JACOB PULIYEL v. UNION OF INDIA & ORS.

The Judgment of the Court was delivered by L. NAGESWARA RAO, J.

1Copy pinpoint1. The Petitioner was a member of the National Technical Advisory Group on Immunization (NTAGI) and was advising the Government of G India on vaccines. He has filed this Writ Petition in public interest seeking the following reliefs: “(a) Direct the respondents to release the entire segregated trial data for each of the phases of trials that have been H

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A undertaken with respect to the vaccines being administered in India; and (b) Direct the respondent No 2 to disclose the detailed minutes of the meetings of the Subject Expert Committee and the NTGAI with regard to the vaccines as directed by the B 59 th Parliamentary Standing Committee Report and the members who constituted the committee for the purpose of each approval meeting; and (c) Direct the respondent No.2 to disclose the reasoned decision of the DCGI granting approval or rejecting an application for emergency use authorization of vaccines and the documents and reports submitted to the DCGI in support of such application; and (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 (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; and (f) Pass any other orders as this Hon’ble Court deems fit.”

2Copy pinpoint2. 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 G 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. H

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3Copy pinpoint3. Notice was issued in the Writ Petition on 09.08.2021. An A additional affidavit was filed by the Petitioner on 03.09.2021 raising additional grounds. It was averred in the additional affidavit that natural immunity is long-lasting and robust in comparison to vaccine immunity and that vaccines do not prevent infection or transmission of COVID-

19. The Petitioner further stated that vaccines are not effective in B preventing against infection from new variants of COVID-19. The Petitioner relied on news articles on the fourth nationwide serological survey conducted by Indian Council of Medical Research (ICMR) in June and July, 2021, according to which up to two-thirds of the Indian population above the age of 6 years had already been infected with COVID-19 and had antibodies specific to the SARS-CoV-2 virus. The C Petitioner relied upon other news articles and research studies conducted to state that there had been breakthrough infections even amongst vaccinated people. Urging that research has shown that vaccinated people also transmit the virus, the Petitioner contended that vaccine mandates are meaningless. D

4Copy pinpoint4. The Petitioner filed an Interlocutory Application seeking a direction to restrain all authorities and institutions, public and private, from mandating the vaccine in any manner whatsoever, on a precondition of accessing any service or on pain of any penalty. The Petitioner has drawn the attention of this Court to various restrictions that were placed by State Governments, other employers and educational institutions on unvaccinated individuals. The Petitioner contended that mandating vaccination for access to resources, public places and means of earning livelihood would be in violation of their fundamental rights, especially so, when scientific studies have shown that unvaccinated persons do not pose more danger of transmission of the virus when compared to vaccinated persons.

5Copy pinpoint5. Respondent No. 1, the Union of India, has raised a preliminary objection regarding the maintainability of the Writ Petition. The Union of India has further contended that the serious threat posed by the unprecedented pandemic which had devastating effects on the entire world called for emergency measures. It is accepted world over that vaccination for COVID-19 is necessary to avoid infection. India was one of the few countries in the world which succeeded in manufacturing vaccines for protection from COVID-19, one of which was COVAXIN, India’s indigenous vaccine and the other being COVISHIELD, which H

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A was manufactured by Serum Institute of India with technology transfer from AstraZeneca / Oxford University. The country started one of the largest inoculation programmes in the world in larger public interest, while tackling challenges of vaccine hesitancy, effect of the second wave of the pandemic and other such adverse circumstances. The Union of India expressed serious doubts about the intention of the Petitioner in B filing this Writ Petition. As we have not seen the end of the pandemic caused due to the COVID-19 virus, any interference with the steps taken by the Union on the basis of the advice given by the NTAGI and other expert bodies would provide impetus to the already prevailing vaccine hesitancy in certain sections of the society. In their counter- C affidavit, the Union of India reminded us that decisions of domain experts should not normally be interfered with in judicial review and that this Court should not sit in appeal over a scientific process undertaken by domain experts on a subject which is not the expertise of any judicial forum. The long-drawn procedure for making applications for issuance of licenses for manufacturing vaccines and the statutory regime governing the same have been referred to in the counter-affidavit to emphasize that the Union of India has not been remiss in grant of emergency licences. There is a detailed procedure for approval with checks at every stage which has been followed for grant of emergency approval. 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.

6Copy pinpoint6. On the subject of monitoring of AEFIs, the Union of India brought to our attention established procedures and protocols in place for surveillance of AEFIs established under the National Adverse Event G Following Immunisation Surveillance Guideline. Further, the multi-tier structure comprising AEFI Committees at the state and national levels, providing guidance, carrying out investigation and causality assessment was elaborated upon. Details of the procedures followed in accordance with globally accepted practices were highlighted in the counter-affidavit. H According to the Union of India, all cases of serious and severe AEFI,

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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.

