The drug regulatory agency of the European Union reiterated its support for vaccine against Covid-19 gives AstraZeneca, saying that no particular age, sex or medical history group is particularly susceptible to blood clots after receiving the vaccine.
While reiterating that the benefits of the vaccine outweigh the risks, the agency pointed out that people should be aware of the “remote possibility” of rare blood clots and that they should seek immediate medical attention if they have symptoms.
“A causal link to the vaccine is not proven, but it is possible, and further analysis is underway,” said the European Medicines Agency (EMA) in a statement.
The EMA issued the statement after a hearing with a group of independent external experts on Monday.
She said after several countries, including Canada, Germany, France and Spain, limited the use of the pharmaceutical vaccine in the wake of reports of a rare blood clot problem after vaccination.
Investigations by EMA and several EU national authorities continue. Initial surveys pointed out that the vaccine is safe after reports of a brain clot problem known as cerebral venous thrombosis (CVT).
A high proportion of reported cases affected young and middle-aged women, but this did not prompt EMA to conclude that this group is at particular risk with the AstraZeneca vaccine.
Women in general are more susceptible to CVT than men, and twice as many women as men have received doses of AstraZeneca in the EU so far, said EMA’s head of safety monitoring, Peter Arlett.
“This is why, at this point, it is difficult to unravel why there is a preponderance of reports of this very rare side effect in younger women in particular,” he added.
The EMA analyzed 62 such cases worldwide, also consulting with regulatory agencies in India, Brazil and the United Kingdom, and 44 cases occurred in the European Economic Area (EEA).
The organization investigated 14 deaths, although not all were associated with TVC, Arlett said. About 9.2 million people in the EEA have already received the vaccine, based on the March 22 deadline of the evaluation.
Arlett acknowledged that the incidence rate of blood clots is higher than would normally be expected in young and middle-aged people. Although he did not quantify the difference, he said that it did not justify a change in recommendation.
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