The EMA confirms a nerve disease as a side effect of a COVID-19 vaccination with the Janssen preparation. After examining all available data, a “causal relationship between the COVID-19 vaccine from Janssen and Guillain-Barré syndrome is possible”.
Europe’s Medicines Agency (EMA) confirmed Thursday that it had listed Guillain-Barré Syndrome (GBS), a nerve disorder, as a possible rare side effect of Johnson & Johnson’s Janssen COVID-19 vaccine after reviewing 108 cases reported worldwide.
“After evaluating the available data, the PRAC estimates that there may be a causal relationship between COVID-19 vaccine Janssen and GBS,” said the European Medicines Agency, referring to its Pharmacovigilance Risk Assessment Committee (PRAC).
Guillain-Barré syndrome (GBS) is an immune system disorder that causes nerve inflammation and can lead to pain, numbness, muscle weakness, and walking difficulties, according to the PRAC.
The German Society for Neurology describes GBS as a severe neurological disease. According to this, around three quarters of all cases occur as a result of infections, be it through bacterial intestinal inflammation or after infections of the respiratory tract. In April last year, the company announced in a press release that SARS-CoV-2 can also trigger Guillain-Barré syndrome.
Dr. Kerry Levin of the Cleveland Health Center said the following symptoms should be looked out for: “This can be accompanied by progressive heaviness and weakness in your legs and arms – and you may later have difficulty swallowing and breathing, but these are unlikely to begin with. “
Other symptoms of GBS can include back pain, muscle weakness, and heart rate or blood pressure problems. Dr. Levin explains that GBS is more likely to get infected from an infection than from a vaccination.
Cases of this syndrome are extremely rare, according to the EMA, but people who have recently been vaccinated and develop symptoms suggestive of Guillain-Barré syndrome, such as weakness or tingling in the limbs or blurred vision, should see a doctor immediately.
The US drug agency FDA had issued a warning for the vaccine from the US pharmaceutical company Johnson & Johnson because there was an “increased risk” of developing GBS. By July 13, when the FDA issued its warning, 100 cases of Guillain-Barré had been reported in people who had received this vaccine. Of these cases, 95 were classified as serious and required hospitalization; one case resulted in death. However, the FDA wanted to continue using the product because “the known and potential benefits clearly outweigh the known and potential risks”.
Earlier in July, the PRAC announced that due to the severity of the disease, it had recommended adding a warning to the product information for Vaxzevria (AstraZeneca’s COVID-19 vaccine) to highlight cases of Guillain-Barré syndrome reported after vaccination.
In May, the Danish health authority decided to remove Johnson & Johnson’s corona vaccine from the vaccination program. She cited the cases of blood clots associated with the vaccine as reasons. The agency came to the conclusion that the benefits of the vaccine did not outweigh possible side effects. The Danish health authority had previously announced that it would permanently refrain from using AstraZeneca’s corona vaccine. The authority referred to isolated thromboses, including deaths, in people vaccinated with the preparation of the British-Swedish manufacturer.
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