Updated June 11th, 2021 at 20:04 IST

COVID-19: European Union recommends product description update for AstraZeneca vaccine

The European Union (EU) drug regulator on June 11 has recommended people with rare blood vessel syndrome to not receive AstraZeneca-Oxford’s COVID-19 vaccine. 

Reported by: Aanchal Nigam
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The European Union (EU) on June 11 has recommended people with rare blood vessel syndrome to not receive AstraZeneca-Oxford’s COVID-19 vaccine. In a statement on Friday, European Medicines Agency (EMA) said that after reviewing at least six cases of people with capillary leak syndrome administered with AstraZeneca jab. The latest recommendation by the EU drug regulator came after the same vaccine has been linked with the cases of rare blood clots among the recipients. However, health officials have said that the benefits of AstraZeneca’s coronavirus vaccine now known as ‘Vaxzevria’ still overpower the small risks associated with it.

The EMA experts have also declared that the capillary leak condition should be added to the product information as a new potential side effect of the dose along with w warning in a bid to raise awareness among the health professionals and patients who face the risk. After reviewing the six individuals who received the AstraZeneca jab, the EU drug regulator said that most of the cases had occurred among women and that too, within four days of vaccination. EMA also said on Friday that “three of those affected had a history of capillary leak syndrome and one of them subsequently died. As of 27 May 2021, more than 78 million doses of Vaxzevria had been administered in the EU/EEA and the UK.”

Further explaining the capillary leak syndrome, EMA said that it is “very rare” and the serious condition causes fluid leakage from small blood vessels or capillaries that lead to swelling mainly in arms and legs. It also causes low blood pressure, thickening of the blood and low blood levels of albumin which is a key blood protein. The European Medicines Agency also said, “Healthcare professionals should be aware of the signs and symptoms of capillary leak syndrome and of its risk of recurrence in people who have previously been diagnosed with the condition.”

AstraZeneca Jabs Linked To Small Risk Of Low Platelet Count

EMA’s recommendation came as a new national study in the UK stated that the Oxford and AstraZeneca’s COVID-19 vaccine also known as Covishield may be associated with a very small risk of developing a blood condition involving low platelet counts. The major risk of a condition called idiopathic thrombocytopenic purpura (ITP) being developed in recipients of the jab is estimated to be 11 per million doses. The researchers noted that similar figures are seen in other vaccines for flu, measles, mumps and rubella (MMR). 

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Published June 11th, 2021 at 20:04 IST