The European Medicines Agency said Wednesday blood clots are a “very rare” side effect of AstraZeneca’s COVID vaccine. However, the EU drug regulator emphasized that the vaccine’s benefits continue to outweigh its risks.
The EMA’s safety committee has concluded that unusual blood clots with low blood platelets should be listed as very rare side effects of the vaccine.
“COVID-19 is associated with a risk of hospitalization and death. The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects,” the regulator said in a statement.
The committee said that it had carried out an in-depth review of 62 cases of cerebral venous sinus thrombosis and 24 cases of splanchnic vein thrombosis. Out of these, 18 had been reported to be fatal.
The committee noted that the blood clots occurred in veins, in the brain and the abdomen and in arteries, together with low levels of blood platelets and sometimes bleeding.
According to the committee, one plausible explanation for the clots and low blood platelets is an immune response. However, it has has requested new studies and amendments to ongoing ones to provide more information.
The EMA reminded healthcare professionals and people receiving the vaccine to remain aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within 2 weeks of vaccination. It also asked people to seek medical assistance if they develop symptoms of this combination of blood clots and low blood platelets.
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