Portugal presided over an informal meeting of European Union Health Ministers this afternoon. The meeting followed the public announcement of the conclusions of the Pharmacovigilance Risk Assessment Committee report from the European Medicines Agency (EMA) on the safety of the Vaxzevria vaccine, previously called AstraZeneca.
EMA concluded that there is a possibility of the occurrence of very rare cases of formation of blood clots associated with low levels of platelets and identified mainly in women aged under 60. However, EMA stressed the fact that the benefits of the vaccine continue to outweigh the risk and that there is as yet no evidence to justify limiting the administration of the vaccine to specific age groups, calling on health professionals and vaccinated citizens to closely monitor the appearance of symptoms.
At the meeting, EMA also guaranteed that it will continue to monitor any side effects of this and of all the vaccines against COVID-19, updating recommendations if necessary.
The EU Member States shared their different interpretations of the conclusions of the report and also sought to clarify aspects related to the safety of Vaxzevria with EMA. All agreed on the need for more pharmacovigilance studies for specific groups.
Given that the Member States’ vaccination plans are at a crucial stage of implementation, the Ministers undertook to prioritise continued discussion of issues related to the entire European process and its future planning.
Stella Kyriakides, European Commissioner for Health and Food Safety, said: "The safety of our vaccines has always been paramount under our EU vaccines strategy. Today’s assessment shows that our pharmacovigilance system works: suspected side effects are reported rapidly, information is shared and our experts come together swiftly to assess all available evidence. Our decisions should now be based on the scientific work of EMA, and a rigorous, continuous assessment of risks and benefits. I have today called on Health Ministers to follow a coordinated approach across Europe to improve public confidence.”
At the end of the meeting, the European Commission and the Portuguese Presidency of the Council of the European Union appealed to all the Member States to work towards the most coordinated position possible in the EU, with the Portuguese Minister for Health, Marta Temido, laying particular emphasis on the fact that: “This is a technical decision. It is not a political decision. We must continue to follow the best scientific information provided by EMA in its opinions. We must not forget that individual decisions affect everybody.”