7Copy pinpoint7. Counter-affidavits have been filed by other Respondents as well. The vaccine manufacturers, i.e.,Respondents Nos. 4 and 5, have brought to the notice of this Court that approval to their vaccines was granted after strict compliance of the procedure prescribed. The States of Tamil Nadu, Maharashtra, Delhi and Madhya Pradesh have also filed counter-affidavits, justifying the restrictions that were placed on unvaccinated persons in public interest. The details of the restrictions have been discussed later. D

8Copy pinpoint8. We have heard Mr. Prashant Bhushan, learned counsel for the Petitioner, Mr. Tushar Mehta, learned Solicitor General of the Union of India, Mr. S. Guru Krishnakumar, learned Senior Counsel for Respondent No. 4, Mr. Amit Anand Tiwari, learned Additional Advocate General for the State of Tamil Nadu, Mr. Rahul Chitnis, learned counsel for the E State of Maharashtra, Ms.Mrinal Gopal Elker, learned counsel for the State of Madhya Pradesh and Ms.Shyel Trehan, learned counsel for Respondent No. 5. Preliminary Issues I. Maintainability F

9Copy pinpoint9. The learned Solicitor General raised a preliminary objection as to the maintainability of the Writ Petition which is filed in public interest. He stated that this Writ Petition, if entertained, would harm public interest, as any observation made by this Court against vaccination would result in potential threat of vaccine hesitancy. G

10Copy pinpoint10. The Petitioner is a paediatrician, who was a member of the NTAGI earlier. It has been stated in the Writ Petition that he has a number of publications in internationally peer-reviewed medical journals to his credit. The Petitioner strongly believes that there cannot be coercive vaccination, especially of inadequately tested vaccines, which amounts H

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A to an intrusion into the individual’s personal autonomy. He is also of the firm opinion that an individual is deprived of the opportunity to give informed consent in the absence of availability of segregated data of clinical trials of the vaccines. He has also aired further grievances pertaining to poor evaluation and reporting of AEFIs.

11Copy pinpoint11. This Court is entitled to entertain a public interest litigation moved by a person having knowledge in the subject-matter of the lis and, thus, having an interest therein, as contradistinguished from a busybody, in the welfare of people1. 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. The consequence would be a debilitating effect on public health and therefore, the petition cannot be said to be in public interest. In other words, the maintainability of the Writ Petition is raised on the ground that the sensitive issue of vaccination should not be dealt with by this Court, as it has the propensity of fuelling doubts about the efficacy of the vaccines.

12Copy pinpoint12. From the rejoinder affidavit submitted by the Petitioner, we note that a petition had been filed by the Petitioner earlier, during his tenure as a member of the NTAGI, with respect to the Rotavac vaccine claiming that adequate data from the clinical trials had not been provided to the NTAGI. The rejoinder affidavit further states that the petition was dismissed by this Court, on the ground that the Petitioner could not have filed the said petition while being a member of the NTAGI. The enthusiasm of the Petitioner in approaching this Court has not gone unobserved. However, as the issues raised by the Petitioner have a bearing on public health and pertain to the fundamental rights of the country’s populace, we are of the opinion that they warrant due consideration by this Court. Therefore, we are not inclined to entertain the challenge mounted by the Union of India to the maintainability of the Writ Petition. II. Judicial review of executive decisions based on expert opinion

13Copy pinpoint13. Yet another ground taken by the Union of India is that this Court has to yield to executive decision and action in the matter of administration of drugs / vaccines. The existence of any other possible 1 H Indian Banks’ Association, Bombay v. Devkala Consultancy Service (2004) 11 SCC 1

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view cannot enable this Court to interfere in matters relating to opinion A of domain experts by sitting in appeal over such decisions, while adjudicating a writ petition filed under Article 32 of the Constitution. The learned Solicitor General supported the stand of the Union of India with reference to the law laid down by this Court in Academy of Nutrition Improvement v. Union of India2, G. Sundarrajan v. Union of India3 B and Shri Sitaram Sugar Company Ltd. v. Union of India4. Further, the learned Solicitor General relied upon the judgments of the Supreme Court of the United States (hereinafter, the “US Supreme Court”) in HenningJacobson v. Commonwealth of Massachusetts5, Zucht v. King6and in Docket No. 21A240 titled Joseph R. Biden v. Missouri dated 13.01.2022 and the judgment of the Supreme Court of New South C Wales (hereinafter, the “NSW Supreme Court”) in Kassam v. Hazzard; Henry v. Hazzard7 to bolster his submissions that courts should not lightly interfere with matters of policy concerning the safety and health of the people and it is not the court’s function to determine the merits of the exercise of power by the executive. The learned Solicitor D General was joined by Mr. Amit Anand Tiwari, learned Additional Advocate General for the State of Tamil Nadu, in emphasising the limited scope of judicial review in matters of policy framed on the basis of expert opinion.

14Copy pinpoint14. In opposition, the Petitioner argued that matters of public importance involving invasion of fundamental rights of individuals cannot be brushed aside by this Court on the ground that they are beyond the jurisdiction of this Court. This Court has a duty to safeguard the fundamental rights of individuals and issues raised herein are of seminal importance which ought to be decided after assessing the relevant material placed before this Court by both sides. Mr. Bhushan referred to the judgement of the High Court of New Zealand in Ryan Yardley v. Minister for Workplace Relations and Safety 8 in support of his submission that the scientific data and evidence that was produced before the High Court of New Zealand was assessed to adjudge the efficacy of vaccines in preventing transmission of the COVID-19 virus. 2 (2011) 8 SCC 274 G 3 (2013) 6 SCC 620 4 (1990) 3 SCC 223 5 197 US 11 (1905) 6 260 US 174 (1922) 7 [2021] NSWSC 1320 8 [2022] NZHC 291 H

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15Copy pinpoint15. It was further argued by Mr. Bhushan that the judgments relied upon by the Union of India are not applicable to the facts of this case. He relied upon the judgments of this Court in Delhi Development Authority v. Joint Action Committee, Allottee of SFS Flats 9 , Directorate of Film Festivals v. Gaurav Ashwin Jain10and an order of this Court in Distribution of Essential Supplies and Services During B Pandemic, In re11 and submitted that policy decisions taken by the executive are not beyond the scope of judicial review, if they are manifestly arbitrary or unreasonable.

