The ASNM has confirmed the existence of a limited risk of atypical thrombosis from the AstraZeneca vaccine. The investigation followed new cases of the rare thrombosis occurring shortly after receiving the AstraZeneca jab in France, including two deaths.
The Agence française de sécurité sanitaire des produits de santé (French Agency for the Safety of Health Products) (or ASNM for short) is a French government agency, tasked primarily with assessing health risks posed by health products, particularly pharmaceutical drugs.
The Agency’s verdict is the newest blow to the vaccine, following the highly politicised ‘vaccine war’ between the EU and the UK, with the EU stopping short of banning vaccine exports after a row with the Anglo-Swedish manufacturer.
The Agency investigated a section of 16 new cases, from a total of 29 cases of thrombosis in total since the start of vaccination in the country. There have been more than 1.4 million vaccinations with the AstraZeneca jab in France, with a total of 5,693 cases of side effects. The majority of cases of thromboembolic events occurred within 15 days of vaccination in patients with known risk factors.
However, among the cases investigated, there were 9 cases of atypical thrombosis of the large veins – mainly cerebral, but also digestive. Two of these cases were fatal. Most importantly, these 9 atypical cases presented no risk factors or specific history identified to date. These cases occurred within an average period of 8.5 days and included the death of a 24-year-old student from Nantes, who died on March 18th.
For the confirmation of the link, the ASNM invoked several reasons, including the very atypical nature of these thromboses, their similar clinical presentations and homogeneous onset times.
Despite confirming the risk, the French Agency emphasized that the benefits of the vaccine outweigh the risks, as per the European Medicines Agency’s assessment which previously declared the vaccine “safe and effective”. The Agency found that the jab was “not associated” with a higher risk of blood clots. The majority of side effects caused by the vaccines were flu-like symptoms, such as a high fever, headaches, and muscle aches.
This confirmation comes after the vaccine developed at the University of Oxford has been suspended in multiple European countries due to suspicions of it causing blood clots and thrombosis. 13 European countries had stopped vaccinations following reports of mostly young patients who suffered severe clotting disorders or rare types of strokes shortly after receiving the AstraZeneca vaccine. Within hours of the EMA’ s statement, Germany, France, Italy, Spain, the Netherlands and at least seven other countries declared they will resume vaccinations.
Despite advice from Europe’s regulators, France’s health authority has recommended reserving the AstraZeneca vaccine for people aged 55 and over, as most cases of cerebral thrombosis have been reported in those aged 55 and under.
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