Johnson & Johnson vaccine, 4 rare thromboses: Ema initiates investigation

Rare post-vaccination thromboembolic events have also been reported for Janssen’s (Johnson & Johnson) Covid vaccine. The Prac Pharmacovigilance Committee of the European Medicines Agency Ema is studying them, reports the EU regulatory body, in a note. The experts have therefore started a review of the safety signal related to the J&J vaccine. Following this shield injection, “4 severe cases of unusual blood clots associated with low platelet levels” have been reported, according to updated data reported today, the rare forms of thrombosis that have also been observed after vaccination with AstraZeneca .

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As for the Janssen vaccine, “one case occurred during a clinical trial and 3 cases during the vaccine launch in the US. One of them was fatal.” The J&J vaccine is currently only used in the United States, with an emergency use authorization. Authorized in the EU on 11 March, the launch of the product has not yet begun in any State of the Union, but is expected in the coming weeks.

These reports indicate a “safety signal”, but at the moment “it is not clear whether there is a causal association between vaccination with the Janssen vaccine and these conditions. The PRAC is investigating these cases and will decide if action may be necessary. legislation, which usually consists of an update of the product information “. And the EMA undertakes to communicate the conclusions of the ongoing evaluation.


“We are aware that thromboembolic events, including those with thrombocytopenia, have been reported for all Covid-19 vaccines. Our close monitoring for side effects revealed a limited number of very rare events following vaccination. Al. at the moment a clear causal relationship has not been established between these rare events and the Janssen vaccine (Johnson & Johnson group, ed) against Covid-19 “, specifies J&J. “The safety and well-being of the people who use our products are our top priority – underlines the company in a note – We share all reports of adverse events on people who have received our Covid-19 vaccine, together with the our evaluation of these reports, with the health authorities in compliance with regulatory standards “.

“We continue to work closely with experts and regulatory authorities to evaluate the data and encourage open communication of this information to health professionals and the public – adds J&J – to help ensure that in the event of a very rare disease , appropriate measures can be taken for rapid diagnosis and treatment. ” “It is important – Johnson & Johnson recalls – that people who receive any vaccine against Covid-19 seek medical assistance immediately if they experience the following symptoms: shortness of breath, chest pain, swelling in the legs, persistent abdominal pain, neurological symptoms, including severe and persistent headache or blurred vision, small patches of blood under the skin beyond the injection site, easy or excessive bruising.


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