JACOB PULIYEL versus UNION OF INDIA & ORS.

[2022] 3 S.C.R. 471

JACOB PULIYEL

UNION OF INDIA & ORS.

(Writ Petition (Civil) No. 607 of 2021)

MAY 02, 2022

[L. NAGESWARA RAO AND B. R. GAVAI, JJ.]

Public health – COVID-19 pandemic – Vaccines and otherpublic health measures – Fundamental rights of individuals – Bodilyintegrity and personal autonomy of an individual – Held: Bodilyintegrity is protected under Art. 21 of the Constitution and noindividual can be forced to be vaccinated – Further, personalautonomy of an individual, which is recognised facet of theprotections guaranteed under Art. 21, encompasses the right torefuse to undergo any medical treatment in the sphere of individualhealth – However, in the interest of protection of communitarianhealth, the Government is entitled to regulate issues of public healthconcern by imposing certain limitations on individual rights, whichare open to scrutiny by constitutional courts to assess whether suchinvasion into an individual’s right to personal autonomy and rightto access means of livelihood meets the threefold requirement aslaid down in K.S. Puttaswamy case, i.e., (i) legality, whichpresupposes the existence of law; (ii) need, defined in terms of alegitimate State aim; and (iii) proportionality, which ensures arational nexus between the objects and the means adopted to achievethem – Constitution of India, 1950 – Art. 21.

Public health – COVID-19 pandemic – Vaccines and otherpublic health measures – Vaccination policy – Restrictions onunvaccinated individuals –Challenge to – Held: Substantial materialfiled before the Court reflecting the near-unanimous views of expertson benefits of vaccination in addressing severe disease from theinfection, reduction in oxygen requirement, hospital and ICUadmissions, mortality and stopping new variants from emerging –Current vaccination policy of the Union of India is informed byrelevant considerations and cannot be said to be unreasonable ormanifestly arbitrary – However, no data placed by Union of Indiaor the States, controverting the material placed by the Petitioner in

CDE

Athe form of emerging scientific opinion which appears to indicatethat the risk of transmission of the virus from unvaccinatedindividuals is almost on par with that from vaccinated persons – Inlight of this, restrictions on unvaccinated individuals imposedthrough various vaccine mandates by State Governments / UnionTerritories cannot be said to be proportionate – Till the infectionBrate remains low and any new development or research findingemerges which provides due justification to impose reasonable andproportionate restrictions on the rights of unvaccinated individuals,it is suggested that all authorities in this country, including privateorganisations and educational institutions, review the relevant ordersCand instructions imposing restrictions on unvaccinated individualsin terms of access to public places, services and resources, if notalready recalled – It is however clarified that in the context of therapidly-evolving situation presented by the COVID-19 pandemic,the suggestion to review the vaccine mandates imposed by States /Union Territories, is limited to the present situation alone and is notDto be construed as interfering with the lawful exercise of power bythe executive to take suitable measures for prevention of infectionand transmission of the virus – The suggestion also does not extendto any other directions requiring maintenance of COVID-appropriatebehaviour issued by the Union or the State Governments.EPublic health – COVID-19 pandemic – Clinical trials ofvaccines – Non-disclosure of segregated clinical data – Held: Theresults of Phase III clinical trials of the vaccines in question havebeen published, in line with the requirement under the statutoryregime in place, Good Clinical Practices (GCP) guidelines and theFWHO Statement on Clinical Trials – Material provided by Union ofIndia, comprising of minutes of the meetings of the SEC, do notwarrant the conclusion that restricted emergency use approvals hadbeen granted to COVISHIELD and COVAXIN in haste, withoutthorough review of the relevant data – Relevant information relating

to meetings of Subject Expert Committee (SEC) [the body whichGsends recommendations to the Central Drugs Standard ControlOrganisation] and National Technical Advisory Group onImmunization (NTAGI) are available in public domain and therefore,challenge to the procedures adopted by the expert bodies whilegranting regulatory approval to the vaccines on the ground of lackHof transparency cannot be entertained – However, subject to the

protection of privacy of individual subjects, with respect to ongoingclinical trials and trials that may be conducted subsequently forCOVID-19 vaccines, all relevant data required to be published underthe extant statutory regime must be made available to the publicwithout undue delay.

Public health – Immunisation – Adverse Events FollowingImmunisation (AEFI) – Central Drugs Standard ControlOrganisation (CDSCO) – Sweeping challenge to the monitoringsystem of AEFIs being faulty and not reflecting accurate figures ofthose with severe reactions or deaths from vaccines, not acceptable– Role of the Pharmacovigilance Programme of India – CDSCO, aselaborated upon by Union of India, collates and studies previouslyunknown reactions seen during monitoring of AEFIs at the time ofvaccine administration – Union of India to ensure that this leg ofthe AEFI surveillance system is not compromised with, while meetingthe requirements of the rapid review and assessment system followedat the national level for AEFIs.

Public health – Immunisation – Adverse effects followingimmunisation – Information relating to – Held: Such information iscrucial for creating awareness around vaccines and their efficacy,apart from being instrumental in further scientific studies aroundthe pandemic – Imperative need for collection of requisite data ofadverse events and wider participation in terms of reporting – Unionof India directed to facilitate reporting of suspected adverse eventsby individuals and private doctors on an accessible virtual platform– These reports shall be made publicly accessible, withoutcompromising on protecting the confidentiality of the personsreporting, with all necessary steps to create awareness of theexistence of such platform and of the information required tonavigate the platform to be undertaken by the Union of India at theearliest.

Public health – Vaccination – Paediatric vaccination – Policydecision – Scope of review – Held: Decision taken by Union ofIndia to vaccinate children in the country is in tune with globalscientific consensus and expert bodies like the WHO, the UNICEFand the CDC – It is beyond the scope of review for the Court tosecond-guess expert opinion, on the basis of which the Governmenthas drawn up its policy – Keeping in line with the WHO Statement

Aon Clinical Trials and the extant statutory regime, Union of Indiadirected to ensure that key findings and results of the relevant phasesof clinical trials of vaccines already approved by the regulatoryauthorities for administration to children, be made public at theearliest, if not already done.

BPublic Health – Policy decisions based on expert opinion –Judicial review – Scope – Held: Court would be slow in interferingwith matters of policy, especially those connected to public health –Wide latitude is provided to the executive in matters involving policydecisions based on expert opinion – Court does not have theexpertise to appreciate and decide on merits of scientific issues onCthe basis of divergent medical opinion – However, this does not barthe Court from scrutinising whether the policy in question can beheld to be beyond the pale of unreasonableness and manifestarbitrariness and to be in furtherance of the right to life of allpersons, bearing in mind the material on record – Constitution ofDIndia, 1950 – Art. 14.

Evidence – News item published in newspaper – Admissibility– Held: The courts cannot take judicial notice of facts stated in anews item published in newspaper – statement of fact containedin newspaper is merely hearsay and therefore, inadmissible inEevidence, unless proved by the maker of the statement appearing incourt and deposing to have perceived the fact reported – JudicialNotice.

Public interest litigation – Public interest litigation moved bya person having knowledge in the subject-matter of the lis and,Fthus, having an interest therein, as contradistinguished from abusybody, in the welfare of people – Maintainability of.

