Valencia provides evidence to EMA on AstraZeneca vaccine

The data show that no increased global risk of thrombosis is detected in vaccinated people compared to the number of cases in 2017-2020.

Monday 29th March 2021 | PRESS RELEASE; translation MIKE SMITH

The Vaccine Research Area (AIV) of the Foundation for the Promotion of Health and Biomedical Research of the Comunidad Valenciana (FISABIO) has participated in the preparation of a report that analyses the incidence rate of thromboembolic events in the general population of the Comunidad Valenciana between 2017 and 2020.

After learning about the occurrence of thromboembolic events that coincided with the administration of the AstraZeneca vaccine against COVID-19, the European Medicines Agency (EMA) urgently asked the ACCESS project, of which the FISABIO AIV is part, to study in more detail the incidence of a series of thromboembolic events in a pre-vaccination period in order to compare them with the post-vaccination period and thus evaluate the safety of the AstraZeneca vaccine.

Of all the project participants, only FISABIO and the Agenzia Regionale di Sanità della Toscana (ARS) were able to provide the EMA in time with results that could “facilitate” the decision-making of the Pharmacovigilance Risk Assessment Committee (PRAC ) regarding the safety of the AstraZeneca vaccine from last Friday.

The data collected, which covered the period between 2017 and 2020, showed that an increase in the global risk of thrombosis in vaccinated people is not detected compared to the number of cases reflected in those years. This allowed the PRAC to conclude that the administration of this vaccine is not considered to be associated with an overall increased risk of thromboembolic events in vaccinated people, and that, in very rare cases, it could be associated with the formation of a rare type of thrombosis with thrombocytopenia. With all this information, it was considered that the benefit of the vaccine continues to outweigh the risk of possible adverse reactions.

The data were extracted from the health databases of the Comunidad Valenciana, one of the most complete in Europe, since they collect any data related to the health of 98% of the inhabitants of the Valencian region, more than five million people.

Information Source
Press Release – Generalitat Valenciana