16Copy pinpoint16. Before examining the parameters of judicial review in this case, it is profitable to refer to judgments from beyond our borders which C have dealt with the scope of judicial review in matters relating to public health and vaccinations, in particular. Compulsory vaccination against small pox was the subject-matter of Jacobson (supra) decided in 1905. The US Supreme Court was of the opinion that the mandate of the local government for compulsory vaccination was binding on every individual. D The safety and health of the people has to be protected by the government and the judiciary is not competent to interfere with decisions taken in the interest of public health. The Court can interfere by way of judicial review of legislative action in matters of public health only when there is no real or substantial relation to the object of the legislation or when there is plain, palpable invasion of rights secured by fundamental law and thereby, give effect to the Constitution.

17Copy pinpoint17. In the wake of the COVID-19 pandemic, restrictions on attendance at religious services in areas classified as ‘red’ or ‘orange’ zones were imposed by an executive order issued by the Governor of New York. The said restrictions were challenged on the ground that they violate the free exercise clause of the First Amendment of the Constitution of the United States. By a majority of 6:3, the US Supreme Court in Roman Catholic Diocese v. Cuomo12 granted injunctive relief on being satisfied that the executive order struck at the very heart of the First Amendment’s guarantee of religious liberty. While doing so, the US G Supreme Court observed that the members of the Court are not public health experts and they should respect the judgment of those with special expertise and responsibility in this area. However, the Constitution cannot 9 (2008) 2 SCC 672 10 (2007) 4 SCC 737 11 (2021) 7 SCC 772 12 H 141 S. Ct. 63 (2020)

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be put away and forgotten even in a pandemic. Gorsuch, J., who wrote A a concurring opinion, observed that Jacobson (supra)hardly supports cutting the Constitution loose during a pandemic. Jacobson (supra) was distinguished by Gorsuch, J., who held that the Court did not interfere with the challenged law in Jacobson (supra) only because it did not “contravene the Constitution of the United States” or “infringe any right granted or secured by” it. A word of caution sounded by Gorsuch, J. is to the effect that the Court cannot stay out of the way in times of crisis, when the Constitution is under attack. In his dissent, Roberts, C.J. held that the injunction sought would not be in public interest, especially when it concerns public health and safety needs which calls for swift government action in everchanging circumstances. He relied upon the earlier order passed by the US Supreme Court in South Bay United Pentecostal Church v. Newsom13 wherein it was recognised that courts must grant elected representatives broad discretion when they undertake to act in areas fraught with medical and scientific uncertainties.

18Copy pinpoint18. Biden v. Missouri (supra) related to vaccine mandates for healthcare providers. The Secretary of Health and Human Services issued a rule on being convinced that vaccination of healthcare workers in facilities in the Medicare and Medicaid Programs against COVID–19 was “necessary for the health and safety of individuals to whom care and services are furnished”. The said rule was challenged and the US District Courts for the Western District of Louisiana and the E Eastern District of Missouri each entered preliminary injunctions against its enforcement. The appeals filed against the said injunction were rejected by the Fifth Circuit in Louisiana and the Eighth Circuit in Missouri. Aggrieved thereby, the Government moved the US Supreme Court seeking for a stay on the preliminary injunctions passed by the US District F Courts. While granting stay of the preliminary injunctions, by its plural opinion the US Supreme Court held that the role of courts in reviewing decisions taken by the executive should be to ensure that the executive “has acted within a zone of reasonableness”.

19Copy pinpoint19. Having been aggrieved by certain orders of the Minister for G Health and Medical Research that required people working in the construction, aged care and education sectors to be compulsorily vaccinated, Al-Munir Kassamand three others, along with Natasha Henry and five others, approached the NSW Supreme Court challenging the 13 140 S. Ct. 1613 (2020) H

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A constitutional validity of the decision. While considering the grounds of challenge, the NSW Supreme Court in Kassam v. Hazzard (supra) was of the view that “it is not the Court’s function to determine the merits of the exercise of the power by the Minister to make the impugned orders, much less for the court to choose between plausible responses to the risks to the public health posed by the Delta B variant”. The NSW Supreme Court further observed that it is not the court’s function to conclusively determine the effectiveness of some of the alleged treatments for those infected or the effectiveness of COVID- 19 vaccines, especially their capacity to inhibit the spread of the disease, which are all matters of merits, policy and fact for the decision maker C and not the court. The NSW Supreme Court emphasised that its only function is to determine the legal validity of the impugned orders. The said view of the NSW Supreme Court was approved by the New South Wales Court of Appeal in Kassam v. Hazzard; Henry v. Hazzard14.

20Copy pinpoint20. The Minister for Workplace Relations and Safety passed D COVID-19 Public Health Response (Specified Work Vaccinations) Order 2021, by which it was determined that work carried out by certain police and defence force personnel could only be undertaken by workers who have been vaccinated. Three police and defence force workers who did not wish to be vaccinated sought judicial review of the said order before the High Court of New Zealand (hereinafter, the “NZ High E Court”). While adjudicating the dispute, the NZ High Court in Ryan Yardley (supra) expressed its opinion that the choices made by governments on their response to COVID-19 involve wide policy questions, including decisions on the use of border closures, lockdowns, isolation requirements, vaccine mandates and many other measures, which are decisions for the elected representatives to make. The NZ High Court made it clear that the Court addresses narrower legal questions and the Court’s function is not to address the wider policy questions. While referring to the evidence of experts, the NZ High Court stressed on the institutional limitations on the Court’s ability to reach definitive conclusions but clarified that the Court must exercise its constitutional responsibility to ensure that decisions are made lawfully. While relying upon a judgment of the Court of Appeal of New Zealand in Ministry of Health v. Atkinson15, the NZ High Court held that the Crown has the burden to demonstrate that a limitation of a fundamental right is 14 [2021] NSWCA 299 15 H [2012] NZCA 184

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demonstrably justified. We have come to know that in the time since the judgment in this matter was reserved, the decision of the NZ High Court in Ryan Yardley (supra) has been appealed by the Government of New Zealand before the New Zealand Court of Appeal.

