Imposing restrictions on the rights of persons who are unvaccinated is totally unwarranted as there is no basis for discriminating against unvaccinated persons. Vaccinated people are also prone to infection and there is no difference between a vaccinated individual and an unvaccinated person with respect to transmission of the virus. As there is no serious threat of spread of the virus by an unvaccinated person in comparison to a vaccinated person, placing restrictions on unvaccinated persons is meaningless.
Vaccine mandates in the absence of informed consent are unconstitutional
IN THE SUPREME COURT OF INDIA
CIVIL ORIGINAL JURISDICTION
Writ Petition (Civil) No. 607 of 2021
BENCH: L. NAGESWARA RAO and B. R. GAVAI
JACOB PULIYEL …..PETITIONER
UNION OF INDIA & ORS. …..RESPONDENTS
DATE: May 2, 2022
The Petitioner was a member of the National Technical Advisory Group on Immunization (NTAGI) and was advising the Government of India on vaccines. He has filed this Writ Petition in public interest seeking the following relief-
(d) Direct the respondents to disclose the post-vaccination data regarding adverse events, vaccinees who got infected with Covid, those who needed hospitalization and those who died after such infection post-vaccination and direct the respondents to widely publicize the data collection of such adverse event through the advertisement of toll-free telephone numbers where such complaints can be registered; and
(e) Declare that vaccine mandates, in any manner whatsoever, even by way of making it a precondition for accessing any benefits or services, is a violation of rights of citizens and unconstitutional;
In the Writ Petition, the Petitioner highlighted the adverse consequences of emergency approval of vaccines in India, the need for transparency in publishing segregated clinical trial data of vaccines, the need for disclosure of clinical data, lack of transparency in regulatory approvals, minutes and constitution of the expert bodies, imperfect evaluation of Adverse Events Following Immunisation (AEFIs) and vaccine mandates in the absence of informed consent being unconstitutional. The Petitioner further stated in the Writ Petition that coercive vaccination would result in interfering with the principle of informed self-determination of individuals, protected by Article 21 of the Constitution of India.
Potentiality of Vaccine: Vaccines do not prevent infection and transmission. She is of the further belief that natural immunity is the gold standard. According to Dr. Bhargava, there has been no documented case of a naturally immune person getting reinfected with severe disease or hospitalised, despite the first case reported nearly two years ago, whereas, there have been thousands of cases of severe infection, hospitalisation, and deaths in fully vaccinated people.
Objection by Govt: The Union of India has objected to the maintainability of the Writ Petition on the ground that the questions raised by the Petitioner may result in raising doubts in the minds of the citizenry about the vaccination, adding to the already existing vaccine hesitancy in the country.
Objection by Govt: competence of the State in exercise of its powers under the Disaster Management Act, 2005 (hereinafter, the “DM Act”) and the Tamil Nadu Public Health Act, 1939. Section 76(2)(b) thereof empowers the State Government to make vaccinations compulsory,
Govt of India said: “In so far as disclosure of clinical trial data is concerned, the Union of India referred to the National Ethical Guidelines for Biomedical and Health Research involving Human Participants published by the ICMR, which require privacy and confidentiality of human participants to be maintained. Accordingly, the Union of India contended that such details pertaining to identity and records of the participants in the clinical trial data cannot be disclosed to the public as per the prevailing statutory regime. It was asserted by the Union of India that the remaining data has already been made available in the public domain”.
Govt of India said: “According to the Union of India, all cases of serious and severe AEFI, including reported deaths, are subjected to scientific and technical review process with causality assessments done at the state and national levels by trained experts to ascertain whether a particular AEFI can be attributed to the vaccine. In the counter-affidavit, it was also made clear that COVID-19 vaccination is voluntary and that the Government of India encourages all individuals to take vaccination in the interest of public health, as the individual’s ill health has a direct effect on the society. It was also made clear that COVID-19 vaccination is not linked to any benefits or services”.
SUPREME COURT SAID: It is true that this Court lacks the expertise to arrive at conclusions from divergent opinions of scientific issues but that does not prevent this Court from examining the issues raised in this Writ Petition, especially those that concern violation of Article 21 of the Constitution of India.
