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TMI Blog2022 (5) TMI 1668X X X X Extracts X X X X X X X X Extracts X X X X ..... re, Advs., Amit Kumar, AOR, Ajay Bansal, Gaurav Yadava and Veena Bansal, Advs. JUDGMENT L. NAGESWARA RAO, J. 1. 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 reliefs: "(a) Direct the respondents to release the entire segregated trial data for each of the phases of trials that have been 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 59th 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, ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... cine mandates are meaningless. 4. 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. 5. 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 necess ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... to our attention established procedures and protocols in place for surveillance of AEFIs established under the National Adverse Event 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. 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. 7. Counter-affidavits have been ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... bjected 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. 12. 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 unobs ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... damental 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 judgment of the High Court of New Zealand in Ryan Yardley v. Minister for Workplace Relations and Safety [2022] NZHC 291 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. 15. 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 (2008) 2 SCC 672, Directorate of Film Festivals v. Gaurav Ashwin Jain (2007) 4 SCC 737 and an order of this Court in Distribution of Essential Supplies and Services During Pandemic, In re (2021) 7 SCC 772 and submitted that policy decisions taken by the executive are not beyond the scope of judicial review, if they are manifestly arbitrary or unreasonable. 16. Before examining ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... s 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. Newsom 140 S. Ct. 1613 (2020) 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. 18. 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 Eastern District of Missouri each entered preliminary injunctions against its enforcement. The appeals filed against the said injunction were ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ardley (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. Atkinson [2012] NZCA 184, the NZ High Court held that the Crown has the burden to demonstrate that a limitation of a fundamental right is 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 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... the State in framing rules, the exercise of that power not 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. Pyarali K. Tejani v. Mahadeo Ramchandra Dange (1974) 1 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... militates against manifest arbitrariness and protects the right to life of all persons. 25. 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 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 from examining the issues raised in this Writ Petition, especially those that concern violation of Article 21 of the Constitution of India. 26. Identifying the issues in the present matter, they 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 doma ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ts. According to serological studies, 75 per cent of the Indian population has already been 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 (2018) 5 SCC 1, Aruna Ramachandra Shanbaug v. Union of India (2011) 4 SCC 454 and K.S. Puttaswamy v. Union of India (2017) 10 SCC 1. 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 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... h unvaccinated patients. Full vaccination conferred a substantially higher protective effect over partial vaccination." The results of the study also indicate that compared with unvaccinated patients, partially vaccinated patients had milder disease, reduced requirement of oxygen, hospital admission, ICU admission and mortality. Again, when fully vaccinated patients were compared with unvaccinated individuals, full vaccination was associated with significantly less disease severity, requirement of respiratory supports, hospital admission, ICU admission and mortality. The study further showed that majority of the patients screened who required hospitalisation were unvaccinated. (c) A study conducted by researchers of All India Institute of Medical Sciences (AIIMS), New Delhi Aakashneel Bhattacharya, Piyush Ranjan, Tamoghna Ghosh, Harsh Agarwal, Sukriti Seth, Ganesh Tarachand Maher, Ashish Datt Upadhyay, Arvind Kumar, Upendra Baitha, Gaurav Gupta, Bindu Prakash, Sada Nand Dwivedi, Naveet Wig "Evaluation of the dose-effect association between the number of doses and duration since the last dose of COVID-19 vaccine, and its efficacy in preventing the disease and reducing disease seve ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... nt 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 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. Th ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ent 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. 34. 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 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 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 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. 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) 36. In the first half of 2021, the Delta variant was identified as the predominant variant in India and was believed to b ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 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. 