Johnson e Johnson, l’Mom study the data on the side effects of the vaccine: «The EMA is analyzing the data provided» by Johnson & Johnson «on the cases of the sindrome Guillain-Barre (Gbs) reported following serum vaccination ‘, and asked J&J to provide’ further detailed data ‘. So the Ema in a note to ANSA after yesterday the US Food and Drug Administration added a warning related to GBS (neurological disorders) to the information sheet for the Janssen vaccine.
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Johnson e Johnson e la sindrome Guillain-Barre
“The EMA – it reads – will continue the review of the cases and will communicate further when new information will be available”.
But what is Guillain-Barre syndrome? It is an immune system disorder that causes inflammation of the nerves and can result pain, numbness, muscle weakness and difficulty walking. The GBS it had already been identified during the product marketing authorization process as “a possible adverse event that requires specific safety monitoring activities”.
The Committee has evaluated «all the available evidence – underlines the Emma – including cases reported to the European database for suspected side effects (EudraVigilance) and data from the scientific literature ‘. Although at the moment the available information does not confirm or exclude a possible link vaccine-Guillain-Barré, given the severity of this rare condition Wash recommended ‘adding a warning in section 4.4 of the summary of product characteristics and section 4 of the package leaflet to alert healthcare professionals and people taking the vaccine of this potential risk’.
«Healthcare professionals should pay attention to the signs and symptoms of GBS, so as to allow early diagnosis and treatment », continues the EMA. The agency advises vaccinated people to ‘seek immediate medical attention if they develop weakness and paralysis in the extremities, which can progress to the chest and face. The risk / benefit ratio of the vaccine – the EU regulatory body points out – remains unchanged ».
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