Specifically, 4 cases of severe severe abnormal blood clots and low platelets were reported after vaccination. One case occurred in the clinical trial, and three more cases occurred during the vaccine delivery process in the United States. In one of these cases, the patient died.
Madrid (EUROPA PRESS)-The European Medicines Agency (EMA) announced on Friday that the Pharmacovigilance Risk Assessment Committee (PRAC) is investigating four serious thromboembolic events after receiving Janssen’s Covid-19 vaccine.
Specifically, 4 cases of severe severe abnormal blood clots and low platelets were reported after vaccination. In the United States, one case occurred in a clinical trial, and the other three occurred during the vaccine release period. In one of these cases, the patient died.
According to a report issued by PRAC on April 6-9, evaluations have begun to assess reports of thromboembolic events (blood vessels blocked by thrombosis) in people receiving the Janssen covid-19 vaccine.
He said: “These reports point to a’safety signal’, but it is not clear whether there is a causal relationship between the COVID-19 vaccine Janssen vaccination and these conditions.”
EMA said: “PRAC is investigating these situations and will determine whether regulatory action is necessary, usually including updating product information.” EMA will communicate all available information in more detail after the evaluation. .
The covid-19 Janssen vaccine is currently only available for emergency use in the United States and is expected to be distributed in the European Union for the next time since it was approved in the European Union on March 11, 2021. It has not yet started in any EU member states, but it is expected to start in the next few weeks.