It's important to understand why the FDA (Food and Drug Administration) of the United States has issued a new warning regarding the usage of J&J vaccine developed for building immunity against Coronavirus. Although, the warning notification clearly states that the benefits of the vaccine are far beyond the risks it imposes. The newly discovered risk from J&J vaccine is carrying significant side effects. Yes, we are talking about the recent announcement made by USFDA regarding a new potential risk associated with Janssen COVID-19 vaccine developed by Johnson & Johnson, one of the top drug manufactures in the United States and having its presence all across the globe.
The warning alerts that out of about 12.5 million recipients of the jab of this vaccine developed by J&J, more than 100 reported diagnosis of Guillain-Barré Syndrome which is an uncommon yet serious neurological disorder that causes numbness in the patient and even could lead to paralysis, complete or partial. While the fact sheet released clearly warns about the risk of this significant side effect, yet it emphasises the benefits of the vaccine that outweigh the risks it carries. Usually, developing Guillain-Barré Syndrome is very rare but the risk of developing it increaes by three to five times after administration of J&J vaccine as reported by The New York Times. This is not something that can be ignored easily as it can lead to serious conditions. Out of the 100 cases reported in the US, 95 had to be hospitalized and there has been one fatality.
Most of these cases reported were of men aged 50 or more and had developed Guillain-Barré Syndrome within two weeks of vaccination. As stated above, Guillain-Barré Syndrome is a rare neurological disorder. It develops when the immune mechanism of the patient starts attacking the peripheral nervous system as a result of malfunctioning of the immune system. As a result, immune cells start hitting the nerve cells network in the body thus resulting in muscle weakness, improper coordination, numbness, and paralysis. Even in severe cases of Guillain-Barré Syndrome, full recoveries have been noticed in most of cases but a few could not recover and developed permanent nerve damage and weakness.
Based on the research work done so far to find out the actual cause of the Guillain-Barré Syndrome, it is not very encouraging. The actual cause is still unknown. Thus, there is no proper cure. But there are certain treatments that have been developed that help in reducing the severity of the disease. The statistics produced by the US Centres for Disease Control and Prevention (CDC) estimates 3,000 to 6,000 people develop Guillain-Barré Syndrome in the United States every year. Although, an increase in risk for the Guillain-Barré Syndrome has clearly been associated with Janssen vaccine developed by J&J, the FDA in its statement says -
"It is insufficient to establish a causal relationship"
It is not the first time that a vaccine has been associated with Guillain-Barré Syndrome. In 1976, a swine flu vaccine was found increasing the risk for the said syndrome. Even the seasonal influenza vaccines seem to do the same but their risk of elevating the chances vary year to year. Interestingly, a research by CDC states that a person is more likely to develop this syndrome after getting the flu than after administration of vaccine. Is it meant to give a breather to the Janssen vaccine developed by Johnson and Johnson? Even earlier the use of the Janssen vaccine was stopped by the US health officials as many women developed rare blood clots post vaccination. It seems the latest release of Janssen has addressed to that issue.
Federal agencies, this time, have not recommended a halt of the J&J rollout stating the benefits of protection against COVID-19 are far more than any risks of side effects. It seems Johnson and Johnson has been able to impress Federal Agencies to continue the vaccine despite the fact that it increases the risk of developing Guillain-Barré Syndrome. Probably, FDA is ready to afford an increase in Guillain-Barré Syndrome cases but at WHAT COST? Johnson and Johnson has released a confirmatory note that the latest version of their vaccine is very much effective against the Delta variant which is spreading at a faster pace especially in partially or no-vaccinated populations.
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