21Copy pinpoint21. We shall now proceed to analyse the precedents of this Court on the ambit of judicial review of public policies relating to health. It is well settled that the Courts, in exercise of their power of judicial review, do not ordinarily interfere with the policy decisions of the executive unless the policy can be faulted on grounds of mala fide, unreasonableness, arbitrariness or unfairness etc. Indeed, arbitrariness, irrationality, perversity and mala fide will render the policy unconstitutional16.It is neither within the domain of the courts nor the scope of judicial review to embark upon an enquiry as to whether a particular public policy is wise or whether better public policy can be evolved. Nor are the courts inclined to strike down a policy at the behest of a petitioner merely because it has been urged that a different policy would have been fairer or wiser or more scientific or more logical17. Courts do not and cannot act as appellate authorities examining the correctness, suitability and appropriateness of a policy, nor are courts advisors to the executive on matters of policy which the executive is entitled to formulate. The scope of judicial review when examining a policy of the Government is to check whether it violates the fundamental rights of the citizens or is opposed to the provisions of the Constitution, or opposed to any statutory provision or manifestly arbitrary18.

22Copy pinpoint22. This Court in a series of decisions has reiterated that courts should not rush in where even scientists and medical experts are careful to tread. The rule of prudence is that courts will be reluctant to interfere with policy decisions taken by the Government, in matters of public health, after collecting and analysing inputs from surveys and research. Nor will courts attempt to substitute their own views as to what is wise, safe, prudent or proper, in relation to technical issues relating to public health in preference to those formulated by persons said to possess technical expertise and rich experience19. Where expertise of a complex nature is expected of the State in framing rules, the exercise of that power not

16 Ugar Sugar Works Ltd. v. Delhi Administration (2001) 3 SCC 635 17 Villianur Iyarkkai Padukappu Maiyam v. Union of India (2009) 7 SCC 561 18 Directorate of Film Festivals v. Gaurav Ashwin Jain (2007) 4 SCC 737 19 Academy of Nutrition Improvement v. Union of India (2011) 8 SCC 274 H

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A demonstrated as arbitrary must be presumed to be valid as a reasonable restriction on the fundamental right of the citizen and judicial review must halt at the frontiers. The Court cannot re-weigh and substitute its notion of expedient solution. Within the wide judge-proof areas of policy and judgment open to the government, if they make mistakes, correction is not in court but elsewhere. That is the comity of constitutional jurisdictions in our jurisprudence. We cannot evolve a judicial policy on medical issues. All judicial thought, Indian and Anglo-American, on the judicial review power where rules under challenge relate to a specialised field and involve sensitive facets of public welfare, has warned courts of easy assumption of unreasonableness of subordinate legislation on the strength of half-baked studies of judicial generalists aided by the ad-hoc learning of counsel. However, the Court certainly is the constitutional invigilator and must act to defend the citizen in the assertion of his fundamental rights against executive tyranny draped in disciplinary power.20

23Copy pinpoint23. There is no doubt that this Court has held in more than one judgment that where the decision of the authority is in regard to a policy matter, this Court will not ordinarily interfere since decisions on policy matters are taken based on expert knowledge of the persons concerned and courts are normally not equipped to question the correctness of a policy decision. However, this does not mean that courts have to abdicate their right to scrutinise whether the policy in question is formulated keeping in mind all the relevant facts and the said policy can be held to be beyond the pale of discrimination or unreasonableness, bearing in mind the material on record.21 In Delhi Development Authority (supra), this Court held that an executive order termed as a policy decision is not beyond the pale of judicial review. Whereas the superior courts may not interfere with the nitty-gritty of the policy, or substitute one by the other but it will not be correct to contend that the court shall lay its judicial hands off, when a plea is raised that the impugned decision is a policy decision. Interference therewith on the part of the superior court would not be without jurisdiction as it is subject to judicial review. It was further held therein that the policy decision is subject to judicial review on the following grounds: a) if it is unconstitutional; 20 Pyarali K. Tejani v. Mahadeo Ramchandra Dange (1974) 1 SCC 167 21 Union of India v. Dinesh Engineering Corporation (2001) 8 SCC 491 H

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b) if it is dehors the provisions of the Act and the regulations; A c) if the delegatee has acted beyond its power of delegation; d) if the executive policy is contrary to the statutory or a larger policy.

24Copy pinpoint24. During the second wave of COVID-19 pandemic, this Court B in Distribution of Essential Supplies & Services during Pandemic (supra), to which one of us was a party (L Nageswara Rao, J.), dealt with issues of vaccination policy, pricing and other connected issues. While doing so, this Court held that policy-making continues to be the sole domain of the executive and the judiciary does not possess the authority or competence to assume the role of the executive. It was made clear that the Court cannot second guess the wisdom of the executive when it chooses between two competing and efficacious policy measures. However, it continues to exercise jurisdiction to determine if the chosen policy measure conforms to the standards of reasonableness, militates against manifest arbitrariness and protects the right to life of all persons.

25Copy pinpoint25. There can be no ambiguity in the principles of law relating to judicial review laid down by this Court. A perusal of the judgments referred to above would clearly show that this Court would be slow in interfering with matters of policy, especially those connected to public health. There E is also no doubt that wide latitude is given to executive opinion which is based on expert advice. However, it does not mean that this Court will not look into cases where violation of fundamental rights is involved and the decision of the executive is manifestly arbitrary or unreasonable. 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 F from examining the issues raised in this Writ Petition, especially those that concern violation of Article 21 of the Constitution of India.

