27th September 2021
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EMA on AstraZeneca: ‘possible link to very rare cases of unusual blood clots’

Latest: Coronavirus in Spain figures (15 Apr)

The safety committee of the European Medicine Agency (EMA) has concluded on Wednesday that ‘unusual blood clots with low blood platelets should be listed as very rare side effects’ of the AstraZeneca vaccine against Covid-19.

The EMA’s safety committee – known as the Pharmacovigilance Risk Assessment Committee (PRAC) – said that it had taken into consideration ‘all currently available evidence, including the advice from an ad hoc expert group’.

It concluded that healthcare professionals and people receiving the vaccine should ‘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’.

It went on to say that, ‘so far, most of the cases reported have occurred in women under 60 years of age and within two weeks of vaccination’.

The EMA has said that people who have received the AstraZeneca vaccine should seek medical assistance immediately if they develop symptoms of this combination of blood clots and low blood platelets:

  • shortness of breath
  • chest pain
  • swelling in your leg
  • persistent abdominal (belly) pain
  • neurological symptoms, including severe and persistent headaches or blurred vision
  • tiny blood spots under the skin beyond the site of injection

The 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.

The EMA’s safety committee reported that it had carried out an in-depth review of 62 cases of ‘cerebral venous sinus thrombosis’ and 24 cases of ‘splanchnic vein thrombosis’ reported in the EU’s drug safety database, as of 22 March, and of which 18 cases proved fatal. The cases came from the EU and the UK, where around 25 million people had received the vaccine.

The EMA has stated that ‘one plausible explanation for the combination of blood clots and low blood platelets is an immune response, leading to a condition similar to one seen sometimes in patients treated with heparin (heparin induced thrombocytopenia, HIT)’. The PRAC has requested new studies and amendments to on-going ones to provide more information and will take any further actions necessary.

In its statement, the EMA also reiterates that Covid-19 is ‘associated with a risk of hospitalisation and death’. It states that the reported combination of blood clots and low blood platelets is very rare, and insists that the ‘overall benefits of the AstraZeneca vaccine in preventing Covid-19 outweigh the risks of side effects’.

Click here to read the EMA’s full report.

AstraZeneca
Research at AstraZeneca. (Library image)

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