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-te ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 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 13.04.2022 Available at https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19-vaccines/advice (last accessed on 01.05.2022). 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 rei ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 1975) 2 SCC 148 and a judgment of the US Supreme Court in Jane Roe v. Henry Wade 410 US 113 (1973), this Court held that though non-disclosure of medical information of an 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. 43. In Association of Medical Super Speciality Aspirants and Residents v. Union of India (2019) 8 SCC 607, to which one of us was a party (L. 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 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... inated staff members in an overall workforce of 15,682 staff. It was found that the position within the New Zealand Defence Forces (NZDF) was similar. From a total of 15,480 NZDF personnel, 3,048 are civil staff. As on 01.02.2022, 99.2 per cent of the regular forces were fully vaccinated, leaving aside 75 members and 98.7 per cent of the civil staff were fully vaccinated, leaving 40 who were not. The NZ High Court was of the view that the relatively low number of unvaccinated police and NZDF personnel impacted by the order may not, by itself, mean that the order was not a reasonable limit on rights that can be demonstrably justified, if there was evidence to establish that the presence of unvaccinated personnel, even in small numbers, created a materially higher risk to the remaining workforce. While observing that the evidence on this issue is sparse, the NZ High Court referred to the evidence of Dr. Petrovsky, who deposed that vaccination has potential benefit in reducing the severity of disease, even with the Omicron variant. However, in his view, mandatory vaccination did not assist in preventing workers in affected roles from contracting COVID-19, or transmitting it to others. ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... of the earlier variants of the virus and that it was also effective at reducing symptomatic infection and detrimental effects of the Delta variant. As the applicants were border workers interacting with international travellers who may be carrying the virus and given the likelihood of vaccines contributing to preventing the risk of transmission, the NZ High Court held that a precautionary approach, in doing everything that can be reasonably done to minimise risk of the outbreak or spread in strong public interest, is justified. Further, the curtailment of the right to refuse to undergo medical treatment was found to be proportionate to the objective, as the applicants, who worked as aviation workers, were situated in a key location where COVID-19 might enter New Zealand. 47. In Ryan Yardley (supra), the NZ High Court held that the principle in Four Aviation Security Service Employees (supra) is not directly applicable as the order was not promulgated to contain the spread of the virus but for the purpose of ensuring continuity of, and confidence in, essential services. Additionally, there was no evidence of a threat to the continuity of the police and NZDF services, which would en ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... upra). In K.S. Puttaswamy (supra), this Court laid down three requirements to be fulfilled by the State while placing restraints on the right to privacy to protect legitimate State interests. It was held: 310. ... The first requirement that there must be a law in existence to justify an encroachment on privacy is an express requirement of Article 21. For, no person can be deprived of his life or personal liberty except in accordance with the procedure established by law. The existence of law is an essential requirement. Second, the requirement of a need, in terms of a legitimate State aim, ensures that the nature and content of the law which imposes the restriction falls within the zone of reasonableness mandated by Article 14, which is a guarantee against arbitrary State action. The pursuit of a legitimate State aim ensures that the law does not suffer from manifest arbitrariness. Legitimacy, as a postulate, involves a value judgment. Judicial review does not reappreciate or second guess the value judgment of the legislature but is for deciding whether the aim which is sought to be pursued suffers from palpable or manifest arbitrariness. The third requirement ensures that the me ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... and it is clear from the scientific data that, an unvaccinated person does not pose a greater risk than a vaccinated person in terms of transmission of the infection. While this submission has been dealt with subsequently, we believe that as long as there is a risk of spreading the disease, there can be restrictions placed on individuals' rights in larger public interest. Further, extensive material from experts has been placed before this Court, which extol the benefits of vaccination in tackling the severe and life-threatening impact of the infection, specifically in terms of reduction in oxygen requirement, hospitalisation, ICU admissions and mortality, thereby easing the disproportionate burden from the upsurge of severe cases on the health infrastructure, which has already been witnessed by the country during the second wave of the pandemic where resources were woefully inadequate to stem the impact of the Delta variant on a then scarcely vaccinated population. We hasten to add that restrictions that are placed by the Government should not be unreasonable and are open to scrutiny by constitutional courts. It is difficult for us to envisage the myriad situations in dealing ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... after the infection and further that, immune memory to many viruses is stable over decades, if not for a lifetime". (b) A study published in the European Journal of Epidemiology Subramanian, S.V., Kumar, A. "Increases in COVID-19 are unrelated to levels of vaccination across 68 countries and 2947 counties in the United States" Eur J Epidemiol 36, 1237-1240 (2021), which has analysed data from 68 countries available as of 03.09.2021 and has found that "at the country level, there appears to be no discernible relationship between percentage of population fully vaccinated and new COVID-19 cases". It is further stated therein that in fact higher percentage of population fully vaccinated have higher COVID-19 per 1 million people. (c) The United Kingdom's COVID-19 vaccine surveillance report, Week 40, which appears to indicate negative efficacy against infection amongst all ages above 30 years, on the basis of data between week 36 and week 39 in 2021. 53. While we are aware that courts cannot decide whether natural immunity is more resilient as compared to vaccine-acquired immunity and we do not seek to substitute our own views in matters of differences in scientific opinion, we ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... rvey - 5 (2019-21) shows that (i) in the age group of 15-49 years, 57 per cent of women and 25 per cent of men are anaemic, (ii) amongst individuals aged above 15 years, 13.5 per cent of women and 15.6 per cent of men have high or very high blood sugar level or take medicines to control blood sugar level, (iii) amongst individuals aged above 15 years, 21.3 per cent of women and 24 per cent of men have hypertension or elevated blood pressure or take medicines to control blood pressure. Further, as per the 75th Round National Sample Survey (NSS), conducted from July 2017 to June 2018, the average age of the elderly population in India was 67.5 years, with 67.1 per cent of India's elderly living in rural areas. A study was conducted Ranjan, A., Muraleedharan, V.R. "Equity and elderly health in India: reflections from 75th round National Sample Survey, 2017-18, amidst the COVID-19 pandemic" Global Health 16, 93 (2020) on the basis of the data from the NSS, aiming to highlight the vulnerability of the aged amidst the COVID-19 pandemic. According to the study, out of every 100 elderly, 27.7 persons reported ailments during the previous 15 days, with cardiovascular conditions includin ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ly equal risks in transmission of the infection to others around them, the State cannot impose restrictions targeting only the unvaccinated and impeding their right to access public resources. The Petitioner has thus, alleged discrimination against the unvaccinated, who in the present situation, are placed more or less on the same footing as vaccinated individuals with respect to the transmission of the virus. In support of his submissions, the Petitioner has relied on scientific studies and reports, some of which are listed below: (a) A letter published in the Lancet, Regional Health Gunter Kampf, Letter titled "The Epidemiological relevance of the COVID-19 vaccinated population is increasing" Lancet Regional Health Vol. 11, 100272, December 01, 2021, 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 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... y material before this Court to justify the discriminatory treatment of unvaccinated individuals in public places by imposition of vaccine mandates. No doubt that when COVID-19 vaccines came into the picture, they were expected to address, and were indeed found to be successful in dealing with, the risk of infection from the variants in circulation at the time. However, with the virus mutating, we have seen more potent variants surface which have broken through the vaccination barrier to some extent. While vaccination mandates in the era of prevalence of the variants prior to the Delta variant may have withstood constitutional scrutiny, in light of the data presented by the Petitioner, which has not been controverted by the Union of India as well as the State Governments, we are of the opinion that the restrictions on unvaccinated individuals imposed through vaccine mandates cannot be considered to be proportionate, especially since both vaccinated and unvaccinated individuals presently appear to be susceptible to transmission of the virus at similar levels. 59. Details of the vaccine mandates passed by the States of Maharashtra, Tamil Nadu, Madhya Pradesh and Delhi have been disc ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... 61. Having expressed our opinion on the vaccine mandates in the prevailing context, we reiterate that vaccines effectively address severe disease arising from COVID-19 infections, are instrumental in reducing oxygen requirement, hospital and ICU admissions and mortality and continue to be the solution to stopping new variants from emerging, as per the advice of the WHO. Since the time arguments were heard in the matter, we have come to know of more variants that have now come into circulation. Given the rapidly-changing nature of the virus and the clear purpose served by the approved vaccines in terms of restoration and protection of public health, our suggestions with respect to review of vaccine mandates are limited to the present situation alone. This judgment is not to be construed as impeding, in any manner, the lawful exercise of power by the executive to take suitable measures for prevention of infection and transmission of the virus in public interest, which may also take the form of restrictions on unvaccinated people in the future, if the situation so warrants. Such restrictions will be subject to constitutional scrutiny to examine if they meet the threefold requirement ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... y, the expert bodies such as the NTAGI and the Subject Expert Committee (SEC), the body which sends recommendations to the Central Drugs Standard Control Organisation, while deliberating on the applications and data of the vaccine manufacturers, and the names and institutional relationships of the experts who participated in each of these meetings. Mr. Bhushan relied on the 59th Report of the Parliamentary Standing Committee on Health and Family Welfare, in support of his submission on a need for transparency in the decision-making of the CDSCO and other regulatory authorities. 