Three new cases of rare thrombosis have been reported to French health agency ANSM, all of which happened on average nine days after the patients had received the AstraZeneca vaccination.
The cases were confirmed in the latest ANSM report on vaccine side effects, for the dates March 19-25.
This brings the total number of thrombosis cases reported to 12, of which four patients have died.
The cases have all been in women without any previous known conditions, of which nine were in people aged under 55, and three aged over 55.
No links to the AstraZeneca vaccination have yet been established, and the ANSM has called the incidents “very rare”.
The European Medicines Agency (EMA) has continued to say that the benefit-to-risk ratio of the vaccine is still positive, and has continued to advise people to have a vaccination as soon as possible.
In a statement, the EMA said: “No causal link has been proven, but it is possible, and analyses are ongoing.”
The EMA has gathered a committee of experts to evaluate any possible future actions, any adjacent risk factors, and any other relevant data that could explain the recent cases. Their findings will be discussed during a European meeting from April 6 to 9.
Symptoms to watch out for
In the meantime the ANSM has continued to advise that people in France should get a vaccine as soon as possible but to be aware of the following symptoms, and to see a doctor immediately in case of severe or persistent side-effects within three days of vaccination:
- bruising at the injection site.
The ANSM said that health professionals should be aware of “the signs and symptoms of thromboembolism with or without thrombocytopenia in individuals vaccinated with AstraZeneca vaccine”.
Thromboembolism refers to when a blood clot blocks a blood vessel; thrombocytopenia is a condition that causes a low blood platelet count, which can cause blood clotting problems.
Risk levels
According to the latest figures from the EMA there have been 44 cases of thrombosis following the AstraZeneca vaccine in the EU Economic Area, including the EU, Iceland, Norway, and Liechtenstein.
In France, there have been 12 cases, of which four deaths, out of 1.9 million doses of the AstraZeneca vaccine given.
In Germany, 31 cases of suspected thrombosis - of which 19 also had a drop in platelets - have been reported so far, including nine deaths. This equates to one case per 100,000 doses.
In Norway, there have been five cases, of which three deaths, out of 120,000 injections.
In the UK, which has mainly used the AstraZeneca vaccine for its campaign, there have been 30 cases, of which seven deaths, out of 18.1 million doses given.
On Wednesday March 31, the EMA said: “The benefits of AstraZeneca's vaccine in preventing Covid-19, which leads to hospitalisations and deaths, outweigh the risks of side effects.
“At the moment, evaluations have not identified specific risk factors for these very rare events such as age, gender or a medical history that includes blood clot problems.”
Court case
Back in France, the family of a 38-year-old woman who died of thrombosis after having received one dose of the AstraZeneca vaccine, has issued an official complaint to the public prosecutor's office in Toulouse, with a view to “achieving an inquiry”, their lawyer told the Agence France-Presse.
Other vaccines
The latest figures from ANSM show that there have been 12,249 side-effects reported for the Pfizer/BioNTech vaccine, most of them “expected and non-severe”. No new cases were reported in the week March 19-25.
For Moderna, there have been 577 side-effects reported, again “expected and non-severe”, and no new cases reported March 19-25.
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