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EU regulator adds neurological disorder as ‘very rare’ side effect of J&J vaccine

Published: in European News by .

The agency’s safety committee, added the rare disorder to the jab’s side effects after assessing 108 cases reported worldwide.

The European Medicines Agency Thursday listed Guillain-Barré syndrome (GBS) as a “very rare” side effect of Johnson & Johnson’s coronavirus vaccine.

GBS is a rare neurological disorder in which the body’s immune system attacks nerve cells, causing weakness, pain and, in the worst cases, paralysis. Most people recover.

The agency’s safety committee, PRAC, added the rare disorder to the jab’s side effects today after assessing 108 GBS cases reported worldwide by the end of June. One person died. By that point, 21 million people had received the one-shot adenovirus vector vaccine.

The agency wrote that “a causal relationship between COVID-19 Vaccine Janssen and GBS is possible.” Still, “the benefits of COVID-19 Vaccine Janssen continue to outweigh the risks of the vaccine.”

Regulators asked health workers to monitor any symptoms of GBS, including tingling, double vision or trouble walking or speaking.

U.S. regulators also said they were preparing to add GBS as a rare side effect from the J&J vaccine.

Earlier this month, EU regulators warned about GBS cases connected to the Oxford/AstraZeneca jab, another adenovirus viral vector vaccine. However, due to insufficient data, they could neither “[confirm] nor rule out a possible association with the vaccine.”

This article is part of POLITICO’s premium policy service: Pro Health Care. From drug pricing, EMA, vaccines, pharma and more, our specialized journalists keep you on top of the topics driving the health care policy agenda. Email for a complimentary trial. 


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