Drug regulators with the European Medicines Agency’s safety committee confirmed that the Oxford-AstraZeneca COVID-19 vaccine can cause blood clots with low blood platelets in some recipients.
The European Union-funded agency said on Wednesday that the “unusual” blood clots should “be listed as very rare side effects” of the vaccine, adding that the vaccine is still effective at reducing COVID-19 hospitalizations and deaths.
“EMA is reminding 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,” the agency said in a news release. “So far, most of the cases reported have occurred in women under 60 years of age within 2 weeks of vaccination.”
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EMA’s committee reviewed 86 cases of thrombosis, or the clotting of blood in the body’s circulatory system, 18 of which were fatal as of March 22.
“The [safety committee] noted that the blood clots occurred in veins in the brain (cerebral venous sinus thrombosis, CVST) and the abdomen (splanchnic vein thrombosis) and in arteries, together with low levels of blood platelets and sometimes bleeding,” the EMA said in its announcement.
The agency has consistently advocated for the efficacy of the vaccine.
On March 18, agency Executive Director Emer Cooke said that “the vaccine is not associated with an increase in the overall risk of thrombotic events or blood clots.” At the time, the group cautioned that regulators “cannot rule out definitively a link” to a “small number of cases of rare and unusual but very serious clotting disorders.”
Despite the rare blood clots, the agency insisted on Wednesday that “the benefits of the vaccine continue to outweigh the risks for people who receive it,” adding, “The vaccine is effective at preventing COVID-19 and reducing hospitalizations and deaths.”
A number of EU countries, including Germany, Denmark, and Norway, paused AstraZeneca vaccinations after reports of fatal blood clots in recipients. Though Denmark and Norway have not resumed the use of the vaccine, Germany limited its use for those under the age of 60.
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The Food and Drug Administration has not authorized the Oxford-AstraZeneca to be used in the United States, but AstraZeneca said in a March 22 press release that it would submit data to the agency “in the coming weeks.”

