According to data from global regulatory agencies
AstraZeneca COVID-19 Vaccine and CHADOX1 NCOV-19 CORONA VIRUS VACCINE (RECOMBINANT), COVISHIELD / CHADOX1 NCOV-19 CORONA VIRUS VACCINE (RECOMBINANT), COVISHIELD (hereinafter – COVISHIELD) are intended for active immunization of persons aged 18 years and older for the prevention of coronavirus disease (COVID-19).
According to the European Medicines Agency, since the registration of the AstraZeneca COVID-19 vaccine in Europe, very rare reports of thrombosis accompanied by thrombocytopenia after vaccination have been received.
Very rare cases of thromboembolism after administration of the AstraZeneca COVID-19 vaccine have been reported in some countries of the European Economic Area. A combination of thrombosis and thrombocytopenia, in some cases accompanied by bleeding, has been observed very rarely in the post-registration period after vaccination with the AstraZeneca COVID-19 vaccine. These cases included venous thrombosis at unusual sites, such as cerebral venous sinus thrombosis and mesenteric vein thrombosis, as well as arterial thrombosis accompanied by thrombocytopenia. Most of these cases in Europe occurred within the first 7-14 days after vaccination. Some cases were fatal.
Center comment
State Enterprise “State Expert Center of the Ministry of Health of Ukraine” analyzed the available data on registered AEFI following use of the COVISHIELD vaccine (a version of the AstraZeneca COVID-19 vaccine manufactured by SERUM INSTITUTE OF INDIA PVT. LTD, currently used in Ukraine), and reports that, according to pharmacovigilance data in Ukraine, no cases of thrombosis have been registered.
Key issues
- After vaccination with AstraZeneca COVID-19 vaccine, a combination of thrombosis and thrombocytopenia, in some cases accompanied by bleeding, has been observed very rarely.
- Healthcare professionals should pay attention to the signs and symptoms of thromboembolism and thrombocytopenia in patients who were previously vaccinated with COVISHIELD.
- Persons vaccinated with COVISHIELD should seek medical attention immediately if, after vaccination, they develop symptoms such as shortness of breath, chest pain, leg swelling and persistent abdominal pain. Medical attention should be sought in the event of any neurological disorders, including sudden onset of severe or persistently worsening headache or blurred vision a few days after vaccination, or the appearance of bruising on the skin (other than at the vaccination site) or petechiae, starting a few days after vaccination.
- According to the scientific review of this issue, the benefits of the COVISHIELD vaccine (version of the AstraZeneca COVID-19 vaccine) continue to outweigh the risks.
Report adverse events following immunization (AEFI)
Identification and management of risks associated with the use of the COVISHIELD vaccine depend on the timely provision of information on AEFI.
Any adverse events following immunization after the COVISHIELD vaccine must be reported to the State Expert Center of the Ministry of Health of Ukraine through the Automated Pharmacovigilance Information System, available at the linkhttps://aisf.dec.gov.ua