63. In response, the Union of India submitted that the procedure prescribed under the statutory regime was scrupulously followed before granting emergency approval of the vaccines manufactured by Respondent Nos. 4 and 5. As per the extant statutory regime, permission to import or manufacture new drugs including vaccines or to undertake clinical trials is granted by the Central Drugs Standard Control Organisation (CDSCO). The CDSCO, in consultation with the SEC, evaluates the applications for grant of such permission, which are to be accompanied with data as required under the Second Schedule to the New Drug ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ial in the country. The data provided by Respondent No. 4 from the various phases were evaluated and analysed by the SEC, which consisted of eminent experts from the fields of microbiology, medicine, pulmonary medicine, paediatrics and immunology and immunogenetics. The resolutions of the various meetings of the SEC, which also required the presence of the developer/manufacturer with the necessary information, have been put up on the website of the MoHFW at every stage. In its meeting dated 02.01.2021, observing that on receiving further updated data, justification and request for consideration of the proposal in the wake of a new mutation of the COVID-19 virus, and on recognising that the data generated till then showed that the vaccine had the potential to target mutated coronavirus strains, the SEC recommended for grant of permission for restricted use in emergency situation in public interest in clinical trial mode, as an abundant precaution. While granting such permission, Respondent No. 4 was directed to continue the ongoing Phase III clinical trial and submit data from the trial, as and when available. Approval for restricted use in emergency situation in clinical trial mode ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... th Oxford University and AstraZeneca under technology transfer. As the clinical development of the said vaccine, including Phase I clinical trial, was conducted in other countries, Phase II/III clinical trials were conducted by Respondent No. 5 in the country. Application for permission to manufacture COVISHIELD for test, examination and analysis was first made by Respondent No. 5 on 03.05.2020. The safety, immunogenicity and efficacy data of Phase II/III clinical trials of the AstraZeneca vaccine carried out in the United Kingdom, Brazil and South Africa were submitted to the SEC, along with the safety and immunogenicity data from the ongoing Phase II/III clinical trials in India. On reviewing this data as well as the approval dated 30.12.2020 granted by the United Kingdom's Medicines and Healthcare Products Regulatory Authority (hereinafter, the "UK-MHRA") for the AstraZeneca vaccine along with its conditions/restrictions, the SEC, in its meeting dated 01.01.2021, noted that the safety and immunogenicity data from the Indian study was comparable with that of the overseas clinical trial data. After detailed deliberation and taking into account the emerging situation, the SEC r ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... h are (i) respect for persons (autonomy), (ii) beneficence, (iii) non-malfeasance and (iv) justice. These four basic principles have been expanded into 12 general principles, including the 'principle of ensuring privacy and confidentiality' which requires maintaining the privacy of potential participants, her/his identity and records, with access given to only those authorised. As regards transparency of functioning of expert bodies, it was submitted by the Union of India that recommendations of the SEC in all its meetings are uploaded on the website of the CDSCO. Additionally, the detailed minutes of NTAGI meetings were already available in public domain, which can be downloaded from both the ICMR and the MoHFW websites. 68. The contention of Respondent No. 4 is that COVAXIN has undergone all clinical trials. In Phase III, trials revealed a 77.8% efficacy against symptomatic COVID-19 disease. The findings of the clinical trials have been published in reputed peer-reviewed journals and are readily available on the website of Respondent No. 4. A reference was made by Respondent No. 4 to the WHO Statement on Clinical Trials, to submit that it is only the key outcomes and fin ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... s proved by the maker of the statement appearing in court and deposing to have perceived the fact reported. Laxmi Raj Shetty v. State of Tamil Nadu (1988) 3 SCC 319 In the absence of anything on record in the present case to substantiate the statement made by Mr. Jayaprakash Muliyil, member of the NTAGI, we are not inclined to take judicial notice of the news Article reported in The Wire, even more so in light of the affidavit filed on behalf of the Union of India stating that the relevant data was examined by the expert bodies at all stages before granting emergency use approval to the vaccines. We are also of the opinion that the evidence relating to the approval process of the Rotavac vaccine has no relevance to the dispute in this case. On the basis of the said two incidents, it cannot be concluded that the emergency use approval to COVISHIELD and COVAXIN recommended by the SEC are not in accordance with the statutory regime. 