The Pharmacovigilance Risk Assessment Committee (PRAC) of EMA issued a warning about unusual blood clots and low platelets due to a COVID-19 Vaccine of a renowned pharmaceutical on 20 April 2021. As a cautionary mesure, PRAC emphasized on adding these events on the product info as uncommon side-effects of the vaccine.

This conclusion was based on considering existing evidence including 8 reports of serious cases of unusual blood clots linked with decreased levels of platelets (aged less than 60 years), one of which had a serious outcome in 3 weeks following the vaccination. This vaccine has been administered  in >7 million people in the US till 13th April, 2021.

This committee observed that the blood clots appeared mainly at uncommon sites, for example in veins in the brain's venous sinuses (cerebral venous sinus thrombosis, CVST) and abdomen (splanchnic vein thrombosis) and in arteries, along with decreased platelets and occasionally bleeding.

Prior to receiving the vaccine, the healthcare providers and individuals should be aware of risks of very rare cases of blood clots and decreased platelets arising in 3 weeks of vaccination.

COVID-19 infection is linked with a peril of hospitalisation and death. The reported combination of blood clots and low platelets is unexpected, and the total advantages of this vaccine in COVID-19 prophylaxis compensates the side effects.

One plausible clarification for occurrence of blood clots and decreased platelets is an immune response, causing a disorder similar to heparin induced thrombocytopenia.

Timely identification and treatment of signs of bloods clots and low platelets can promote recovery and elude complications in affected patients.

EMA will endure to screen the vaccine’s safety and efficacy and offer up-to-date information concerning all the vaccines.