Centre to SC: Covid vaccines voluntary, govt cannot be held liable to compensate for vaccine-related deaths

The government cannot be held liable to pay compensation for the deaths which occurred due to the administration of COVID-19 vaccines, the union government stated in an affidavit filed before the Supreme Court. However, several government notifications had indicated that vaccination was almost compulsory for its employees.  

Responding to a petition filed by parents of two girls who died due to the adverse effects of Covishield vaccine, the Ministry of Health and Family Welfare stated that: “The vaccines in use under the vaccination programme 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 Government has 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 government said: “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 MoHFW highlighted that the concept of informed consent was inapplicable to the voluntary use of a drug such as a vaccine. While the Government of India strongly encouraged all eligible persons to undertake vaccination in public interest, there was no legal compulsion for the same.

The Union submitted that the Covid-19 vaccines (including Covshield) had 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 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,” stated the government.

The affidavit underscored that all the relevant information on COVID-19 vaccination was made freely available in the 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 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 arise. 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,” said the health ministry in the affidavit.

The ministry stated that if a person suffered from physical injury or death from an AEFI, the family could approach 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,” said the government.

However, in April 2021 the union government had directed all its employees who are 45 or above to get a shot of Covid-19 to ensure that the spread of the infection was contained. The government memorandum, sent to all the ministries, said that the decision has been taken after monitoring the current Covid-19 situation in the country.

Guidelines released by several state governments had mandated that those travelling by air had to be fully vaccinated, or COVID recovered, or with a negative RTPCR report of the last 72 hours.

MOHFW guidelines state that though the vaccination is voluntary, it is advisable to receive the complete schedule of COVID-19 vaccine to protect oneself against this disease and also to limit the spread of this disease to close contacts including family members, friends, relatives
and co-workers.

Early this year in May, the Supreme Court had made it clear that no individual could be forced to take any vaccination but stated that the government could impose some restrictions in the interest of the community.

The top court bench of Justices L Nageswara Rao and BR Gavai said the condition imposed by a few state governments in restricting access of unvaccinated people to public places is arbitrary and should not be recalled under the present conditions.

The government’s affidavit stated that a total of 219.86 crore doses of Covid 19 vaccines have been administered in the country as on November 19, 2022. 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%).