Miniscule bleeding, clotting events post Covishield inoculation in India

New Delhi: India has reported 26 potential cases of bleeding and clotting after administration of Covishield vaccine, a government panel investigating adverse events following COVID-19 immunisation has found.

The Union Health Ministry said in a statement on Monday that over 23,000 adverse events have been reported since the vaccination drive involving Covishield and Covaxin vaccines started in the country and of these 700 cases were reported to be serious.

The National Adverse Event Following Immunisation committee (AEFI) 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 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,” the ministry said.

As alerts were raised in some countries on post-vaccination “embolic and thrombotic events” on March 11 particularly with AstraZeneca-Oxford vaccine (Covishield), a decision was taken to conduct an urgent in-depth analysis of the adverse events (AE) in India in the light of global concerns, the ministry said.

The National AEFI committee noted that as of April 3, 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 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 statement said.

“The 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,” the statement stated.

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.

The 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 vaccine was administered.

The symptoms listed 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 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).

The symptoms also include weakness or 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 or any other symptom or health condition which is of concern to the recipient or the family.

The ministry said that 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 27 April in India.

The ministry is continuously monitoring the safety of all COVID-19 vaccines and is promoting reporting of suspected adverse events.