Bleeding and clotting following COVID vaccination in India are minuscule and in line with the expected number of diagnoses of these conditions in the country, said a report by the Adverse Event Following Immunization (AEFI) Committee.
Some countries had raised alerts with respect to post-vaccination “embolic and thrombotic events” particularly with AstraZeneca-Oxford vaccine [Covishield in India]. However, the report said that there was no such situation in the country. The committee submitted the report to the Ministry of Health. The ministry decided to conduct an urgent in-depth analysis of the adverse events in the light of the global concerns, an official statement said.
The National AEFI committee noted that as of April 3, 2021, 75,435,381 vaccine doses were administered (Covishield – 68,650,819; Covaxin – 6,784,562). Of these, 65,944,106 were first doses and 9,491,275 second dose. Since the initiation of COVID-19 vaccination drive, more than 23,000 adverse events were reported through the CO-WIN platform. Of these, only 700 cases (@ 9.3 cases /million doses administered) were reported to be serious and severe nature,, the statement said.
The AEFI Committee completed an in-depth case review of 498 serious and severe vents, of which 26 cases reported to be potential thromboembolic (formation of a clot in a blood vessel that might also break loose and carried by the blood stream to plug another vessel) events – following the administration of Covishield vaccine – with a reporting rate of 0.61 cases/ million doses. There were no potential thromboembolic events reported following administration of Covaxin vaccine, the report said.
AEFI data showed that there is a very miniscule but definitive risk of thromboembolic events. The reporting rate of these events in India is around 0.61/million doses, which is much lower than the four cases/million reported by UK’s regulator Medical and Health Regulatory Authority (MHRA). Germany has reported 10 events per million doses.
It is important to know that thromboembolic events keep occurring in general population as background and scientific literature suggests that this risk is almost 70 per cent less in persons of South and South East Asian descent in comparison to those from European descent.