Unusual blood clots with low blood platelets should be listed as a very rare side effect of the AstraZeneca vaccine, the safety committee of the European Medicines Agency (EMA) has concluded.
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The agency has checked 62 cases of cerebral venous sinus thrombosis and 24 cases of splanchnic vein thrombosis reported in the EU drug safety database, as of March 22, 2021.
One of the explanations for the combination of blood clots and low blood platelets is an immune response, leading to a condition similar to one sometimes seen in patients treated with heparin, according to EMA.
“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,” EMA reported.
Still, people who have received the vaccine should seek medical assistance immediately if they develop symptoms related to a combination of blood clots and low blood platelets.
Patients should seek medical assistance immediately if they have the following symptoms:
- shortness of breath;
- chest pain;
- swelling in the leg;
- persistent abdominal (belly) pain;
- neurological symptoms, including severe and persistent headaches or blurred vision;
- tiny blood spots under the skin beyond the injection site.
EMA has reminded 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.
Most cases reported have occurred in women under 60 years of age within 14 days after vaccination so far. Based on currently available evidence, specific risk factors have not been confirmed.
One explanation for the combination of blood clots and low blood platelets is an immune response, leading to a condition similar to one sometimes seen in patients treated with heparin, according to EMA.
The agency will continue monitoring the vaccine’s safety and effectiveness.
Slovakia to monitor the situation
The State Institute for Drug Control (ŠÚKL) respects the EMA statement and is ready to monitor the safety of the AstraZeneca vaccine as well.
Similarly to the European authority, the institute stressed the need for early diagnosis and treatment, claiming that it helps prevent more serious complications, the SITA newswire reported.
ŠÚKL has meanwhile contacted the Health Ministry, ready to discuss a vaccination strategy in Slovakia.
The topic will be discussed by a group of epidemiological and immunology experts, who are supposed to meet on April 8, Health Ministry spokesperson Zuzana Eliášová said, as reported by the TASR newswire.
Read more about the coronavirus developments in Slovakia:
- Measures valid in Slovakia as of March
- Statistics of the positive coronavirus cases
- Tightened border regime: State orders self-isolation and testing for all incomers as of February 17
- Do I have the new coronavirus? How to proceed if you have a suspicion
- I encountered a person who is COVID-19 positive. What do I do next? (FAQ)
- When will I get my COVID vaccine? FAQs about vaccination in Slovakia