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.