26Copy pinpoint26. Identifying the issues in the present matter, they can be divided as follows: G 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. H

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A IV. Vaccination of children. I. Vaccine Mandates A. Submissions

27Copy pinpoint27. Mr. Bhushan submitted that there is nothing wrong in the B Government encouraging the people to get vaccinated. However, coercive vaccination from the pain of denial of essential services is plainly unconstitutional, being violative of the principle of bodily autonomy and the right to access one’s means of livelihood. Though the Union of India has made a categorical submission that vaccines are voluntary, the State Governments have been placing restrictions on unvaccinated people by denying them access to public places and services. He referred to: (i) an order passed by the Government of NCT of Delhi on 08.10.2021 by which government employees, including frontline workers and healthcare workers, as well as teachers and staff working in schools and colleges were not to be allowed to attend their respective offices and institutions without the first dose of vaccination with effect from 16.10.2021; (ii) a directive issued by the Government of Madhya Pradesh on 08.11.2021 stating that it was mandatory to be vaccinated with two doses of the vaccine to get food grains at fair price shops; (iii) an order passed by the Government of Maharashtra dated 27.11.2021 requiring persons to be fully vaccinated if they are connected with any program, event, shop, establishment, mall and for utilising public transport; (iv) an order issued by the Government of Tamil Nadu dated 18.11.2021 permitting only vaccinated people into open, public places, schools, colleges, hostels, boarding houses, factories and shops; and other instances where students in the age group of 15 to 18 years were not permitted to appear for their examinations without being vaccinated.

28Copy pinpoint28. Mr. Bhushan contended that there is need to balance individuals’ rights with public interest concerning health. According to him, vaccine mandates can be on the basis of efficacy and safety of vaccination and prevention of transmission. He submitted that there is sufficient evidence to the effect that natural immunity acquired from a COVID-19 infection is long-lasting and robust in comparison to vaccine immunity. Studies also indicate that vaccines do not prevent infection from the virus or transmission amongst people. Vaccines are also ineffective in preventing infection from new variants. According to serological studies, 75 per cent of the Indian population has already been H

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infected and is seropositive and, therefore, they have better immunity to infection than what is provided by the vaccines. The vaccines which are being administered in this country are only authorised for emergency use and the procedure for clinical trials of such vaccines has not been fully complied with. In view of the lack of transparency in disclosure of trial data resulting in absence of informed consent, any vaccine mandate would be unconstitutional. Mr. Bhushan contended that every individual has personal autonomy and cannot be forced to be vaccinated against his will. For the said proposition, he relied on the judgments of Common Cause (A Registered Society) v. Union of India 22 , Aruna Ramachandra Shanbaug v. Union of India23 and K. S. Puttaswamy v. Union of India24. Imposing restrictions on the rights of persons who are unvaccinated is totally unwarranted as there is no basis for discriminating against unvaccinated persons. He relied upon scientific studies, opinions of experts and news articles to contend that 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.

29Copy pinpoint29. Per contra, the learned Solicitor General of India contended that more than 180 crore doses had been administered, resulting in a substantial number of individuals in the country being vaccinated. He E submitted that the vaccines have proved to be effective and safe and any indulgence by this Court would result in vaccine hesitancy. The Government had taken extra care to appoint various committees to examine the efficacy, safety, immunogenicity, pharmacodynamics of the vaccines before granting approvals. Some of the material placed before F this Court to bolster the Union of India’s submissions have been listed below: (a) ‘Science Brief: SARS-CoV-2 Infection-induced and Vaccine-induced immunity’ of the United States Centers for Disease Control and Prevention (CDC) updated as on G 29.10.2021, which in its conclusion states that: “Numerous immunologic studies and a growing number of 22 (2018) 5 SCC 1 23 (2011) 4 SCC 454 24 (2017) 10 SCC 1 H

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vaccination status (the number of vaccine shots received and time interval since the last dose) and the vaccines’ clinical efficacy in India in preventing the disease and its severity. This study has several noteworthy findings. Firstly, both the Indian vaccines provided a significant protective role in preventing the disease among people who had a clinical suspicion of COVID-19. Secondly, These vaccines protected from progression to a severe form of the disease among the patients who turned RT- PCR positive despite getting vaccinated. The probability of hospitalisation was about eight times less, and ICU admission/death was about fourteen times lesser among fully vaccinated patients in comparison to unvaccinated RT-PCR positive patients. Thirdly, the protective efficacy of the vaccines had a dose-dependent effect. The effectiveness is maximum among individuals who received both doses of vaccination at least two weeks before the onset of their symptoms.” (d) A study conducted by researchers of AIIMS, Patna 27, which concludes as follows: “COVID-19 vaccination was found to be effective in infection prevention. One out of two and four out of five individuals were found to be protected against SARS-CoV-2 infection following partial and full vaccination, respectively. The vaccinated individuals had lesser LOS compared to unvaccinated ones. Additionally, the fully vaccinated individuals were less likely to develop severe disease.” LOS herein refers to the length of hospital stays. F

30Copy pinpoint30. On behalf of the State of Tamil Nadu, Mr. Amit Anand Tiwari, learned Additional Advocate General, submitted that the restrictions placed by way of the circular dated 18.11.2021 are within the competence of the State in exercise of its powers under the Disaster Management the dose-effect association between the number of doses and duration since the last G dose of COVID-19 vaccine, and its efficacy in preventing the disease and reducing disease severity: A single centre, cross-sectional analytical study from India” Diabetes & Metabolic Syndrome: Clinical Research & Reviews Volume 15, Issue 5 (2021), 102238 27 Singh C, Naik BN, Pandey S, et al. “Effectiveness of COVID-19 vaccine in preventing infection and disease severity: a case-control study from an Eastern State of India.” Epidemiology and Infection. 2021;149:e224 H

