TaxTMI 
TaxTMI 
2022 (5) TMI 1668
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....ajora, Akhileshwar Jha, Kavita S. More, Advs., Amit Kumar, AOR, Ajay Bansal, Gaurav Yadava and Veena Bansal, Advs. JUDGMENT L. NAGESWARA RAO, J. 1. The Petitioner was a member of the National Technical Advisory Group on Immunization (NTAGI) and was advising the Government of India on vaccines. He has filed this Writ Petition in public interest seeking the following reliefs: "(a) Direct the respondents to release the entire segregated trial data for each of the phases of trials that have been undertaken with respect to the vaccines being administered in India; and (b) Direct the respondent No 2 to disclose the detailed minutes of the meetings of the Subject Expert Committee and the NTGAI with regard to the vaccines as directed by the 59th Parliamentary Standing Committee Report and the members who constituted the committee for the purpose of each approval meeting; and (c) Direct the respondent No.2 to disclose the reasoned decision of the DCGI granting approval or rejecting an application for emergency use authorization of vaccines and the documents and reports submitted to the DCGI in support of such application; and (d) Direct the respo....
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....shown that vaccinated people also transmit the virus, the Petitioner contended that vaccine mandates are meaningless. 4. The Petitioner filed an Interlocutory Application seeking a direction to restrain all authorities and institutions, public and private, from mandating the vaccine in any manner whatsoever, on a precondition of accessing any service or on pain of any penalty. The Petitioner has drawn the attention of this Court to various restrictions that were placed by State Governments, other employers and educational institutions on unvaccinated individuals. The Petitioner contended that mandating vaccination for access to resources, public places and means of earning livelihood would be in violation of their fundamental rights, especially so, when scientific studies have shown that unvaccinated persons do not pose more danger of transmission of the virus when compared to vaccinated persons. 5. Respondent No. 1, the Union of India, has raised a preliminary objection regarding the maintainability of the Writ Petition. The Union of India has further contended that the serious threat posed by the unprecedented pandemic which had devastating effects on the entire world calle....
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....n the public domain. 6. On the subject of monitoring of AEFIs, the Union of India brought to our attention established procedures and protocols in place for surveillance of AEFIs established under the National Adverse Event Following Immunisation Surveillance Guideline. Further, the multi-tier structure comprising AEFI Committees at the state and national levels, providing guidance, carrying out investigation and causality assessment was elaborated upon. Details of the procedures followed in accordance with globally accepted practices were highlighted in the counter-affidavit. According to the Union of India, all cases of serious and severe AEFI, including reported deaths, are subjected to scientific and technical review process with causality assessments done at the state and national levels by trained experts to ascertain whether a particular AEFI can be attributed to the vaccine. In the counter-affidavit, it was also made clear that COVID-19 vaccination is voluntary and that the Government of India encourages all individuals to take vaccination in the interest of public health, as the individual's ill health has a direct effect on the society. It was also made clear that COVI....
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.... Indian Banks' Association, Bombay v. Devkala Consultancy Service (2004) 11 SCC 1. The Union of India has objected to the maintainability of the Writ Petition on the ground that the questions raised by the Petitioner may result in raising doubts in the minds of the citizenry about the vaccination, adding to the already existing vaccine hesitancy in the country. The consequence would be a debilitating effect on public health and therefore, the petition cannot be said to be in public interest. In other words, the maintainability of the Writ Petition is raised on the ground that the sensitive issue of vaccination should not be dealt with by this Court, as it has the propensity of fuelling doubts about the efficacy of the vaccines. 12. From the rejoinder affidavit submitted by the Petitioner, we note that a petition had been filed by the Petitioner earlier, during his tenure as a member of the NTAGI, with respect to the Rotavac vaccine claiming that adequate data from the clinical trials had not been provided to the NTAGI. The rejoinder affidavit further states that the petition was dismissed by this Court, on the ground that the Petitioner could not have filed the said petition whi....
