JACOB PULIYEL v. UNION OF INDIA & ORS.

A (b) ensure continuity of services that are essential for public safety, national defence, or crisis response; and (c) maintain trust in public services.”

45Copy pinpoint45. Considering the submissions of the applicants therein that the order placed unjustified limitations on fundamental rights protected by the NZ Bill of Rights, the NZ High Court held that the impugned order limits the right of affected workers to refuse to undergo a medical treatment as well as the right (or significant interest) to retain employment. While examining the question of whether the limitation of the said rights was justified, the NZ High Court noted that the order mandating vaccinations for the police and defence personnel was imposed to ensure the continuity of services that are essential for public safety, national defence, or crisis response, and to promote public confidence in those services, rather than to stop the spread of COVID-19. The NZ High Court further took note of the fact that by October, 2021, 83.1 per cent of police personnel had received at least one or more doses of the vaccination, and 70.1 per cent had received both doses. By the time the order took effect on 17.01.2022, there were only 164 unvaccinated 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 E 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. The NZ High Court further considered the evidence of Dr. Town, the Ministry’s Chief Science Adviser, who, according to the NZ High Court, did not directly respond to Dr. Petrovsky’s analysis of the effectiveness of the H

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vaccine to inhibit the spread of COVID-19 in a workforce, but instead provided his more generalised opinions. In his evidence, Dr. Town stated that vaccines show reduced effectiveness compared with Delta in terms of becoming infected with and transmitting Omicron.

46Copy pinpoint46. After weighing the evidence, the NZ High Court was of the view that vaccination may still be effective in limiting infection and transmission, but at a significantly lower level than was the case with the earlier variants. It was further concluded that vaccination does not prevent persons contracting and spreading COVID-19, particularly with the Omicron variant. The NZ High Court referred to an earlier judgment in Four Aviation Security Service Employees v. Minister of COVID- 19 Response38, where the precautionary principle had been applied, to make the point that even a modest vaccination protection on a modest number of personnel needs to be considered in the context of potential effects of a pandemic. The NZ High Court referred to a judgment of the Federal Court of Ontario in Spencer v. Attorney General of Canada39 to elaborate on the precautionary principle, as “a foundational approach to decision-making under uncertainty, that points to the importance of acting on the best available information to protect the health of” the citizens. In Four Aviation Security Service Employees (supra), which dealt with restrictions placed on aviation security workers, the NZ High Court held that even though the applicants therein were not being forcibly treated, they were required to be vaccinated as a condition of their employment, refusal of which led to termination. Observing that a right does not need to be taken away in its entirety before it is regarded as having been limited, the NZ High Court opined that the level of pressure in that case was significant and amounted to coercion, and therefore, the applicants’ right to refuse to undergo medical treatment was limited. F However, the said limitation was held to be justified. From the evidence adduced before the NZ High Court, it concluded that the vaccine was effective at reducing the transmission 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 G 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 38 [2021] NZHC 3012 39 [2021] FC 361 H

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A 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.

47Copy pinpoint47. 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 enable the C NZ High Court to give the benefit of the doubt to the New Zealand Crown in imposing measures to address that risk. Placing reliance on the evidence adduced as well as the public health advice which was to the effect that vaccine mandates were not considered necessary for addressing the risk of the outbreak or spread of COVID-19, the High D Court made it clear that while vaccination significantly improved the prospects of avoiding illness and death even with the Omicron variant, given the variant’s propensity to break through vaccination barriers, it concluded that there was no real threat to the continuity of these essential services that the impugned order sought to address. Further, finding that suspension of the unvaccinated would address any potential problems, the terminations arising from the order in light of the temporary, albeit significant, period of peak impact of the infection, were found to be disproportionate and unjustified. While the Petitioner has sought support from this judgment to demonstrate how courts in other jurisdictions have struck down vaccine mandates taking into account Omicron’s impact on the effectiveness of vaccines in addressing spread, we believe that this judgment may not be of much assistance to us for determining the issue at hand for two reasons. First, the judgment expressly recognised that the impugned vaccine mandate was not brought about to suppress the spread of the virus but to ensure continuity of, and confidence in, essential services, such as the police and the defence personnel, which we are not concerned with in the present case. Second, while the NZ High Court looked into depositions of expert witnesses to come to its own conclusion on efficacy of vaccines vis-à-vis the Omicron variant, the scope of our review does not entail assessment of competing scientific opinions, as the judiciary is not equipped to decide issues of medical expertise and epidemiology.

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48Copy pinpoint48. The crucial point that requires to be considered by us is whether limitations placed by the Government on personal autonomy of an individual can be justified in the interest of public health in the wake of the devastating COVID-19 pandemic. As stated, personal autonomy has been recognized as a critical facet of the right to life and right to self-determination under Article 21 of the Constitution, by this Court in B Common Cause (supra). 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 means which are adopted by the legislature are proportional to the object and needs sought to be fulfilled by the law. Proportionality is an essential facet of the guarantee against arbitrary State action because it ensures that the nature and quality of the encroachment on the right is not disproportionate to the purpose of the law. Hence, the threefold requirement for a valid law arises out of the mutual interdependence between the fundamental guarantees against arbitrariness on the one hand and the protection of life and personal liberty, on the other. The right to privacy, which is an intrinsic part of the right to life and liberty, and the freedoms embodied in Part III is subject to the same restraints which apply to those freedoms.” H

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A While the judgment is in context of the right to privacy, the analysis with respect to the threefold requirement for curtailment of such right is on the anvil of the protection guaranteed to fundamental freedoms under Article 21, and therefore, would also be the litmus test for invasion of an individual’s bodily autonomy under Article 21.

49Copy pinpoint49. The upshot of the above discussion leads to the following conclusions: a) Bodily integrity is protected under Article 21 of the Constitution of India and no individual can be forced to be vaccinated. C b) Personal autonomy of an individual involves the right of an individual to determine how they should live their own life, which consequently encompasses the right to refuse to undergo any medical treatment in the sphere of individual health. D c) Persons who are keen to not be vaccinated on account of personal beliefs or preferences, can avoid vaccination, without anyone physically compelling them to be vaccinated. However, if there is a likelihood of such individuals spreading the infection to other people or contributing to mutation of the virus or burdening of the public health infrastructure, thereby affecting communitarian health at large, protection of which is undoubtedly a legitimate State aim of paramount significance in this collective battle against the pandemic, the Government can regulate such public health concerns by imposing certain limitations on individual rights that are reasonable and proportionate to the object sought to be fulfilled.