Disposing the writ petition, the Court

HELD: Judicial review of public policies relating to health- Ambit ofG

1.1. The Courts, in exercise of their power of judicial review,do not ordinarily interfere with the policy decisions of theexecutive unless the policy can be faulted on grounds of malafide, unreasonableness, arbitrariness or unfairness etc. Indeed,arbitrariness, irrationality, perversity and mala fide will renderHthe policy unconstitutional. It is neither within the domain of the

courts nor the scope of judicial review to embark upon an enquiryas to whether particular public policy is wise or whether betterpublic policy can be evolved. Nor are the courts inclined to strikedown policy at the behest of petitioner merely because it hasbeen urged that different policy would have been fairer or wiseror more scientific or more logical. Courts do not and cannot actas appellate authorities examining the correctness, suitability andappropriateness of policy, nor are courts advisors to theexecutive on matters of policy which the executive is entitled toformulate. The scope of judicial review when examining policyof the Government is to check whether it violates the fundamentalrights of the citizens or is opposed to the provisions of theConstitution, or opposed to any statutory provision or manifestlyarbitrary. [Para 21][497-B-E]1.2. The courts should not rush in where even scientistsand medical experts are careful to tread. The rule of prudence isthat courts will be reluctant to interfere with policy decisionstaken by the Government, in matters of public health, aftercollecting and analysing inputs from surveys and research. Norwill courts attempt to substitute their own views as to what iswise, safe, prudent or proper, in relation to technical issuesrelating to public health in preference to those formulated bypersons said to possess technical expertise and rich experience.Where expertise of complex nature is expected of the State inframing rules, the exercise of that power not demonstrated asarbitrary must be presumed to be valid as reasonable restrictionon the fundamental right of the citizen and judicial review musthalt at the frontiers. The Court cannot re-weigh and substituteits notion of expedient solution. Within the wide judge-proof areasof policy and judgment open to the government, if they makemistakes, correction is not in court but elsewhere. That is thecomity of constitutional jurisdictions in our jurisprudence. Onecannot evolve judicial policy on medical issues. All judicialthought, Indian and Anglo-American, on the judicial review powerwhere rules under challenge relate to specialised field andinvolve sensitive facets of public welfare, has warned courts ofeasy assumption of unreasonableness of subordinate legislationon the strength of half- baked studies of judicial generalists aided

Aby the ad-hoc learning of counsel. However, the Court certainlyis the constitutional invigilator and must act to defend the citizenin the assertion of his fundamental rights against executivetyranny draped in disciplinary power. [Para 22][497-E-G;498-A-D]

B1.3. The Court would be slow in interfering with matters ofpolicy, especially those connected to public health. There is alsono doubt that wide latitude is given to executive opinion which isbased on expert advice. However, it does not mean that this Courtwill not look into cases where violation of fundamental rights isinvolved and the decision of the executive is manifestly arbitraryCor unreasonable. It is true that this Court lacks the expertise toarrive at conclusions from divergent opinions of scientific issuesbut that does not prevent this Court from examining the issuesraised in this Writ Petition, especially those that concern violationof Article 21 of the Constitution of India. [Para 25][499-E-F]DVaccine mandates – If violative of Art.21 of the Constitution

2.1. Bodily integrity is protected under Article 21 of theConstitution of India and no individual can be forced to bevaccinated. Personal autonomy of an individual involves the rightof an individual to determine how they should live their own life,Ewhich consequently encompasses the right to refuse to undergoany medical treatment in the sphere of individual health. Personswho are keen to not be vaccinated on account of personal beliefsor preferences, can avoid vaccination, without anyone physicallycompelling them to be vaccinated. However, if there is likelihoodFof such individuals spreading the infection to other people orcontributing to mutation of the virus or burdening of the publichealth infrastructure, thereby affecting communitarian health atlarge, protection of which is undoubtedly legitimate State aimof paramount significance in this collective battle against thepandemic, the Government can regulate such public healthGconcerns by imposing certain limitations on individual rights thatare reasonable and proportionate to the object sought to befulfilled. [Para 49][516-B-F]

2.2. The Union of India is justified in centering itsvaccination policy around the health of the population at large,H

with emphasis on insulating the weaker and more vulnerablesections from the risk of severe infection and its consequences,as opposed to basing its decision keeping in mind the interestsof healthy few. Given the considerable material filed before thisCourt reflecting the near-unanimous views of experts on thebenefits of vaccination in dealing with severe disease, reductionin oxygen requirement, hospital and ICU admissions and mortalityand stopping new variants from emerging, this Court is satisfiedthat the current vaccination policy of the Union of India, formulatedin the interest of public health, is informed by relevantconsiderations and cannot be said to be unreasonable. [Para 56][520-D-F]

2.3. While there is abundant data to show that gettingvaccinated continues to be the dominant expert advice even inthe face of new variants, no submission nor any data has been putforth to justify restrictions only on unvaccinated individuals whenemerging scientific evidence appears to indicate that the risk oftransmission of the virus from unvaccinated individuals is almoston par with that from vaccinated persons. To put it differently,neither the Union of India nor the State Governments haveproduced any material before this Court to justify thediscriminatory treatment of unvaccinated individuals in publicplaces by imposition of vaccine mandates. No doubt that whenCOVID-19 vaccines came into the picture, they were expectedto address, and were indeed found to be successful in dealingwith, the risk of infection from the variants in circulation at thetime. However, with the virus mutating, one has seen more potentvariants surface which have broken through the vaccinationbarrier to some extent. While vaccination mandates in the era ofprevalence of the variants prior to the Delta variant may havewithstood constitutional scrutiny, in light of the data presentedby the Petitioner, which has not been controverted by the Unionof India as well as the State Governments, the restrictions onunvaccinated individuals imposed through vaccine mandatescannot be considered to be proportionate, especially since bothvaccinated and unvaccinated individuals presently appear to besusceptible to transmission of the virus at similar levels.[Para 58][522-D-G; 523-A-B]

A2.4. Till the infection rate and spread remains low, as it iscurrently, and any new development or research finding comesto light which provides the Government due justification to imposereasonable and proportionate restrictions on the rights ofunvaccinated individuals in furtherance of the continuing effortsto combat this pandemic, it is suggested that all authorities inBthis country, including private organisations and educationalinstitutions, review the relevant orders and instructions imposingrestrictions on unvaccinated individuals in terms of access topublic places, services and resources. [Para 59][523-D-F]

2.5. However, given the rapidly-changing nature of the virusCand the clear purpose served by the approved vaccines in termsof restoration and protection of public health, the suggestionswith respect to review of vaccine mandates are limited to thepresent situation alone. This judgment is not to be construed asimpeding, in any manner, the lawful exercise of power by theDexecutive to take suitable measures for prevention of infectionand transmission of the virus in public interest, which may alsotake the form of restrictions on unvaccinated people in the future,if the situation so warrants. Such restrictions will be subject toconstitutional scrutiny to examine if they meet the threefoldrequirement for intrusion into rights of individuals. [Para 61]E[524-C-E]

Judicial notice of news item published in newspaper

3. The courts cannot take judicial notice of facts stated in anews item published in newspaper. statement of fact containedFin newspaper is merely hearsay and therefore, inadmissible inevidence, unless proved by the maker of the statement appearingin court and deposing to have perceived the fact reported. In theabsence of anything on record in the present case to substantiatethe statement made by member of the NTAGI, this Court is notinclined to take judicial notice of the news article reported inGThe Wire, even more so in light of the affidavit filed on behalf ofthe Union of India stating that the relevant data was examined bythe expert bodies at all stages before granting emergency useapproval to the vaccines. Also, the evidence relating to theapproval process of the Rotavac vaccine has no relevance to theH

dispute in this case. On the basis of the said two incidents, itcannot be concluded that the emergency use approval toCOVISHIELD and COVAXIN recommended by the SEC are notin accordance with the statutory regime. [Para 70][530-G-H;531-A-B]