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....Court on the ground that they are beyond the jurisdiction of this Court. This Court has a duty to safeguard the fundamental rights of individuals and issues raised herein are of seminal importance which ought to be decided after assessing the relevant material placed before this Court by both sides. Mr. Bhushan referred to the judgment of the High Court of New Zealand in Ryan Yardley v. Minister for Workplace Relations and Safety [2022] NZHC 291 in support of his submission that the scientific data and evidence that was produced before the High Court of New Zealand was assessed to adjudge the efficacy of vaccines in preventing transmission of the COVID-19 virus. 15. It was further argued by Mr. Bhushan that the judgments relied upon by the Union of India are not applicable to the facts of this case. He relied upon the judgments of this Court in Delhi Development Authority v. Joint Action Committee, Allottee of SFS Flats (2008) 2 SCC 672, Directorate of Film Festivals v. Gaurav Ashwin Jain (2007) 4 SCC 737 and an order of this Court in Distribution of Essential Supplies and Services During Pandemic, In re (2021) 7 SCC 772 and submitted that policy decisions taken by the executive....
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....cured by" it. A word of caution sounded by Gorsuch, J. is to the effect that the Court cannot stay out of the way in times of crisis, when the Constitution is under attack. In his dissent, Roberts, C.J. held that the injunction sought would not be in public interest, especially when it concerns public health and safety needs which calls for swift government action in everchanging circumstances. He relied upon the earlier order passed by the US Supreme Court in South Bay United Pentecostal Church v. Newsom 140 S. Ct. 1613 (2020) wherein it was recognised that courts must grant elected representatives broad discretion when they undertake to act in areas fraught with medical and scientific uncertainties. 18. Biden v. Missouri (supra) related to vaccine mandates for healthcare providers. The Secretary of Health and Human Services issued a Rule on being convinced that vaccination of healthcare workers in facilities in the Medicare and Medicaid Programs against COVID-19 was "necessary for the health and safety of individuals to whom care and services are furnished". The said Rule was challenged and the US District Courts for the Western District of Louisiana and the Eastern District o....
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....e the High Court of New Zealand (hereinafter, the "NZ High Court"). While adjudicating the dispute, the NZ High Court in Ryan Yardley (supra) expressed its opinion that the choices made by governments on their response to COVID-19 involve wide policy questions, including decisions on the use of border closures, lockdowns, isolation requirements, vaccine mandates and many other measures, which are decisions for the elected representatives to make. The NZ High Court made it clear that the Court addresses narrower legal questions and the Court's function is not to address the wider policy questions. While referring to the evidence of experts, the NZ High Court stressed on the institutional limitations on the Court's ability to reach definitive conclusions but clarified that the Court must exercise its constitutional responsibility to ensure that decisions are made lawfully. While relying upon a judgment of the Court of Appeal of New Zealand in Ministry of Health v. Atkinson [2012] NZCA 184, the NZ High Court held that the Crown has the burden to demonstrate that a limitation of a fundamental right is demonstrably justified. We have come to know that in the time since the judgm....
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....experience Academy of Nutrition Improvement v. Union of India (2011) 8 SCC 274. Where expertise of a complex nature is expected of the State in framing rules, the exercise of that power not demonstrated as arbitrary must be presumed to be valid as a reasonable restriction on the fundamental right of the citizen and judicial review must halt at the frontiers. The Court cannot re-weigh and substitute its notion of expedient solution. Within the wide judge-proof areas of policy and judgment open to the government, if they make mistakes, correction is not in court but elsewhere. That is the comity of constitutional jurisdictions in our jurisprudence. We cannot evolve a judicial policy on medical issues. All judicial thought, Indian and Anglo-American, on the judicial review power where Rules under challenge relate to a specialised field and involve sensitive facets of public welfare, has warned courts of easy assumption of unreasonableness of subordinate legislation on the strength of half-baked studies of judicial generalists aided by the ad-hoc learning of counsel. However, the Court certainly is the constitutional invigilator and must act to defend the citizen in the assertion of hi....
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....efficacious policy measures. However, it continues to exercise jurisdiction to determine if the chosen policy measure conforms to the standards of reasonableness, militates against manifest arbitrariness and protects the right to life of all persons. 25. There can be no ambiguity in the principles of law relating to judicial review laid down by this Court. A perusal of the judgments referred to above would clearly show that this Court would be slow in interfering with matters of policy, especially those connected to public health. There is also no doubt that wide latitude is given to executive opinion which is based on expert advice. However, it does not mean that this Court will not look into cases where violation of fundamental rights is involved and the decision of the executive is manifestly arbitrary or unreasonable. It is true that this Court lacks the expertise to arrive at conclusions from divergent opinions of scientific issues but that does not prevent this Court from examining the issues raised in this Writ Petition, especially those that concern violation of Article 21 of the Constitution of India. 26. Identifying the issues in the present matter, they can be divi....