50Copy pinpoint50. The submission made on behalf of the Petitioner is that the Delta and Omicron variants have shown breakthrough infections 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 H

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life-threatening impact of the infection, specifically in terms of reduction A 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 B 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 with the evolving pandemic that may call for restraint on individual rights in larger public interest and therefore, as and when such limitations are challenged, they can be assessed by constitutional courts to see whether they meet the threefold requirement laid down in K.S. Puttaswamy (supra). D. Assessment of the vaccine mandates imposed by State Governments

51Copy pinpoint51. The grievance of the Petitioner pertains to the vaccine mandates imposed by various State Governments and private organisations, resulting in restrictions on fundamental freedoms of persons who have chosen not to be vaccinated. The Petitioner has alleged duality in the stand of the Respondents, as on one hand, the Union of India has categorically stated that vaccines are voluntary and on the other, the E State Governments have imposed and defended restrictions on access to public places and resources for persons who are unvaccinated. The Petitioner contested the vaccine mandates on the following grounds: (a) Natural immunity acquired from COVID-19 infection is more long-lasting and robust as compared to vaccine F immunity. (b) Serological studies show that more than 75 per cent of the Indian population has already been infected and is seropositive and therefore, has better immunity to the infection than that which can be provided by the vaccine. G (c) Vaccines do not prevent infection from or transmission of COVID-19 and are especially ineffective in preventing against infection from new variants.

52Copy pinpoint52. In support of the above grounds, other than on the aspect of transmission of the virus, the Petitioner has relied on individual opinions H

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A of doctors and other advisors, news articles and findings from research studies, some of which are preprints meaning they have not been peer- reviewed and report new medical research which has yet to be evaluated and therefore, should not be used to guide clinical practice, as explained by medRxiv, a platform where several preprint articles in the field of health sciences are published. Some of the material relied on by the B Petitioner has been listed below: (a) An article in the scientific journal Nature40, which states that “studies have shown that memory plasma cells secreted antibody specific for the spike protein encoded in SARS-CoV-2 even 11 months 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 Epidemiology41, 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. E (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.

53Copy pinpoint53. While we are aware that courts cannot decide whether natural F 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 cannot help but notice that in the first article referred to above, published in Nature, it has been noted that immunity in convalescent individuals (i.e., those who have recovered from COVID- G 19) can be boosted further by vaccinating them after a year. According to the said article, this results in the generation of more plasma cells, 40 Andreas Radbruch and Hyun-Dong Chang, “A long-term perspective on immunity to Covid” Nature 595, 359-360 (2021) 41 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) H

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together with an increase in the level of SARS-CoV-2 antibodies that A was up to 50 times greater than before vaccination. In the second article referred to above, published in the European Journal of Epidemiology, it has been mentioned therein that the interpretation of the findings should be as follows: “The sole reliance on vaccination as a primary strategy to mitigate COVID-19 and its adverse consequences needs to be re- B examined, especially considering the Delta (B.1.617.2) variant and the likelihood of future variants. Other pharmacological and non- pharmacological interventions may need to be put in place alongside increasing vaccination rates.” We do not see how these conclusions and interpretations are in favour of an argument that natural immunity has proven to be better in protection against COVID-19 infection, as C compared to vaccine-acquired immunity.

54Copy pinpoint54. In any event, what we have to assess, in accordance with the law laid down by this Court, is whether the Union of India has taken note of scientific and medical inputs and research findings in putting together its policy advocating vaccination for the entire eligible population. D Article 47 of the Constitution of India imposes an obligation on the Union of India to improve public health. It is the obligation of the State to ensure the creation and the sustaining of conditions congenial to good health. From the several obligations of the State enshrined in Part IV of the Constitution, maintenance and improvement of public health rank high as these are indispensable to the very physical existence of the community.42

55Copy pinpoint55. It should be noted that the submission made on behalf of the Petitioner championing natural immunity is from the perspective of a healthy person. Even the Petitioner does not dispute the fact that the same standard is not applicable to persons with co-morbidities, the sick and elderly people. A cursory glance at the data recorded in the India Fact Sheet on the basis of the National Family Health Survey – 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 42 Vincent Panikurlangara v. Union of India (1987) 2 SCC 165 H

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A 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 conducted43 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 B during the previous 15 days, with cardiovascular conditions including hypertension (32.0%), endocrine conditions including diabetes (22.5%), musculoskeletal conditions (13.9%), infectious diseases (10.0%), and respiratory ailments (7.3%) being the top five conditions for seeking outpatient care among the elderly in the preceding 15 days. The C Constitution, through Article 41, mandates the State to make available to the elderly the right to live with dignity and to provide the elderly, ill and disabled with assistance, medical facilities and geriatric care44.

56Copy pinpoint56. Surely, the Union of India is justified in centering its vaccination policy around the health of the population at large, with emphasis on insulating the weaker and more vulnerable sections from the risk of severe infection and its consequences, as opposed to basing its decision keeping in mind the interests of a healthy few. Given the considerable material filed before this Court reflecting the near-unanimous views of experts on the benefits of vaccination in dealing with severe disease, reduction in oxygen requirement, hospital and ICU admissions and mortality and stopping new variants from emerging, this Court is satisfied that the current vaccination policy of the Union of India, formulated in the interest of public health, is informed by relevant considerations and cannot be said to be unreasonable. Whether there is contrasting scientific opinion supporting the argument of natural immunity offering better protection against infection from COVID-19 and whether these scientific opinions can be substantiated are not pertinent for determination of the issue before this Court.