Non-disclosure of segregated clinical trial data in publicdomain

4. It is seen that there is strict statutory regime in forcefor grant of approvals to vaccines. Specialist bodies establishedunder the provisions of the Drugs and Cosmetics Act, 1940 andthe rules framed thereunder comprise of domain experts in therelevant field, who conduct thorough scrutiny of the materialproduced by the manufacturers before granting approval. Theinformation provided on behalf of the Union of India substantiatesthat the data provided by the vaccine manufacturers wasconsidered by the SEC over period of time and severalconditions were imposed at the time of recommending approvals,which have been modified or lifted subsequently on availabilityof further data arising from the clinical trials before the SEC, ascan be seen from the minutes of the meetings of the SEC, availableon the website of the MoHFW. It cannot be said that emergencyapprovals to the vaccines were given in haste, without properlyreviewing the data from clinical trials. Also, the ParliamentaryStanding Committee report relied upon by the Petitioner is notrelevant and the lapses pointed out therein pertain to the year2011, which have no obvious connection to the grant of approvalto Respondent Nos. 4 and 5 for the restricted emergency use oftheir respective vaccines. As long as the relevant informationrelating to the minutes of the meetings of the regulatory bodiesand the key outcomes and findings of the trials are available inpublic domain, the Petitioner cannot contend that every minutedetail relating to clinical trials be placed in public domain to enablean individual to take an informed, conscious decision to bevaccinated or not. Given the widespread affliction caused by thevirus, there was an imminent need of manufacturing vaccineswhich would keep the infection at bay. Both the vaccines havebeen approved by the WHO as well. perusal of the materialplaced on record would show that there is material compliance

DEF

Awith the procedure prescribed under the Drugs and CosmeticsAct, 1940 and the New Drugs and Clinical Trials Rules, 2019framed under the said Act, before grant of approval for theemergency use of the two vaccines. However, it is made clearthat subject to the protection of privacy of individual subjectsand to the extent permissible by the 2019 Rules, the relevantBdata which is required to be published under the statutory regimeand the WHO Statement on Clinical Trials shall be made availableto the public without undue delay, with respect to the ongoingpost-marketing trials of COVAXIN and COVISHIELD as well asongoing clinical trials or trials that may be conducted subsequentlyCfor approval of other COVID-19 vaccines / vaccine candidates.[Para 76][535-E-H; 536-A-D]Improper collection and reporting of Adverse EventsFollowing Immunisations (AEFIs).5. There should be mechanism by which individuals andDprivate doctors should be permitted to report suspected adverseevents. Information relating to adverse effects followingimmunisation is crucial for the purpose of understanding thesafety of the vaccines that are being administered, apart frombeing instrumental in further scientific studies around theEpandemic. There is an imminent need for collection of requisitedata of adverse events and wider participation of people inreporting the adverse events is necessary for the purpose ofgathering correct information. Thus, the Union of India is directedto facilitate the reporting of suspected adverse events byindividuals and private doctors on virtual platform and theFreports so made shall be publicly accessible after being givenunique identification numbers, without listing any personal orconfidential data of the persons reporting. All necessary steps tocreate awareness of, and to navigate, this platform for self-reporting shall be effectuated by the Government, roping in andGtraining relevant participants right from the ground level ofvaccine administration. [Para 84][541-F-H; 542-A]

Vaccination of children

6.1. This Court cannot sit in judgment of leading scientificanalysis relating to the safety of paediatric vaccination. ExpertsH

in science may themselves differ in their opinions while takingdecisions on matters related to safety and allied aspects, but thatdoes not entitle the Court to second-guess expert opinion, onthe basis of which the Government has drawn up its policies. Thedecision taken by the Union of India to vaccinate paediatricpopulation in this country is in tune with global scientificconsensus and expert bodies like the WHO, the UNICEF andthe CDC have also advised paediatric vaccination. It would notonly be beyond jurisdiction of this Court but also hazardous ifthis Court were to examine the accuracy of such expert opinion,based on competing medical opinions. The scope of judicial reviewdoes not entail the Court embarking upon such misadventures.Therefore, the contention of the Petitioner, that this Court hasto intervene in paediatric vaccination on the ground that it isunscientific, is rejected. [Para 87][543-C-F]

6.2. With respect to results of clinical trials, it is noted thatthe Union of India has stated that the results of clinical trials ofCOVAXIN for paediatric population have already been published.It is further noted that for the age group of 12 to 14 years,Biological E’s Corbevax is being administered. Keeping in linewith the WHO Statement on Clinical Trials, the Declaration ofHelsinki and the GCP guidelines, the Union of India is directedto ensure that key findings and results of the clinical trials ofCorbevax be published at the earliest, if not already done. Neithervaccine is an mRNA vaccine and to this extent, the apprehensionsof the Petitioner with respect to the associated risks of mRNAvaccines are unfounded in the present situation. [Para 88][543-F-H]

7. Conclusion

(i) Given the issues urged by the Petitioner have bearingon public health and concern the fundamental rights of individualsin this country, this Court is not inclined to entertain any challengeto the maintainability of the Writ Petition.

(ii) As far as judicial review of policy decisions based onexpert opinion is concerned, there is no doubt that wide latitudeis provided to the executive in such matters and the Court doesnot have the expertise to appreciate and decide on merits of

Ascientific issues on the basis of divergent medical opinion.However, this does not bar the Court from scrutinising whetherthe policy in question can be held to be beyond the pale ofunreasonableness and manifest arbitrariness and to be infurtherance of the right to life of all persons, bearing in mind thematerial on record.B

(iii) With respect to the infringement of bodily integrity andpersonal autonomy of an individual considered in the light ofvaccines and other public health measures introduced to dealwith the COVID-19 pandemic, this Court is of the opinion thatbodily integrity is protected under Article 21 of the ConstitutionCand no individual can be forced to be vaccinated. Further, personalautonomy of an individual, which is recognised facet of theprotections guaranteed under Article 21, encompasses the rightto refuse to undergo any medical treatment in the sphere ofindividual health. However, in the interest of protection ofDcommunitarian health, the Government is entitled to regulateissues of public health concern by imposing certain limitationson individual rights, which are open to scrutiny by constitutionalcourts to assess whether such invasion into an individual’s rightto personal autonomy and right to access means of livelihoodmeets the threefold requirement as laid down in K.S. PuttaswamyEcase, i.e., (i) legality, which presupposes the existence of law; (ii)need, defined in terms of legitimate State aim; and (iii)proportionality, which ensures rational nexus between theobjects and the means adopted to achieve them.

(iv) On the basis of substantial material filed before thisFCourt reflecting the near-unanimous views of experts on thebenefits of vaccination in addressing severe disease from theinfection, reduction in oxygen requirement, hospital and ICUadmissions, mortality and stopping new variants from emerging,this Court is satisfied that the current vaccination policy of theGUnion of India is informed by relevant considerations and cannotbe said to be unreasonable or manifestly arbitrary.

