The Government cannot be held liable to compensate for the deaths occurring due to the administration of COVID-19 vaccines, said the Central Government in an affidavit filed before the Supreme Court.
Responding to a petition filed by parents of two girls who died due to the adverse effects of Covishield vaccine, the Union Government submitted that : "The vaccines in use under the vaccination program are manufactured by third parties and have successfully undergone thorough regulatory review in India as well as other nations. In these facts, holding the State directly liable to provide compensation under the narrow scope of strict liability for extremely rare cases of death occurring due to Adverse Effects Following Immunisation from the use of vaccines may not be legally sustainable"
The Union of India stated that there is "no material to suggest how the State can be fastened with strict liability for the tragic death of the respective children of the Petitioners".
The affidavit filed by the Ministry of Health and Family Welfare highlighted that there was no legal compulsion to obtain vaccination and that the same was purely voluntary.
"The concept of informed consent is inapplicable to the voluntary use of a drug such as a vaccine. While the Government of India strongly encourages all eligible persons to undertake vaccination in public interest, there is no legal compulsion for the same.
All relevant information on COVID-19 vaccination is made freely available in public domain by both the vaccine manufacturer and MoHFW. Further, a vaccine beneficiary has the option to access more information about the vaccine and its possible adverse effects from the health workers at the vaccination site or their doctor before making an informed decision on their own. As such, once a vaccine beneficiary who has access to all relevant information, voluntarily chooses to enter a vaccination center and receive vaccination, the question of a lack of informed consent does not
"Just as a medicine has side effects, AEFIs are reported for every vaccine in the world. A vaccine beneficiary always has the option to access even more information about the vaccine and its possible adverse effects from health workers at the vaccination site or their doctor before making an informed choice of their own," the Union Health Ministry contended
The Affidavit further stated that, "If a person suffers physical injury or death from an AEFI appropriate remedies in law are open to the vaccine beneficiary of their family including approaching civil courts for a claim of damages/compensation for negligence, malfeasance or misfeasance. Such claims may be determined on a case-to-case basis in an appropriate forum."
At the outset, the Union Government expressed its condolences for the death of the daughters of the petitioners, who were aged 19 years and 20 years respectively, and stated that it is deeply sensitive to the concerns raised in the Petition.
The Union has in its affidavit submitted that the vaccine had gone through rigorous process of approval.
"COVID-19 vaccines, including the Covishield vaccine, have gone 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 and continues to be done on a rolling basis. All decisions on vaccine administration are made on the basis of relevant scientific evidence."
Details of AEFIs
According to the affidavit, till 19th November 2022, a total of 219.86 crores doses of Covid 19 vaccines have been administered in the country. A total of 92,114 AEFI cases (0.0042%) have been reported in this period, of which 89,332 (0.0041%) are minor AEFI cases and a total of 2,782 cases are serious and severe AEFIs (0.00013%). The affidavit further stated that the existing mechanism for monitoring, investigation and analysis of AEFIs is adequate and transparent.
The affidavit extensively referred to the Supreme Court's decision in the case Dr.Jacob Puliyel vs Union of India2022 LiveLaw (SC) 439 which approved the Centre Government's vaccine policy.
The petitioners also prayed for direction for appointment an independent expert medical board to inquire and investigate into the deaths of the daughters of the Petitioners No. 1 and 2 and to share the autopsy and investigation in a time bound manner.
It was further prayed for direction to the medical board to prepare a protocol for early detection and timely treatment for the AEFI due to Covid-19 vaccine and a direction to the Respondents to grant significant monetary compensation to the Petitioners.
Case Title : Rachana Gangu & Anr vs. Union of India & Ors. – WP (C) No. 1220/2021