57Copy pinpoint57. We now come to the crux of the challenge against coercive vaccine mandates, with respect to which the Petitioner has argued that they amount to restrictions on the fundamental rights of unvaccinated individuals and cannot be said to be proportionate, as according to the 43 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) 44 Ashwani Kumar v. Union of India (2019) 2 SCC 636 H

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Petitioner, with the prevalence of the Omicron variant, unvaccinated people pose no greater danger to the transmission of the virus in comparison to vaccinated persons. It was claimed by the Petitioner that even if the vaccines reduced the severity of the disease, it was up to the individual to decide whether they wanted to be the beneficiary of vaccines. The State’s lookout was the protection of larger public health and with both the vaccinated and unvaccinated posing nearly 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 Health45, which states: “In the UK it was described that secondary attack rates among household contacts exposed to fully vaccinated index cases was similar to household contacts exposed to unvaccinated index cases (25% for vaccinated vs 23% for unvaccinated). 12 of 31 infections in fully vaccinated household contacts (39%) arose from fully vaccinated epidemiologically linked index cases. Peak viral load did not differ by vaccination status or variant type….The US Centres for Disease Control and Prevention (CDC) identifies four of the top five counties with the highest percentage of fully vaccinated population (99.9–84.3%) as “high” F transmission counties. Many decisionmakers assume that the vaccinated can be excluded as a source of transmission. It appears to be grossly negligent to ignore the vaccinated population as a possible and relevant source of transmission when deciding about public health control measures.” G

(b) A study conducted on breakthrough infection in Massachusettsin July, 2021 and reported in the Morbidity 45 Gunter Kampf, Letter titled “The Epidemiological relevance of the COVID-19 vaccinated population is increasing” Lancet Regional Health Vol. 11, 100272, December 01, 2021 H

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A and Mortality Weekly Report46, which investigated 469 COVID-19 cases that had been identified among the Massachusetts residents who had travelled to a town where multiple large public events had been held and 346 cases, i.e., 74 per cent of the infections occurred in fully vaccinated individuals. Findings from the investigation suggest that even jurisdictions without substantial or high COVID-19 transmission might consider expanding prevention strategies, including masking in indoor public settings regardless of vaccination status, given the potential risk of infection during attendance at large public gatherings that include travelers from many areas with differing levels of transmission. The Petitioner has also cited various news articles reporting instances of breakthrough infections in fully vaccinated people, carrying as much virus as those who were unvaccinated, abroad as well as within India.

58Copy pinpoint58. We have already referred to the material placed by the Union of India and the States appearing before this Court. While there is abundant data to show that getting vaccinated continues to be the dominant expert advice even in the face of new variants, no submission nor any data has been put forth to justify restrictions only on unvaccinated individuals when emerging scientific evidence appears to indicate that the risk of transmission of the virus from unvaccinated individuals is almost on par with that from vaccinated persons. To put it differently, neither the Union of India nor the State Governments have produced any 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 46 Brown CM, Vostok J, Johnson H, et al. “Outbreak of SARS-CoV-2 Infections, Including COVID-19 Vaccine Breakthrough Infections, Associated with Large Public Gatherings — Barnstable County, Massachusetts, July 2021". MMWR Morb Mortal H Wkly Rep 2021;70:1059-1062

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been controverted by the Union of India as well as the State Governments, A 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. B

59Copy pinpoint59. Details of the vaccine mandates passed by the States of Maharashtra, Tamil Nadu, Madhya Pradesh and Delhi have been discussed earlier. It has come to our knowledge that since the judgment in this matter was reserved, the National Disaster Management Authority took a decision that there may not be any further need to invoke provisions of the DM Act for COVID-19 containment measures, taking into consideration the overall improvement in the situation. Further, the States of Maharashtra and Tamil Nadu, taking into account the present situation in which near-normalcy has been restored, have rolled back the restrictions placed on unvaccinated persons. The State of Madhya Pradesh had withdrawn the restrictions imposed on unvaccinated individuals in terms of withholding distribution of food grains from fair price shops and had notified this Court of the same during the hearing. Till the infection rate and spread remains low, as it is currently, and any new development or research finding comes to light which provides the Government due justification to impose reasonable and proportionate restrictions on the rights of unvaccinated individuals in furtherance of the continuing efforts to combat this pandemic, 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. F

60Copy pinpoint60. While we appreciate that it is the domain of the executive to determine how best to encourage vaccination without unduly encroaching into the fundamental rights of unvaccinated individuals, we wish to highlight the mechanism of the “health pass” employed in France, as an apt example of a proportionate measure intended to cope with the perils G of the spread of the virus. We understand that a “health pass” may take the form of either the results of a viral screening test not concluding that a person has been infected with COVID-19, or proof of vaccination status, or a certificate of recovery following an infection. In a referral by the Prime Minister to review the law on managing the public health H

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A state of emergency, the Constitutional Council in France, in Decision no. 2021-824 DC dated 05.08.2021, determined that the “health pass” did not infringe the right to personal privacy guaranteed by Article 2 of the Declaration of Human and Civic Rights of 1789 as the requirement did not introduce an obligation to vaccinate.

61Copy pinpoint61. 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 C 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 D 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 for intrusion into rights of individuals, as discussed earlier. II. Non-disclosure of segregated clinical trial data in public domain

62Copy pinpoint62. It is the complaint of the Petitioner that the COVID-19 vaccines, manufactured by Respondent Nos. 4 and 5, have been given restricted emergency approval by the Drugs Controller General of India (DCGI) in a hurried and opaque manner. Mr. Bhushan argued that clinical trials in respect of the vaccines had not been completed and at present, the vaccines are only authorised for emergency use. According to the Petitioner, while clinical trials are scheduled to be completed in the year G 2023, even the full dataset from the interim analysis conducted has not been made public. The disclosure of segregated data of clinical trials is essential to determine the adverse effects, if any, across various age groups and diverse populations and accordingly, enable individuals to make more informed decisions on whether to be vaccinated. Reliance H

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was placed on an order of this Court in Aruna Rodrigues (4) v. Union A of India47 and a judgment of the Delhi High Court dated 15.01.2019 in W.P. (C) No. 343 of 2019 titled Master Hridaan Kumar (minor) v. Union of India with respect to the importance of disclosure of relevant technical data and informed consent. Additionally, the last amended version of the Declaration of Helsinki – Ethical principles from medical research involving human subjects (hereinafter, the “Declaration of Helsinki”) and a statement by the WHO dated 09.04.2015 on ‘public disclosure of clinical trial results’ (hereinafter, the “WHO Statement on Clinical Trials”) were pressed into service to establish the significance of disclosure of data of clinical trials, so as to enable the data to be assessed independently, and not only by the vaccine manufacturer who has a commercial interest in production of the vaccines. Mr. Bhushan submitted that there would be no invasion of privacy of individuals, if personal identification data and past medical history of the trial participants was redacted and the raw data pertaining to clinical trials is made public. The further grievance of the Petitioner D pertained to lack of transparency in regulatory approvals, minutes of meetings and constitution of expert bodies. The Petitioner has sought for clear detailing of the information furnished before, and evidence relied on by, 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 E 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 F CDSCO and other regulatory authorities.