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....ison to vaccine immunity. Studies also indicate that vaccines do not prevent infection from the virus or transmission amongst people. Vaccines are also ineffective in preventing infection from new variants. According to serological studies, 75 per cent of the Indian population has already been infected and is seropositive and, therefore, they have better immunity to infection than what is provided by the vaccines. The vaccines which are being administered in this country are only authorised for emergency use and the procedure for clinical trials of such vaccines has not been fully complied with. In view of the lack of transparency in disclosure of trial data resulting in absence of informed consent, any vaccine mandate would be unconstitutional. Mr. Bhushan contended that every individual has personal autonomy and cannot be forced to be vaccinated against his will. For the said proposition, he relied on the judgments of Common Cause (A Registered Society) v. Union of India (2018) 5 SCC 1, Aruna Ramachandra Shanbaug v. Union of India (2011) 4 SCC 454 and K.S. Puttaswamy v. Union of India (2017) 10 SCC 1. Imposing restrictions on the rights of persons who are unvaccinated is totally ....
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....7-2113, wherein it has been concluded as follows: "Among symptomatic COVID-19 patients, prior vaccination with either Covishield(tm) or Covaxin(r) impacted the severity of illness and reduced mortality when compared with unvaccinated patients. Full vaccination conferred a substantially higher protective effect over partial vaccination." The results of the study also indicate that compared with unvaccinated patients, partially vaccinated patients had milder disease, reduced requirement of oxygen, hospital admission, ICU admission and mortality. Again, when fully vaccinated patients were compared with unvaccinated individuals, full vaccination was associated with significantly less disease severity, requirement of respiratory supports, hospital admission, ICU admission and mortality. The study further showed that majority of the patients screened who required hospitalisation were unvaccinated. (c) A study conducted by researchers of All India Institute of Medical Sciences (AIIMS), New Delhi Aakashneel Bhattacharya, Piyush Ranjan, Tamoghna Ghosh, Harsh Agarwal, Sukriti Seth, Ganesh Tarachand Maher, Ashish Datt Upadhyay, Arvind Kumar, Upendra Baitha, Gaurav Gupta, Bindu Prakas....
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....n exercise of its powers under the Disaster Management Act, 2005 (hereinafter, the "DM Act") and the Tamil Nadu Public Health Act, 1939. Section 76(2)(b) thereof empowers the State Government to make vaccinations compulsory, in the event of a declaration by the Government of an outbreak of a notified disease. He submitted that the restrictions placed by the circular dated 18.11.2021 are in larger public interest and cannot be said to be unreasonable restrictions, as these were an essential facet of the precautionary approach adopted by the State of Tamil Nadu in dealing with the unprecedented pandemic. According to Mr. Tiwari, these restrictions were in furtherance of the State realising the importance of curtailing the spread of COVID-19. The unchecked spread of the virus could lead to further dangerous mutations. While referring to opinions of experts in the field of health, including that of the World Health Organization (WHO), the United Nations International Children's Emergency Fund (UNICEF) and the Oxford Vaccine group, as well as scientific studies published in the New England Journal of Medicine, the Lancet and the International Journal of Scientific Studies, it was su....
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....e spread of COVID-19, and in furtherance of this, also permitted States to impose further local restrictions. The Delhi Disaster Management Authority, in a meeting held on 29.09.2021, decided to ensure 100 per cent vaccination of all Government employees, frontline workers, healthcare workers as well as teachers and staff working in schools and colleges, on the advice of medical and other experts. It was considered necessary as these individuals have frequent interaction with the general public and vulnerable Sections of the society and therefore, pose greater risk of spreading the virus. While an individual may have a right to decide against getting vaccinated, the State, however, has a statutory duty to regulate the interaction of unvaccinated persons within the society in the interest of public health. 34. In his rejoinder, Mr. Bhushan, while reiterating his submissions, took exception to the contradictory stand taken by the Union of India on COVID-19 vaccination being voluntary and not mandatory. On one hand, the Union of India made it clear in the counter-affidavit that vaccination is voluntary and on the other, a series of advisories and material had been filed by the Unio....
