Govt cannot be held liable for deaths due to COVID-19 vaccination: Centre tells SC

New Delhi: The Union Government has recently informed the Supreme Court that the Centre can not be held liable to compensate for the deaths occurring due to the administration of COVID-19 vaccines.

Clarifying its stand, the Central Government has recorded its response in an affidavit while responding to a plea filed by parents of two girls who lost their lives because of the administration of COVID-19 vaccines.

The Union Government has submitted, "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."

Stating 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 Union Ministry of Health and Family Welfare has further highlighted that there was no legal compulsion for obtaining vaccination and it was completely 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," stated the affidavit.

The Centre's response came in respect to the petitions filed over the death of two girls who had died because of COVID-19 vaccination. Medical Dialogues had earlier reported that the Supreme Court had issued notice in the pleas. Filing the plea the parents of the deceased girls had direction for the appointment of an expert medical board, independent of the government, to inquire into and investigate the deaths of their daughters, and to share the report with them.

Also Read: SC issues notice to Govt over Vaccination Related Deaths Of Two Girls

In the plea, the parent of one of the deceased girls submitted that his daughter had passed away a month after receiving the vaccine. Additionally, he claimed that neither he nor his daughter were given early warning of the possibility of such a serious AEFI (Adverse events following immunization) and that their informed consent was not obtained.

The petitioner had also sought the Apex Court's direction to the expert medical board to prepare a protocol for early detection and timely treatment of AEFI due to the COVID-19 vaccine.

However, as per the latest media report by Live Law, the Union Health Ministry submitted, "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."

"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," further read the affidavit.

However, the Union Health Ministry expressed its condolences for the death of the daughters of the petitioners and also stated that it is deeply sensitive to the concerns raised in the pleas.

Stating that the vaccine had gone through rigorous process of approval, the Central Government further mentioned in the affidavit, "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."