71. At this stage, it is worthwhile to refer to the statutory regime in place. According to Rule 19 of the 2019 Rules, no person, institution or organisation shall conduct clinical trial of a new drug or investigational new drug, except in accordance with ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... lly reviewing and approving the "Protocol", the suitability of the investigator(s), facilities, methods and material to be used for obtaining and documenting "Informed Consent" of the study subjects and adequacy of confidentiality safeguards. Para 2.4 of the GCP guidelines deal with ethical and safety considerations, which provide that all research involving human subjects should be conducted in accordance with the ethical principles contained in the current version of the Declaration of Helsinki, as annexed to the guidelines. Amongst the principles to be followed, the GCP guidelines require adherence to the "principles of accountability and transparency" and "principles of public domain": Principles of accountability and transparency, whereby the research or experiment will be conducted in a fair, honest, impartial and transparent manner, after full disclosure is made by those associated with the Study of each aspect of their interest in the Study, and any conflict of interest that may exist; and whereby, subject to the principles of privacy and confidentiality and the rights of the researcher, full and complete records of the research inclusive of data and notes are retained fo ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... m unless there is a specific reason why open access cannot be used, or otherwise made available publicly at most within 24 months of study completion. 2. In addition, the key outcomes are to be made publicly available within 12 months of study completion by posting to the results Section of the primary clinical trial registry. Where a registry is used without a results database available, the results should be posted on a free-to-access, publicly available, searchable institutional website of the Regulatory Sponsor, Funder or Principal Investigator. 74. The GCP guidelines are being scrupulously followed, according to the Union of India. The principles of "public domain" in the GCP guidelines provide for research, experimentation or evaluation in response to the research to be brought into the public domain. The results of the clinical trials are generally to be made known through scientific and other publications. The requirement of publication, according to the WHO, also relates to the main findings of clinical trials to be published in a peer-reviewed journal and the key outcomes to be made publicly available, within 12 months of study completion. The Petitioner complains of o ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... Cosmetics Act, 1940 and the Rules framed thereunder comprise of domain experts in the relevant field, who conduct a thorough scrutiny of the material produced by the manufacturers before granting approval. The information provided on behalf of the Union of India substantiates that the data provided by the vaccine manufacturers was considered by the SEC over a period of time and several conditions were imposed at the time of recommending approvals, which have been modified or lifted subsequently on availability of further data arising from the clinical trials before the SEC, as can be seen from the minutes of the meetings of the SEC, available on the website of the MoHFW. We do not agree with the submission on behalf of the Petitioner that emergency approvals to the vaccines were given in haste, without properly reviewing the data from clinical trials. We are also of the opinion that the Parliamentary Standing Committee report relied upon by Mr. Bhushan is not relevant and the lapses pointed out therein pertain to the year 2011, which have no obvious connection to the grant of approval to Respondent Nos. 4 and 5 for the restricted emergency use of their respective vaccines. As long ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ssociation with vaccine', if a significant increase in such reactions during Phase III trials had not been recorded. According to the Petitioner, this acquires significance in the context of trials conducted in this country, as the control trial in Phase III did not go on in the manner intended, with several members of the original control group prematurely unblinded and offered the vaccine. The Petitioner contends that owing to 'dilution of Phase III control trials prematurely', there are no controls to compare against, making it difficult to ascertain which adverse events are caused by the vaccine. Therefore, reactions which are not "known reactions" to the vaccine are not considered AEFIs. In light of this, it is necessary for the authorities to carefully monitor all vaccine recipients and publicly record all adverse events. 78. Taking this argument further, the Petitioner contended that the adverse events reporting system in India is not transparent, with obscure investigation and follow-up of deaths and other serious adverse events after COVID-19 vaccination. The Petitioner relied on a letter published in The Hindu on 17.03.2021, written by a group of experts in p ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ation Program (UIP) and Non-UIP vaccines has been established. The National AEFI Committee gets periodical reports regarding 'minor AEFIs', 'severe AEFIs' and 'serious AEFIs'. Online reporting of all serious and severe AEFIs at the district level to be communicated to relevant authorities at the state/national level is done on a web-based portal, SAFEVAC (Surveillance and Action for Events Following Vaccination). All serious and severe adverse events following vaccination even at district level are uploaded online on SAFEVAC. It was submitted on behalf of the Union of India that case details, scanned copies of reports are uploaded on SAFEVAC, which also has facilities for generating dashboards and line-lists at different levels. 