Statements by pharmacologist Marco Cavaleri reveal an association of thrombus risk with AstraZeneca's vaccine in women under 50 years of age

EMA member confirms link between AstraZeneca vaccines and risk of thrombosis

AFP/JUSTIN TALLIS - EMA member confirms link between AstraZeneca vaccine and thrombosis

The head of the European Medicines Agency's (EMA) vaccine strategy, Marco Cavaleri, told an Italian newspaper that the cases of thrombosis that have arisen as a result of AstraZeneca's vaccination have a "clear link".

In response, the Italian Ministry of Health has decided not to use AstraZeneca's vaccine "for a certain category". This category to which the vaccination of this pharmaceutical company would be stopped would be the population sector of women under 50 years of age because, according to Cavaleri, they have a higher risk of thrombosis. The pharmacologist assured that "it is increasingly difficult to affirm that there is no cause and effect relationship between vaccination".

In this sense, in order to decide the future of this vaccine and its action, the EMA "is looking for a more precise picture".  However, Cavaleri said that the cases of thrombosis are due to "an association with the vaccine, but we still don't know what causes this reaction". He went on to say that "in the next few hours we will say that the relationship exists, but we must understand how it is produced". Even so, he said that the risk-benefit balance is "always in favour of the vaccine".

Cavaleri also stressed that such cases of thrombosis are "extremely rare" and that the benefits far outweigh the risks.

The first reactions have been carried out by the Italian Medicines Agency and the Italian Ministry of Health to start taking decisions on the use of AstraZeneca. In addition, the EMA will comment on the matter in a statement expected on Thursday.

Italy's under-secretary for health, Pierpaolo Sileri, made a statement ahead of the EMA's final reaction, stating that the Agency may indicate that "for a certain category it is better not to use AstraZeneca's vaccine". 

In this context, the European reporting database has revealed that 2,599 cases of side effects from this vaccine are being studied in Spain. After the suspension of this vaccine in Spain, the Spanish health authorities decided to resume vaccination with AstraZeneca after having "reviewed in detail the cases of adverse knowledge" and ensured that it continues to be "an effective and safe vaccine, as indicated by current scientific evidence". 

On the other hand, Europe is beginning to spread its concern about adverse effects following inoculation with AstraZeneca. In the case of the Netherlands, it has been decided to cancel vaccination with this drug and in Italy, many of the appointments with this vaccine have been cancelled. 

Spain is beginning to take action after learning of this relationship. The first community to take action has been Castilla y León after deciding to suspend AstraZeneca's vaccination of children under 65 years of age. According to the health report, so far 1,700,500 doses of the vaccine have been received and a total of 769,415 immunisations have been administered.