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A 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, in the event of a declaration by the Government of an outbreak of a notified disease. He submitted that the restrictions placed by the circular dated 18.11.2021 are in larger public interest and cannot be said to be unreasonable restrictions, as these were an essential facet of the precautionary approach adopted by the State of Tamil Nadu in dealing with the unprecedented pandemic. According to Mr. Tiwari, these restrictions were in furtherance of the State realising the importance of curtailing the spread of COVID-19. The unchecked spread of the virus could lead to further dangerous mutations. While referring to opinions of experts in the field of health, including that of the World Health Organization (WHO), the United Nations International Children’s Emergency Fund (UNICEF) and the Oxford Vaccine group, as well as scientific studies published in the New England Journal of Medicine, the Lancet and the International Journal of Scientific Studies, it was submitted on behalf of the State of Tamil D Nadu that vaccination prevents severe disease and significantly reduces hospitalisation and mortality and that vaccines continued to be highly effective in preventing severe disease and death. The measures were justified on the ground that they were not only aimed for the safety of a particular individual but also served a greater purpose of ensuring safety of the community at large.

31Copy pinpoint31. Mr. Rahul Chitnis, learned counsel appearing for the State of Maharashtra, referred to the information provided by the WHO to contend that vaccines save infected individuals from “life threatening complications, … and consequential untimely death” and therefore, vaccine mandate issued by the State of Maharashtra is in the interest of general public. The restrictions that are imposed are reasonable and cannot be said to “manifestly arbitrary” as they are issued only for a temporary period with exclusions and are reviewed periodically by the State to assess if relaxations can be granted. He submitted that there is no compulsion to get vaccinated, however, in view of the serious threat that not being vaccinated poses to the right of life and personal liberty of the larger population, certain unavoidable restrictions have been imposed, especially given that strict adherence to social distancing and masking is significantly compromised in bigger cities.

32Copy pinpoint32. The complaint of the Petitioner in relation to prevention of access to essential resources in the State of Madhya Pradesh pertains

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to ration not being provided to unvaccinated persons through the public distribution system. We were informed by the learned counsel for the State of Madhya Pradesh that the order dated 08.11.2021, by which vaccination was made mandatory for receiving ration from fair price shops, was not implemented and was eventually withdrawn on 07.01.2022.

33Copy pinpoint33. In the counter-affidavit filed on behalf of the Government of B NCT of Delhi, it was submitted that the order dated 08.10.2021 was issued by the Delhi Disaster Management Authority after due application of mind, to control the spread of COVID-19 and mitigate its effects. Under Section 6(2)(i) of the DM Act, the National Disaster Management Authority has been issuing orders from time to time directing State Governments and Union Territories, amongst other authorities, to take effective measures to prevent the spread of COVID-19, and in furtherance of this, also permitted States to impose further local restrictions. The Delhi Disaster Management Authority, in a meeting held on 29.09.2021, decided to ensure 100 per cent vaccination of all Government employees, frontline workers, healthcare workers as well as teachers and staff working in schools and colleges, on the advice of medical and other experts. It was considered necessary as these individuals have frequent interaction with the general public and vulnerable sections of the society and therefore, pose greater risk of spreading the virus. While an individual may have a right to decide against getting vaccinated, the State, however, has a statutory duty to regulate the interaction of unvaccinated persons within the society in the interest of public health.

34Copy pinpoint34. In his rejoinder, Mr. Bhushan, while reiterating his submissions, took exception to the contradictory stand taken by the Union of India on COVID-19 vaccination being voluntary and not mandatory. On one hand, the Union of India made it clear in the counter-affidavit that vaccination is voluntary and on the other, a series of advisories and material had been filed by the Union of India, supporting the claim of vaccination being mandatory. Mr. Bhushan submitted that the Union of India has not provided any material to the Court contrary to what has been supplied by the Petitioner furthering his scientific and legal contention that unvaccinated people pose no greater danger than vaccinated individuals in the matter of transmission of the COVID-19 virus, and therefore, there is no public health rationale in vaccine mandates. In addition to the various points raised in his submissions, the learned counsel for the H

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A Petitioner relied upon the opinion of Dr. Aditi Bhargava, who is a professor at University of California, San Francisco and a molecular biologist with 33 years of research experience, from her presentation made before the US Senate on 02.11.2021. Her opinion is to the effect that vaccines do not prevent infection and transmission. She is of the further belief that natural immunity is the gold standard. According to B 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. Mr. Bhushan concluded by submitting that any restrictions placed on personal autonomy of individuals would be violative of Article 21, unless the criteria laid down in K. S. Puttaswamy (supra) is met. B. Evolution of COVID-19 and vaccines

