No material to link girls’ deaths with Covid vaccine: Govt to SC

The government said that Covid-19 vaccines, including Covishield, went through a rigorous regulatory approval process with several layers of independent expert review. “The data submitted by the vaccine manufacturer on the safety and efficacy of the said vaccine has been closely examined by various expert bodies…,” it said, adding “all decisions on vaccine administration are made on the basis of relevant scientific evidence”.

The ministry said that AEFI are expected to occur in the administration of every vaccine and are as such monitored by all countries. It added that AEFI “may or may not have a casual relationship with the usage of the vaccine”.

The government said that till November 19, 2022, a total of 210.96-crore doses of Covid-19 vaccines were administered in the country and that a total of 92,114 AEFI cases were reported during this period, which works out to 0.0042 per cent. Of this, 89,332 (0.0041 per cent) are “minor” cases and 2,782 (0.00013 per cent) are “serious and severe”.

It added that “…any such serious/severe AEFI, including death, cannot be attributed to vaccination till the same is casually assessed by the National AEFI Committee”.

The affidavit pointed out that in the case of one of the girls, the committee officially classified Thrombosis and Thromocytopenia Syndrome (TTS) as the cause of death. A total of 26 TTS cases linked to AEFI were reported in India till September 30, 2022, of which 12 patients died, it said.

The other girl, it said, was diagnosed with Multisystem Inflammatory Syndrome of Children (MIS-C) and that “as of now, there is no global evidence to associate” it “with Covid-19 vaccines…” and, hence, can only be considered an Adverse Event of Special Interest (AESI) and not AEFI.