PANDEMIC: The ANSM stresses however that the benefit/risk balance of the AstraZeneca Covid-19 vaccine remained “favourable”
The Medical Products Agency (ANSM) Friday confirmed the existence of a risk “rare” atypical thrombosis associated with the vaccine against Covid-19 from AstraZeneca, after the occurrence of new cases in France, including two deaths, while by emphasizing that the risk/benefit balance remained “favourable”.
“Nine cases of thrombosis of the large veins, atypical in terms of their location (mainly cerebral, but also digestive), which may be associated with thrombocytopenia – decrease in the number of platelets in the blood – or with coagulation disorders have been declared”, i.e. six more than the previous week indicates the ANSM in its latest update on the surveillance of vaccines against the coronavirus.
Two deaths reported
Among these cases, “two deaths” were reported between March 12th and 18th, including that of a Nantes medical student who died on March 18 several days after being vaccinated, mentioned Monday evening by the ANSM in a press release and for which additional analyzes are in progress, as part of a judicial inquiry.
“The very atypical nature of these thromboses, their close clinical pictures and the homogeneous time to onset lead the monitoring committee to confirm the very rare occurrence of this thrombotic risk in people vaccinated with the AstraZeneca vaccine”, explains the agency. sanitary.
These cases occurred “within a median of 8.5 days after vaccination in people with no particular history identified to date”, she adds, specifying that seven patients were under 55 years old, and two, over. 55 years.
After the vaccine was suspended for a time, the High Health Authority recommended that it be reserved for people aged 55 and over because until then cases of cerebral venous thrombosis had only been observed in people under 55 years of age.
The EMA concluded that the vaccine was not associated with an increased overall risk of blood clots but that a ‘possible link with two very rare forms of blood clots (disseminated intravascular coagulation (DIC) and cerebral venous sinus thrombosis ) associated with a blood platelet deficiency (could) not be excluded at this stage ”.
About 5,700 side effects analyzed
“A group of experts” from the EMA is studying “the mechanism of action, any underlying risk factors and any additional data to explain the events observed”, recalls the ANSM.
Out of 1.4 million AstraZeneca vaccines injected in France on March 18, around 5,700 adverse effects were analyzed by pharmacovigilance centers, the “vast majority” of “flu-like syndromes, often of high intensity” (fever, headache, muscle aches).