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....came to be administered in the western part of the world. However, by then, the spread of COVID-19 around the globe was considerable. Around the same period, a variant called B.1.1.7 was found in the United Kingdom. The said variant was renamed as Alpha, as per the naming scheme recommended by the expert group convened by the WHO, which also includes scientists from the WHO's Technical Advisory Group on Virus Evolution (TAG-VE). Another variant, called B.1.351 and later renamed as Beta, was found to be linked to a second wave of infections in South Africa. Both these variants were identified as Variants of Concern (VOC) by the WHO on 18.12.2020, meaning that they were variants with genetic changes that would affect virus characteristics such as transmissibility, disease severity or immune escape and through a comparative assessment, are found to be associated with an increase of transmission or increase in virulence or decrease in effectiveness of public health measures such as vaccines, therapeutics etc. Soon thereafter, the highly transmissible variant called Gamma was found in Brazil and was identified as a VOC by the WHO on 11.01.2021. Tracking SARS-CoV-2 variants, World He....
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....O on updated vaccine compositions, as required. The group has spelt out in their statement that at present, with the available COVID-19 vaccines, the focus is on reducing severe disease and death, as well as protecting health systems. According to the TAG-CO-VAC, vaccines, which have received WHO Emergency Use Listing across several vaccine platforms, provide a high level of protection against severe disease and death caused by VOCs. The group takes note of data which indicates that vaccine effectiveness will be reduced against symptomatic disease caused by the Omicron variant but at the same time, it was of the opinion that protection against severe disease is more likely to be preserved. Along with the Strategic Advisory Group of Experts on Immunization (SAGE) and its Working Group on COVID-19 vaccines, TAG-CO-VAC has recommended COVID-19 vaccines for priority populations worldwide to provide protection against severe disease and death globally and, in the longer term, to mitigate the emergence and impact of new VOCs by reducing the burden of infection. Interim Statement on COVID-19 vaccines in the context of the circulation of the Omicron SARS-CoV-2 Variant from the WHO Technica....
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....ss, hospitalisation and death and getting vaccinated is one of the most crucial steps towards protecting oneself from COVID-19, stopping new variants from emerging and helping end the pandemic. It should be noted that the advice of the WHO with respect to COVID-19 has been consistent since the time vaccines became available, even after recognising that it was still possible to get infected and spread the infection to others despite being vaccinated, as is evident from the latest version of the WHO's 'COVID-19 advice for the public: Getting vaccinated' as of 13.04.2022 Available at https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19-vaccines/advice (last accessed on 01.05.2022). The Union of India has placed considerable material on record in terms of scientific briefs and published studies which stand testimony to the significance of vaccination as a crucial public health intervention in this pandemic and its continued benefits to individual health as well as public health infrastructure. Vaccination of a majority of the population of this country has undoubtedly been instrumental in preventing severe disease, hospitalisation and deaths, and benefit....
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....l treatment. 42. Disclosure of data of a patient suffering from AIDS was the subject matter of a decision of this Court in X v. Hospital 'Z' (1998) 8 SCC 296. Placing reliance on Kharak Singh v. State of U.P. (1964) 1 SCR 332, Gobind v. State of M.P. (1975) 2 SCC 148 and a judgment of the US Supreme Court in Jane Roe v. Henry Wade 410 US 113 (1973), this Court held that though non-disclosure of medical information of an individual can be traced to the right to privacy protected Under Article 21, it is not absolute and is subject to action lawfully taken for protection of health or morals or protection of rights and freedoms of others. 43. In Association of Medical Super Speciality Aspirants and Residents v. Union of India (2019) 8 SCC 607, to which one of us was a party (L. Nageswara Rao, J.), this Court, while considering validity of service bonds to be executed at the time of admission to postgraduate and superspeciality courses in medical science, held as follows: 33. The above discussion leads us to the conclusion that right to life guaranteed by Article 21 means right to life with human dignity. Communitarian dignity has been recognised by this Court. Wh....