(v) However, no data has been placed by the Union of Indiaor the States, controverting the material placed by the Petitionerin the form of emerging scientific opinion which appears to indicatethat the risk of transmission of the virus from unvaccinatedH

individuals is almost on par with that from vaccinated persons. Inlight of this, restrictions on unvaccinated individuals imposedthrough various vaccine mandates by State Governments / UnionTerritories cannot be said to be proportionate. Till the infectionrate remains low and any new development or research findingemerges which provides due justification to impose reasonableand proportionate restrictions on the rights of unvaccinatedindividuals, it is suggested that all authorities in this country,including private organisations and educational institutions,review the relevant orders and instructions imposing restrictionson unvaccinated individuals in terms of access to public places,services and resources, if not already recalled. It is clarified thatin the context of the rapidly-evolving situation presented by theCOVID-19 pandemic, the suggestion to review the vaccinemandates imposed by States / Union Territories, is limited to thepresent situation alone and is not to be construed as interferingwith the lawful exercise of power by the executive to take suitablemeasures for prevention of infection and transmission of the virus.The suggestion also does not extend to any other directionsrequiring maintenance of COVID-appropriate behaviour issuedby the Union or the State Governments.(vi) As regards non-disclosure of segregated clinical data,it is found that the results of Phase III clinical trials of the vaccinesin question have been published, in line with the requirementunder the statutory regime in place, the GCP guidelines and theWHO Statement on Clinical Trials. The material provided by theUnion of India, comprising of minutes of the meetings of the SEC,do not warrant the conclusion that restricted emergency useapprovals had been granted to COVISHIELD and COVAXIN inhaste, without thorough review of the relevant data. Relevantinformation relating to the meetings of the SEC and the NTAGIare available in public domain and therefore, challenge to theprocedures adopted by the expert bodies while grantingregulatory approval to the vaccines on the ground of lack oftransparency cannot be entertained. However, subject to theprotection of privacy of individual subjects, with respect to ongoingclinical trials and trials that may be conducted subsequently forCOVID-19 vaccines, all relevant data required to be published

Aunder the extant statutory regime must be made available to thepublic without undue delay.

(vii) One cannot accept the sweeping challenge to themonitoring system of AEFIs being faulty and not reflectingaccurate figures of those with severe reactions or deaths fromBvaccines. The role of the Pharmacovigilance Programme of Indiaand the CDSCO, as elaborated upon by the Union of India, collatesand studies previously unknown reactions seen during monitoringof AEFIs at the time of vaccine administration and one trusts theUnion of India to ensure that this leg of the AEFI surveillancesystem is not compromised with, while meeting the requirementsCof the rapid review and assessment system followed at the nationallevel for AEFIs.

(viii) Information relating to adverse effects followingimmunisation is crucial for creating awareness around vaccinesand their efficacy, apart from being instrumental in furtherDscientific studies around the pandemic. Recognising theimperative need for collection of requisite data of adverse eventsand wider participation in terms of reporting, the Union of Indiais directed to facilitate reporting of suspected adverse events byindividuals and private doctors on an accessible virtual platform.EThese reports shall be made publicly accessible, withoutcompromising on protecting the confidentiality of the personsreporting, with all necessary steps to create awareness of theexistence of such platform and of the information required tonavigate the platform to be undertaken by the Union of India atthe earliest.F

(ix) On paediatric vaccination, this Court recognises thatthe decision taken by the Union of India to vaccinate children inthis country is in tune with global scientific consensus and expertbodies like the WHO, the UNICEF and the CDC and it is beyondthe scope of review for this Court to second-guess expert opinion,Gon the basis of which the Government has drawn up its policy.Keeping in line with the WHO Statement on Clinical Trials andthe extant statutory regime, the Union of India is directed toensure that key findings and results of the relevant phases ofclinical trials of vaccines already approved by the regulatory

authorities for administration to children, be made public at theearliest, if not already done. [Para 89 (ii) to (ix)][544-A-H; 545-A-H; 546-A-H; 574-A-E]

Delhi Development Authority v. Joint Action Committee,Allottee of SFS Flats (2008) 2 SCC 672 : [2007]13 SCR 811; In re: Distribution of Essential Suppliesand Services During Pandemic, (2021) 7 SCC 772;Ugar Sugar Works Ltd. v. Delhi Administration (2001)3 SCC 635; Villianur Iyarkkai Padukappu Maiyam v.Union of India (2009) 7SCC 561; Directorate of FilmFestivals v. Gaurav Ashwin Jain (2007) 4 SCC 737:[2007] 5 SCR 7; Pyarali K.Tejani v. MahadeoRamchandra Dange (1974) 1 SCC 167 : [1974]2 SCR 154; Union of India v. Dinesh EngineeringCorporation (2001) 8 SCC 491; Common Cause (ARegistered Society) v. Union of India (2018) 5 SCC 1 :[2018] 6 SCR 1; K. S. Puttaswamy v. Union of India(2017) 10 SCC 1 : [2017] 10 SCR 569 and AshwaniKumar v. Union of India (2019) 2 SCC 636 : [2018]13 SCR 1286 – relied on

Indian Banks’ Association, Bombay v. DevkalaConsultancy Service (2004) 11 SCC 1 : [2004] 1 Suppl.SCR 225; Academy of NutritionImprovement v. Unionof India, (2011) 8 SCC 274: [ 2011] 8 SCR 680; G.Sundarrajan v. Union of India (2013) 6 SCC 620 :[2013] 8 SCR 631; Shri Sitaram Sugar Company Ltd.v. Union of India (1990) 3 SCC 223 : [1990] 1 SCR 909; Aruna Ramachandra Shanbaug v. Union of India(2011) 4 SCC 454 : [2011] 4 SCR 1057; NationalLegal Services Authority v. Union of India (2014) 5 SCC438 : [2014] 5 SCR 119; X v. Hospital ‘Z’ (1998) 8SCC 296 : [1998] 1 Suppl. SCR 723; Kharak Singh vState of U.P., [1964] 1 SCR 332; Gobind v. State ofM.P. (1975) 2 SCC 148 : [1975] 3 SCR 946;Association of Medical Super Speciality Aspirants andResidents v. Union of India (2019) 8 SCC 607 : [2019]12 SCR 1011; Vincent Panikurlangara v. Union ofIndia (1987) 2 SCC 165; ArunaRodrigues (4) v. Union

Aof India (2011) 12 SCC 481; and Laxmi Raj Shetty v.State of Tamil Nadu (1988) 3 SCC 319 : [1988] 3 SCR 706 – referred to.

Henning Jacobson v. Commonwealth of Massachusetts197 US 11 (1905); Zucht v. King, 260 US 174 (1922);BHenry v. Hazzard [2021] NSWSC 1320; Ryan Yardleyv. Minister for Workplace Relations and Safety [2022]NZHC 291; Roman Catholic Diocese v. Cuomo 141 S.Ct. 63 (2020); South Bay United Pentecostal Church v.Newsom 140 S. Ct. 1613 (2020); Kassam v. Hazzard;Henry v. Hazzard [2021] NSWCA 299; Ministry ofCHealth v. Atkinson [2012] NZCA 184; Jane Roe v.Henry Wade 410 US 113 (1973); Four Aviation SecurityService Employees v. Minister of COVID-19 Response[2021] NZHC 3012 and Spencer v. Attorney Generalof Canada [2021] FC 361 – referred to.

CIVIL ORIGINAL JURISDICTION : Writ Petition (Civil) No.607of 2021.

(Under Article 32 of The Constitution of India)

Prashant Bhushan, Ms. Cheryl Dsouza, Advs. for the Petitioner.

