Bleeding and clotting cases following coronavirus 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 and Family Welfare said.
"Following the alerts in some countries on post-vaccination “embolic and thrombotic (clotting) events” with AstraZeneca-Oxford vaccine (Covishield in India), a decision was taken to conduct an urgent in-depth analysis of the adverse events in India in the light of the global concerns," the health ministry said on Monday.
However, the government, citing AEFI data, said that even if it's very miniscule, there is a definitive risk of clotting events.
Since the vaccination drive was initiated – more than 23,000 adverse events were reported through the Co-Win platform reported from 684 districts of the country. Of these, only 700 cases (9.3 cases per million doses administered) were reported to be serious and severe nature.
The AEFI committee has completed an in-depth case review of 498 serious events, of which 26 cases have been reported to be potential clotting events – following the administration of Covishield vaccine – with a reporting rate of 0.61 cases per million doses.
This reporting rate of clotting is much lower than the 4 cases per million reported by UK’s regulator Medical and Health Regulatory Authority (MHRA). Germany has reported 10 events per million doses, according to the union health ministry.
There were no potential clotting events reported following administration of Covaxin vaccine.
The health ministry says it is important to know that clotting 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.
"Covishield continues to have a definite positive benefit risk profile with tremendous potential to prevent infections and reduce deaths due to Covid-19 across the world and in India," it said.