The Safety Committee of the European Medicines Agency (EMA) decided. In one press release published on April 7, the European regulator concludes that the appearance of blood clots associated with a drop in the number of blood platelets should appear in the list of side effects “very rare“AstraZeneca anti-covid vaccine, renamed Vaxzevria. According to the agency, the link between these rare cases of thrombosis and the vaccine is”possible“.
As yet unknown risk factors
So far, most of the reported cases have occurred in women under the age of 60 within two weeks of vaccination, notes the EMA. But no specific risk factors could be identified, EMA executive director Emer Cooke said in a video conference.
“Specific risk factors such as age, gender or medical history could not be confirmed as rare events are seen at all ages“, she explained.
The cause of the occurrence of these clots is also not known. “A plausible explanation for these rare side effects is an immune response to the vaccine“, observed Emer Cooke.
Also read: AstraZeneca vaccine and risk of thrombosis: is accidental injection into the blood involved?
“Positive” risk / benefit balance
The executive director also recalled that the vaccine is “very effective“and that he”save lives“. And the benefit / risk balance of Vaxervria remains”positive“, assures the EMA.
In fact, as of March 22, the EMA had 86 cases of thrombosis, including 18 fatalities out of 25 million people vaccinated in the European Economic Area (EEA) and in the United Kingdom. That is less than one death per million vaccinated, when the lethality of the covid – against which the vaccine protects at 76% – varies from 0.8 per 1,000 to 2% depending on the age group.
Consult in case of symptoms
In its press release, the EMA asks healthcare professionals to be aware of this thrombotic risk which can occur within two weeks after vaccination with a probability “very rare“.
Finally, the agency recommends that people vaccinated with AstraZeneca consult immediately or call for help if they have the following symptoms:
- Shortness of breath;
- Pain in the chest;
- Swelling in the legs;
- Persistent abdominal pain;
- Neurological symptoms, including blurred vision or severe headaches that persist despite taking paracetamol;
- Appearance of tiny blood spots under the skin at the vaccine injection site.
The use of this vaccine is still suspended in some countries. In France, it is reserved for people over 55 years old because the cases of thrombosis listed concerned younger people. Health ministers from European Union member countries are due to meet via video conference in the evening to review the EMA’s findings and possibly deliver new opinions.