Guillain-Barré syndrome (GBS) will be reported as a very rare side effect of the vaccine against COVID-19 Janssen and a warning will be included in the product information to raise the awareness of healthcare professionals and people receiving the vaccine.
GBS is a rare neurological disorder in which the body's immune system damages nerve cells that can lead to pain, numbness and muscle weakness, and lead to paralysis in the most severe cases. Most people recover completely from the disorder.
The EMA Safety Committee, PRAC, evaluated the available data, including cases reported in the European database on suspected side effects (EudraVigilance) and information from the scientific literature. The PRAC looked at 108 GBS cases reported worldwide as of June 30, when more than 21 million people had been vaccinated. There was a reported death among these reports.
After evaluating the available data, PRAC considered that a causal link between the vaccine and COVID-19 Janssen and GBS.
Although very rare cases of GBS have been reported after vaccination with the vaccine COVID-19, health professionals should be alert to signs and symptoms of GBS, due to the severity of this condition, to allow early diagnosis, supportive care and treatment.
Vaccinated people are advised to seek immediate medical attention if they experience signs and symptoms suggestive of GBS, such as weakness in the limbs, double vision or difficulty moving the eyes (see below for a list of symptoms).
The EMA confirms that the benefits of the vaccine against COVID-19 Janssen continue to outweigh the risks of the vaccine.
GBS cases of Vaxzevria (formerly vaccine against COVID-19 AstraZeneca). Vaxzevria product information now includes a GBS warning and PRAC continues to monitor this issue closely.
No association has been found between GBS and COVID-19 Comirnaty and Spikevax (formerly vaccine against COVID-19 Modern).
For all vaccines, EMA will continue to monitor the safety and efficacy of vaccines and provide the public with the latest information.
Information for vaccinated people
- Guillain-Barré syndrome (GBS) is very rare in people who have been vaccinated against COVID-19 janssen.
- GBS is a rare neurological disorder in which the body's immune system accidentally attacks nerves outside the brain and spinal cord. Symptoms of GBS range from mild weakness to more severe paralysis. Most people eventually recover completely from even the most severe symptoms, while some may continue to have some degree of weakness.
- Seek immediate medical attention if you experience symptoms of GBS after vaccination with the COVID-19 janssen.
- Symptoms to look out for include:
- double vision or difficulty moving the eyes
- difficulty swallowing, speaking or chewing
- coordination problems and instability
- difficulty walking
- tingling sensation in the arms and legs
- weakness in the limbs, chest or face
- problems with bladder control and bowel function.
Information for health professionals
- Cases of GBS have occurred very rarely after vaccination with the vaccine COVID-19 janssen.
- Advise people receiving the vaccine against it COVID-19 Janssen seek immediate medical attention if they experience symptoms suggestive of GBS.
- Be alert to signs and symptoms of GBS to ensure proper diagnosis, initiate adequate supportive care and treatment, and rule out other causes.
- Product information for the vaccine against COVID-19 Janssen will report GBS as a very rare side effect (section 4.8). Section 4.4 is also updated with a warning.
More about the drug
The vaccine against COVID-19 Janssen is a vaccine for the prevention of coronavirus 2019 (COVID-19) to people aged 18 and over. The COVID-19 caused by the SARS-CoV-2 virus.
The vaccine against COVID-19 Janssen is made up of another virus (of the adenovirus family) that has been modified to contain the gene for the production of a protein found in SARS-CoV-2.
The vaccine against COVID-19 Janssen does not contain SARS-CoV-2 itself and can not cause COVID-19.
More on the process
This review was conducted by the Pharmacovigilance Risk Assessment Committee (PRAC) of the EMA, the committee responsible for the safety assessment of medicines for human use, in a process known as "type II modification". The PRAC recommendations were approved by the EMA Human Resources Committee, CHMP.