GBS itself is a rare disease, affecting only 3,000 to 6,000 people in the United States each year. In the most severe cases, paralysis can occur.
Warning label attached to the Johnson & Johnson vaccine (symbolic image)
The US Food and Drug Administration (FDA) is adding a new warning label to Johnson & Johnson’s COVID-19 vaccine, according to which the vaccine has led to rare cases of Guillain-Barré syndrome (GBS), a neurological There are neurological disorders, in which the body’s immune system can mistakenly attack the nervous system.
The warning is another major setback for the Johnson & Johnson vaccine, which was considered an important part of the US vaccination effort. However, its use in vaccination has lagged behind and this vaccine has been plagued with problems. Earlier in April this year, the CDC and FDA halted the use of the J&J vaccine for more than a week after another rare and potentially life-threatening case of blood clots was reported.
Rare disease can cause paralysis
The company has also faced production problems of this vaccine at its only US manufacturing plant. The FDA said in a statement that after approximately 12.5 million doses have been administered, there have been 100 initial reports of post-vaccination GBS, of which 95 were severe and required hospitalization. At the same time, one death has been reported so far.
Usually the patient recovers in a few days to a few weeks if GBS occurs. Other disorders develop slowly and may recur when they are over. Symptoms include weakness in major muscles throughout the body, problems with coordination and instability, as well as a prickling feeling in the hands and feet. In the most severe cases, paralysis can occur. The exact cause of the disease is not known but most cases usually begin a few days or weeks after a respiratory or gastrointestinal viral infection.
Potential risk not ruled out
At the same time, the US Centers of Disease Control (CDC) said in a statement that massive cases of GBS occurred about two weeks after the J&J vaccination and were mostly in men, 50 years of age and older. ‘These cases are rare but there are potential risks from this side effect after a vaccine.’ The CDC said that data available after more than 321 million doses administered in the US showed no pattern of GBS in mRNA vaccines.
Vaccine still safe and effective
A new warning for the vaccine, among the rapidly spreading delta variants, could complicate the Biden administration’s efforts to tackle vaccine hesitation and skepticism, but one expert said he was not worried. Paul Offit, a vaccine specialist at Children’s Hospital of Philadelphia, said that I do not think it will have much effect on the use of this vaccine. ‘It is still a very rare occurrence.’ The FDA also stated that the Johnson & Johnson vaccine is still safe and effective and that its potential benefits clearly outweigh its potential risks. CDC will discuss this issue at an upcoming meeting of its Vaccine Advisory Committee.
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