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The European Medicines Agency (EMA) on Wednesday said its vaccine safety committee has concluded that unusual blood clots with low blood platelets caused by AstraZeneca’s coronavirus vaccine should be considered as a “very rare" side effect.

Given its benefits far outweigh risks, the regulator decided against imposing any curbs on the vaccine, which is sold in India as Covishield.

The regulator’s Pharmacovigilance Risk Assessment Committee (PRAC) 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, the EMA said in a statement.

It reached the conclusion after carrying out an in-depth review of 62 cases of cerebral venous sinus thrombosis—blood clot in the brain—and 24 cases of splanchnic vein thrombosis—blood clot in the abdomen—reported in the European Union drug safety database as of 22 March. Of the total cases, 18 were fatal. The cases were reported from the European Economic Area and the UK.

So far, most of the cases reported have occurred in women under 60 years of age within two weeks of vaccination.

A possible explanation cited by the committee for the combination of blood clots and low blood platelets was an immune response that was similar to the side-effects seen in the blood-thinning drug heparin, but the panel suggested more studies to gather information.

AstraZeneca’s covid-19 vaccine, Vaxzevria, is one of four that have received emergency use authorization in the EU.

In India, Serum Institute of India manufactures the vaccine under the brand Covishield. So far, more than 78 million doses of the vaccine have been administered, which is around 90% of total vaccine doses given in the country, according to government data. The remaining vaccines are of Bharat Biotech International’s locally developed Covaxin.

A spokesperson for Serum Institute was not immediately available for comment.

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