The European Medicines Agency (EMA) classified the neurological disease Guillain-Barré syndrome (GBS) among the very rare side effects of Janssen against COVID-19 on Thursday. The vaccine is made by Johnson & Johnson.
The EMA added that the warning will be included in the information accompanying the product to alert healthcare professionals and people receiving the vaccine about the problem.
GBS is a rare neurological disorderThe human immune system mistakenly attacks and damages nerve cells, which can lead to pain, numbness, muscle weakness, and in the most severe cases, it can develop into paralysis. Most people recover completely from this disease.
The European Medicines Agency (EMA) Medicinal Products Risk Assessment Committee (PRAC) evaluated the available evidence, including cases reported to the European Suspected Side Effects database, as well as information from the scientific literature. The commission examined 108 cases of the syndrome reported from around the world on June 30. At that time, more than 21 million people had already received this vaccine.
After evaluating the available data, the Committee considers a causal link between Janssen and GBS neurological disease as possible.
Although very rare cases of GBS have been reported after covid vaccination with Janssen, health care professionals should be aware of the signs and symptoms of GBS such as This neurological disease is serious – it will also allow for early diagnosis and supportive care and treatment.
The EMA advises vaccinated people to seek immediate medical attention if they develop signs and symptoms suggestive of GBS, such as: Weakness in the extremities and face, double vision or difficulty moving the eyes, swallowing, speaking or chewing.
The EMA confirms that Janssen’s benefits against covid outweigh the risks of the vaccine.
The EMA also recently looked at cases of GBS after vaccination with Vaxzevria (from AstraZeneca). The product information now includes a warning from GBS and the committee is monitoring the matter closely.
No association was found between the GBS vaccine, Comirnaty and Spikevax covid (from Pfizer/BioNtech and Moderna), the EMA added on its website.
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