Tushar Mehta, SG, K. M. Nataraj, Ms. Aishwarya Bhati, ASGs,Amit Anand Tiwari, AAG, S. Guru Krishnakumar, Sr. Adv., Rajat Nair,Kanu Agrawal, Ketan Paul, Mayank Pandey, Gurmeet Singh Makker,Vipin Nair, P. B. Suresh, Sughosh Subramanyam, Arindam Ghosh, AgnishAditya, Shyel Trehan, Ms. Malvika Kapila, Ms. Bhagya Yadav, Ms.Tanwangi Shukla, Shailesh Madiyal, Ms. Mrinal Gopal Elker, KameshwarNath Mishra, Ms. Pratibha Yadav, Rahul Chitnis, Sachin Patil, AadityaA. Pande, Geo Joseph, Ms. Shwetal Shepal, Ms. Jyoti Mendiratta, Dr.Joseph Aristotle S., Ms. Mary Mitzy, Ms. Devyani Gupta, Advs. for theRespondents.

Ms. Meenakshi S. Kamble, Hitesh Kumar Sharma, AkhileshwarJha, Ms. Kavita S. More, Advs. for the Intervenors.

The Judgment of the Court was delivered by

L. NAGESWARA RAO, J.

1. The Petitioner was member of the National Technical AdvisoryGroup on Immunization (NTAGI) and was advising the Government ofIndia on vaccines. He has filed this Writ Petition in public interest seekingthe following reliefs:

“(a) Direct the respondents to release the entire segregatedtrial data for each of the phases of trials that have been

Aundertaken with respect to the vaccines being administeredin India; and

(b) Direct the respondent No 2 to disclose the detailed minutesof the meetings of the Subject Expert Committee and theNTGAI with regard to the vaccines as directed by theB59[th]Parliamentary Standing Committee Report and themembers who constituted the committee for the purpose ofeach approval meeting; and

(c) Direct the respondent No.2 to disclose the reasoneddecision of the DCGI granting approval or rejecting anCapplication for emergency use authorization of vaccines andthe documents and reports submitted to the DCGI in supportof such application; and

(d) Direct the respondents to disclose the post vaccinationdata regarding adverse events, vaccinees who got infectedDwith Covid, those who needed hospitalization and those whodied after such infection post vaccination and direct therespondents to widely publicize the data collection of suchadverse event through the advertisement of toll free telephonenumbers where such complaints can be registered; and

E(e) Declare that vaccine mandates, in any manner whatsoever,even by way of making it precondition for accessing anybenefits or services, is violation of rights of citizens andunconstitutional; and

(f) Pass any other orders as this Hon’ble Court deems fit.”

F2. In the Writ Petition, the Petitioner highlighted the adverseconsequences of emergency approval of vaccines in India, the need fortransparency in publishing segregated clinical trial data of vaccines, theneed for disclosure of clinical data, lack of transparency in regulatoryapprovals, minutes and constitution of the expert bodies, imperfectevaluation of Adverse Events Following Immunisation (AEFIs) andGvaccine mandates in the absence of informed consent beingunconstitutional. The Petitioner further stated in the Writ Petition thatcoercive vaccination would result in interfering with the principle ofinformed self-determination of individuals, protected by Article 21 of theConstitution of India.H

3. Notice was issued in the Writ Petition on 09.08.2021. Anadditional affidavit was filed by the Petitioner on 03.09.2021 raisingadditional grounds. It was averred in the additional affidavit that naturalimmunity is long-lasting and robust in comparison to vaccine immunityand that vaccines do not prevent infection or transmission of COVID-19. The Petitioner further stated that vaccines are not effective inpreventing against infection from new variants of COVID-19. ThePetitioner relied on news articles on the fourth nationwide serologicalsurvey conducted by Indian Council of Medical Research (ICMR) inJune and July, 2021, according to which up to two-thirds of the Indianpopulation above the age of 6 years had already been infected withCOVID-19 and had antibodies specific to the SARS-CoV-2 virus. ThePetitioner relied upon other news articles and research studies conductedto state that there had been breakthrough infections even amongstvaccinated people. Urging that research has shown that vaccinated peoplealso transmit the virus, the Petitioner contended that vaccine mandatesare meaningless.4. The Petitioner filed an Interlocutory Application seeking adirection to restrain all authorities and institutions, public and private,from mandating the vaccine in any manner whatsoever, on preconditionof accessing any service or on pain of any penalty. The Petitioner hasdrawn the attention of this Court to various restrictions that were placedby State Governments, other employers and educational institutions onunvaccinated individuals. The Petitioner contended that mandatingvaccination for access to resources, public places and means of earninglivelihood would be in violation of their fundamental rights, especially so,when scientific studies have shown that unvaccinated persons do notpose more danger of transmission of the virus when compared tovaccinated persons.

5. Respondent No. 1, the Union of India, has raised preliminaryobjection regarding the maintainability of the Writ Petition. The Union ofIndia has further contended that the serious threat posed by theunprecedented pandemic which had devastating effects on the entireworld called for emergency measures. It is accepted world over thatvaccination for COVID-19 is necessary to avoid infection. India wasone of the few countries in the world which succeeded in manufacturingvaccines for protection from COVID-19, one of which was COVAXIN,India’s indigenous vaccine and the other being COVISHIELD, which

Awas manufactured by Serum Institute of India with technology transferfrom AstraZeneca / Oxford University. The country started one of thelargest inoculation programmes in the world in larger public interest,while tackling challenges of vaccine hesitancy, effect of the second waveof the pandemic and other such adverse circumstances. The Union ofIndia expressed serious doubts about the intention of the Petitioner inBfiling this Writ Petition. As we have not seen the end of the pandemiccaused due to the COVID-19 virus, any interference with the stepstaken by the Union on the basis of the advice given by the NTAGI andother expert bodies would provide impetus to the already prevailingvaccine hesitancy in certain sections of the society. In their counter-Caffidavit, the Union of India reminded us that decisions of domain expertsshould not normally be interfered with in judicial review and that thisCourt should not sit in appeal over scientific process undertaken bydomain experts on subject which is not the expertise of any judicialforum. The long-drawn procedure for making applications for issuanceof licenses for manufacturing vaccines and the statutory regime governingDthe same have been referred to in the counter-affidavit to emphasizethat the Union of India has not been remiss in grant of emergency licences.There is detailed procedure for approval with checks at every stagewhich has been followed for grant of emergency approval. In so far asdisclosure of clinical trial data is concerned, the Union of India referredEto the National Ethical Guidelines for Biomedical and Health Researchinvolving Human Participants published by the ICMR, which requireprivacy and confidentiality of human participants to be maintained.Accordingly, the Union of India contended that such details pertaining toidentity and records of the participants in the clinical trial data cannot bedisclosed to the public as per the prevailing statutory regime. It wasFasserted by the Union of India that the remaining data has already beenmade available in the public domain.6. On the subject of monitoring of AEFIs, the Union of Indiabrought to our attention established procedures and protocols in placefor surveillance of AEFIs established under the National Adverse EventGFollowing Immunisation Surveillance Guideline. Further, the multi-tierstructure comprising AEFI Committees at the state and national levels,providing guidance, carrying out investigation and causality assessmentwas elaborated upon. Details of the procedures followed in accordancewith globally accepted practices were highlighted in the counter-affidavit.HAccording to the Union of India, all cases of serious and severe AEFI,

including reported deaths, are subjected to scientific and technical reviewprocess with causality assessments done at the state and national levelsby trained experts to ascertain whether particular AEFI can beattributed to the vaccine. In the counter-affidavit, it was also made clearthat COVID-19 vaccination is voluntary and that the Government ofIndia encourages all individuals to take vaccination in the interest ofpublic health, as the individual’s ill health has direct effect on the society.It was also made clear that COVID-19 vaccination is not linked to anybenefits or services.

