The number of bleeding and clotting events following a Covid vaccine jab in India is “miniscule”, a panel on National Adverse Event Following Immunisation (AEFI) told the Union Health Ministry on Monday.
The panel said it had studied 498 (of 700) “serious and severe events” and found that 26 had been reported as “potential thromboembolic events”, referring to the potentially fatal formation of a blood clot that could break loose and be carried by the blood stream to block another vessel.
The panel further said Covishield—the AstraZeneca-Oxford University vaccine linked by some studies to clotting issues—reported fewer than 0.61 cases per million doses administered.
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.