Ema recommended updating the information on the Johnson & Johnson (Janssen Covid-19) vaccine leaflet to include immune thrombocytopenia (a condition in which the immune system mistakenly attacks and destroys platelets) as an adverse reaction, as well as an adverse reaction. warning about this possible side effect.
The EMA also recommended an update of the J&J vaccine risk management plan to reclassify thrombocytopenia, currently reported as an important potential risk, to a major identified risk.
It reads in a note from the EMA.