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Janssen vaccine.  The European Agency defines immune thrombocytopenia as a side effect

Janssen vaccine. The European Agency defines immune thrombocytopenia as a side effect

The European Medicines Regulator (EMA, its English acronym) has also concluded that many of the reported cases of fainting and tinnitus are associated with taking this single-dose vaccine.

Despite this, the EMA maintains the risk-benefit ratio of the vaccine from the North American Johnson & Johnson group drug company, stressing that it prevents hospitalizations and deaths due to covid-19.

EMA Safety Committee experts at this week’s meeting recommended updating vaccine information to include immune thrombocytopenia as an “adverse reaction” and advised that it be mentioned in the risk management plan as an “important risk identified.”

The recommendation was based on reported cases from the European and North American database of potential side effects, as well as global pharmaceutical safety data and scientific articles.

The EMA decided to include a warning for healthcare professionals and people taking the Janssen vaccine to be aware of symptoms such as excessive bruising and bleeding.

In the case of immune thrombocytopenia, the immune system mistakenly attacks and destroys platelets, “blood cells” essential for normal blood clotting,” the regulator explained.