NewsWorldJohnson & Johnson vaccine, thrombosis and side effects: Ema...

Johnson & Johnson vaccine, thrombosis and side effects: Ema examines data

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Ema examines data on thrombosis cases after Johnson & Johnson covid vaccine. The Pharmacovigilance Committee (Prac) of the European Medicines Agency “data on cases of venous thromboembolism (blood clots in the veins)” after vaccination with Janssen’s single-dose anti-Covid (J&J), as communicated by the regulatory body EU at the end of the last Prac meeting (30 August-2 September), specifying that “this safety problem is distinct from the very rare side effect of thrombosis with thrombocytopenia syndrome (TTS, ie blood clots associated with low platelets) “. “Venous thromboembolism – explains EMA – was included in the risk management plan for the Janssen vaccine as a safety problem to be investigated, based on a higher percentage of cases observed within the vaccinated group than in the placebo group. in the first clinical trials analyzed to authorize this vaccine. The PRAC will evaluate further data from two large clinical trials on the “J&J,” vaccine, to be submitted shortly by the marketing authorization holder “of the product,” in order to to further assess whether the condition is related to the vaccine “. The Pharmacovigilance Committee is also evaluating” whether there is a risk of multisystem inflammatory syndrome (MIS) with Covid-19 vaccines “, after a case of post-Mis administration of the Pfizer vaccine. “The case occurred in Denmark in a 17-year-old male who has completely recovered”, explains the EMA, underlining that “some cases of Mis have also been reported in the See”, the European Economic Area, “following the vaccination with other Covid-19 vaccines “. The EU regulatory body points out that “at this stage there is no change to the current EU recommendations for the use of Covid-19 vaccines”. The MIS, recalls the EMA, is “a serious inflammatory condition that affects many parts of the body and symptoms may include fatigue, persistent severe fever, diarrhea, vomiting, stomach pain, headache, chest pain and difficulty breathing. ” The syndrome “was previously reported following the Covid-19 disease, however – the agency points out – the Danish patient did not have a history of Covid”. “Mis is rare – continues the EMA – and its incidence rate before the Covid-19 pandemic estimated by 5 European countries it was about 2-6 cases per 100 thousand per year in children and adolescents under the age of 20, and less than 2 cases / 100 thousand / year in adults aged 20 or more “.” The Prac encourages all health professionals to report any case of MIS and other adverse events in people receiving Covid vaccines, “reports the regulatory body. The technicians will now evaluate the available data on MIS, “to determine if the condition may be caused by the vaccine and recommend if changes to the product information are needed.”

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