the staff of the Ridgewood blog
Washington DC, the US FDA announced that it is including a warning regarding the risk of Guillain-Barré syndrome (GBS), a rare but potentially serious autoimmune neurological condition, associated with the J&J-Janssen SARS-CoV-2 vaccine. To date, there have been approximately 100 preliminary reports of GBS among 12.8 million recipients of the J&J-Janssen vaccine, but additional data are required in order to establish a causal relationship. Most of the cases have been identified within 2 weeks of vaccination, and mostly among men aged 50 years and older. Regulatory officials have not identified a similar trend associated with the Pfizer-BioNTech or Moderna vaccines. However, the FDA’s update comes only days after the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee recommended including a warning to raise awareness among healthcare professionals and people taking the AstraZeneca-Oxford vaccine of GBS cases reported following vaccination. Both the J&J-Janssen and AstraZeneca-Oxford vaccines are adenovirus vector vaccines.
