Cannot Be Held Liable for Deaths Caused by Adverse Reactions to COVID Vaccine: Centre to SC

In an affidavit, the government said that holding the State directly liable to provide compensation for "extremely rare deaths" occurring due to AEFIs from the use of vaccines may not be legally sustainable.

New Delhi: The Union government told the Supreme Court that it cannot be held liable to pay compensation for deaths caused by adverse reactions to COVID-19 vaccines.

The Ministry of Health and Family Welfare (MoHFW) made this submission in an affidavit filed in the apex court in response to a petition by the parents of two women – aged 19 and 20 – who allegedly died due to the adverse effects of a COVID-19 vaccine.

According to the affidavit, as of November 19 2022, 219.86 crore doses of COVID-19 vaccines have been administered in the country. So far, the country has recorded 92,114 cases (0.0042%) of adverse events following immunisation (AEFIs) have been reported in this period, of which 89,332 (0.0041%) are “minor” cases. The remaining 2,782 cases are serious and severe AEFIs (0.00013%).

According to a Scroll report, 1,148 people have died after suffering AEFIs.

The government told the Supreme Court that 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.

The affidavit said that the Union government has made “substantial efforts” in ensuring a safe and effective vaccination programme against COVID-19 amidst the challenges presented by the pandemic. There was no material to suggest how the state can be fastened with strict liability to compensate, it said.

“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 affidavit said.

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 Union government 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 center and receive vaccination, the question of a lack of informed consent does not arise,” the affidavit said.

According to LiveLaw, the affidavit referred to the Supreme Court’s decision in Dr Jacob Puliyel vs Union of India, in which the top court said that no person can be forced to get vaccinated and asked the government to revise restrictions on unvaccinated people. The court also noted in that case that it was “satisfied that the current vaccination policy of the Union of India is informed by relevant considerations and cannot be said to be unreasonable or manifestly arbitrary”.

Apart from seeking compensation, the petitioners also prayed that an independent expert medical board should be appointed to to inquire into and investigate the deaths of their daughters. According to LiveLaw, the petition also prayed for a direction to the medical board to prepare a protocol for early detection and timely treatment for the AEFI due to COVID-19 vaccines.