurological syndrome with Johnson & Johnson’s serum, while also stressing that she considered that the benefits of the vaccine “clearly outweighed the potential risks.”