63Copy pinpoint63. 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 G 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 47 (2011) 12 SCC 481 H

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A New Drugs and Clinical Trials Rules, 2019 (hereinafter, the “2019 Rules”) framed under the Drugs and Cosmetics Act, 1940. The SEC is a statutory body, constituted by the CDSCO under Rule 100 of the 2019 Rules, comprising group of experts with specialisation in relevant fields. According to the Union of India, the SEC looks into the details of trials and results presented before it and examines them, interacts with the B developers of the vaccines and gives them appropriate directions and eventually makes recommendations in writing, by way of a resolution, reflecting the collective opinion of all the domain experts. We were informed that the trials have been registered on the database of the Clinical Trials Registry – India, which is hosted at the ICMR’s National C Institute of Medical Statistics. The provisions in relation to ‘Accelerated Approval Process’ under the Second Schedule to the 2019 Rules were pointed out to this Court, which stipulate that “accelerated approval process may be allowed to a new drug for a disease or condition taking into account its severity, rarity, or prevalence and the availability or lack of alternative treatments, provided that there is D a prima facie case of the product being of meaningful therapeutic benefit over the existing treatment”. It is further stated that “After granting accelerated approval for such drug, the post marketing trials shall be required to validate the anticipated clinical benefit.” It was submitted that applying these provisions on Accelerated Approval E Process, the CDSCO, in detailed consultation with the SEC and after examining the efficacy of the vaccine and its effects, granted permission for restricted emergency use of COVAXIN and COVISHIELD, as manufactured by Respondent Nos. 4 and 5, respectively.

64Copy pinpoint64. As regards COVAXIN (Whole Virion Inactivated Corona Virus F Vaccine), the Union of India stated that application for permission to manufacture the vaccine was made by Bharat Biotech on 23.04.2020. The CDSCO, in consultation with the SEC, granted permission to Bharat Biotech for conducting Phase I/II clinical trials on 29.06.2020 and Phase III clinical trials on 23.10.2020. Respondent No. 4 submitted interim safety and immunogenicity data of Phase I and Phase II clinical trials carried out in the country, along with safety data, including Serious Adverse Events data, of the ongoing Phase III clinical trial 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

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meetings of the SEC, which also required the presence of the developer A / 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 with various conditions / restrictions was granted by the CDSCO to Respondent No. 4 to manufacture COVAXIN on 03.01.2021.

65Copy pinpoint65. Thereafter, Respondent No. 4 submitted the interim safety and efficacy data of Phase III clinical trial, which was reviewed by the D SEC in meetings held periodically. In its meeting conducted on 10.03.2021, the SEC, after detailed deliberation on the updated interim safety and efficacy data of the phase III clinical trial, recommended omission of the condition of the use of the vaccine in clinical trial mode. However, it was recommended that the vaccine be continued to be used under restricted use in emergency situation condition. Following expansion of the Government’s vaccination drive to include individuals in the age group of 18-45 years, in its meeting held on 23.04.2021, the SEC considered Bharat Biotech’s proposal to unblind the trial participants in the said age group. After detailed deliberations, the SEC recommended the unblinding of the participants in the said age group, upon the request of the participants or the principal investigator after completion of two months from the second dose. Eventually, on consideration of relevant data of Phase I and Phase II clinical trials along with safety data of 6 months’ Phase III clinical trial, including data of serious adverse events till the date, the SEC in its meeting dated 19.01.2022 noted that there had been no safety issues and the vaccine maintained its efficacy, specially to avoid hospitalisation and severe infections in the existing situation as well. Accordingly, the SEC recommended that the status of approval of COVAXIN from the restricted use in emergency situation to the New Drug permission be updated, along with the condition that the firm shall continue to submit data of ongoing clinical trial and monitor AEFIs. The H

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A Union of India pointed out that Phase I and Phase II clinical trial reports were published in the Lancet Infectious Diseases Journal, which was publicly available. Further, to the knowledge of the Union of India, Phase III trial publication had been submitted to the Lancet journal by Respondent No. 4 on 02.07.2021, a copy of the manuscript of which has been provided to this Court. B

66Copy pinpoint66. COVISHIELD (ChAdOx1 nCoV-19 Corona Virus Vaccine (Recombinant)) manufactured by Respondent No. 5 was developed by the Serum Institute of India in collaboration with 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 E / 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 recommended grant of permission for restricted emergency use of the vaccine, subject F to various regulatory provisions and conditions, including requirement to submit relevant data from the ongoing clinical trials nationally and internationally at its earliest. Eventually, in its meeting dated 19.01.2022, the SEC considered the request of Respondent No. 5 to grant permission to manufacture the vaccine, excluding the conditions for restricted use in emergency situation and other conditions, on the lines of Marketing G Authorisation by the UK-MHRA for the parent vaccine. After detailed deliberation and consideration of safety, immunogenicity and efficacy data from Indian and overseas clinical trials, amongst other data, the SEC recommended grant of New Drug permission or regular approval, with conditions that data of ongoing clinical trials and vaccine shall continue to be supplied and AEFIs shall continue to be monitored.

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67Copy pinpoint67. We were directed to Rule 25 of the 2019 Rules, framed under the Drugs and Cosmetics Act, 1940, which provides that the clinical trial shall be conducted in accordance with approved clinical trial protocol and other related documents as per the requirements of Good Clinical Practices (GCP) guidelines and the other rules. The expert committee set up by the CDSCO under Rule 25(vi) in consultation with clinical experts formulated the GCP guidelines for generation of data on drugs. The ‘Ethical Principles’, which are part of the said guidelines, protect principles of privacy and confidentiality of human subjects of research. The learned Solicitor General also relied upon para 2.4.4 of the GCP guidelines, which require safeguarding of the confidentiality of research data that might lead to identification of individual subjects. He further referred to the important role played by the Ethics Committee under Rule 11 of the 2019 Rules, which includes safeguarding the rights, safety and well-being of trial subjects in accordance with the said rules. The 2019 Rules also empower the Ethics Committee to discontinue or suspend the clinical trial in case it concludes that the trial is likely to compromise the right, safety or well-being of the trial subject. As per the ICMR’s National Ethical Guidelines for Biomedical and Health Research involving Human Participants, the four basic ethical principles for conducting biomedical and health research 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 E ‘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.

