The European Medicines Agency’s (EMA) safety committee has added another blood condition to the potential side effects of AstraZeneca’s vaccine branded as Covishield in India – the Capillary Leak Syndrome.
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The EMA’s addition of the syndrome to its list of potential side effects for the AstraZeneca Covid-19 jab comes as the regulator also examines reports of heart inflammation in recipients of the vaccine.
Capillary leak syndrome is a condition that causes fluid to leak out of blood vessels and could cause very low blood pressure, leading to pain, nausea and tiredness or, in the worst case, kidney failure and strokes.
The agency said that the safety committee carried out an in-depth review of six reported cases of the condition among recipients of the AstraZeneca vaccine, over 78 million doses of which have been administered within the EU and UK by the end of May.
“Most of the cases occurred in women and within four days of vaccination,” the EMA said.
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Following its decision, the EMA has told AstraZeneca that it must add Capillary Leak Syndrome to the labeling of its Covid-19 vaccine, called Vaxzevria in Europe and branded as Covishield in India.
“The Committee concluded that Capillary Leak Syndrome should be added to the product information as a new side effect of the vaccine, together with a warning to raise awareness among healthcare professionals and patients of this risk.”
The regulator also warned individuals with a history of the illness to not receive the shot. The European safety committee has been examining reports into the risk of the condition in people who received the vaccine since April amid an investigation into concerns about potential links between the jab and blood clotting.
Earlier, German scientists found out how the broken parts of Johnson & Johnson and AstraZeneca COVID-19 vaccines branded as Covishield in India mutate to trigger blood clots in recipients.
Scientists say the vaccine is sent into the cell nucleus instead of surrounding fluid, where parts of it break off and create mutated versions of themselves. The mutated versions then enter the body and trigger the blood clots.