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The Janssen/Johnson & Johnson COVID-19 vaccination fact sheets for healthcare professionals and general have been updated to include a contraindication to the use of the vaccine for people with a history thrombocytopenia. The US Food and Drug Administration has announced.
The Thrombocytopenia Syndrome (TTS), thrombocytopenia with thrombocytopenia (thrombocytopenia) -it is a thrombocytopenia condition that has an increased risk of bleeding and documented thrombosis — is still rare . The agency said that about one in seven cases of death has been reported across all age groups.
“Currently available evidence supports the existence of a causal link between TTS and the Janssen COVID-19 vaccine,” the fact sheet for the provider states.
Although TTS linked to the Janssen COVID-19 vaccine has been reported among men and women aged 18 and older, the highest reported rate has been for women aged 30 to 49 The agency says. The rate for this group is about one case per 100,000 doses given.
TTS symptoms may develop within 1-2 weeks of treatment with Janssen COVID-19 vaccine. FDA’s data is based on the Vaccine Adverse Events Reporting System.
Its clinical course has many similarities with autoimmune Heparin-Induced Thrombocytopenia. In individuals with suspected TTS following the administration of the COVID-19 vaccine from Janssen, the FDA warns that the use of heparin “may be dangerous and alternative treatments may be needed. Consultation with hematology specialists is strongly recommended.”
The apparent increased risk of TTS is still under review However “the FDA continues to find that the known and potential benefits of the Janssen COVID-19 vaccine outweigh the known and potential risks for individuals 18 years of age and older,” the agency states.
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