26 Cases of Miniscule Bleeding, Clotting Reported Post Covishield Jab: Govt Committee

The AEFI Committee, which made this observation after completed an in-depth case review of 498 serious and severe events, however, noted there were no potential thromboembolic events reported following administration of Covaxin vaccine.

New Delhi: 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, said the National AEFI (Adverse Event Following Immunization) Committee in its report submitted to the Union Health Ministry, adding 26 cases have been reported to be potential thromboembolic following the administration of Covishield vaccine.

The AEFI Committee, which made this observation after completed an in-depth case review of 498 serious and severe events, however, noted there were no potential thromboembolic events reported following administration of the Covaxin vaccine.

This came as a decision was taken to conduct an urgent in-depth analysis of the adverse events in India in the light of the global concerns as alerts were raised in some countries on post-vaccination “embolic and thrombotic events” on March 11 particularly with the AstraZeneca-Oxford vaccine [Covishield in India].

The National AEFI committee noted that 75,435,381 vaccine doses had been administered (Covishield – 68,650,819; Covaxin – 6,784,562) as of April 3. 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 through the CO-WIN platform reported from 684 of the 753 districts of the country. Of these, only 700 cases (@ 9.3 cases /million doses administered) were reported to be serious and severe in nature.

The 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/million doses, which is much lower than the four cases/million reported by UK’s regulator Medical and Health Regulatory Authority (MHRA). Germany has reported 10 events per million doses.

According to the Health Ministry, the thromboembolic events keep occurring in the general population as background and scientific literature suggests that this risk is almost 70 percent less in persons of South and Southeast Asian descent in comparison to those of European descent.

READ: CoWIN Reconfigured To Show 12-16 Weeks Gap Between Covishield Doses, Adds Sputnik Info

In tune with the same, advisories have been issued to be aware of suspected thromboembolic symptoms. These include:

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 previous history of seizures with or without vomiting; severe and persistent headache with or without vomiting (in the absence of 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 - occurring within 20 days after receiving any Covid-19 vaccine, particularly Covishield, and report preferably to the health facility where the vaccine was administered.

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, said the Health Ministry, adding over 13.4 crore doses of Covishield vaccine have been administered as of April 27 in India.