68Copy pinpoint68. 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 findings which are required to be made publicly available. It was contended that Respondent No. 4 H

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A is in compliance with the WHO Statement on Clinical Trials as the key outcomes and results of the Phase III clinical trial have been published in the Lancet. On behalf of Respondent No. 5, it was submitted that the clinical data generated during the trials had been submitted to the regulatory authorities for obtaining permissions / licences etc. Further, the peer- reviewed study of the partial clinical data of Phase II / III trials had already been published in reputed scientific journals, which included all the information necessary for safeguarding the public as well as informing them of the credibility and efficacy of the vaccine. According to Respondent No. 5, the raw data of the clinical trials served no greater public purpose than the data which was already available in the public domain. All applicable medico-legal, scientific and ethical requirements had been strictly adhered to by Respondent No. 5.

69Copy pinpoint69. In rejoinder, the learned counsel for the Petitioner argued that there is no transparency in the process of approvals of vaccines and relevant data is not always placed before the NTAGI. He referred to a D news article in The Wire, according to which Jayaprakash Muliyil, a member of the NTAGI had stated that the NTAGI had not recommended vaccination of children in the age group of 12-14 years. He also drew the attention of this Court to non-supply of relevant data to the NTAGI at the time of approval of the Rotavac vaccine against rotavirus. The Petitioner further complained of the haste shown in grant of emergency approval to Respondent No. 4. The Petitioner has sought support of a decision of the United States District Court for the Northern District of Texas dated 06.01.2022 in Public Health and Medical Professionals for Transparency v. Food and Drug Administration, which highlighted the need for transparency in disclosure of clinical trial data. It was reiterated by the Petitioner that privacy of individuals would not be at risk as their personal identification data can be redacted before disclosing segregated data of clinical trials.

70Copy pinpoint70. It is settled law that courts cannot take judicial notice of facts stated in a news item published in a newspaper. A statement of fact contained in a newspaper is merely hearsay and therefore, inadmissible in evidence, unless proved by the maker of the statement appearing in court and deposing to have perceived the fact reported.48 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 48 H Laxmi Raj Shetty v. State of Tamil Nadu (1988) 3 SCC 319

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inclined to take judicial notice of the news article reported in The Wire, A 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.

71Copy pinpoint71. 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 the permission granted by the Central Licensing Authority (i.e., the CDSCO) and without following the protocol approved by the Ethics Committee for clinical trial, registered in accordance with the provisions of Rule 8. Rule 19 (2) of the 2019 Rules provides that every person associated with the conduct of clinical trial of D a new drug or investigational new drug shall follow the general principles and practices as specified in the First Schedule. The methodology to be adopted in a clinical trial is provided for in the First Schedule to the 2019 Rules, relevant clauses of which are as under: - “GENERAL PRINCIPLES AND PRACTICES FOR CLINICAL E TRIAL

1. General Principles.¯ (1) The principles and guidelines for protection of trial subjects as described in Third Schedule as well as Good Clinical Practices guidelines shall be followed in conduct of any clinical trial. F xxx

4. Conduct of Clinical Trial.¯ Clinical trial should be conducted in accordance with the principles as specified in Third Schedule. Adherence to the clinical trial protocol is essential and if amendment of the protocol becomes necessary G the rationale for the amendment shall be provided in the form of a protocol amendment. Serious adverse events shall be reported during clinical trial in accordance with these Rules. xxx H

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A 6. Reporting.¯ Report of clinical trial shall be documented in accordance with the approaches specified in Table 6 of the Third Schedule. The report shall be certified by the principal investigator or if no principal investigator is designated then by each of the participating investigators of the study.” B It is clear from the above, that there are stringent statutory requirements which have to be complied with by the manufacturers of vaccines and other participants, during different stages of clinical trials of vaccines. Further, we also note that the GCP guidelines are statutorily required to be followed.

72Copy pinpoint72. The GCP guidelines further elaborate on the role of the Ethics Committee. According to the GCP guidelines, the Ethics Committee is an independent review board or a committee comprising of medical / scientific and non-medical / non-scientific members, whose responsibility it is to verify the protection of the rights, safety and well-being of human subjects involved in a study. The independent review provides public reassurance by objectively, independently and impartially 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”: F “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 for such reasonable period as may be prescribed or considered necessary for the purposes of post-research monitoring, evaluation of the research, conducting further

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research (whether by the initial researcher or otherwise) and in order to make such records available for scrutiny by the appropriate legal and administrative authority, if necessary. xxx Principles of public domain, whereby the research and any further research, experimentation or evaluation in response to, and emanating from such research is brought into the public domain so that its results are generally made known through scientific and other publications subject to such rights as are available to the researcher and those associated with the research under the law in force at that time.” C

73Copy pinpoint73. The GCP guidelines have been formulated following the Declaration of Helsinki. The relevant portion of the said Declaration is as follows: - “Privacy and Confidentiality D

24. Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information. Research Registration and Publication and Dissemination of Results E …

36. Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. All parties should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results must be published or otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of interest must be declared in the publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication.” It is profitable to refer to the relevant portion of the WHO Statement on Clinical Trials, which is as under: - H

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A “Reporting timeframes for clinical trials Clinical trial results are to be reported according to the timeframes outlined below. Reporting is to occur in BOTH of the following two modalities.

1. The main findings of clinical trials are to be submitted for B publication in a peer reviewed journal within 12 months of study completion and are to be published through an open access mechanism 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.

C 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.”

74Copy pinpoint74. 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 opaqueness in clinical trials as the general public do not have access to, and the opportunity to be aware of, all the necessary details by segregated clinical trial data (primary datasets) not being available. There is no challenge by the Petitioner to the GCP guidelines. As required by the WHO Statement on Clinical Trials and the GCP guidelines, findings of the clinical trials and the key outcomes of the trials have been published. In light of the existing statutory regime, we do not see it fit to mandate the disclosure of primary clinical trial data, when the results and key findings of such clinical trials have already been published.