Identifying the issues in the present matter, can be divided as follows:
I. Vaccine mandates being violative of Article 21 of the Constitution of India.
II. Non-disclosure of segregated clinical trial data in public domain.
III. Improper collection and reporting of AEFIs.
IV. Vaccination of children.
Supreme Court Considered: A letter published in the Lancet, Regional Health45, which states: “In the UK it was described that secondary attack rates among household contacts exposed to fully vaccinated index cases was similar to household contacts exposed to unvaccinated index cases (25% for vaccinated vs 23% for unvaccinated). 12 of 31 infections in fully vaccinated household contacts (39%) arose from fully vaccinated epidemiologically linked index cases. Peak viral load did not differ by vaccination status or variant type….The US Centres for Disease Control and Prevention (CDC) identifies four of the top five counties with the highest percentage of fully vaccinated population (99.9–84.3%) as “high” transmission counties. Many decision-makers assume that the vaccinated can be excluded as a source of transmission. It appears to be grossly negligent to ignore the vaccinated population as a possible and relevant source of transmission when deciding about public health control measures.”
Supreme Court has summarised the various issues as below :
(i) Given the issues urged by the Petitioner have a bearing on public health and concern the fundamental rights of individuals in this country, we are not inclined to entertain any challenge to the maintainability of the Writ Petition.
(ii) As far as judicial review of policy decisions based on expert opinion is concerned, there is no doubt that wide latitude is provided to the executive in such matters and the Court does not have the expertise to appreciate and decide on merits of scientific issues on the basis of divergent medical opinion. However, this does not bar the Court from scrutinising whether the policy in question can be held to be beyond the pale of unreasonableness and manifest arbitrariness and to be in furtherance of the right to life of all persons, bearing in mind the material on record.
(iii) 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. However, 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 to assess whether such invasion into an individual’s right to personal autonomy and right to access means of livelihood meets the threefold requirement as laid down in K.S. Puttaswamy (supra), i.e., (i) legality, which presupposes the existence of law; (ii) need, defined in terms of a legitimate State aim; and (iii) proportionality, which ensures a rational nexus between the objects and the means adopted to achieve them.
(iv) On the basis of substantial material filed before this Court 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.
(v) However, no data has been placed by the Union of India or the States appearing before us, 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. It is 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 to take suitable measures for prevention of infection and transmission of the virus. Our suggestion also does not extend to any other directions requiring maintenance of COVID-appropriate behaviour issued by the Union or the State Governments.
(vi) As regards non-disclosure of segregated clinical data, we find that 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 GCP guidelines and the WHO Statement on Clinical Trials. The material provided by the Union of India, comprising of minutes of the meetings of the SEC, 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 NTAGI 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. However, we reiterate 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.
(vii) We do not accept the sweeping challenge to the monitoring system of AEFIs being faulty and not reflecting accurate figures of those with severe reactions or deaths from vaccines. We note that the role of the Pharmacovigilance Programme of India and the CDSCO, as elaborated upon by the Union of India, collates and studies previously unknown reactions seen during monitoring of AEFIs at the time of vaccine administration and we trust the Union of India to ensure that this leg of the AEFI surveillance system is not compromised with, while meeting the requirements of the rapid review and assessment system followed at the national level for AEFIs.
(viii) We are also of the opinion that information relating to adverse effects following immunisation is crucial for creating awareness around vaccines and their efficacy, apart from being instrumental in further scientific studies around the pandemic. Recognising the imperative need for collection of requisite data of adverse events and wider participation in terms of reporting, the Union of India is directed to facilitate reporting of suspected adverse events by individuals and private doctors on an accessible virtual platform. These reports shall be made publicly accessible, without compromising on protecting the confidentiality of the persons reporting, with all necessary steps to create awareness of the existence of such a platform and of the information required to navigate the platform to be undertaken by the Union of India at the earliest.
(ix) On paediatric vaccination, we recognise that the decision taken by the Union of India to vaccinate children in this country is in tune with global scientific consensus and expert bodies like the WHO, the UNICEF and the CDC and it is beyond the scope of review for this Court to second-guess expert opinion, on the basis of which the Government has drawn up its policy. Keeping in line with the WHO Statement on Clinical Trials and the extant statutory regime, we direct the Union of India to ensure that key findings and results of the relevant phases of clinical trials of vaccines already approved by the regulatory authorities for administration to children, be made public at the earliest, if not already done.
May 2, 2022
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