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.
The Union Health Ministry is separately issuing advisories to Healthcare Workers and Vaccine Beneficiaries to encourage people to be aware of suspected thromboembolic symptoms occurring within 20 days after receiving any COVID-19 vaccine (particularly COVISHIELD) and report preferably to the health facility where the vaccine was administered.
The symptoms are breathlessness, pain in chest, pain in limbs/pain on pressing limbs or swelling in limbs (arm or calf), multiple, pinhead size red spots or bruising of skin in an area beyond the injection site, persistent abdominal pain with or without vomiting, seizures in the absence of the previous history of seizures with or without vomiting, severe and persistent headache with or without vomiting (in the absence of the previous history of migraine or chronic headache), weakness/paralysis of limbs or any particular side or part of the body (including face), persistent vomiting without any obvious reason, blurred vision or pain in eyes or having double vision, change in mental status or having confusion or depressed level of consciousness and any other symptom or health condition which is of concern to the recipient or the family.
"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. Over 13.4 crore doses of Covishield vaccine have been administered as on April 27 in India," the ministry added.
MoHFW is continuously monitoring the safety of all COVID-19 vaccines and is promoting reporting of suspected adverse events.
( With inputs from ANI )
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