Vaccine Johnson & Johnson and AstraZeneca, new thrombosis risks in ‘leaflet’

New thrombosis risks will be included among the effects in the leaflet warnings for Johnson & Johnson and AstraZeneca adenoviral Covid vector vaccines. This was communicated by the European Medicines Agency Ema, which reports the outcome of the last meeting of the Prac Pharmacovigilance Committee. For the J&J (Janssen) vaccine, the experts concluded that there is a possible link with rare cases of venous thromboembolism (Tev) and therefore recommends listing it as a rare side effect in the product information, and issuing a warning to raise awareness among healthcare professionals. and people taking the vaccine, particularly those at increased risk of Tev. The Prac has agreed on the content of a communication addressed to health professionals. This problem (which leads to the formation of a blood clot in a deep vein, usually in a leg, arm or groin, and can travel to the lungs causing a blockage of blood supply) is distinct from the more well-known side effect very rare thrombosis with thrombocytopenia syndrome (TTS, blood clots associated with low platelets). The other effect considered is immune thrombocytopenia (Itp). Cases have been reported following vaccination with both J&J vaccine and Vaxzevria from AstraZeneca. The PRAC evaluated all available data and recommended updating the product information of both vaccines to include Itp as an adverse reaction with an unknown frequency. Again a warning statement was agreed to highlight that very rarely cases of very low blood platelet levels have been reported, usually within the first 4 weeks following vaccination. If a person has a history of Itp is the indication given, the risk of developing low platelet levels should be considered prior to vaccination and monitoring of platelets after administration is recommended.