CoViD vaccines and thrombotic events: EMA issued warning to patients and healthcare professionals

lots and thrombocytopenia following administration of CoViD-19 vaccines that have raised concerns over the safety of genetic vaccines for people with pre-existing coagulation disorders or those on certain medications. Tis had also led to temporary suspension of Oxford/AZ CoViD vaccine in a number of countries across Europe [1]. As a result, Medicine and Healthcare Regulatory Authority, UK (MHRA) and European Medicines Agency (EMA) initiated a rigorous scientifc review of pharmacovigilance data and available evidence to assess the potential association of the vaccine to recent thrombotic events. MHRA confrmed on 18th March 2021 that the ‘evidence does not suggest that blood clots are caused by COVID-19 Vaccine AstraZeneca and assured that the benefts of the vaccine in preventing COVID-19 far outweigh the thrombotic risks and people should continue taking the vaccine when ofered [2]. Medicine and Healthcare Regulatory Authority (MHRA) further stated that sinus vein thrombosis along with thrombocytopenia has been reported in less than one in a million people vaccinated so far in the UK, it can occur naturally and that a causal association with the vaccine could not be established. However, they will continue to monitor the situation, and as a precautionary measure advised that anyone with a headache lasting more than 4 days after vaccination, or bruising beyond the site of vaccination, should seek medical attention. EMA on the other hand also investigated the events and concluded on 18th March 2021 that the ‘vaccine may be associated with very rare cases of blood clots associated with thrombocytopenia with or without bleeding, including rare cases of clots in the vessels draining blood from the brain’ [3]. EMA stated that a causal link with the vaccine is ‘not proven but possible’ and deserves further analysis. Tey, however, also reassured that the benefts of having a CoViD vaccine still outweigh the risks despite a possible link to the rare blood clots with low blood platelets. Tey also assured a continued monitoring of the situation and further review of thrombotic risk with other CoViD vaccines.

lots and thrombocytopenia following administration of CoViD-19 vaccines that have raised concerns over the safety of genetic vaccines for people with pre-existing coagulation disorders or those on certain medications. Tis had also led to temporary suspension of Oxford/AZ CoViD vaccine in a number of countries across Europe [1]. As a result, Medicine and Healthcare Regulatory Authority, UK (MHRA) and European Medicines Agency (EMA) initiated a rigorous scientifc review of pharmacovigilance data and available evidence to assess the potential association of the vaccine to recent thrombotic events. MHRA confrmed on 18th March 2021 that the ‘evidence does not suggest that blood clots are caused by COVID-19 Vaccine AstraZeneca and assured that the benefts of the vaccine in preventing COVID-19 far outweigh the thrombotic risks and people should continue taking the vaccine when ofered [2]. Medicine and Healthcare Regulatory Authority (MHRA) further stated that sinus vein thrombosis along with thrombocytopenia has been reported in less than one in a million people vaccinated so far in the UK, it can occur naturally and that a causal association with the vaccine could not be established. However, they will continue to monitor the situation, and as a precautionary measure advised that anyone with a headache lasting more than 4 days after vaccination, or bruising beyond the site of vaccination, should seek medical attention. EMA on the other hand also investigated the events and concluded on 18th March 2021 that the ‘vaccine may be associated with very rare cases of blood clots associated with thrombocytopenia with or without bleeding, including rare cases of clots in the vessels draining blood from the brain’ [3]. EMA stated that a causal link with the vaccine is ‘not proven but possible’ and deserves further analysis. Tey, however, also reassured that the benefts of having a CoViD vaccine still outweigh the risks despite a possible link to the rare blood clots with low blood platelets. Tey also assured a continued monitoring of the situation and further review of thrombotic risk with other CoViD vaccines.