European Medicines Agency investigates 62 cases of rare thrombosis after AstraZeneca vaccine | Coronavirus

The European Medicines Agency is aware of 62 cases of venous thrombosis in the cerebral cavernous sinus that appear to be associated with taking the vaccine against covid-19 registered in the European Economic Area (European Union countries plus Iceland, Liechtenstein and Norway) . This more than doubles the number of this type of thromboembolic phenomenon rare to those who were documented until March 18, when the EMA gave the green light to this vaccine, although promising more research on the subject. These 62 cases were recorded among 9.2 million people who took a dose of the AstraZeneca vaccine in these countries, which puts a one in 100,000 risk of venous thrombosis in the cerebral cavernous sinus in a population under 60 years of age, announced Emer Cooke, director of EMA. And these 62 are cases registered until March 22 – next week there will be a new update, he said.

The incidence is higher in women under the age of 55 – but it is not yet possible to say whether this is an effect of this sudden illness or if it is simply due to the fact that in this population, more young women are being immunized with the vaccinated AstraZeneca , explained Emer Cooke. “The vast majority of cases are women, there is a 10 to one ratio”, he acknowledged and this is a disease that is also more common in women. The cases are also concentrated in an age group that he defined as going from “35 to 45 years old”.

However, the EMA is not yet ready to make a decision, or to make a recommendation for the use of this vaccine that is specific to a gender or an age. “Our position has not changed. According to current scientific knowledge, there is no evidence to support a decision to suspend the use of this vaccine, ”said Emer Cooke. “So far an explanation has not been found that links a previous clinical history of blood clots, the person’s gender or age with the risk of having one of these thromboembolic events,” he explained.

The first analysis resulted in an update of the vaccine package insert, to contain warning signs to be aware of after vaccination that recommend seeking immediate medical help: shortness of breath, chest pain, swelling of the legs and persistent abdominal pain after vaccination .

However, some studies have linked these sudden illness phenomena after taking the vaccine with disorders in which blood clots and bleeding occur, caused by a decrease in the number of platelets, which are rare but treatable – as done by the team of Andreas Greinacher , from the University of Greifswald, which says it resembles heparin-induced thrombocytopenia.

Emer Cooke said that these studies will be analyzed at the meeting that takes place between 6 and 9 April of the EMA Pharmacovigilance and Risk Assessment Committee, responsible for analyzing safety issues of medicines for human use, is working on the evaluation of this case and should issue a new recommendation at the end of that meeting.

Several countries, however, have taken the decision to reserve the AstraZeneca vaccine only for people over 55, as the overwhelming majority of these cases are occurring among younger people: Germany, Canada, France, Sweden, Finland and Iceland .