Drug regulators at the European Medicines Agency concluded that the AstraZeneca vaccine is safe and effective following investigations into possible links between the shot and cases of fatal blood clotting in patients who were vaccinated.
Emer Cooke, the agency’s executive director, said Thursday that “the vaccine is not associated with an increase in the overall risk of thrombotic events or blood clots.”
The agency declared that the benefits of the vaccine outweigh the risks but cautioned that regulators “cannot rule out definitively a link” to a “small number of cases of rare and unusual but very serious clotting disorders.” There have been 15 reports of clots in the legs, called deep vein thrombosis, and 22 cases of blood clots that reached the lungs, known as a pulmonary embolism.
About a dozen countries, including Germany, Italy, France, the Netherlands, Austria, Iceland, Latvia, and Ireland, have paused the rollout of the vaccine in response to the reports of serious adverse reactions. While the EMA indicated that countries can resume the rollout, regulators warned that doctors and patients should be alerted to the possibility of an adverse reaction.
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The European Union pledged to vaccinate 70% of the adult population by the summer, but the effort has been plagued by early supply issues and distribution delays. The EU has fully vaccinated 3.5% of its adult population. In the United States, about 12% of the adult population has been fully vaccinated.