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EMA finds overall benefit-risk 'remains positive' for J&J COVID-19 vaccine


EMA finds overall benefit-risk ‘remains positive’ for J&J COVID-19 vaccine
Safety committee finds possible link to ‘very rare cases’ of unusual blood blots with low blood platelets
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed that the overall benefit-risk profile of Johnson & Johnson’s (J&J) COVID-19 vaccine is positive.
The PRAC concluded in a meeting yesterday, however, that a warning regarding unusual blood clots with low blood platelets should be added to the product information for the vaccine, after finding a possible link between the rare adverse events and the jab.
The committee considered all currently available evidence in its review, including eight reports in the US of serious cases of unusual blood clots associated with low blood platelet levels – one of which was fatal. ....

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Johnson & Johnson COVID-19 Vaccine Roll-out to Resume in Europe - New Jersey Business Magazine


Johnson & Johnson COVID-19 Vaccine Rollout to Resume in Europe
On Apr 21, 2021
New Brunswick-based Johnson & Johnson announced that the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has provided updated guidance for use of the company’s COVID-19 vaccine and confirmed the overall benefit-risk profile remains positive. The guidance follows PRAC review of a small number of cases of a very rare adverse event involving blood clots in combination with low platelet counts that can occur within approximately one to three weeks following injection with the dompany’s COVID-19 vaccine.
As a result, Johnson & Johnson will update its COVID-19 vaccine Summary of Product Characteristics and Package Leaflet to include important information on the diagnosis and management of this very rare adverse event. Healthcare professionals will be alerted to the signs and symptoms of thromboembolism with thrombocytopenia, as ....

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