According to MedPage Today, the FDA sent a letter to the manufacturer of the Johnson & Johnson COVID-19 vaccine on Monday containing a warning about its link to Guillain-Barre syndrome (GBS) in a small population. A spokesperson for the FDA confirmed that there were around 100 cases of GBS within the 12.5 million who received their dose. Of these 100 cases, one person passed away and 95 were hospitalized.
A warning will now appear on the fact sheets that Johnson & Johnson provides to their patients and healthcare professionals. The contents of the warning include:
- Heightened risk of GBS in the 42 days post-vaccination
- Seek immediate treatment if you are experiencing:
- Difficulty walking or with facial movements
- Issues with bowel function and/or bladder control
- Spreading or progressive tingling/weakness in the extremities
- Double vision
- Inability to move the eyes
The FDA notes that while a link has been identified between this vaccine and GBS, that link is not necessarily causal. In addition, they have pointed out that no connection exists between this rare condition and the Moderna or Pfizer shots.
GBS and COVID-19 Vaccines
While there is no known connection between the Pfizer and Moderna versions of the COVID-19 vaccine to GBS, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recently added a similar warning to AstraZeneca’s shot. This warning contains an alert to the possible link between GBS and the jab.
Both the AstraZeneca and Johnson & Johnson vaccines are adenovirus vector vaccines, which could explain these similarities. These reports have investigated an unusual variant of GBS in AstraZeneca shot receivers, while this Boston case report tells of a woman who developed the rare disease ten days after her Johnson & Johnson shot if you would like to learn more.
GBS, an acquired demyelinating polyneuropathy, affects about one of every 100,000 people. It occurs when the immune system mistakenly attacks the peripheral nervous system (PNS). Medical professionals do not know exactly why the immune system does this, but they know that it breaks down the myelin sheath on the nerves of the PNS. They have also noted that it tends to occur after a viral infection.
The first symptom of GBS is typically tingling and weakness in the extremities, which will spread and progress over time. This can turn into nearly complete paralysis in severe cases, which can then lead to other complications. These symptoms can intensify quickly, although the majority of patients are able to recover. Plasmapheresis and high-dose immunoglobulin therapy can lead to recovery, although this may take years. In fact, 30% of patients still feel weak after three years. Treatment also consists of preventing and combatting complications.