In a 276-page reply to a court notice seeking its response to the petition, the government said the vaccine, Covishield, had gone through a rigorous safety review and regulatory approval process before it got the clearance.
The parents of the women, meanwhile, said they were going to counter every point of the government’s response.
The government, which also provided details of the approval procedure, said the regulatory approval process of vaccines under the Drugs and Cosmetics Act and Rules was a “well-established”, “internationally recognised system” with “several layers of independent expert review for safety and efficacy”.
Detailing the process for Covid-19 vaccines, the government said once a vaccine was approved for use by the Central Drugs Standard Control Organisation, a detailed examination of scientific evidence and data would be conducted by the National Immunisation Technical Advisory Group (NTAGI).
Further, it said, the recommendations of the NTAGI would undergo another layer of expert review by the National Expert Group on Vaccine Administration for Covid-19. The final recommendations on use and administration would then be placed before the Ministry of Health for its approval.
In September this year, the Supreme Court had admitted a writ petition filed jointly by the families of the two women and issued notice to the government.
A 20-year-old woman had died last year, about a month after she was given the vaccine. The second woman, an 18-year-old from Hyderabad, died allegedly due to vaccine induced thrombotic thrombocytopenia (TTC).
While the parents had claimed that they were not informed about the consequences of the vaccine before it was administered, the government in its affidavit said requisite information and advisories on TTS had been placed in public domain by both the health ministry and the vaccine manufacturer.
The government also said the concept of informed consent was inapplicable to the voluntary use of a drug such as a vaccine as there was no legal compulsion for taking it.
The government also said the existing mechanism for monitoring, investigating and analysis of adverse events following immunisation was adequate, effective and transparent.
Venugopalan Govindan, the father of the 20-year-old who died, said the affidavit by the government “is shocking to say the least”.
“In the affidavit, the government claims that adverse events such as blood clots were publicised and people knew. But the fact is that the government publicised the vaccines as completely safe and effective without any riders, misleading people like us and sending my daughter and many others to their untimely deaths,” he said.