7. Counter-affidavits have been filed by other Respondents aswell. The vaccine manufacturers, i.e.,Respondents Nos. 4 and 5, havebrought to the notice of this Court that approval to their vaccines wasgranted after strict compliance of the procedure prescribed. The Statesof Tamil Nadu, Maharashtra, Delhi and Madhya Pradesh have also filedcounter-affidavits, justifying the restrictions that were placed onunvaccinated persons in public interest. The details of the restrictionshave been discussed later.

8. We have heard Mr. Prashant Bhushan, learned counsel for thePetitioner, Mr. Tushar Mehta, learned Solicitor General of the Union ofIndia, Mr. S. Guru Krishnakumar, learned Senior Counsel for RespondentNo. 4, Mr. Amit Anand Tiwari, learned Additional Advocate General forthe State of Tamil Nadu, Mr. Rahul Chitnis, learned counsel for theState of Maharashtra, Ms.Mrinal Gopal Elker, learned counsel for theState of Madhya Pradesh and Ms.Shyel Trehan, learned counsel forRespondent No. 5.

Preliminary Issues

I. Maintainability

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

10. The Petitioner is paediatrician, who was member of theNTAGI earlier. It has been stated in the Writ Petition that he has anumber of publications in internationally peer-reviewed medical journalsto his credit. The Petitioner strongly believes that there cannot be coercivevaccination, especially of inadequately tested vaccines, which amounts

Ato an intrusion into the individual’s personal autonomy. He is also of thefirm opinion that an individual is deprived of the opportunity to giveinformed consent in the absence of availability of segregated data ofclinical trials of the vaccines. He has also aired further grievancespertaining to poor evaluation and reporting of AEFIs.

B11. This Court is entitled to entertain public interest litigationmoved by person having knowledge in the subject-matter of the lisand, thus, having an interest therein, as contradistinguished from abusybody, in the welfare of people[1]. The Union of India has objected tothe maintainability of the Writ Petition on the ground that the questionsraised by the Petitioner may result in raising doubts in the minds of theCcitizenry about the vaccination, adding to the already existing vaccinehesitancy in the country. The consequence would be debilitating effecton public health and therefore, the petition cannot be said to be in publicinterest. In other words, the maintainability of the Writ Petition is raisedon the ground that the sensitive issue of vaccination should not be dealtDwith by this Court, as it has the propensity of fuelling doubts about theefficacy of the vaccines.

12. From the rejoinder affidavit submitted by the Petitioner, wenote that petition had been filed by the Petitioner earlier, during histenure as member of the NTAGI, with respect to the Rotavac vaccineEclaiming that adequate data from the clinical trials had not been providedto the NTAGI. The rejoinder affidavit further states that the petitionwas dismissed by this Court, on the ground that the Petitioner could nothave filed the said petition while being member of the NTAGI. Theenthusiasm of the Petitioner in approaching this Court has not goneunobserved. However, as the issues raised by the Petitioner have bearingFon public health and pertain to the fundamental rights of the country’spopulace, we are of the opinion that they warrant due consideration bythis Court. Therefore, we are not inclined to entertain the challengemounted by the Union of India to the maintainability of the Writ Petition.

II. Judicial review of executive decisions based on expertGopinion

13. Yet another ground taken by the Union of India is that thisCourt has to yield to executive decision and action in the matter ofadministration of drugs / vaccines. The existence of any other possible

H1 Indian Banks’ Association, Bombay v. Devkala Consultancy Service (2004) 11 SCC 1

view cannot enable this Court to interfere in matters relating to opinionof domain experts by sitting in appeal over such decisions, whileadjudicating writ petition filed under Article 32 of the Constitution. Thelearned Solicitor General supported the stand of the Union of India withreference to the law laid down by this Court in Academy of NutritionImprovement v. Union of India[2], G. Sundarrajan v. Union of India[3]and Shri Sitaram Sugar Company Ltd. v. Union of India[4]. Further,the learned Solicitor General relied upon the judgments of the SupremeCourt of the United States (hereinafter, the “US Supreme Court”) inHenningJacobson v. Commonwealth of Massachusetts[5], Zucht v.King[6]and in Docket No. 21A240 titled Joseph R. Biden v. Missouridated 13.01.2022 and the judgment of the Supreme Court of New SouthWales (hereinafter, the “NSW Supreme Court”) in Kassam v.Hazzard; Henry v. Hazzard[7] to bolster his submissions that courtsshould not lightly interfere with matters of policy concerning the safetyand health of the people and it is not the court’s function to determinethe merits of the exercise of power by the executive. The learned SolicitorGeneral was joined by Mr. Amit Anand Tiwari, learned AdditionalAdvocate General for the State of Tamil Nadu, in emphasising the limitedscope of judicial review in matters of policy framed on the basis ofexpert opinion.14. In opposition, the Petitioner argued that matters of publicimportance involving invasion of fundamental rights of individuals cannotbe brushed aside by this Court on the ground that they are beyond thejurisdiction of this Court. This Court has duty to safeguard thefundamental rights of individuals and issues raised herein are of seminalimportance which ought to be decided after assessing the relevantmaterial placed before this Court by both sides. Mr. Bhushan referred tothe judgement of the High Court of New Zealand in Ryan Yardley v.Minister for Workplace Relations and Safety[8] in support of hissubmission that the scientific data and evidence that was produced beforethe High Court of New Zealand was assessed to adjudge the efficacy

of vaccines in preventing transmission of the COVID-19 virus.2 (2011) 8 SCC 2743 (2013) 6 SCC 6204 (1990) 3 SCC 2235 197 US 11 (1905)6 260 US 174 (1922)7 [2021] NSWSC 13208 [2022] NZHC 291

A15. It was further argued by Mr. Bhushan that the judgmentsrelied upon by the Union of India are not applicable to the facts of thiscase. He relied upon the judgments of this Court in Delhi DevelopmentAuthority v. Joint Action Committee, Allottee of SFS Flats[9],Directorate of Film Festivals v. Gaurav Ashwin Jain[10]and an orderof this Court in Distribution of Essential Supplies and Services DuringBPandemic, In re[11] and submitted that policy decisions taken by theexecutive are not beyond the scope of judicial review, if they aremanifestly arbitrary or unreasonable.

16. Before examining the parameters of judicial review in thiscase, it is profitable to refer to judgments from beyond our borders whichChave dealt with the scope of judicial review in matters relating to publichealth and vaccinations, in particular. Compulsory vaccination againstsmall pox was the subject-matter of Jacobson (supra) decided in 1905.The US Supreme Court was of the opinion that the mandate of the localgovernment for compulsory vaccination was binding on every individual.DThe safety and health of the people has to be protected by the governmentand the judiciary is not competent to interfere with decisions taken in theinterest of public health. The Court can interfere by way of judicial reviewof legislative action in matters of public health only when there is no realor substantial relation to the object of the legislation or when there isplain, palpable invasion of rights secured by fundamental law and thereby,Egive effect to the Constitution.