75Copy pinpoint75. After examining the judgment of the United States District Court for the Northern District of Texas (hereinafter, the “US District H

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Court”), we are afraid that the said decision cannot be said to be relevant A for adjudication of the dispute in the present case. The grievance of the plaintiff in the said case pertained to all data and information for the Pfizer vaccine, enumerated under the relevant provisions of the Freedom of Information Act, not being provided by the United States Food and Drug Administration. The US District Court referred to the Freedom of B Information Act to hold that the citizenry has a right to be provided with the relevant information pertaining to the Pfizer vaccine and that such ‘information is often useful only if it is timely’. The US District Court directed expeditious completion of the plaintiff’s request after concluding that the request under the Freedom of Information Act was of paramount importance. We note that with respect to COVAXIN and COVISHIELD, C results of clinical trials have been published in accordance with our statutory regime in place. Reliance placed by the Petitioner on European Medicines Agency policy on publication of clinical data for medicinal products for human use is also not relevant as the GCP guidelines relating to the disclosure of clinical trial data, framed under the 2019 Rules, D currently govern the field of disclosure of clinical trial data in India.

76Copy pinpoint76. An analysis of the submissions made by the learned counsel appearing for the parties and a close scrutiny of the material placed on record would show that there is a strict statutory regime in force for grant of approvals to vaccines. Specialist bodies established under the provisions of the Drugs and 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 H

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A respective vaccines. As long as the relevant information relating to the minutes of the meetings of the regulatory bodies and the key outcomes and findings of the trials are available in public domain, the Petitioner cannot contend that every minute detail relating to clinical trials be placed in public domain to enable an individual to take an informed, conscious decision to be vaccinated or not. Given the widespread affliction caused B by the virus, there was an imminent need of manufacturing vaccines which would keep the infection at bay. We would like to highlight that both the vaccines have been approved by the WHO as well. A perusal of the material placed on record would show that there is material compliance with the procedure prescribed under the Drugs and Cosmetics C Act, 1940 and the 2019 Rules, before grant of approval for the emergency use of the two vaccines. However, it is made clear that subject to the protection of privacy of individual subjects and to the extent permissible by the 2019 Rules, the relevant data which is required to be published under the statutory regime and the WHO Statement on Clinical Trials shall be made available to the public without undue delay, with respect to D the ongoing post-marketing trials of COVAXIN and COVISHIELD as well as ongoing clinical trials or trials that may be conducted subsequently for approval of other COVID-19 vaccines / vaccine candidates. III. Improper collection and reporting of AEFIs

77Copy pinpoint77. The contention of the Petitioner is that there have been several adverse effects from vaccines, including deaths. The Petitioner has sought to fault the Government’s mechanisms in place for handling of the adverse events. According to the Petitioner, during Phase III trials, where small controlled trials of a limited number of participants are conducted, a significant increase in adverse events may not be seen. But after licensure, when the vaccines are administered to the masses, rare reactions show up, which is why Phase IV post-marketing trials are legally mandated. It was pointed out by the Petitioner that there has been a revision of the rules by the WHO for classifying AEFIs in 2018. As per the revised mechanism, only reactions that are previously acknowledged to be caused by the vaccine are classified as vaccine-related reactions. Reactions observed during post-marketing surveillance are not considered as ‘consistent with causal association 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 H

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the manner intended, with several members of the original control group A 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 B light of this, it is necessary for the authorities to carefully monitor all vaccine recipients and publicly record all adverse events.

78Copy pinpoint78. 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 C published in The Hindu on 17.03.2021, written by a group of experts in public health, ethics, medicine, law, and journalism to the Minister for Health & Family Welfare and the DCGI, appealing for “time-bound and transparent investigation” following deaths and serious adverse effects after COVID-19 vaccination. A presentation made by the National AEFI D Committee in a meeting held on 31.03.2021 was referred to by the Petitioner to claim that complete documentation was not available for all the severe and serious adverse events (including deaths) that had occurred till the time. Additionally, it was contended that no data pertaining to the AEFIs already classified nor any analysis of the same had been published publicly till date. The Petitioner also drew the attention of this Court to E the Vaccine Adverse Event Reporting System (VAERS) in place in the United States, which published all vaccine injury reports every Friday, received till about a week prior to the release date. It was brought to the notice of this Court that 77,314 adverse events have been reported in India as on 12.03.2022, amounting to 0.004% of the total vaccination. F The Petitioner has pointed out that the percentage of adverse events reported in Europe is much larger than the percentage identified in India, which would show that correct figures are not being published by the Government.

79Copy pinpoint79. On behalf of the Union of India, the procedures and protocols G for monitoring of adverse event following immunisation under the National Adverse Event Following Immunisation Surveillance Guideline were elaborated upon. The National Adverse Event Following Immunisation Surveillance Secretariat, established in the Immunisation Technical Support Unit in 2012, had staff dedicated for managing Adverse Event H

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A Following Immunisation surveillance system. It was further strengthened by the National Adverse Event Following Immunisation Surveillance Technical Collaborating Centre, comprising of experts from Lady Hardinge Medical College and Allied Hospitals in New Delhi. Adverse Event Following Immunisation Committees were formed at the national and state levels to provide guidance to the National AEFI Surveillance B and carry out documentation, investigation and causality assessment, besides training and orientation of health care workers and others involved in AEFI. According to the Union of India, a foolproof protocol for reporting and causality assessment for any AEFI with Universal Immunisation 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.

80Copy pinpoint80. 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 by the DIOs through Co-WIN. The Union of India has brought to the notice of this Court that an alignment with the Pharmacovigilance Programme of India (PvPI) under Indian Pharmacopoeia Commission has been developed for receipt of information regarding AEFI cases from around 300 Adverse Drug Reaction Monitoring Centers in medical colleges and large hospitals. The Union G of India has highlighted that information from the PvPI and the CDSCO are collated and studied, in case of any new, previously unknown events identified through AEFI surveillance. A press release of the MoHFW dated 17.02.2017 titled ‘Maximum Possible Marks to Indian NRA in WHO Assessment’ has been placed before this Court to state that the H AEFI Surveillance System in India (which is in use for COVID-19

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vaccination) has been approved by global experts in an assessment A conducted by the WHO in 2017. Given the novel nature of the virus, membership of the National AEFI Committee has been expanded to include neurologists, cardiologists, respiratory medicine specialists and medical specialists, with even States / Union Territories requested to expand their AEFI Committees on a similar scale to strengthen AEFI B surveillance for COVID-19 vaccines. Causality assessment of AEFI cases is conducted at the state and the national levels by experts trained as per the causality assessment checklist, based on the definition and algorithm developed by the WHO. Once approved by experts of the National AEFI Committee, results of causality assessment of AEFI cases are made available in the public domain and are shared with the CDSCO, C amongst other authorities, for appropriate regulatory action.