35Copy pinpoint35. COVID-19 emerged in late 2019. The WHO officially declared the novel coronavirus outbreak as a pandemic on 11.03.2020. The virus was detected in the country in the last week of January, 2020 and spread rapidly. As the threat of infections from the virus loomed large, an unprecedented national lockdown was announced on 24.03.2020, which extended for a few months, with restrictions being removed thereafter in a phased manner. India was not alone in this; several countries imposed lockdowns to arrest the spread of the deadly disease, which has led to a drastic loss of human life worldwide and presented a threat of extraordinary proportions to public health, food systems, economic and social conditions. Scientific studies and research for manufacture of vaccines to prevent severe infections were undertaken on an emergency basis. Towards the end of 2020, emergency vaccines came to be administered in the western part of the world. However, by then, the spread of COVID-19 around the globe was considerable. Around the same period, a variant called B.1.1.7 was found in the United Kingdom. The said variant was renamed as Alpha, as per the naming scheme recommended by the expert group convened by the WHO, which also includes scientists from the WHO’s Technical Advisory Group on Virus Evolution (TAG-VE). Another variant, called B.1.351 and later renamed as Beta, was found to be linked to a second wave of infections in South Africa. Both these variants were identified as Variants of Concern (VOC) by the WHO on 18.12.2020, meaning that they were variants with genetic H

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changes that would affect virus characteristics such as transmissibility, disease severity or immune escape and through a comparative assessment, are found to be associated with an increase of transmission or increase in virulence or decrease in effectiveness of public health measures such as vaccines, therapeutics etc. Soon thereafter, the highly transmissible variant called Gamma was found in Brazil and was identified as a VOC by the WHO on 11.01.2021.28

36Copy pinpoint36. In the first half of 2021, the Delta variant was identified as the predominant variant in India and was believed to be 60 per cent more transmissible than the Alpha variant. Thereafter, Delta rapidly spread beyond the borders to other countries. Another variant, Omicron, surfaced in November, 2021, whose spread was much more accelerated than earlier variants, including that of Delta. On the basis of the evidence available as on 21.01.2022, the WHO was of the opinion that the Omicron has a significant growth advantage over Delta, leading to rapid spread in the community with higher levels of incidence than previously seen in the pandemic. It was further observed that despite a lower risk of severe disease and death following infection, the very high levels of transmission nevertheless have resulted in significant increases in hospitalisation and continue to pose overwhelming demands on health care systems in most countries. It was found that because of the 26-32 mutations that it has in the spike protein, Omicron has infected even those who have been previously infected or vaccinated. 29 Though the infections and transmission from Omicron at present within the country are not as serious as they were in the first two months of 2022, expert opinion is to the effect that Omicron might not be the last of the variants, as we have since witnessed.

37Copy pinpoint37. The WHO established the Technical Advisory Group on F COVID-19 Vaccine Composition (TAG-CO-VAC) in September, 2021. According to the statement made by the said group on 11.01.2022 in the context of circulation of the Omicron variant, the group reviews and assesses the public health implications of emerging VOCs on the performance of COVID-19 vaccines and provides recommendations G 28 Tracking SARS-CoV-2 variants, World Health Organization, available at https:// www.who.int/en/activities/tracking-SARS-CoV-2-variants/ (last accessed on 01.05.2022) 29 Statement by Dr Hans Henri P. Kluge, WHO Regional Director for Europe, 11.01.2011, available at https://www.euro.who.int/en/media-centre/sections/statements/ 2022/statement-update-on-covid-19-omicron-wave-threatening-to-overcome-health- workforce (last accessed on 01.05.2022) H

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A on COVID-19 vaccine composition. The said group is developing a framework to analyse the evidence on emerging VOCs in the context of criteria that would trigger a recommendation to change COVID-19 vaccine strain composition and will advise the WHO on updated vaccine compositions, as required. The group has spelt out in their statement that at present, with the available COVID-19 vaccines, the focus is on reducing severe disease and death, as well as protecting health systems. According to the TAG-CO-VAC, vaccines, which have received WHO Emergency Use Listing across several vaccine platforms, provide a high level of protection against severe disease and death caused by VOCs. The group takes note of data which indicates that vaccine effectiveness will be reduced against symptomatic disease caused by the Omicron variant but at the same time, it was of the opinion that protection against severe disease is more likely to be preserved. Along with the Strategic Advisory Group of Experts on Immunization (SAGE) and its Working Group on COVID-19 vaccines, TAG-CO-VAC has recommended COVID-19 vaccines for priority populations worldwide to provide protection against severe disease and death globally and, in the longer term, to mitigate the emergence and impact of new VOCs by reducing the burden of infection.30

38Copy pinpoint38. With the outbreak of the devastating pandemic, as many as 5,23,843 lives have been lost in this country, as per the latest data available on the website of the Ministry of Health and Family Welfare (MoHFW). Initially, efforts made by the Government of India were to protect people by arresting serious infection. With treatment protocol and clinical management protocol for COVID-19 being revised periodically as more and more data and research on the virus came to be known, persons affected by the virus were treated with the information that was available at the point. Using whatever little was known about the virus in the initial stages, dedicated efforts have been made to save countless lives in this country. With the approval of vaccines on an emergency basis in January, 2021, there was some hope about preventing infections from the virus. Inoculation, which commenced slowly in view of the non-availability of G 30 Interim Statement on COVID-19 vaccines in the context of the circulation of the Omicron SARS-CoV-2 Variant from the WHO Technical Advisory Group on COVID- 19 Vaccine Composition (TAG-CO-VAC), 11.01.2022, available at https:// www.who.int/news/item/11-01-2022-interim-statement-on-covid-19-vaccines-in-the- context-of-the-circulation-of-the-omicron-sars-cov-2-variant-from-the-who-technical- H advisory-group-on-covid-19-vaccine-composition (last accessed on 01.05.2022)

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sufficient doses of vaccines, gained pace with the increase in manufacture by Respondent Nos. 4 and 5. With the Government embarking upon extensive awareness drives encouraging vaccination, more than 189 crore doses of vaccine have been administered within the country till date, as per the data available on the website of the MoHFW.