17. In the wake of the COVID-19 pandemic, restrictions onattendance at religious services in areas classified as ‘red’ or ‘orange’zones were imposed by an executive order issued by the Governor ofNew York. The said restrictions were challenged on the ground thatFthey violate the free exercise clause of the First Amendment of theConstitution of the United States. By majority of 6:3, the US SupremeCourt in Roman Catholic Diocese v. Cuomo[12 ]granted injunctive reliefon being satisfied that the executive order struck at the very heart of theFirst Amendment’s guarantee of religious liberty. While doing so, the USGSupreme Court observed that the members of the Court are not publichealth experts and they should respect the judgment of those with specialexpertise and responsibility in this area. However, the Constitution cannot

9 (2008) 2 SCC 67210 (2007) 4 SCC 73711 (2021) 7 SCC 772H12 141 S. Ct. 63 (2020)

be put away and forgotten even in pandemic. Gorsuch, J., who wrotea concurring opinion, observed that Jacobson (supra)hardly supportscutting the Constitution loose during pandemic. Jacobson (supra) wasdistinguished by Gorsuch, J., who held that the Court did not interferewith the challenged law in Jacobson (supra) only because it did not“contravene the Constitution of the United States” or “infringe anyright granted or secured by” it. word of caution sounded by Gorsuch,J. is to the effect that the Court cannot stay out of the way in times ofcrisis, when the Constitution is under attack. In his dissent, Roberts, C.J.held that the injunction sought would not be in public interest, especiallywhen it concerns public health and safety needs which calls for swiftgovernment action in everchanging circumstances. He relied upon theearlier order passed by the US Supreme Court in South Bay UnitedPentecostal Church v. Newsom[13 ]wherein it was recognised that courtsmust grant elected representatives broad discretion when they undertaketo act in areas fraught with medical and scientific uncertainties.

18. Biden v. Missouri (supra) related to vaccine mandates forhealthcare providers. The Secretary of Health and Human Services issueda rule on being convinced that vaccination of healthcare workers infacilities in the Medicare and Medicaid Programs against COVID–19was “necessary for the health and safety of individuals to whomcare and services are furnished”. The said rule was challenged andthe US District Courts for the Western District of Louisiana and theEastern District of Missouri each entered preliminary injunctions againstits enforcement. The appeals filed against the said injunction wererejected by the Fifth Circuit in Louisiana and the Eighth Circuit in Missouri.Aggrieved thereby, the Government moved the US Supreme Courtseeking for stay on the preliminary injunctions passed by the US DistrictCourts. While granting stay of the preliminary injunctions, by its pluralopinion the US Supreme Court held that the role of courts in reviewingdecisions taken by the executive should be to ensure that the executive“has acted within zone of reasonableness”.

19. Having been aggrieved by certain orders of the Minister forHealth and Medical Research that required people working in theconstruction, aged care and education sectors to be compulsorilyvaccinated, Al-Munir Kassamand three others, along with Natasha Henryand five others, approached the NSW Supreme Court challenging the

Aconstitutional validity of the decision. While considering the grounds ofchallenge, the NSW Supreme Court in Kassam v. Hazzard (supra)was of the view that “it is not the Court’s function to determine themerits of the exercise of the power by the Minister to make theimpugned orders, much less for the court to choose between plausibleresponses to the risks to the public health posed by the DeltaBvariant”. The NSW Supreme Court further observed that it is not thecourt’s function to conclusively determine the effectiveness of some ofthe alleged treatments for those infected or the effectiveness of COVID-19 vaccines, especially their capacity to inhibit the spread of the disease,which are all matters of merits, policy and fact for the decision makerCand not the court. The NSW Supreme Court emphasised that its onlyfunction is to determine the legal validity of the impugned orders. Thesaid view of the NSW Supreme Court was approved by the New SouthWales Court of Appeal in Kassam v. Hazzard; Henry v. Hazzard[14].

20. The Minister for Workplace Relations and Safety passed

DCOVID-19 Public Health Response (Specified Work Vaccinations)Order 2021, by which it was determined that work carried out by certainpolice and defence force personnel could only be undertaken by workerswho have been vaccinated. Three police and defence force workerswho did not wish to be vaccinated sought judicial review of the saidorder before the High Court of New Zealand (hereinafter, the “NZ HighECourt”). While adjudicating the dispute, the NZ High Court in RyanYardley (supra) expressed its opinion that the choices made bygovernments on their response to COVID-19 involve wide policyquestions, including decisions on the use of border closures, lockdowns,isolation requirements, vaccine mandates and many other measures,Fwhich are decisions for the elected representatives to make. The NZHigh Court made it clear that the Court addresses narrower legal questionsand the Court’s function is not to address the wider policy questions.While referring to the evidence of experts, the NZ High Court stressedon the institutional limitations on the Court’s ability to reach definitive

conclusions but clarified that the Court must exercise its constitutionalGresponsibility to ensure that decisions are made lawfully. While relyingupon judgment of the Court of Appeal of New Zealand in Ministry ofHealth v. Atkinson[15], the NZ High Court held that the Crown has theburden to demonstrate that limitation of fundamental right is14 [2021] NSWCA 299H15 [2012] NZCA 184

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

21. We shall now proceed to analyse the precedents of this Courton the ambit of judicial review of public policies relating to health. It iswell settled that the Courts, in exercise of their power of judicial review,do not ordinarily interfere with the policy decisions of the executive unlessthe policy can be faulted on grounds of mala fide, unreasonableness,arbitrariness or unfairness etc. Indeed, arbitrariness, irrationality,perversity and mala fide will render the policy unconstitutional[16].It isneither within the domain of the courts nor the scope of judicial reviewto embark upon an enquiry as to whether particular public policy iswise or whether better public policy can be evolved. Nor are the courtsinclined to strike down policy at the behest of petitioner merely becauseit has been urged that different policy would have been fairer or wiseror more scientific or more logical[17]. Courts do not and cannot act asappellate authorities examining the correctness, suitability andappropriateness of policy, nor are courts advisors to the executive onmatters of policy which the executive is entitled to formulate. The scopeof judicial review when examining policy of the Government is to checkwhether it violates the fundamental rights of the citizens or is opposed tothe provisions of the Constitution, or opposed to any statutory provisionor manifestly arbitrary[18].

22. This Court in series of decisions has reiterated that courtsshould not rush in where even scientists and medical experts are carefulto tread. The rule of prudence is that courts will be reluctant to interferewith policy decisions taken by the Government, in matters of public health,after collecting and analysing inputs from surveys and research. Norwill courts attempt to substitute their own views as to what is wise, safe,prudent or proper, in relation to technical issues relating to public healthin preference to those formulated by persons said to possess technicalexpertise and rich experience[19]. Where expertise of complex nature isexpected of the State in framing rules, the exercise of that power not

16 Ugar Sugar Works Ltd. v. Delhi Administration (2001) 3 SCC 635

17 Villianur Iyarkkai Padukappu Maiyam v. Union of India (2009) 7 SCC 561

18 Directorate of Film Festivals v. Gaurav Ashwin Jain (2007) 4 SCC 737

19 Academy of Nutrition Improvement v. Union of India (2011) 8 SCC 274

Ademonstrated as arbitrary must be presumed to be valid as reasonablerestriction on the fundamental right of the citizen and judicial reviewmust halt at the frontiers. The Court cannot re-weigh and substitute itsnotion of expedient solution. Within the wide judge-proof areas of policyand judgment open to the government, if they make mistakes, correctionis not in court but elsewhere. That is the comity of constitutionalBjurisdictions in our jurisprudence. We cannot evolve judicial policy onmedical issues. All judicial thought, Indian and Anglo-American, on thejudicial review power where rules under challenge relate to specialisedfield and involve sensitive facets of public welfare, has warned courts ofeasy assumption of unreasonableness of subordinate legislation on theCstrength of half-baked studies of judicial generalists aided by the ad-hoclearning of counsel. However, the Court certainly is the constitutionalinvigilator and must act to defend the citizen in the assertion of hisfundamental rights against executive tyranny draped in disciplinarypower.[20]

