In a report, the National Agency for the Safety of Medicines and Health Products (ANSM) points to the existence of a “very rare” risk of thrombosis.
- Several cases of thrombosis have been observed in people vaccinated with the AstraZeneca product
- The ANSM confirms the existence of the risk of such side effects but qualifies them as “rare”
Nine cases of large vein thrombosis associated with the administration of the AstraZeneca vaccine have been recorded, and two deaths have been reported, between March 12 and 18. The ANSM announces it in a communicated. The agency has set up a “enhanced monitoring device“to study the effects of vaccines used against Covid-19. It confirms the existence of a very rare risk of venous thrombosis, following the vaccine.”The very atypical nature of these thromboses, their common clinical picture and the homogeneous time to onset lead the monitoring committee to confirm the occurrence, very rare, of this thrombotic risk in people vaccinated with the AstraZeneca vaccine.“, states the document. A thrombosis is defined by the formation of a clot in the blood, which can block a vein or an artery and prevent the circulation of blood.
“Atypical” thrombosis
As of March 18, 2021, more than 1.4 million doses of the vaccine have been administered in France. 29 cases of thromboembolic disorders were noted by the surveillance committees. Between March 12 and 18, nine cases of large vein thrombosis caught the attention of the ANSM, because they are considered “atypical“given their location: in the brain or the digestive organs. These side effects concerned seven patients under the age of 55 and two patients over the age of 55. On Thursday March 18, a 24-year-old medical student died. He had been vaccinated ten days earlier with AstraZeneca’s product.”At this stage, there is no evidence to support the role of the vaccineindicates the ANSM. This case of death is the subject of an in-depth clinical investigation by the Regional Pharmacovigilance Centers (CRPV).“In its new report, the agency specifies that side effects generally occur within 15 days of vaccination and in patients with risk factors. It recalls the opinion issued by the European Medicines Agency, which “confirms the positive benefit/risk balance of vaccination with AstraZeneca in the prevention of Covid-19“. On March 18, the EMA claimed that the product was “safe and effective“.
Interrupted use, then authorized under conditions
The use of the serum was interrupted for a few days in France and in several European countries, following several cases of venous thrombosis. It has resumed in most of these countries, but in France, the AstraZeneca vaccine is now reserved for people over 55. In particular, it can be administered to people over 70 without comorbidities, for whom vaccination has been open since Saturday March 27.
