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.
The agency also decided that it would add syncope and tinnitus to the Janssen vaccine prospectus as a possible adverse reaction.
To reach this conclusion, the EMA Safety Committee analyzed 1,183 syncope cases identified as part of immunization anxiety-related reaction reports and investigated six cases of tinnitus seen in clinical trials and 108 reported by the following drug company reports.
In Portugal, the Janssen vaccine can be given to men 18 years of age or older and women 50 years of age or older.
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