Rohit Shishodia

A report submitted by the National Adverse Event Following Immunization (AEFI) committee has revealed that there is a very miniscule but definitive risk of thromboembolic events after getting Covishield.

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.

India's Health Ministry has said that the committee 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 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,” claimed the ministry.

“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, said the ministry in a press release.

“Alerts have been raised in some countries on post-vaccination “embolic and thrombotic events” on March 11, 2021, particularly with 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,” said the ministry.

The National AEFI committee noted that as of April 3, 2021, a total of 75,435,381 vaccine doses had been administered (Covishield – 68,650,819; Covaxin – 6,784,562).

The ministry informed that 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 in nature.

The ministry has emphasized that it is important to know that thromboembolic events keep occurring in the 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.