One possible explanation cited by the committee for the combination of blood clots and low blood platelets was an immune response which was similar to the side-effects seen in the blood thinning drug heparin
European Medicines Agency (EMA) on Wednesday said that its vaccine safety committee has concluded that unusual blood clots with low blood platelets should be listed as very rare side effects of AstraZeneca’s covid-19 vaccine.
The 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 its statement.
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Premium It reached the conclusion after carrying out an in-depth review of 62 cases of cerebral venous sinus thrombosis—blood clot in brain—and 24 cases of splanchnic vein thrombosis—blood clot in abdomen—reported in the European Union drug safety database as of 22 March. Of the total cases, 18 were fatal. The cases were from reported in the European Economic Area and the UK.
So far, most of the cases reported have occurred in women under 60 years of age within 2 weeks of vaccination.
One possible explanation cited by the committee for the combination of blood clots and low blood platelets was an immune response which was similar to the side-effects seen in the blood thinning drug heparin, but the panel suggested more studies to provide more information.
However, officials at the European regulator said that despite the side-effects the benefits provided by the vaccine still outweigh the risk, especially as the side-effect of blood clots is very rare.
AstraZeneca’s covid-19 vaccine, Vaxzevria, is one of four vaccines that have received emergency use authorisation in the EU.
In India, Serum Institute of India manufactures the vaccine under the brand Covishield. So far, over 78 million doses of the vaccine have been administered, which is around 90% of the total vaccine doses given in the country, with the rest being Bharat Biotech International’s Covaxin, according to government data.
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Premium Premium The spokesperson for Serum Institute was not immediately available for comment.
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