Bleeding and clotting cases following COVID vaccination in India are minuscule and in line with the expected number of diagnoses of these conditions in the country, a report submitted by the National AEFI (Adverse Event Following Immunization) Committee to the Ministry of Health & Family Welfare said.

Alerts have been raised in some countries on post-vaccination “embolic and thrombotic events” on 11 March 2021 particularly with the AstraZeneca-Oxford vaccine [Covishield in India]. A decision was taken to conduct an urgent in-depth analysis of the adverse events (AE) in India in the light of the global concerns.

The National AEFI committee noted that as of 03 April 2021, 75,435,381 vaccine doses had been 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 COVID-19 vaccination drive was initiated – more than 23,000 adverse events were reported through the CO-WIN platform reported from 684 of the 753 districts of the country. Of these, only 700 cases (@ 9.3 cases /million doses administered) were reported to be serious and severe nature.

The AEFI Committee has completed an in-depth case review of 498 serious and severe events, of which 26 cases have been reported to be potential thromboembolic (formation of a clot in a blood vessel that might also break loose and carried by the bloodstream 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.

AEFI data in India showed that there is a very minuscule 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 4 cases/million reported by UK’s regulator Medical and Health Regulatory Authority (MHRA). Germany has reported 10 events per million doses.

(SAM)