EU Regulator Finds Oxford/AstraZeneca Vaccine Is Not Associated With Increased Blood Clot Risk

Dr. Alfredo Carpineti

Senior Staff Writer & Space Correspondent

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Breaking News banner. Image Credit: IFLScience — The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) reports that the vaccine remains safe and not associated with an increase in the risk of blood clots. Image Credit: Juan Roballo/Shutterstock.com

The European Medicines Agency (EMA) has finally announced the result of its investigation into the link between the Oxford/AstraZeneca COVID-19 vaccine and the several thromboembolic events that have been recorded in Europe over the last few months.

The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) reports that the vaccine remains safe and not associated with an increase in the risk of blood clots. That said, they couldn't exclude that blood clots are a possible side effect of the vaccine in very rare cases.

"The committee has come to a clear scientific conclusion. This is a safe and effective vaccine," Emer Cooke, executive director of the EMA said in a press conference. "Its benefits in protecting people from COVID-19 with the associated risks of death and hospitalization outweigh the possible risks. The committee also concluded that the vaccine is not associated with an increase in the overall risk of thromboembolic events or blood clots.”

The committee also stresses that based on the analysis, they can’t rule out that a link might exist, so they are working on highlighting what possible signs and what medical intervention might be necessary in these extremely rare cases. They are also launching new investigations to better understand the exact causes behind the blood clots of the 37 cases (among the over 17 million people that received an AstraZeneca vaccine).

No vaccine or medical intervention is absolutely risk-free, and this is why it is important to examine the relative risk of intervention compared to not intervening. The mortality of COVID-19 in the general population is around one in a thousand (much higher for high-risk people). In comparison, the mortality from blood clotting events is closer to one on a million.

Concerns regarding a possible link spurred a suspension of the jab across several European countries. This was a precautionary move just in case danger was found, but experts believe that it could have deleterious consequences – both in terms of vaccine uptake due to eroded confidence, as well as lost time. This is particularly important given that in many European countries there is currently a surge in new cases.