The Centre clarified to the Supreme Court that there was no legal compulsion to get a vaccination for COVID-19. In an affidavit filed in the Supreme Court, the Centre submitted that 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,” the affidavit read.
The Centre’s response came to a petition filed by two parents whose daughters have allegedly passed away due to the side effects of the COVID vaccine. If a person suffers physical injury or death from Adverse Events Following Immunization (AEFI), appropriate remedies in law are open to the vaccine beneficiary or 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,” the Centre said further submitting: “there is no material evidence to suggest how the State can be fastened with strict liability for the tragic death of the respective children of the petitioners which is the requirement in law to sustain a claim for compensation against the State under Article 32 of the Constitution.”
On the contrary, the union government said that the facts placed in this affidavit show how the Government of India has made substantial efforts in ensuring a safe National COVID-19 Vaccination Program. The Centre also clarified that information on COVID-19 vaccination is made freely available in the public domain by both the vaccine manufacturer and the Ministry of Health and Family Welfare (MoHFW).
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 the health workers at the vaccination site or their doctor before making an informed decision on their own, the government said that as it submitted that 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, it added. The Centre has opposed the petition seeking compensation from the respondents on the death of their respective children and said that causation analysis has revealed that the death of the daughter of the first petitioner was from a vaccine product-related reaction while in the case of the daughter of the second petitioner, there is insufficient evidence to arrive at a definitive conclusion.
The Centre also said that the existing mechanism for monitoring, investigation and analysis of AEFIs under the National AEFI Committee and Secretariat is adequate, effective, transparent, and guided by global best practices and scientific medical experts. “The prayers made by the Petitioners in regard to an independent review of AEFI cases ought not to be granted by this Court as the same would plant a seed of doubt in the existing regulatory and AEFI monitoring mechanism and harm the public interest. It may be noted that the Petitioners have failed to show how the existing AEFI monitoring and investigation system has proven to be inadequate in the present case,” Centre said urging the court to dismiss the plea.