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....ID-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 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....
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....unted to coercion, and therefore, the applicants' right to refuse to undergo medical treatment was limited. 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 the virus and given the likelihood of vaccines contributing to preventing the risk of transmission, the NZ High Court held that a precautionary approach, in doing everything that can be reasonably done to minimise risk of the outbreak or spread in strong public interest, is justified. Further, the curtailment of the right to refuse to undergo medical treatment was found to be proportionate to the objective, as the applicants, who worked as aviation workers, were situated in a key location where COVID-19 might enter New Zealand. 47. In Ryan Yardley (supra), the NZ High Court held that the principle in Four Aviation Security Service Employees (supra) ....
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....ual 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 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. ....
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....t 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. 50. 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 life-threatening impact of the infection, specifically in terms of reduction in oxygen requirement, hospitalisation, ICU admissions and mortality, thereby easing the disproportionate burden from the upsurge of severe cases on the health infrastructure, which has already been witnessed by the country during the second wave of the pandemic where re....
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.... on by the Petitioner has been listed below: (a) An Article in the scientific journal Nature Andreas Radbruch and Hyun-Dong Chang, "A long-term perspective on immunity to Covid" Nature 595, 359-360 (2021), 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 Epidemiology Subramanian, S.V., Kumar, A. "Increases in COVID-19 are unrelated to levels of vaccination across 68 countries and 2947 counties in the United States" Eur J Epidemiol 36, 1237-1240 (2021), which has analysed data from 68 countries available as of 03.09.2021 and has found that "at the country level, there appears to be no discernible relationship between percentage of population fully vaccinated and new COVID-19 cases". It is further stated therein that in fact higher percentage of population fully vaccinated have higher COVID-19 per 1 million people. (c) The United Kingdom's COVID-19 vaccine surveillance report, Week 40, which a....
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....d 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 75th Round National Sample Survey (NSS), conducted from July 2017 to June 2018, the average age of the elderly population in India was 67.5 years, with 67.1 per cent of India's elderly living in rural areas. A study was conducted Ranjan, A., Muraleedharan, V.R. "Equity and elderly health in India: ref....
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....nger 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 Health Gunter Kampf, Letter titled "The Epidemiological relevance of the COVID-19 vaccinated population is increasing" Lancet Regional Health Vol. 11, 100272, December 01, 2021, which states: "In the UK it was describe....
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....en 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 been controverted by the Union of India as well as the State Governments, we are of t....
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....n a referral by the Prime Minister to review the law on managing the public health 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. 61. Having expressed our opinion on the vaccine mandates in the prevailing context, we reiterate that vaccines effectively address severe disease arising from COVID-19 infections, are instrumental in reducing oxygen requirement, hospital and ICU admissions and mortality and continue to be the solution to stopping new variants from emerging, as per the advice of the WHO. Since the time arguments were heard in the matter, we have come to know of more variants that have now come into circulation. Given the rapidly-changing nature of the virus and the clear purpose served by the approved vaccines in terms of restoration and protection of public health, our suggestions with respect to review of vaccine mandates are limited to the present situation alone. This judgment is not to be ....
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....ersonal 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 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 applications and data of the vaccine manufacturers, and the names and institutional relationships of the experts who participated in each of these meetings. Mr. Bhushan relied on the 59th Report of the Parliamentary Standing Committee on Health and Family Welfare, in support of his submission on a need for transparency in the decision-making of the CDSCO and other regulatory authorities. 63. In response, the Union of India submitted that the procedure prescribed under the statutory regime was scrupulously followed before granting emergency approval of the vaccines manufactured by ....
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....4.2020. 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 meetings of the SEC, which also required the presence of the developer/manufacturer with the necessary information, have been put up on the website of the MoHFW at every stage. In its meeting dated 02.01.2021, observing that on receiving further updated data, justification and request for consideration of the proposal in the wake of a new mutation of the COVID-19 virus, and on recognising that the data generated till then showed that the vaccine had the potential to target muta....
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....nal, 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. 66. 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....
