Bleeding, clotting events after COVID vaccination 'miniscule': Central panel report

India has an adversity reporting rate of only 9.3 cases per million doses

People over 18 years of age wait to receive COVID-19 vaccine doses at one of the largest vaccination sites set up by BLK-Max hospital at Radha Soami Satsang Beas grounds, in New Delhi | PTI The committee completed an in-depth case review of 498 serious and severe events, of which 26 cases have been reported to be potential thromboembolic | PTI

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, a report submitted by the National AEFI (Adverse Event Following Immunization) Committee to the Union health ministry said on Monday.

As of April 3, of the 7.54 crore vaccine doses administered (Covishield – 6.86 crore and Covaxin – 67.84 lakh), there were only 700 cases that were reported to be serious and severe in nature. That puts it at a rate of 9.3 cases per million doses administered. More than 23,000 adverse events were reported through the CO-WIN platform from 684 of the 753 districts of the country, the national AEFI committee noted. 

The committee stated that it 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 per 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 per million doses, which is much lower than the 4 cases per million reported by UK’s regulator Medical and Health Regulatory Authority (MHRA). Germany has reported 10 events per million doses," the report stated. 

The panel report comes in the backdrop of some countries reporting “embolic and thrombotic events” post-vaccination with the AstraZeneca-Oxford vaccine, which is branded as Covishield in India. As on April 27, more than 13.4 crore doses of Covishield vaccine have been administered in India.



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