The National Adverse Event Following Immunization (AEFI) Committee in its report submitted to the Union Health Ministry said that 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. According to a statement issued on Monday by the Ministry of Health and Family Welfare, alerts have been raised in some countries on post-vaccination “embolic and thrombotic events” on March 11 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 Health Ministry statement said. The National AEFI committee noted that as of April 3, 75,435,381 vaccine doses had been administered (COVISHIELD – 68,650,819 and 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 from 684 of the 753 districts of the country through CoWIN. Of these, only 700 cases i.e., 9.3 cases per million doses administered, were reported to be serious and severe nature,” the AEFI Committee report said.
According to the AEFI Committee, it 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 per million doses.
“There were no potential thromboembolic events reported following administration of COVAXIN vaccine,” the statement issued by the Health Ministry said. 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 per million doses, which is much lower than the 4 cases per million reported by the United Kingdoms’s regulator Medical and Health Regulatory Authority (MHRA).
Germany has reported 10 events per million doses.
The ministry further said that thromboembolic events keep occurring in the general population as background and scientific literature suggest that this risk is almost 70 per cent less in persons of South and Southeast Asian descent in comparison to those of European descent.
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