The Medicines Agency (ANSM) confirmed on Friday March 24 the existence of a risk « rare » of thrombosis atypical associated with vaccine against the Covid-19 d’AstraZeneca, after the occurrence of new cases in France, including two deaths, while emphasizing that the balance benefit / risk remained « favorable ».
“Nine cases of thrombosis of the large veins, atypical by their location (mainly cerebral, but also digestive), which may be associated with thrombocytopenia – decrease in the number of platelets in the blood, Editor’s note – or coagulation disorders have been declared “, six more than the previous week, indicates the ANSM in its latest update on the surveillance of vaccines against Covid-19.
Among these cases, “Two deaths” were reported between March 12 and 18, including that ofa 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 investigation.
Among these cases, “Two deaths” were reported between March 12 and 18, including that ofa 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 investigation.
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.
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 cases of blood clots, sometimes fatal.’
France lifted the suspension on Friday, after an opinion from the European Medicines Agency (EMA) deeming it “Safe and effective” and affirming that its benefit / risk balance in the face of the Covid-19 epidemic was positive.
The Haute Autorité de santé, 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 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 lack of blood platelets could not be ruled out at this stage”.
“A group of experts” of 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 reactions were analyzed by pharmacovigilance centers, in ” large majority “ of “Flu-like syndromes, often of high intensity” (fever, headache, muscle aches).
Source : Archyd
