GBS is a rare neurological disorder in which the body’s immune system damages nerve cells which can result in pain, numbness and muscle weakness, progressing to paralysis in the most severe cases. Most people fully recover from the disorder.
EMA’s safety committee, Pharmacovigilance Risk Assessment Committee (PRAC), assessed the available evidence, including cases reported to the European database for suspected side effects, and information from scientific literature. PRAC looked at 108 cases of GBS reported worldwide as of 30 June, when over 21 million people had received the vaccine.There was one reported death among these reports.
After assessing the available data, PRAC considered that a causal relationship between COVID-19 Vaccine Janssen and GBS is possible.
However, EMA confirms that the benefits of COVID-19 Vaccine Janssen continue to outweigh the risks of the vaccine.
As it was reported earlier, the EMA concluded that the blood clotting should be included in the list of rare side effects caused by Johnson & Johnson vaccine.