EMA lists rare neurological disorder as 'very rare side effect' of Janssen vaccine

GBS is a rare neurological disorder where 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.

A rare neurological disorder has been named as a “very rare side effect” of the Janssen vaccine, the European Medicines Agency (EMA) has said.

The European health watchdog announced on Thursday that Guillain-Barré syndrome (GBS) is to be listed on the vaccines product information to raise awareness among healthcare professionals and people taking the vaccine.

GBS is a rare neurological disorder where 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.

The EMA said that most people fully recover from the disorder.

It added that the benefits of the one-shot Janssen vaccine continue to outweigh the risks.

The EMA safety committee, Pharmacovigilance Risk Assessment Committee (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.

‼️ Following an EMA review, Guillain Barré syndrome is listed as a very rare side effect for #COVID19Vaccine Janssen. Healthcare professionals & vaccinated people should be alert to symptoms of this syndrome, to allow for early diagnosis & treatment:
👉https://t.co/a1Gayik85V pic.twitter.com/ojDtfDsW0a

— EU Medicines Agency (@EMA_News) July 22, 2021

After assessing the available data, the PRAC considered that a causal relationship between Covid-19 Vaccine Janssen and GBS is possible.

The EMA said in a statement: “Although cases of GBS after vaccination with Covid-19 Vaccine Janssen have been reported very rarely, healthcare professionals should be alert to signs and symptoms of GBS, in view of the seriousness of this condition, to allow for early diagnosis, supportive care and treatment”.

It added that vaccinated people should seek immediate medical attention if they develop signs and symptoms suggestive of GBS, such as weakness in the extremities, double vision or difficulty moving eyes.

The EMA added: “A review of GBS cases has also taken place recently for Vaxzevria (previously Covid-19 Vaccine AstraZeneca).

“The product information of Vaxzevria now includes a warning on GBS and PRAC continues to closely monitor this issue.” No association has been identified between GBS and the Pfizer or Moderna vaccines.

In Ireland, people over the age of 18 can register for the Janssen vaccine in a pharmacy.

So far in Ireland, 66% of adults have been fully vaccinated while 80% have got at least one jab.