What is Guillain–Barré syndrome? FDA to flag Johnson & Johnson vaccine over nerve disorder
FDA mentioned that benefits of the Johnson & Johnson vaccine in preventing severe disease or death from coronavirus still majorly outweigh the danger
The Food and Drug Administration (FDA) is reportedly planning to attach warnings of an increased risk of Guillain–Barré syndrome to the Johnson & Johnson vaccine. It comes as another jolt to an already sidelined vaccine in the United States. The Biden administration is expected to announce the new warning as early as Tuesday, July 13.
According to reports, regulators have found that the chances of developing the rare condition appear to be three to five times higher among recipients of the Johnson & Johnson vaccine as compared to the general population in the US. The FDA plans to include the information in fact sheets about the drug for providers and patients.
However, the FDA also mentioned that the benefits of the vaccine in preventing severe disease or death from the Coronavirus still majorly outweigh any danger. Dr Luciana Borio, a former acting chief scientist at the FDA said, "It’s not surprising to find these types of adverse events associated with vaccination." She also added that the data collected by the FDA so far suggested that the vaccine's benefits "continue to vastly outweigh the risks." So far, federal officials have identified roughly 100 suspected cases of Guillain-Barré disease among recipients of the Johnson & Johnson vaccine. The Centers for Disease Control and Prevention said on Monday, July 12, that the cases (of Guillain–Barré syndrome) were mostly reported about two weeks after vaccination and majorly in males of 50 years and older. The database also indicates that the symptoms of Guillain-Barré syndrome developed within about three weeks of vaccination.
What is Guillain–Barré syndrome?
Guillain–Barré syndrome is a rare rare neurological condition in which the body's immune system attacks the nerves. The first symptoms generally include weakness and tingling in the extremities. The symptoms can spread quickly, resulting in paralysis of the whole body. Guillain-Barre syndrome is a medical emergency in its most severe form.
The exact cause of Guillain-Barre syndrome is still not known. Also, there's no known cure for Guillain-Barre syndrome, but several treatments can help ease symptoms and reduce the duration of the illness. The mortality rate of the disorder is between 4% to 7%. Between 60-80% of people are able to walk after six months. Lingering effects of the syndrome that people may experience are weakness, numbness or fatigue.
Vaccines developed by Pfizer-BioNTech or Moderna, (the other two federally-authorized manufacturers) rely on entirely different technology and no link has been found between Guillain-Barré syndrome and the vaccines developed by them so far. Almost 13 million people in the US have received Johnson & Johnson’s shot. Back in April, the Biden administration had paused the Johnson & Johnson vaccine after six women, aged between 18 and 48, who received the shots had suffered unusual blood clots.
Johnson & Johnson’s chief executive, Alex Gorsky said last month that he was still hopeful that the J&J vaccine, which has been used in 27 countries so far, would help contain the pandemic overseas. According to reports, studies have proven that the Johnson & Johnson vaccine protects people against more transmissible virus variants, including the Delta variant, and is highly effective at preventing severe Covid-19, hospitalizations and death.