The Union government on Monday May 17 said that the panel investigating adverse events following COVID-19 immunisation has found that there have been 26 cases (a reporting rate of 0.61 per million doses) so far of bleeding and clotting after administration of Serum Institute of India’s Covishield vaccine. A report submitted by the National AEFI (Adverse Event Following Immunization) Committee to the Ministry of Health and Family Welfare said that the number of cases in India are minuscule and are in line with the expected number of diagnoses of these conditions in the country.
The government in a statement said that an in-depth analysis of adverse events was carried out after alerts were raised in some countries in March on post-vaccination “embolic and thrombotic events,” particularly with AstraZeneca-Oxford vaccine. There were no potential thromboembolic events reported following administration of Covaxin vaccine, the government added.
As of April 3, 2021, 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 doses.
The government said that since the COVID-19 vaccination drive was initiated in January 2021, more than 23,000 adverse events were reported through the CO-WIN platform, 684 of the 753 districts of the country. Of these, only 700 cases (which translates to 9.3 cases per million doses administered) were reported to be serious and severe in nature.
After conducting an in-depth case review of 498 serious and severe events, 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, the government 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/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,” a release by the government said.
The Union government said that it is important to know that 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 South East Asian descent in comparison to those from European descent.
The Health Ministry said it 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:
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; and/or change in mental status or having confusion or depressed level of consciousness.
The government has allayed fears over the effectiveness of Covishield and added that it continues to have a 'tremendous potential' in fighting COVID-19 and reducing the intensity of the disease as well as the death rate.
"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 2021 in India. MoHFW is continuously monitoring the safety of all COVID-19 vaccines and is promoting reporting of suspected adverse events," the government added.