After alerts had been raised in some countries on post-vaccination “embolic and thrombotic events’, especially in the case of the AstraZeneca-Oxford vaccine which is being sold as Covishield in India, an in-depth analysis was conducted of the adverse events in India by the National Adverse Event Following Immunization (NDEFI) Committee to the Ministry of Health & Family Welfare. In the in-depth analysis, it was found out that the cases of the adverse events post-vaccination in India were ‘minuscule’, but as a precautionary measure, the ministry uploaded a list of suspected thromboembolic symptoms, which are usually witnessed within 20 days after receiving the vaccination. The syAfter alerts had been raised in some countries on post-vaccination “embolic and thrombotic events’, especially in the case of the AstraZeneca-Oxford vaccine which is being sold as Covishield in India, an in-depth analysis was conducted of the adverse events in India by the National Adverse Event Following Immunization (NDEFI) Committee to the Ministry of Health & Family Welfare. In the in-depth analysis, it was found out that the cases of the adverse events post-vaccination in India were ‘minuscule’, but as a precautionary measure, the ministry uploaded a list of suspected thromboembolic symptoms, which are usually witnessed within 20 days after receiving the vaccination.
The symptoms as per the Ministry are:-
- breathlessness
- pain in the 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 the eyes or having double vision
- change in mental status or having confusion or depressed level of consciousness
- Any other symptom or health condition which is of concern to the recipient of the family.
Minutes of the report- Cases of clotting ‘Minuscule’
The report stated that as of April 3, 2021- 7,54,35,381 vaccine doses had been administered, of which 6,86,50,819 were Covishield doses while 67,84,562 were Covaxin doses, and 5,59,44,106 were administered as the first dose while 94,91,275 were administered as the second dose. Since the initiation of the vaccination drive and the administration of the aforementioned doses, over 23,000 adverse events were reported through the Co-WIN platform, of these 700 cases were reported to serious and severe in nature.
Elaborating on it, the committee in the report submitted, “From an in-depth case review of 498 serious and severe events, 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/ million doses.” The report further added, “There were no potential thromboembolic events reported following administration of Covaxin vaccine.”
It is pertinent to mention here that while the reporting rate of these events in India 0.61 million/doses, in the United Kingdom, it is 4 cases/ million doses as reported by UK’s regulator Medical and Health Regulatory Authority and as per the Authorities in Germany, it is 10 cases per million doses. One of the reasons for that is, as per scientific literature, the risk of thromboembolic events is almost 70 percent less in persons of South and South-East Asian descent in comparison to those of European descent.
