The Johnson and Johnson Vaccine has been known for making headlines ever since its inaugural release. A recent development suggests that the one-dose shot may be causing a rare neurological disease. U.S Food and Drug Administration has gone on to label the vaccine for potentially resulting in a serious complication- Guillain Barre Syndrome.
Although the FDA hasn’t reached a concrete conclusion, it did note a sharp increase in reports of the condition. “Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination,” reads the revised label.
However, the label clearly states that there is a lack of information to “establish a causal relationship.” But such a case hasn’t been discovered with the Moderna or Pfizer Vaccine and thus, issuing a warning to takers of the J&J vaccine was important on part of the FDA.
The newly revised label of the vaccine also sheds important details about the Guillain Barre Syndrome itself. A disease where the nerve cells are irrevocably damaged due to the body’s immune system, the GBS will manifest in the individual within 42 days of taking the shot.
The FDA also issued a warning to those who are experiencing unusual symptoms, especially after being administered with the J&J vaccine. A few common warning signs include a slight tingling in the arms and legs, difficulty in walking, having double vision, and bladder control issues.
According to the data extracted by the FDA, 95 out of 100 people who contracted GBS required hospitalization.
At present, J&J has confirmed to be in talks with the FDA about the issue at hand. In a public statement, the company spoke of the disease and how the chances of contracting the syndrome are extremely low. Even if the vaccine does enhance the risk of catching the syndrome, it is still better to get vaccinated against the deadly coronavirus, affirmed the CDC.
Their views were mirrored by Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases. With more than a million vaccinations in play, there will always be a solid chance of someone contracting a rare disease, just like the Guillain Barre Syndrome itself.
The representative of CDC’s Advisory Committee on Immunization norms said the matter would be discussed in depth in an upcoming meeting. Meanwhile, the CDC and FDA will keep a keen eye out for the Guillain Barre Syndrome.