Restrictions on the use of the AstraZeneca vaccine could be set for particular categories, based on the balance of benefits and risks, for example for women under 55. Ema, the European Medicines Agency, is conducting further investigations to try to clarify any correlations between cases of thrombosis registered in several countries, especially in the young female population, and the AstraZeneca vaccine. The review is in progress. This was also confirmed with a tweet by the EU Commissioner for Health, Stella Kyriakides: «We are in close contact with the European Medicines Agency on the evaluation of the pharmacovigilance of the AstraZeneca vaccine.
The evaluation is expected on Wednesday».
In close contact with @EMA_News on the pharmacovigilance assessment of the AstraZeneca vaccine. Evaluation expected late Wednesday.
– Stella Kyriakides (@SKyriakidesEU) April 6, 2021
“It is possible, for greater precaution, that the EMA indicates that for a certain category it is better not to use the AstraZeneca anti-Covid vaccine”, explained the Undersecretary of Health Pierpaolo Sileri on Radio 24: «That is, he can identify gods population subgroups which have a common denominator for a higher level of risk, and evaluate the cause-and-effect relationship in these groups in relation to the rare thrombotic events that have been reported ‘. As, on the other hand, it has already happened for other drugs, “starting with aspirin, for which a limit of use was set for the range of children under 12 years of age for some events starting from the 1980s adverse “. In Germany, France, Holland, Sweden, Iceland, Finland and Canada, on the other hand, the use of this vaccine is already limited to elderly people, over 60.
As for AstraZeneca, he stresses, however, “the vaccine has been used in an extremely high number of subjects, while very few reported thrombotic events are reported. There is no doubt that there is a positive risk-benefit ratio».
Marco Cavalry, head of Ema’s vaccine strategy, in an interview with Messenger, confirms that “in rare cases of thrombosis there is association with the vaccineBut “what causes this reaction, however, we still do not know”. He too confirms the positive relationship between risks and benefits, but specifies: «We will go into the various age groups in more detail. Young women, often protagonists of thrombosis cases, suffer less from the effect of Covid, so we will have to evaluate the risk-benefit ratio for them. Not forgetting that young women also end up in intensive care for Covid. Therefore, very meticulous work will be needed to understand if the risk-benefit ratio is in favor of the vaccine for all ages ».