Incidents of rare bleeding or blood clotting after Covishield vaccination in India is six cases per 10 million compared with 40 such cases in the UK and 100 in Germany, an expert panel that examined adverse effects has said in its first report.
“The AEFI (Adverse Events Following Immunisation) data in India shows a very minuscule but definitive risk of thromboembolic events,” the Union Health Ministry said in a statement after the National AEFI Committee submitted its report analysing over 7.5 crore vaccine shots, of which 700 cases were considered serious.
With data available up to April 3, the panel completed an in-depth case review of 498 serious and severe events of which 26 cases have been reported to be potential thromboembolic.
Such cases may lead to the formation of a clot in a blood vessel that might also break loose and be carried by the bloodstream to plug another vessel.
“The reporting rate of such events in India is around 0.61/million doses, which is much lower than four cases per million reported by the UK regulator, Medical and Health Regulatory Authority. Germany has reported 10 events per million doses,” the ministry said.
There were no such potential thromboembolic events reported following the administration of the homegrown Covid-19 vaccine, Covaxin, manufactured by Bharat Biotech.
Public concern on the reports of blood clotting associated with the Oxford University-AstraZeneca vaccine was considered one of the factors contributing towards vaccine hesitancy seen in India. This is the same vaccine, which is being made by the Serum Institute of India, with the brand name Covishield.
While such blood clotting does occur in the general population as background, scientific literature suggests that the risk is almost 70% less in people of South and Southeast Asian descent in comparison to those of European descent.
The ministry will now issue advisories to healthcare workers and vaccine beneficiaries to encourage people to be aware of suspected thromboembolic symptoms occurring within 20 days after receiving Covishield and report preferably to the health facility where the dose vaccine was administered.
Despite the risk, Covishield continued to have a definite positive benefit-risk profile with tremendous potential to prevent infections and reduce deaths due to Covid-19 in India and across the world, the ministry added.