80. Further, a similar feature of reporting of all AEFIs (including minor) by the vaccinator was made available on the Co-WIN portal. District Immunisation Officers (DIOs) were given the facility to report AEFI cases about which they have information from such individuals who do not have access to Co-WIN. Departmental orders and standard operating procedures have been issued for further investigations and sharing of hospital records ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... usality assessment analysis. The National Expert Group on Vaccine Administration for COVID-19 (NEGVAC), an additional body of experts, is also involved in providing guidance on vaccine safety and surveillance, thus, aiding in the prompt identification of AEFIs for the purpose of identifying and understanding evolving trends in the disease and taking prompt action. 2,116 serious and severe AEFIs have been reported from 1,19,38,44,741 doses of COVID-19 vaccine administered till 24.11.2021. While a report of rapid review and analysis completed for 495 cases had been submitted, a further report of 1,356 serious and severe AEFI cases had been presented to the NEGVAC and the rapid review and analysis of balance cases was underway. Press releases around a report on bleeding and clotting events following COVID-19 vaccination being submitted to the MoHFW by the National AEFI Committee and on clarification on deaths following vaccination and process of causality assessment were placed before this Court. Therefore, the Union of India submitted that there was continuous monitoring and examination of AEFI cases in India and there is no basis for the allegations around AEFIs not being properly c ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ted to recognise all relevant reactions as vaccine-related reactions prior to such unblinding. What the Petitioner seeks is the monitoring of all adverse events and publication of the results of investigation. The Union of India has painstakingly taken this Court through the details of the procedure followed to closely monitor, review and escalate the incidence of AEFIs to appropriate authorities. As regards previously unknown/unidentified reactions seen during the monitoring of AEFIs at the time of vaccine administration, the Union of India has elaborated on the role of the PvPI and the CDSCO, which collate and study such reactions. We believe this adequately addresses the Petitioner's concerns, as this Court has been informed that previously unidentified events are also being taken into consideration and investigated. We trust the Union of India to have the appropriate authorities 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. 84. The Petitioner had taken issue with the present system to the extent it allows only DIOs or the vaccinators to re ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... at serological studies would show that a large number of children have already acquired antibodies to COVID-19. The Petitioner has highlighted the risk of myocarditis associated with the mRNA vaccines, on the basis of which, several European countries have recently stopped the use of Moderna vaccines for those under the age of 30. He has also pointed out that these risks had not been identified in the initial vaccine trials as the trial size was too small to uncover rare risks, which were discovered after mass vaccination. The Petitioner has sought for results as well as the primary data of clinical trials conducted on the paediatric population to be made public. 86. In response thereto, the Union of India contended that paediatric vaccination is advised by global agencies such as the WHO, the UNICEF and the CDC. Expert opinion in India is in tune with global consensus in favour of vaccination of children. We are informed that 8,91,39,455 doses of COVAXIN have been administered to individuals in the age group of 15 to 18 years as on 12.03.2022. The AEFIs reported are 1,739 minor complaints, 81 serious complaints and 6 severe. According to the Union of India, the said data would sh ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... h misadventures. Therefore, we reject the contention of the Petitioner that this Court has to intervene in paediatric vaccination on the ground that it is unscientific. 88. With respect to results of clinical trials, we note that the Union of India has stated that the results of clinical trials of COVAXIN for paediatric population have already been published. We also note that for the age group of 12 to 14 years, Biological E's Corbevax is being administered. Keeping in line with the WHO Statement on Clinical Trials, the Declaration of Helsinki and the GCP guidelines, we direct the Union of India to ensure that key findings and results of the clinical trials of Corbevax be published at the earliest, if not already done. Neither vaccine is an mRNA vaccine and to this extent, the apprehensions of the Petitioner with respect to the associated risks of mRNA vaccines are unfounded in the present situation. Conclusion 89. In conclusion, we have summarised our findings on the various issues considered by us, 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 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... rasting 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 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... ional 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, o ..... X X X X Extracts X X X X X X X X Extracts X X X X
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