Thursday, April 15, 2021
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List blood clots as 'very rare side effect' of AstraZeneca vaccine, advises European Medicines Agency

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Amsterdam | April 7, 2021 11:14:08 PM IST
Experts at the European Medicines Agency (EMA) on Wednesday said that the blood clots with low blood platelets should be listed as very rare side effects of AstraZeneca's COVID-19 vaccine.

"EMA's safety committee (PRAC) has concluded today that unusual blood clots with low blood platelets should be listed as very rare side effects of Vaxzevria (formerly COVID-19 Vaccine AstraZeneca)," according to the EMA statement.

Vaxzevria is one of four vaccines authorised in the EU for protection against COVID-19.

"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 two weeks of vaccination. So far, most of the cases reported have occurred in women under 60 years of age within two weeks of vaccination. Based on the currently available evidence, specific risk factors have not been confirmed," the statement said.

People, who have received the vaccine, should seek medical assistance immediately if they develop symptoms of this combination of blood clots and low blood platelets, read the statement.

Pharmacovigilance Risk Assessment Committee (PRAC) 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.

"COVID-19 is associated with a risk of hospitalisation 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 statement added. (ANI)

 
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