The government cannot be held liable to compensate for the deaths due to an adverse event following immunisation (AEFI) post administration of Covid-19 vaccines, the Centre has told the Supreme Court.
The affidavit filed in the apex court by the Centre assumes significance in view of the fact that the government has been zealously pursuing the Covid-19 vaccination programme to fight the pandemic and, as per latest reports, over 219 crore doses have been administered.
The affidavit was filed in response to a petition by the parents of two girls who died allegedly due to adverse effects following Covid vaccination.
It claimed vaccines manufactured by third parties had successfully undergone regulatory review, and holding the state directly liable to provide compensation may not be legally sustainable.
"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, being recognised globally as safe and effective," it said.
"In these facts, it is most humbly submitted that holding the State directly liable to provide compensation under the narrow scope of strict liability for extremely rare deaths occurring due to AEFIs from the use of vaccines may not be legally sustainable," the affidavit said.
It said the Centre has made substantial efforts in ensuring a safe and effective vaccination programme against Covid-19 in the middle of a highly challenging situation presented by the pandemic.
The affidavit, filed by the Union ministry of health and family welfare (MoHFW), said there was no material to suggest how the State can be fastened with strict liability to compensate.
It added there was no legal compulsion to obtain vaccination and that it 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," it said.
The Centre further added that all relevant information on Covid-19 vaccination was made freely available in public domain by both the vaccine manufacturers and MoHFW and that the petitioners were free to access more information on their own about possible adverse effects of a vaccine.
"As such, once a vaccine beneficiary who has access to all relevant information, voluntarily chooses to enter a vaccination centre and receive vaccination, the question of a lack of informed consent does not arise," the affidavit said.
The daughters of the petitioners were aged 19 and 20 years.
