“The data suggests a link” – Despite the small number of cases detected, the FDA estimates that the likelihood of developing the syndrome is three to five times higher among those who received the Janssen vaccine than the entire US population. The US agency reiterated that the benefits of the vaccine in preventing death or hospitalization remain greater than the risks. Following the latest findings, however, it was decided to include a new warning in the J&J vaccine information sheets.
American authorities have identified 100 suspected cases of Guillain-Barré among those immunized with Janssen. Of these, 95% were classified as “severe”. Most have been reported in men over 50 and usually about two to three weeks after vaccination. These data “suggest a link” with the vaccine, as the FDA itself explains in a note, but “still not sufficient to establish a causal relationship with certainty”.
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La sindrome di Guillain-Barré – Disease occurs when the immune system mistakenly attacks some of its nerve cells. This can cause muscle weakness and, in severe cases, temporary paralysis of the limbs or other parts of the body. During the acute phase, the disease can lead to weakening of the respiratory muscles, forcing patients to resort to mechanical ventilation.
The syndrome is rare, affecting an average of one or two cases per 100 thousand inhabitants every year. At the same time, however, it is one of the most common causes of non-traumatic paralysis.
Johnson & Johnson’s response – The pharmaceutical company Johnson & Johnson has made it known that it is “in contact” with the Food and Drug Administration to clarify possible links with neurological diseases. But he pointed out that the syndrome continues to be “very rare”, even following the administration of the vaccine.
In the coming days, Joe Biden could make an announcement regarding the findings of the FDA and it is not excluded that the European drug agencies will do the same.
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