Publish reports on adverse events of vaccines from the public and doctors, Govt told
New Delhi, May 2 (PTI): The Supreme Court on Monday held that no individual can be forced to be vaccinated against Covid-19, observing that bodily integrity is protected under Article 21 of the Constitution.
Asking the Centre to make public data on the Covid immunisation’s adverse events, the top court, however, said that in the interest of protection of communitarian health, the government is entitled to regulate issues of public health concern by imposing certain limitations on individual rights, which are open to scrutiny by constitutional courts.
Upholding the government’s current Covid vaccination policy, the court said on the basis of available material and considering expert views the policy “cannot be said to be manifestly arbitrary and unreasonable”.
Noting that the Covid infection rate in the country remains low, the court also suggested a review of the existing orders and that no restriction be imposed on unvaccinated individuals on access to public areas or recall the same if already not done. The number of active Covid cases rose by 408 in a 24-hour span to reach 19,500 on Monday, according to the latest Union Health ministry data.
Observing that restrictions on unvaccinated individuals imposed through various vaccine mandates by State Governments/Union Territories cannot be said to be proportionate, the court clarified that the suggestion to review the vaccine mandates imposed is limited to the present situation alone.
“With respect to the infringement of bodily integrity and personal autonomy of an individual considered in the light of vaccines and other public health measures introduced to deal with the Covid-19 pandemic, we are of the opinion that bodily integrity is protected under Article 21 of the Constitution and no individual can be forced to be vaccinated.
“Further, personal autonomy of an individual, which is a recognised facet of the protections guaranteed under Article 21, encompasses the right to refuse to undergo any medical treatment in the sphere of individual health,” said a bench of Justices L Nageswara Rao and B R Gavai in its 115-page judgement.
The judgement came on a petition filed by Dr Jacob Puliyel, a former member of the National Technical Advisory Group on Immunisation, who has sought directions to disclose post-vaccination data regarding adverse events among other pleas.
The bench also reiterated that subject to the protection of privacy of individual subjects, with respect to ongoing clinical trials and trials that may be conducted subsequently for Covid-19 vaccines, all relevant data required to be published under the extant statutory regime must be made available to the public without undue delay.
“On the basis of substantial material, reflecting the near-unanimous views of experts on the benefits of vaccination in addressing severe disease from the infection, reduction in oxygen requirement, hospital and ICU admissions, mortality and stopping new variants from emerging, this Court is 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.”
Contrasting scientific opinion coming forth from certain quarters to the effect that natural immunity offers better protection against Covid-19 is not pertinent for determination of the issue before us, the court said.
The bench said that no data has been placed by the Union of India or the States controverting the material placed by the petitioner in the form of emerging scientific opinion which appears to indicate that the risk of transmission of the virus from unvaccinated individuals is almost on par with that from vaccinated persons.
“In light of this, restrictions on unvaccinated individuals imposed through various vaccine mandates by State Governments/Union Territories cannot be said to be proportionate.
“Till the infection rate remains low and any new development or research finding emerges which provides due justification to impose reasonable and proportionate restrictions on the rights of unvaccinated individuals, we suggest that all authorities in this country, including private organisations and educational institutions, review the relevant orders and instructions imposing restrictions on unvaccinated individuals in terms of access to public places, services and resources, if not already recalled,” the bench said.
It clarified that in the context of the rapidly-evolving situation presented by the Covid-19 pandemic, our suggestion to review the vaccine mandates imposed by States /Union Territories, is limited to the present situation alone and is not to be construed as interfering with the lawful exercise of power by the executive.
Noting that information relating to adverse effects following immunisation is crucial for understanding the safety of the vaccines, the apex court directed the Centre to set up a virtual public platform to facilitate individuals and private doctors to report adverse vaccine events.
“Union of India is directed to facilitate the reporting of suspected adverse events by individuals and private doctors on a virtual platform and the reports so made shall be publicly accessible after being given unique identification numbers, without listing any personal or confidential data of the persons reporting.
“All necessary steps to create awareness of, and to navigate, this platform for self-reporting shall be effectuated by the Government, roping in and training relevant participants right from the ground level of vaccine administration,” the top court said.
On the issue of vaccination for children, the bench said that it is not possible to second guess the opinion of experts and the vaccination indeed follows global standards and practices.
“The decision taken by the Union of India to vaccinate paediatric population in this country is in tune with global scientific consensus and expert bodies like the WHO, the UNICEF and the United States Center for Disease Control and Prevention have also advised paediatric vaccination.
“It would not only be beyond our jurisdiction but also hazardous if this Court were to examine the accuracy of such expert opinion, based on competing medical opinions. As already stated, the scope of judicial review does not entail the Court embarking upon such misadventures,” the court said while rejecting the contention of the petitioner that this Court has to intervene in paediatric vaccination on the ground that it is unscientific.
As regards non-disclosure of segregated clinical data, the court said the results of Phase III clinical trials of the vaccines in question have been published, in line with the requirement under the statutory regime in place.
“The material provided by the Union of India, comprising of minutes of the meetings of the Subject Expert Committee, do not warrant the conclusion that restricted emergency use approvals had been granted to COVISHIELD and COVAXIN in haste, without thorough review of the relevant data.
“Relevant information relating to the meetings of the SEC and the National Technical Advisory Group on Immunisation are available in public domain and therefore, challenge to the procedures adopted by the expert bodies while granting regulatory approval to the vaccines on the ground of lack of transparency cannot be entertained,” the court said.