The European Medicines Agency has confirmed that the AstraZeneca coronavirus vaccine can lead to blood clots in “very rare cases.”
The regulator noted that the benefits of the vaccine outweigh the risk of any side effects.
It called for unusual blood clots with low blood platelets to be listed as one of the “very rare side effects” of the vaccine, which was recently renamed 'Vaxzevria.'
It noted that a total of 86 cases have been detected in the European Economic Area (EEA) and the UK – where around 25 million people have received the vaccine.
Emer Cooke, EMA's Exec. Director: "EMA’s expert committee on the safety of medicines (#PRAC) has confirmed that the benefits of the AstraZeneca vaccine in preventing #COVID19 overall outweigh the risks of side effects.”
— EU Medicines Agency (@EMA_News) April 7, 2021
In a statement, the regulator said healthcare professionals should be 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 noted that most of the cases to date have occurred in women under 60 years of age within two weeks of vaccination.
“COVID-19 is associated with a risk of hospitalisation and death,” it said.
“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.”
It said anyone who has received the vaccine should seek medical help if they develop any of the following symptoms:
- 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 review examined a total of 86 reported cases - including 62 where blood clots occurred in the brain (cerebral venous sinus thrombosis or CVST) and 24 where they occurred in the abdomen (splanchnic vein thrombosis of SVT).
The review examined a total of 86 reported cases - including 62 where blood clots occurred in the brain (cerebral venous sinus thrombosis or CVST) and 24 where they occurred in the abdomen (splanchnic vein thrombosis of SVT).
Some 18 of the cases were fatal.
The EMA said the vaccine is effective at preventing COVID-19 and reduces the risk of hospitalisation and death from the virus.