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....nce 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 'principle of ensuring privacy and confidentiality' which requires maintaining the privacy of potential participants, her/his identity and records, with access given to only those authorised. As regards transparency of functioning of expert bodies, it was submitted by the Union of India that recommendations of the SEC in all its meetings are uploaded on the website of the CDSCO. Additionally, the detailed minutes of NTAGI meetings were already available in public domain, which can be downloaded from both the ICMR and the MoHFW websites. 68. The contention of Responden....
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....l 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. 70. 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. Laxmi Raj Shetty v. State of Tamil Nadu (1988) 3 SCC 319 In the absence of anything on record in the present case to substantiate the statement made by Mr. Jayaprakash Muliyil, member of the NTAGI, we are not inclined to take judicial notice of the news Article reported in The Wire, even more so in light of the affidavit filed on behalf of the Union of India stating that the relevant data was examined by the expert bodies at all stages before granting emergency use approval to the vaccines. We are also of the opinion that the evidence relating to the approval process of the Rotavac vaccine has no relevance to the dispute in this case. On the basis of t....
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....wed. 72. 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": Principles o....
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....ld 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: 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 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. 2. In addition, the key outcomes are to be made publicly available within 12 months of study completion by posting to the results Section of the primary clinical trial registry. Where a registry is used without a results database available, the results should be posted on a free-to-access, publicly available, searchable institutional website of the Regulatory Sponsor, Funder or Principal Investigator. 74. The GCP guidelines are being scrupulously followed, according to th....
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.... 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, currently govern the field of disclosure of clinical trial data in India. 76. 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 meetin....
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....se 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 the manner intended, with several members of the original control group prematurely unblinded and offered the vaccine. The Petitioner contends that owing to 'dilution of Phase III control trials prematurely', there are no controls to compare against, making it difficult to ascertain which adverse events are caused by the vaccine. Th....
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....wing 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 and carry out documentation, investigation and causality assessment, besides training and orientation of health care workers and Ors. 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 det....
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.... 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 information in 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....
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.... 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 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 co....
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....overnment, roping in and training relevant participants right from the ground level of vaccine administration. IV. Vaccination of Children 85. 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 clinic....
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.... the Court to second-guess expert opinion, on the basis of which the Government has drawn 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. 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. 88. With respect to results of clinical trials, we note that the Union of India has stated that the results of clinical trials of COVAXIN for paediatric population have already been published. We also note that for the age group of 12 to 14 years, Biological E's Corbevax is being administered. Keeping in line with the WHO Statement on Clinical Trials, the Declaration of Helsinki and the GCP guidelines, we direct the Unio....
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....te State aim; and (iii) proportionality, which ensures a rational nexus between the objects and the means adopted to achieve them. (iv) On the basis of substantial material filed before this Court reflecting the near-unanimous views of experts on the benefits of vaccination in addressing severe disease from the infection, reduction in oxygen requirement, hospital and ICU admissions, mortality and stopping new variants from emerging, this Court is satisfied that the current vaccination policy of the Union of India is informed by relevant considerations and cannot be said to be unreasonable or manifestly arbitrary. Contrasting scientific opinion coming forth from certain quarters to the effect that natural immunity offers better protection against COVID-19 is not pertinent for determination of the issue before us. (v) However, no data has been placed by the Union of India or the States appearing before us, controverting the material placed by the Petitioner in the form of emerging scientific opinion which appears to indicate that the risk of transmission of the virus from unvaccinated individuals is almost on par with that from vaccinated persons. In light of this, ....
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....undue delay. (vii) We do not accept the sweeping challenge to the monitoring system of AEFIs being faulty and not reflecting accurate figures of those with severe reactions or deaths from vaccines. We note that the role of the Pharmacovigilance Programme of India and the CDSCO, as elaborated upon by the Union of India, collates and studies previously unknown reactions seen during monitoring of AEFIs at the time of vaccine administration and we trust the Union of India to ensure that this leg of the AEFI surveillance system is not compromised with, while meeting the requirements of the rapid review and assessment system followed at the national level for AEFIs. (viii) We are also of the opinion that information relating to adverse effects following immunisation is crucial for creating awareness around vaccines and their efficacy, apart from being instrumental in further scientific studies around the pandemic. Recognising the imperative need for collection of requisite data of adverse events and wider participation in terms of reporting, the Union of India is directed to facilitate reporting of suspected adverse events by individuals and private doctors on an access....