No cases of adverse event involving blood clots have been reported in India in the case of the Oxford-AstraZeneca vaccine, according to top officials involved in the country's coronavirus inoculation campaign, who also said a deeper review of post-vaccination side effects will be carried out next week.
The announcement came after several countries halted the roll-out of the AZD1222 vaccine, which is separately being administered in India as Covishield (the version made by Serum Institute of India). AstraZeneca, the World Health Organization (WHO) and European Medicines Agency (EMA) have said the shot is safe to use.
Nonetheless, India will review adverse events following immunisation (AEFI) data from across the country for any reports of blood clots or similar adverse reaction. "The review is taking place as a matter of abundant precaution, even though India so far has not reported any cases of clotting related damage that is in medical terms called thromboembolic phenomenon. It has been reported in a Scandinavian country, but we have decided to scrutinise India data very carefully," said Dr NK Arora, member of the national task force on Covid-19 vaccination's committee on AEFI.
"The health ministry will be providing raw AEFI data from across the country for next week's review," he added.
Union ministry of health and family welfare held a separate meeting with nodal officers of AEFI committees at the state level on Friday, to collate updated data on adverse events reported from across the country.
After reports of blood clots and one death from Denmark, eight other countries—Norway, Iceland, Austria, Estonia, Lithuania, Luxembourg, Italy, and Latvia— also temporarily suspended use of AZD1222 as a precautionary measure.
The EMA said that it is reviewing the matter and has not established a link between vaccination and these clotting events.
"The Covid Task Force has been asked to look into the issue, but for them to review the matter they need raw data that we will provide. Though there has been no case of blood clots reported so far in the country, we are finding out if anything similar has been reported from anywhere in the country in individuals who have been administered the vaccines," said Rajesh Bhushan, secretary, Union health ministry.
The meeting will continue on Saturday, and the date for national committee meeting will be decided based on the outcome of Saturday's meeting.
The central and state governments have been conducting AEFI surveillance at multiple levels. There is an AEFI expert committee in place at the district, state and national level. The health ministry is collating AEFI data from the state AEFI committee nodal officers.
"Broadly speaking there are two types of adverse events post vaccination: mild and those that cause death or hospitalization. It is the latter that is of concern to us, and we want to be doubly sure that this is not happening in our country," said Dr Arora.
"It will be an entirely independent review that will involve high-level experts from the field. It will also be a rolling kind of a review so that we analyse real-time data. All deaths and hospitalizations post Covid-19 vaccinations will be reviewed in great detail," he added.