AEFI committee's report reveals bleeding, clotting cases from AstraZeneca Covid-19 vaccine minuscule in India
More than 13.4 crore doses of the AstraZeneca Covid-19 vaccine have been administered in the country as on April 27, according to government data.
The National AEFI (Adverse Event Following Immunization) Committee on Monday in a report to the Union health ministry said that the bleeding and clotting cases following coronavirus disease (Covid-19) vaccination in the country are minuscule in line with the expected number of diagnoses of these conditions.
"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," the report said.
"There were no potential thromboembolic events reported following administration of Covaxin vaccine," it added.
More than 23,000 adverse events through the CoWin platform were reported by 684 districts of the 753 of them in the country, since the beginning of the Covid-19 drive, as of April 3. Only 700 cases of these cases (9.3 cases /million doses administered) were reported to be serious and of severe nature, according to the report.
After completing an in-depth case review of 498 serious and severe events, the AEFI committee said that 26 of them have been reported to be potential thromboembolic events.
Also read: 0.61 per million Covishield doses reported clotting, bleeding, says Health ministry
The in-depth analysis of the adverse events in India post-Covid-19 vaccination was conducted after global concerns were raised for “embolic and thrombotic events” in relation to the Oxford/AstraZeneca vaccine. Many European nations halted their vaccination drives as reports of people developing rare blood clots after the administration of the vaccine started surfacing.
Out of the total of more than 20 million vaccine doses administered in the United Kingdom, MHRA, the country's medical regulator reported 79 cases of the adverse event, of which 19 died, as of April 26, reported BBC.
The Oxford/AstraZeneca Covid-19 vaccine is produced in India by the Serum Institute of India in Pune and administered as Covishield.
The national AEFI committee's report suggested that the thromboembolic events keep taking place in the general population, but this risk is almost 70% less in people of south and southeast Asian descent as compared to people from European descent.
The health ministry has also decided to separately issue the advisories to healthcare workers and vaccine beneficiaries to spread awareness about the symptoms occurring within 20 days after the administration of any Covid-19 vaccine, particularly Covishield and to encourage people to report to the health facilities where the shot was administered.
However, the benefits of the Covishield vaccine still outweigh its risks. It continues to "have a definite positive benefit-risk profile with tremendous potential to prevent infections and reduce deaths," as per the government. More than 13.4 crore doses of the AstraZeneca vaccine have been administered in the country as on April 27, according to government data.
India on Monday reported less than 300,000 cases of viral infection for the first time in 26 days, as per the ministry's data.