the existence of a “rare” risk of thrombosis confirmed by the National Medicines Safety Agency

It is “Rare”, but the National Medicines Safety Agency (ANSM) confirmed on Friday March 26 the existence of a risk of atypical thrombosis associated with the vaccine against the SARS-CoV-2 of AstraZeneca, after the occurrence of new cases in France, including two deaths, while stressing that the risk / benefit balance remained “Favorable”.

“Nine cases of thrombosis of the large veins, atypical by their location [cérébrale en majorité, mais également digestive], which may be associated with thrombocytopenia [la diminution du nombre de plaquettes dans le sang] or coagulation disorders have been reported ‘, six more than the previous week, writes the ANSM in his latest update on the surveillance of vaccines against Covid-19.

Among these cases, “Two deaths” were reported between March 12 and 18, 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 underway , as part of a judicial inquiry. The health agency explains:

“The very atypical nature of these thromboses, their similar 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. “

These cases have occurred “Within a median of 8.5 days after vaccination in people with no particular history identified to date”, she adds, adding that seven patients were under 55 years old, and two, over 55 years old.

A benefit / risk balance deemed positive

The vaccine developed by the Swedish-British laboratory and the University of Oxford was suspended on March 15 by several European countries after reports of blood clots, sometimes fatal.

France lifted the suspension on Friday, after an opinion from the European Medicines Agency (EMA) judging it “Safe and effective” and affirming that its benefit / risk balance in the face of the Covid-19 epidemic was positive.

The High Authority for Health, however, recommended that it be reserved for people aged 55 and over because until then cases of cerebral venous thrombosis had only been observed in children under 55 years of age.

The AEM 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 lack of blood platelets [pouvait] not be excluded at this stage ”.

“A group of experts” of the AEM 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, in ” large majority “ of “Flu-like syndromes, often of high intensity” (fever, headache, muscle aches).