Home » Johnson & Johnson, Ema: “Rare thrombosis, but benefits outweigh the risks”

Johnson & Johnson, Ema: “Rare thrombosis, but benefits outweigh the risks”

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For the European Medicines Agency, the risks of rare thrombosis related to Johnson & Johnson’s Covid vaccine are lower than the benefits. And there are no limitations related to risk factors. After the ruling, the Italian Medicines Agency gave its green light, recommending its use for the over 60s. Sea. The indication was ordered by the Extraordinary Commissioner Francesco Paolo Figliuolo. The administration will start from the next day. Lazio has already announced that it will allocate the first doses to prison police officers and prisoners.

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The European Medicines Agency (EMA) finds a possible link between the Covid vaccine developed by Johnson & Johnson to very rare cases of unusual blood clots with low platelets. This was announced by Ema, which confirms that the overall risk-benefit ratio remains positive. “All cases occurred in people under the age of 60 within three weeks of vaccination, the majority in women. Based on the evidence currently available, the specific risk factors have not been confirmed,” the agency said. there are no limitations related to risk factors.

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The Agency’s Safety Committee (Prac) concluded at today’s meeting that a warning about unusual blood clots with low platelets should be added to the product information related to the Covid 19 vaccine developed by Janssen. The PRAC also concluded that these events should be listed as very rare side effects of the vaccine. In reaching its conclusion, the Committee considered all the evidence currently available, including eight reports from the United States of severe cases of unusual blood clots associated with low platelet levels, one of which resulted in a fatal outcome.
As of April 13, 2021, over 7 million people had received Janssen’s vaccine in the United States.

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In particular, “the cases examined were very similar to cases that occurred with the covid-19 vaccine developed by AstraZeneca, Vaxzevria. The Prac noted that blood clots occurred mainly in unusual sites such as in the veins of the brain (sinus thrombosis cerebral venous, Cvst) and abdomen (thrombosis of the splanchnic vein) and in the arteries, along with low levels of blood platelets and sometimes bleeding. A plausible explanation – the note reads again – for the combination of blood clots and platelets Bassa is an immune response, leading to a condition similar to that sometimes seen in patients treated with heparin called heparin-induced thrombocytopenia.

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“Individuals should seek urgent medical attention if they have any of the following symptoms in the three weeks following the administration of the Janssen vaccine: shortness of breath, chest pain, swelling in the legs, persistent abdominal pain, neurological symptoms, such as severe and persistent headache, or blurred vision, tiny bloodstains under the skin beyond the injection site “, writes the EMA, concluding:” The scientific evaluation of the EMA is the basis for the safe and effective use of Covid-19 vaccines. use of the vaccine during national immunization campaigns will take into account the pandemic situation and the availability of vaccines in individual Member States “.

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by Michele Bocci, Alberto D’Argenio

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