The European medical regulatory agency reiterated its support for AstraZeneca and pointed out that people without age or sex and those with a history of the disease are particularly prone to blood clots after vaccination.
However, although the European Medicines Agency (EMA) reiterates that the benefits of the vaccine outweigh the risks, it warns that people should be aware of the “remote possibility” of developing rare blood clots and seek immediate medical attention when symptoms appear.
EMA said: “The causal relationship with the vaccine has not been confirmed, but it is possible, and further analysis is ongoing.”
EMA issued a new statement after meeting with a panel of independent external experts on Monday.
Following reports of blood clots after vaccination in several countries including Canada, Germany, France and Spain, the vaccination of AstraZenecom has been restricted.
After preliminary investigations have assessed that the vaccine is safe to use, investigations by EMA and the competent authorities of several EU countries are still continuing.
Most of the reported cases of blood clots related to young and middle-aged women have not led the EMA to conclude that this population is particularly susceptible to AstraZeneca vaccine.
EMA Chief Safety Officer Peter Arlett said that women are generally more likely to develop cerebral venous thrombosis (CVST) than men, and that the number of women who have received AstraZeneca vaccine in the EU is twice that of men.
Arlett added: “This is why it is difficult at this stage to distinguish why reports are very rare, and reports of potential side effects are especially true.”
EMA analyzed 62 such cases globally and consulted with regulators in India, Brazil and the United Kingdom. Of these, 44 cases were reported in the European Economic Area (EEA).
Arlette said that European medical regulators analyzed 14 deaths, although not all of them were related to cerebral venous thrombosis. As of March 22, approximately 9.2 million people in the European Economic Area (EEA) had received AstraZeneca treatment.
Arlett admits that the incidence of blood clotting is higher than what young and middle-aged people usually expect. Although he did not quantify the difference, he said that there is no reason to change the proposal.
Arlett said: “If we study people under the age of 60, we will find more CVST cases than the background investigation.
German vaccine monitoring agency PEI announced on Tuesday that it has registered 31 CVST cases, resulting in the death of 9 of the 2.7 million people vaccinated with AstraZenece.
EMA pointed out that several subsequent cases in Germany were not included in the analysis.