81Copy pinpoint81. As regards the present status of AEFI surveillance for COVID- 19 vaccination, it was submitted that as the causality assessment of reported AEFI cases is a time-consuming process, a method of rapid review and assessment had been initiated at the national level to quickly review available informationin each case and look for trends in reporting of specific events or unusual cases requiring further early investigation and assessment. All cases of serious and severe AEFIs, including reported deaths, are subjected to rapid reviews, analysis and causality assessment done by a team of trained subject experts. It was clarified that mere reporting of AEFI case should not be attributed to the vaccine unless proved by the causality 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 H

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A monitoring and examination of AEFI cases in India and there is no basis for the allegations around AEFIs not being properly collected and lack of transparency in their investigation.

82Copy pinpoint82. From the material placed before us, we note that the National AEFI Surveillance Secretariat has been functioning for 10 years and as has been pointed out, there is a well-established protocol in place for identification and monitoring of AEFIs. The website of the MoHFW carries the results of causality assessment of AEFI cases, from which the public can obtain relevant information pertaining to AEFIs. We have been informed that a thorough causality assessment analysis of AEFIs is carried out by experts and not every severe disease and death can be attributed to vaccination. Reactions are examined by experts specifically trained to undertake causality analysis before notifying such reactions as adverse events arising from vaccination. There is a well-defined mechanism for collection of data relating to adverse events that occur due to COVID-19 vaccines and the Government of India has taken steps to direct all concerned medical professionals at the ground level to report adverse events. Even medical practitioners at private hospitals are associated with reporting of adverse events. Therefore, we are not inclined to accept the broad-strokes challenge mounted by the Petitioner that the surveillance system of AEFIs in this country is faulty and the correct figures of those who have suffered any side effects, severe reactions or deaths post-inoculation have not been disclosed.

83Copy pinpoint83. As regards the contention of the Petitioner on abandoning of Phase III trials, we note that unblinding of participants during the Phase III trial was done on the recommendation of the SEC. The Union of India has emphasized that at every stage, the deliberations of domain experts, which involved discussions with the manufacturers, focused on safety and immunogenicity of the vaccines and it was only when there was consensus among domain experts that it was safe to extend the immunisation drive beyond the category of ‘healthcare workers / frontline workers’, the appropriate decisions were taken. In doing so, the available trial data, trajectory of the pandemic, evidence, future contingencies and several other factors have always been heeded. There is no challenge to the decision of the SEC, a body of domain experts, as being unreasonable or arbitrary, nor have we been called upon to determine whether adequate time was devoted to recognise all relevant reactions as vaccine-related reactions prior to such unblinding. What the Petitioner H

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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.

84Copy pinpoint84. The Petitioner had taken issue with the present system to the extent it allows only DIOs or the vaccinators to report AEFIs. According to the Petitioner, the repository of AEFIs should be as detailed as the D VAERS in the United State of America. The Petitioner further submitted that individuals and doctors must be able to report adverse events, with the reporter being given a unique identification number and the reports being openly accessible. The response of the Union of India on this issue is that the DIOs have been instructed to set up a network with private hospitals to report AEFIs. Training has been provided to state officers, medical officers, private practitioners and frontline health workers on their role in AEFI surveillance. Even auxiliary nurse midwives have been instructed to notify all AEFIs. However, we are in agreement with the suggestion made by the Petitioner that there should be a mechanism by which individuals and private doctors should be permitted to report suspected adverse events. Information relating to adverse effects following immunisation is crucial for the purpose of understanding the safety of the vaccines that are being administered, apart from being instrumental in further scientific studies around the pandemic. There is an imminent need for collection of requisite data of adverse events and wider participation of people in reporting the adverse events is necessary for the purpose of gathering correct information. Thus, the Union of India is directed to facilitate the reporting of suspected adverse events by individuals and private doctors on a virtual platform and the reports so made shall be publicly accessible after being given unique identification numbers, without listing any personal or confidential data of the persons H

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A reporting. All necessary steps to create awareness of, and to navigate, this platform for self-reporting shall be effectuated by the Government, roping in and training relevant participants right from the ground level of vaccine administration. IV. Vaccination of Children

85Copy pinpoint85. The opinion of the Petitioner is that children are at almost no risk from COVID-19 and instances of previously healthy children requiring hospitalisation due to COVID-19 are exceedingly rare. While referring to articles in the Nature and the Lancet, the Petitioner contended that scientific evidence shows that risk of administering vaccines to children outweigh the benefits offered by the vaccine in children. The Petitioner further submitted that 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.

86Copy pinpoint86. 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 F 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 show that the vaccine does not pose threat to the safety of children. As regards the clinical trials, para 2.4.6.2 of the GCP guidelines were relied on to show that children are not required to be involved in research that could be carried out equally well with adults and further that, for the clinical evaluation of a new drug, study in children should be carried out after the Phase III clinical trials in adults. It has been stated that paediatric vaccination was considered at a stage where more than substantial data on safety and immunogenicity of COVAXIN in adults was available. To avoid any risks, clinical trials were also conducted on a limited number of children as per the protocol approved

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by domain experts. Having found no serious adverse event in the said trials, paediatric vaccination was initiated in a phased manner, starting from the eldest paediatric age group of 15 to 18 years. On 12.05.2021, on the basis of recommendations of the SEC, the CDSCO granted permission to Respondent No. 4 to conduct Phase II / Phase III clinical trials of COVAXIN for the age group of 2 to 18 years. Thereafter, B Respondent No. 4 had submitted an application for grant of permission to manufacture COVAXIN paediatric vaccines for emergency use, which was subsequently granted by the CDSCO. It was argued on behalf of the Union of India that expert opinion is to the effect that paediatric vaccinations are always preventive in nature and are administered to avoid any risk of infection and of prolonged clinical symptoms. C

87Copy pinpoint87. This Court cannot sit in judgment of leading scientific analysis relating to the safety of paediatric vaccination. Experts in science may themselves differ in their opinions while taking decisions on matters related to safety and allied aspects, but that does not entitle the Court to second- guess expert opinion, on the basis of which the Government has drawn D up its policies. The decision taken by the Union of India to vaccinate paediatric population in this country is in tune with global scientific consensus and expert bodies like the WHO, the UNICEF and the CDC have also advised paediatric vaccination. It would not only be beyond our jurisdiction but also hazardous if this Court were to examine the accuracy of such expert opinion, based on competing medical opinions. E As already stated, the scope of judicial review does not entail the Court embarking upon such 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.

