Johnson & Johnson vaccine, EMA reports a new possible adverse event. At its latest meeting (7-10 March), the Prac Pharmacovigilance Committee of the European Medicines Agency recommended adding to the product information, as “possible side effect of unknown frequency”, vasculitis of small vessels with skin manifestations.
It is an inflammation of the blood vessels of the skin – explains the EU regulatory body – which can cause a rash with red dots or spots, pinpoint marks under the surface of the skin, and bruising. It can be caused by viral or bacterial infections, as well as by medicines and vaccines. The manifestations generally resolve spontaneously over time, with adequate supportive therapy.
The Prac – reports the EMA – examined a total of 21 cases reported globally as part of the last summary report on safety, including 10 episodes consistent with the established definition of single-organ cutaneous vasculitis (vasculitis affecting only one organ ). For most of these 10 cases, no other obvious explanation was identified, and 8 of these episodes occurred soon after vaccine administration. As of December 31, 2021, approximately 42.5 million doses of the J&J vaccine had been administered worldwide.