![]() ![]() The PRAC has requested new studies and amendments to ongoing ones to provide more information and will take any further actions necessary. 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). Use of the vaccine during vaccination campaigns at national level will also take into account the pandemic situation and vaccine availability in the individual Member State. 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.ĮMA’s scientific assessment underpins the safe and effective use of COVID-19 vaccines. 1 The cases came mainly from spontaneous reporting systems of the EEA and the UK, where around 25 million people had received the vaccine.ĬOVID-19 is associated with a risk of hospitalisation and death. ![]() The Committee 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 drug safety database ( EudraVigilance) as of 22 March 2021, 18 of which were fatal. 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. People who have received the vaccine should seek medical assistance immediately if they develop symptoms of this combination of blood clots and low blood platelets (see below). Based on the currently available evidence, specific risk factors have not been confirmed. So far, most of the cases reported have occurred in women under 60 years of age within 2 weeks of vaccination. In reaching its conclusion, the committee took into consideration all currently available evidence, including the advice from an ad hoc expert group.ĮMA is reminding 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 2 weeks of vaccination. EMA confirms overall benefit-risk remains positiveĮMA’s safety committee ( PRAC) has concluded today that unusual blood clots with low blood platelets should be listed as very rare side effects of Vaxzevria (formerly COVID-19 Vaccine AstraZeneca).
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