88Copy pinpoint88. With respect to results of clinical trials, we note that the Union F 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 G 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. H

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A Conclusion

89Copy pinpoint89. 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 B individuals in this country, we are not inclined to entertain any challenge to the maintainability of the Writ Petition. (ii) As far as judicial review of policy decisions based on expert opinion is concerned, there is no doubt that wide latitude is provided to the executive in such matters and the Court C does not have the expertise to appreciate and decide on merits of scientific issues on the basis of divergent medical opinion. However, this does not bar the Court from scrutinising whether the policy in question can be held to be beyond the pale of unreasonableness and manifest arbitrariness and to be in furtherance of the right to life of all persons, bearing in mind the material on record. (iii) With respect to the infringement of bodily integrity and personal autonomy of an individual considered in the light of vaccines and other public health measures introduced to deal with the COVID-19 pandemic, we are of the opinion that bodily integrity is protected under Article 21 of the Constitution and no individual can be forced to be vaccinated. Further, personal autonomy of an individual, which is a recognised facet of the protections guaranteed under Article 21, encompasses the right to refuse to undergo any medical treatment in the sphere of individual health. However, in the interest of protection of communitarian health, the Government is entitled to regulate issues of public health concern by imposing certain limitations on individual rights, which are open to scrutiny by constitutional courts to assess whether such invasion into an individual’s right to personal autonomy and right to access means of livelihood meets the threefold requirement as laid down in K.S. Puttaswamy (supra), i.e., (i) legality, which presupposes the existence of law; (ii) need, defined in terms of a legitimate State aim; and (iii) proportionality, which ensures a rational H

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nexus between the objects and the means adopted to achieve A them. (iv) On the basis of substantial material filed before this Court reflecting the near-unanimous views of experts on the benefits of vaccination in addressing severe disease from the infection, reduction in oxygen requirement, hospital and B ICU admissions, mortality and stopping new variants from emerging, this Court is satisfied that the current vaccination policy of the Union of India is informed by relevant considerations and cannot be said to be unreasonable or manifestly arbitrary. Contrasting scientific opinion coming forth from certain quarters to the effect that natural immunity offers better protection against COVID-19 is not pertinent for determination of the issue before us. (v) However, no data has been placed by the Union of India or the States appearing before us, controverting the material placed by the Petitioner in the form of emerging scientific opinion which appears to indicate that the risk of transmission of the virus from unvaccinated individuals is almost on par with that from vaccinated persons. In light of this, restrictions on unvaccinated individuals imposed through various vaccine mandates by State Governments / Union Territories cannot be said to be proportionate. Till the infection rate remains low and any new development or research finding emerges which provides due justification to impose reasonable and proportionate restrictions on the rights of unvaccinated individuals, we suggest that all authorities in this country, including private organisations and educational institutions, review the relevant orders and instructions imposing restrictions on unvaccinated individuals in terms of access to public places, services and resources, if not already recalled. It is clarified that in the context of the rapidly- evolving situation presented by the COVID-19 pandemic, our suggestion to review the vaccine mandates imposed by States / Union Territories, is limited to the present situation alone and is not to be construed as interfering with the lawful exercise of power by the executive to take suitable measures for prevention of infection and transmission of H

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A the virus. Our suggestion also does not extend to any other directions requiring maintenance of COVID-appropriate behaviour issued by the Union or the State Governments. (vi) As regards non-disclosure of segregated clinical data, we find that the results of Phase III clinical trials of the vaccines in question have been published, in line with the requirement under the statutory regime in place, the GCP guidelines and the WHO Statement on Clinical Trials. The material provided by the Union of India, comprising of minutes of the meetings of the SEC, do not warrant the conclusion that restricted emergency use approvals had been granted to COVISHIELD and COVAXIN in haste, without thorough review of the relevant data. Relevant information relating to the meetings of the SEC and the NTAGI are available in public domain and therefore, challenge to the procedures adopted by the expert bodies while granting regulatory approval to the vaccines on the ground of lack of transparency cannot be entertained. However, we reiterate that subject to the protection of privacy of individual subjects, with respect to ongoing clinical trials and trials that may be conducted subsequently for COVID-19 vaccines, all relevant data required to be published under the extant statutory regime must be made available to the public without undue delay. (vii) We do not accept the sweeping challenge to the monitoring system of AEFIs being faulty and not reflecting accurate figures of those with severe reactions or deaths from vaccines. We note that the role of the Pharmacovigilance Programme of India and the CDSCO, as elaborated upon by the Union of India, collates and studies previously unknown reactions seen during monitoring of AEFIs at the time of vaccine administration and we trust the Union of G India to ensure that this leg of the AEFI surveillance system is not compromised with, while meeting the requirements of the rapid review and assessment system followed at the national level for AEFIs. (viii) We are also of the opinion that information relating to adverse effects following immunisation is crucial for creating

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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 C Union of India at the earliest. (ix) On paediatric vaccination, we recognise that the decision taken by the Union of India to vaccinate children in this country is in tune with global scientific consensus and expert bodies like the WHO, the UNICEF and the CDC and it is beyond the scope of review for this Court to second-guess expert opinion, on the basis of which the Government has drawn up its policy. Keeping in line with the WHO Statement on Clinical Trials and the extant statutory regime, we direct the Union of India to ensure that key findings and results of the relevant phases of clinical trials of vaccines already approved by the regulatory authorities for administration to children, be made public at the earliest, if not already done.

90Copy pinpoint90. We express our gratitude to the learned counsel on either side for their able assistance in enabling this Court to reach the above conclusion. F

91Copy pinpoint91. The Writ Petition is disposed of accordingly.

Bibhuti Bhushan Bose Petition disposed.