Bleeding and clotting cases following Corona vaccination in India are minuscule and are in line with the expected number of diagnoses of these conditions in the country, a report submitted by the National Adverse Event Following Immunization (AEFI) Committee to the ministry of health and family welfare said.
The health ministry advisory follows alerts raised in some countries on post-vaccination “embolic and thrombotic events,” 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.
The National AEFI committee noted that as of 3 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 Corona 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 (ie, 9.3 cases /million doses administered) were reported to be serious and severe in 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 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.
AEFI data in India showed that there is a very miniscule 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.
It is important to know that thromboembolic 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.
MOHFW 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 Corona vaccine (particularly Covishield) and report preferably to the health facility where vaccine was administered:
Watch out these blood clot symptoms:
- Difficulty in breathing/breathlessness
- Chest pain
- ·Pain/swelling in limbs or pain on pressing limbs
- Pinhead sized red spots or skin bruising beyond injection site
- Abdominal pain with or without vomiting
- Seizures with no record history of seizures with or without vomiting
- Severe headache with or without vomiting (absence of recorded history of migraine or chronic headache)
- Weakness or paralysis of limbs or any particular part of the body including face
- Persistent vomiting without any obvious reason
- Pain in eyes or blurred vision or double vision
- Changes in mental status including depressed level of consciousness
- Any other symptom or health condition of concern to the recipient of the vaccine