The European Medicines Agency (EMA) stressed on Wednesday that it “has not changed” its position during the ongoing investigation of rare cases of thromboembolism in patients who had received the covid-19 vaccine from AstraZeneca, and maintains that the benefit ” outweighs “the risk of this drug.
Executive Director Emer Cooke explained at a press conference that the EMA convened a group of independent experts in a variety of medical specialties on Monday, including hematologists, neurologists and epidemiologists, who discussed “specifics” of the events of thromboembolism detected.
However, these experts have not been able to identify underlying drug risk factors, physiological mechanisms, or concrete data to better characterize the observed cases and the potential risk of the vaccine in “very rare” cases of unusual blood clotting such as those already detected in people vaccinated with AstraZeneca.
According to the agency, at the moment, the review has not identified “any specific risk factors, such as age, sex or a previous medical history of bleeding disorders for these” very rare “events and neither has” a causal link been proven. with the vaccine “, although this” is possible “and for that reason they continue with the analyzes.
For now, the EMA still believes that the benefits of the AstraZeneca vaccine in preventing covid-19, which has an associated risk of hospitalization and deaths, “outweigh the risks of side effects” that the drug may have and recalls that ” (EMA’s) recommendations are guided by science. ”
National authorities continue to notify the EMA of any suspected cases of unusual blood clots so that the PRAC can evaluate them as part of its investigation.
The safety committee expects to announce an updated recommendation on AstraZeneca during its April plenary meeting, April 6-9, although Cooke will provide information on the status of the investigation today, a day after German authorities suspended vaccination with this drug in people under 60 years of age.