The European Medicines Agency (EMA) “has not yet reached a conclusion” on the relationship of the AstraZeneca vaccine with the unusual cases of blood clotting detected in some European countries, an investigation that “is still underway”, as a source from the regulatory body has assured Efe.
The Pharmacovigilance Risk Assessment Committee (PRAC) has scheduled meetings from this Tuesday to next Friday to conclude its investigation on these cases of thromboembolism and, “as soon as it completes its evaluation” of all the available reports, the conclusions will “be communicated” in a press conference.
This information contradicts the statement of the head of the EMA’s vaccine strategy, Marco Cavaleri, who assured this Tuesday in an interview with an Italian newspaper that there is a “clear” link between the AstraZeneca vaccine and very rare cases of thrombi.
The EMA estimates that the PRAC will reach a conclusion on the possible relationship of the vaccine with thrombi “this Wednesday or Thursday” and will report back at a press conference when the analysis is complete. For her part, the European health commissioner, Stella Kyriakides, has assured in a message on Twitter that the “evaluation is scheduled late 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
Cavaleri commented to the newspaper Il Messaggero that, in his opinion, it can now be “said that it is clear that there is an association (of thrombi) with the vaccine “, but “it is not yet known what causes this reaction”, detected in citizens vaccinated with AstraZeneca since it received the green light in the European Union (EU) at the end of January.
“Now it is increasingly difficult to say that there is no cause and effect relationship between vaccination with AstraZeneca and very rare cases of unusual blood clots associated with low platelet counts, “he added.
Waiting for the conclusions
Germany and the Netherlands opted for stop using this vaccine in children under 60 years of age awaiting the conclusions of the EMA.
The regulatory body has convened external experts in various medical specialties, including hematologists, neurologists and epidemiologists, who discuss specific aspects of the detected cases, looking for identify risk factors and additional data to characterize observed thromboembolic events and define a potential risk, if any.
This review, which will be part of the PRAC’s final report, you have not identified a specific risk factor, such as age, sex or a previous medical history of bleeding disorders that may explain these very rare cases of thromboembolism that occurred after vaccination, but, believing that there could be a risk, it was decided to continue with the analysis.
In their last meeting, last Wednesday, the PRAC did not rule out the cause-effect relationship, but it also found no clear evidence of a link between AstraZeneca and the development of blood clots with a low number of platelets, so the EMA continued to consider that the benefits of this vaccine against covid-19, a disease with risk of hospitalization and death , continue to outweigh any risk of side effect.