39Copy pinpoint39. With the introduction of vaccines, it was understood that vaccines would aid in preventing infections. To protect their populace from infection, countries worldwide promoted vaccination as, needless to say, an uninfected person will not transmit the disease. Thereafter, with the mutation of the virus eventually resulting in multiple VOCs, breakthrough infections were noticed. Vaccinated people were found to be infected with the virus and could also act as carriers, transmitting the virus to others. Even in such a situation, there is no question of whether vaccination for COVID-19 should be continued. The recommendations of the WHO’s TAG-CO-VAC and SAGE make it amply clear that vaccines, which have received emergency use approvals, provide strong protection against serious illness, hospitalisation and death and getting vaccinated is one of the most crucial steps towards protecting oneself from COVID-19, stopping new variants from emerging and helping end the pandemic. It should be noted that the advice of the WHO with respect to COVID-19 has been consistent since the time vaccines became available, even after recognising that it was still possible to get infected and spread the infection to others despite being vaccinated, as is evident from the latest version of the WHO’s ‘COVID-19 advice for the public: Getting vaccinated’ as of 13.04.202231. The Union of India has placed considerable material on record in terms of scientific briefs and published studies which stand testimony to the significance of vaccination as a crucial public health intervention in this pandemic and its continued benefits to individual health as well as public health infrastructure. Vaccination of a majority of the population of this country has undoubtedly been instrumental in preventing severe disease, hospitalisation and deaths, and benefited the community at large, especially those members with co-morbidities, the elderly and sick persons. Even the Petitioner is not opposed to the vaccination programme and does not challenge the vaccination drive of the Government of India, as has been reiterated by him during the course of his arguments. Exception to the vaccination programme taken by the Petitioner is only to coercive vaccination through 31 Available at https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid- 19-vaccines/advice (last accessed on 01.05.2022) H

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A vaccine mandates, which place unjustifiable restrictions on those who wish to not be vaccinated.

40Copy pinpoint40. In light of the virulent mutations of the COVID-19 virus and advice of experts from the WHO as well as common findings of several studies on this subject, the vaccination drive that is being undertaken by the Government of India in the interest of public health cannot be faulted with. C. Personal autonomy and public health

41Copy pinpoint41. Before dealing with the issue of coercive vaccination, it is necessary to consider whether the right of privacy of individuals can override public health, more so, when the submission on behalf of the Respondents is that steps taken to restrict the rights of individuals are in the larger interest of public health. It is true that to be vaccinated or not is entirely the choice of the individual. Nobody can be forcefully vaccinated as it would result in bodily intrusion and violation of the individual’s right to privacy, protected under Article 21 of the Constitution D of India. Personal autonomy was read into Article 21 by this Court in Common Cause (supra), by placing reliance on National Legal Services Authority v. Union of India32, and Aruna Ramachandra Shanbaug (supra). This Court, in Common Cause (supra), emphasized the right of an individual to choose how he should live his own life, without any control or interference by others. It recognised the right of an individual to refuse unwanted medical treatment and to not be forced to take any medical treatment that is not desired. In view of the categoric statement of the Union of India that vaccination of COVID-19 is voluntary, the question of any intrusion into bodily integrity does not arise for consideration in this case. However, the Petitioner has asserted that limitations placed on access to public places and public resources for unvaccinated persons result in coercive vaccination, and therefore, limit the right of unvaccinated persons to refuse medical treatment.

42Copy pinpoint42. Disclosure of data of a patient suffering from AIDS was the subject matter of a decision of this Court in X v. Hospital ‘Z’33. Placing G reliance on Kharak Singh v State of U.P.34, Gobind v. State of M.P.35 and a judgment of the US Supreme Court in Jane Roe v. Henry Wade36, 32 (2014) 5 SCC 438 33 (1998) 8 SCC 296 34

(1964) 1 SCR 332

35 (1975) 2 SCC 148 36 H 410 US 113 (1973)

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this Court held that though non-disclosure of medical information of an A individual can be traced to the right to privacy protected under Article 21, it is not absolute and is subject to action lawfully taken for protection of health or morals or protection of rights and freedoms of others.

43Copy pinpoint43. In Association of Medical Super Speciality Aspirants and Residents v. Union of India37, to which one of us was a party (L B Nageswara Rao, J.), this Court, while considering validity of service bonds to be executed at the time of admission to postgraduate and superspeciality courses in medical science, held as follows: “33. The above discussion leads us to the conclusion that right to life guaranteed by Article 21 means right to life with human dignity. Communitarian dignity has been recognised by this Court. While balancing communitarian dignity vis-à-vis the dignity of private individuals, the scales must tilt in favour of communitarian dignity. The laudable objective with which the State Governments have introduced compulsory service bonds is to protect the fundamental right of the deprived sections of the society guaranteed to them under Article 21 of the Constitution of India. The contention of the appellants that their rights guaranteed under Article 21 of the Constitution of India have been violated is rejected.”

44Copy pinpoint44. Strong reliance was placed by the Petitioner on the judgment of the High Court of New Zealand in Ryan Yardley (supra). The principal contention of the applicants therein was that the impugned order, requiring police and defence force personnel to be vaccinated, placed unjustified limitation on the rights protected by the New Zealand Bill of Rights Act 1990 (hereinafter, the “NZ Bill of Rights”), particularly the right to refuse to undergo medical treatment, the right to manifest religion, the right to be free from discrimination and other rights under Section 28 of the said Act (including the right to work, and of minority groups to enjoy their culture and practice their religion). The purpose of the order, as clarified by the Minister by way of an amendment order in February, 2022 is as below: G “(a) avoid, mitigate, or remedy the actual or potential adverse effects of the COVID-19 outbreak (whether direct or indirect); and 37 (2019) 8 SCC 607 H

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