The government has told the Supreme Court that taking a Covid-19 vaccine is not binding on anyone, and so the concept of informed consent is not applicable.
Vaccine beneficiaries, according to the government, have the option to access more information about the vaccine and its adverse events. In an affidavit filed before the top court, it said there is no legal compulsion to take the vaccine.
“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 government’s remarks come in response to a petition that links the deaths of two young women to the side effects of the Covid-19 vaccine they were administered. The parents of the two women had filed a joint petition in the Supreme Court.
“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 operational guidelines issued by the central government to all states and Union Territories state that vaccination is voluntary, the affidavit said, adding that just as a medicine has side effects, adverse events following immunisation (AEFI) are reported for every vaccine in the world.
In a 276-page reply to a court notice seeking its response to the petition, the government said the vaccine, Covishield, had gone through a rigorous safety review and regulatory approval process before it got clearance.
Refuting the claims of the government, Malini Aisola, co-convenor of All India Drugs Action Network (AIDAN), said Covid vaccination was aggressively promoted by the government.
“In spite of rolling out relatively untested vaccines, repeated assurances were provided regarding their safety and efficacy, but the government failed to provide adequate information about potential serious side effects, such that individuals could assert a choice.
“In the case of Covishield, advisories for identifying and treating TTS were never publicly disseminated for the benefit of vaccine beneficiaries and medical personnel. They were never even uploaded to the MOHFW website,” she said.