The European Medicines Agency (EMA) pointed out this Friday, August 6, 2021, which identified the “immune thrombocytopenia”As a side effect of Janssen and concluded that several reported cases of dizziness and tinnitus (ringing in the ear) are linked to the injection of this vaccine of the COVID-19.
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However, the EMA, based in Amsterdam, maintains unchanged the balance between benefit and risk of the COVID-19 vaccine of Janssen, which he considers still positive in the prevention of hospitalizations and deaths caused by the disease.
During this week’s meeting of the safety committee (WASH), its experts recommended updating the product information to include the “immune thrombocytopenia”As an“ adverse reaction ”, and advised to mark it in the risk management plan as an“ identified significant risk ”of the vaccine.
The EMA It will also include a warning to healthcare professionals and patients receiving this preparation to be alert to symptoms of this disorder, which may include bruising and excessive bleeding.
“The thrombocytopenia immune it is a condition in which the immune system mistakenly attacks and destroys blood cells known as platelets, which are necessary for normal blood clotting, ”the agency explains.
The WASH evaluated the cases reported in the European database of possible side effects (EudraVigilance) and the American VAERS, as well as the available scientific literature and the global safety database of the American pharmaceutical company Johnson & Johnson, of which Janssen is a subsidiary .
In addition, the PRAC also concluded that reported cases of dizziness and tinnitus (ringing or noise in one or both ears) are related to the administration of the Janssen vaccine, based on the available evidence, so you will add to the vaccine package insert that these two effects are possible adverse reactions of the vaccine.
To reach this conclusion, the WASH analyzed 1,183 cases of dizziness identified as part of reports of anxiety-related immunization reactions, and investigated six cases of tinnitus observed in clinical trials and 108 identified by the company during follow-up of the reports.
With information from EFE