This warning is different from the extremely rare side effect of coagulopathy with thrombocytopenia, according to Bloomberg News.
Venous thromboembolism was already included in the Janssen vaccine risk management plan for COVID-19 as among the safety concerns to be investigated, based on the higher proportion of venous thromboembolism observed among the vaccinated versus placebo group in the study. The clinical major used to authorize this vaccine.
The Committee therefore recommends that venous thromboembolism as a rare side effect of Janssen vaccine against COVID-19 be included in the product information, along with a warning to raise awareness among healthcare workers and persons receiving the vaccine, especially those who may have an increased risk of venous thromboembolism. .