The Centre told Supreme Court that while vaccination was strongly encouraged, there was "no legal compulsion" to take the COVID-19 vaccine. More importantly, the health ministry clarified that "the concept of informed consent was inapplicable to the voluntary use of a drug such as a vaccine".
The Centre's submissions came on a plea filed by parents who lost both their daughters because of a side effect from the 'Covishield' vaccine. In their plea, the parents sought compensation, a probe into the adverse effects of vaccines and guidelines for early detection and treatment for the same.
Just like any medicine, vaccine may have side effects: Centre
The Health Ministry said just like medicines have side effects, vaccines may also have side effects. Approval for a vaccine undergoes a rigorous process with independent expert review before being released to the public, the reply said.
"The Centre along with the states/union territories have merely administered the National COVID-19 Vaccination Program/ the vaccines in use under the vaccination program are manufactured by third parties and have successfully undergone thorough regulatory review..." the exhaustive 276-page reply read.
The Supreme Court also gave its stamp of approval to the process in its 2021 Jacob Puliyel matter, it said. In a key judgment on the government's COVID-19 vaccine policy, the top court said no one could be forced to get vaccinated; Centre's vaccine policy was not arbitrary; data on vaccine trials and adverse events after immunization must be made public; and the court could not second guess expert opinion on the issue of the vaccination policy for children.
"Adverse Events Following Immunization (AEFIs) are reported for every vaccine," the reply said. "India has extensive experience in large-scale vaccinations and has a robust system of vaccination administration and AEFI surveillance," it added. Over the years, India has developed a world-class AEFI monitoring and investigation system, it further said.
"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," it said.
"All relevant information on COVID-19 vaccination is made freely available in the public domain by both the vaccine manufacturer and Ministry of Health and Family Welfare," the reply read. Thus, if an individual—who has access to all relevant information—chooses to voluntarily take the vaccine then the question of lack of informed consent does not arise," the Centre said.
The health ministry circulated "Operational Guidelines" to all states and stakeholders which clearly recommended that all vaccination beneficiaries should be informed about the benefits and side effects of the vaccine they choose to take. The Center said the guidelines also stated that beneficiaries must be observed for 30 minutes post taking the shot against the novel coronavirus "to detect, manage and treat any immediate adverse reactions".
Thus, in such cases, holding the government responsible under the narrow scope of strict liability was legally unsustainable, said the Centre