Guillain-Barré Syndrome (GBS) will be reported as a very rare side effect of the Janssen COVID-19 vaccine and a warning will be included in the product information to raise the awareness of healthcare professionals and people receiving the vaccine.
In a statement issued by the Ministry of Health , he explained that 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 was possible between the COVID-19 Janssen vaccine and GBS.
Although very rare cases of GBS have been reported after vaccination with the COVID-19 vaccine, health professionals should be alert to signs and symptoms of GBS due to the severity of the 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 Janssen COVID-19 vaccine continue to outweigh the risks of the vaccine.
GBS cases for Vaxzevria (formerly a vaccine against COVID-19 AstraZeneca) were recently reviewed. Vaxzevria product information now includes a GBS warning and PRAC continues to monitor this issue closely.
No association has been identified between the GBS vaccines and COVID-19 Comirnaty and Spikevax (formerly COVID-19 Moderna vaccine).
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.
- Get immediate medical attention if you experience symptoms of GBS after vaccination with the Janssen COVID-19 vaccine.
- 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 occurred very rarely after vaccination with the COVID-19 Janssen vaccine.
- Advise people receiving the Janssen COVID-19 vaccine to seek immediate medical attention if they develop 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 on the Janssen COVID-19 vaccine will refer to GBS as a very rare side effect (section 4.8). Section 4.4 is also updated with a warning.
More about the drug
The Janssen COVID-19 Vaccine is a vaccine to prevent coronavirus disease 2019 (COVID-19) in people aged 18 and over. COVID-19 is caused by the SARS-CoV-2 virus.
The Janssen COVID-19 vaccine consists 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 Janssen COVID-19 vaccine does not contain SARS-CoV-2 itself and cannot 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.
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