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Johnson & Johnson COVID-19 vaccine may lead to Guillain-Barre syndrome, FDA to issue warning
USA: Rare cases of Guillain-Barre syndrome (GBS) have been reported following vaccination with Johnson & Johnson's COVID-19 vaccine, most of which occurred within 42 days of the vaccination.
Based on which, the US Food and Drug Administration (FDA) may issue a warning that the Johnson & Johnson's COVID-19 vaccine may trigger GBS in a small number of people, according to the agency report.
While chancces of GBS occurrence is very low, the company has updated its COVID-19 Vaccine Factsheet including important information of these rare cases and on the signs and symptoms of Guillain-BarrƩ syndrome. Updates with this new information will be implemented in other regions of the world according to local regulatory procedures.
"The safety and well-being of the people who use our products is our number one priority," the company said in a statement.
The company has shared any adverse event report about individuals receiving Johnson & Johnson's single-shot COVID-19 vaccine, as well as our own assessment of the report with the European Medicines Agency, the U.S. Food and Drug Administration, the World Health Organization and other health authorities around the world where our vaccine is authorized.
"We strongly support raising awareness of the signs and symptoms of rare events to ensure they can be quickly identified and effectively treated," they wrote.
Evidence has demonstrated that Johnson & Johnson's single-shot COVID-19 vaccine offers protection against COVID-19 disease and prevents hospitalization and death, including in countries where viral variants are highly prevalent. A single-shot vaccine that provides this level of protection represents an important tool in the global fight against COVID-19, as we strive to help end this deadly pandemic.
"Although the available evidence suggests an association between the Janssen vaccine and increased risk of GBS, it is insufficient to establish a causal relationship," the FDA said in a statement. "Importantly, the FDA has evaluated the available information for the Janssen COVID-19 Vaccine and continues to find the known and potential benefits clearly outweigh the known and potential risks."
About Guillain-BarrƩ syndrome
GBS is an acquired demyelinating polyneuropathy that often begins in the lower extremities and ascends over time with loss of reflexes, causing muscle weakness, or in the most severe cases, paralysis. Some cases start a few days or weeks after respiratory or gastrointestinal viral infection. Often, GBS is reversible.
MSc. Biotechnology
Medha Baranwal joined Medical Dialogues as an Editor in 2018 for Speciality Medical Dialogues. She covers several medical specialties including Cardiac Sciences, Dentistry, Diabetes and Endo, Diagnostics, ENT, Gastroenterology, Neurosciences, and Radiology. She has completed her Bachelors in Biomedical Sciences from DU and then pursued Masters in Biotechnology from Amity University. She has a working experience of 5 years in the field of medical research writing, scientific writing, content writing, and content management. She can be contacted atĀ Ā editorial@medicaldialogues.in. Contact no. 011-43720751
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751