D23. There is no doubt that this Court has held in more than onejudgment that where the decision of the authority is in regard to policymatter, this Court will not ordinarily interfere since decisions on policymatters are taken based on expert knowledge of the persons concernedand courts are normally not equipped to question the correctness of apolicy decision. However, this does not mean that courts have to abdicateEtheir right to scrutinise whether the policy in question is formulated keepingin mind all the relevant facts and the said policy can be held to be beyondthe pale of discrimination or unreasonableness, bearing in mind the materialon record.[21] In Delhi Development Authority (supra), this Court heldthat an executive order termed as policy decision is not beyond theFpale of judicial review. Whereas the superior courts may not interferewith the nitty-gritty of the policy, or substitute one by the other but it willnot be correct to contend that the court shall lay its judicial hands off,when plea is raised that the impugned decision is policy decision.Interference therewith on the part of the superior court would not bewithout jurisdiction as it is subject to judicial review. It was further heldGtherein that the policy decision is subject to judicial review on the followinggrounds:

a)if it is unconstitutional;

20 Pyarali K. Tejani v. Mahadeo Ramchandra Dange (1974) 1 SCC 167

21 Union of India v. Dinesh Engineering Corporation (2001) 8 SCC 491

b)if it is dehors the provisions of the Act and the regulations;A

c)if the delegatee has acted beyond its power of delegation;

d)if the executive policy is contrary to the statutory or largerpolicy.

24. During the second wave of COVID-19 pandemic, this Courtin Distribution of Essential Supplies & Services during Pandemic(supra), to which one of us was party (L Nageswara Rao, J.), dealtwith issues of vaccination policy, pricing and other connected issues.While doing so, this Court held that policy-making continues to be thesole domain of the executive and the judiciary does not possess theauthority or competence to assume the role of the executive. It wasmade clear that the Court cannot second guess the wisdom of theexecutive when it chooses between two competing and efficacious policymeasures. However, it continues to exercise jurisdiction to determine ifthe chosen policy measure conforms to the standards of reasonableness,militates against manifest arbitrariness and protects the right to life of allpersons.

25. There can be no ambiguity in the principles of law relating tojudicial review laid down by this Court. perusal of the judgments referredto above would clearly show that this Court would be slow in interferingwith matters of policy, especially those connected to public health. Thereis also no doubt that wide latitude is given to executive opinion which isbased on expert advice. However, it does not mean that this Court willnot look into cases where violation of fundamental rights is involved andthe decision of the executive is manifestly arbitrary or unreasonable. Itis true that this Court lacks the expertise to arrive at conclusions fromdivergent opinions of scientific issues but that does not prevent this Courtfrom examining the issues raised in this Writ Petition, especially thosethat concern violation of Article 21 of the Constitution of India.

26. Identifying the issues in the present matter, they can be dividedas follows:

I.Vaccine mandates being violative of Article 21 of theConstitution of India.

II.Non-disclosure of segregated clinical trial data in publicdomain.

III.Improper collection and reporting of AEFIs.

AIV.Vaccination of children.

I. Vaccine Mandates

A. Submissions

27. Mr. Bhushan submitted that there is nothing wrong in theBGovernment encouraging the people to get vaccinated. However,coercive vaccination from the pain of denial of essential services is plainlyunconstitutional, being violative of the principle of bodily autonomy andthe right to access one’s means of livelihood. Though the Union of Indiahas made categorical submission that vaccines are voluntary, the StateGovernments have been placing restrictions on unvaccinated people byCdenying them access to public places and services. He referred to: (i) anorder passed by the Government of NCT of Delhi on 08.10.2021 bywhich government employees, including frontline workers and healthcareworkers, as well as teachers and staff working in schools and collegeswere not to be allowed to attend their respective offices and institutionsDwithout the first dose of vaccination with effect from 16.10.2021; (ii) adirective issued by the Government of Madhya Pradesh on 08.11.2021stating that it was mandatory to be vaccinated with two doses of thevaccine to get food grains at fair price shops; (iii) an order passed by theGovernment of Maharashtra dated 27.11.2021 requiring persons to befully vaccinated if they are connected with any program, event, shop,Eestablishment, mall and for utilising public transport; (iv) an order issuedby the Government of Tamil Nadu dated 18.11.2021 permitting onlyvaccinated people into open, public places, schools, colleges, hostels,boarding houses, factories and shops; and other instances where studentsin the age group of 15 to 18 years were not permitted to appear for theirFexaminations without being vaccinated.

28. Mr. Bhushan contended that there is need to balanceindividuals’ rights with public interest concerning health. According tohim, vaccine mandates can be on the basis of efficacy and safety ofvaccination and prevention of transmission. He submitted that there isGsufficient evidence to the effect that natural immunity acquired from aCOVID-19 infection is long-lasting and robust in comparison to vaccineimmunity. Studies also indicate that vaccines do not prevent infectionfrom the virus or transmission amongst people. Vaccines are alsoineffective in preventing infection from new variants. According toserological studies, 75 per cent of the Indian population has already beenHinfected and is seropositive and, therefore, they have better immunity toinfection than what is provided by the vaccines. The vaccines which arebeing administered in this country are only authorised for emergencyuse and the procedure for clinical trials of such vaccines has not beenfully complied with. In view of the lack of transparency in disclosure oftrial data resulting in absence of informed consent, any vaccine mandatewould be unconstitutional. Mr. Bhushan contended that every individualhas personal autonomy and cannot be forced to be vaccinated againsthis will. For the said proposition, he relied on the judgments of CommonCause (A Registered Society) v. Union of India[22], ArunaRamachandra Shanbaug v. Union of India[23] and K. S. Puttaswamyv. Union of India[24]. Imposing restrictions on the rights of persons whoare unvaccinated is totally unwarranted as there is no basis fordiscriminating against unvaccinated persons. He relied upon scientificstudies, opinions of experts and news articles to contend that vaccinatedpeople are also prone to infection and there is no difference between avaccinated individual and an unvaccinated person with respect totransmission of the virus. As there is no serious threat of spread of thevirus by an unvaccinated person in comparison to vaccinated person,placing restrictions on unvaccinated persons is meaningless.

29. Per contra, the learned Solicitor General of India contendedthat more than 180 crore doses had been administered, resulting in asubstantial number of individuals in the country being vaccinated. Hesubmitted that the vaccines have proved to be effective and safe andany indulgence by this Court would result in vaccine hesitancy. TheGovernment had taken extra care to appoint various committees toexamine the efficacy, safety, immunogenicity, pharmacodynamics of thevaccines before granting approvals. Some of the material placed beforethis Court to bolster the Union of India’s submissions have been listedbelow:

(a)‘Science Brief: SARS-CoV-2 Infection-induced andVaccine-induced immunity’ of the United States Centersfor Disease Control and Prevention (CDC) updated as on29.10.2021, which in its conclusion states that: “Numerousimmunologic studies and growing number of

22 (2018) 5 SCC 1

23 (2011) 4 SCC 454

24 (2017) 10 SCC 1

Aepidemiologic studies have shown that vaccinatingpreviously infected individuals significantly enhancestheir immune response and effectively reduces the riskof subsequent infection, including in the setting ofincreased circulation of more infectious variants.Although the Delta variant and some other variants haveBshown increased resistance to neutralization by bothpost-infection and post-vaccination sera in laboratorystudies, observed reduction in effectiveness has beenmodest, with continued strong protection againsthospitalization, severe disease and death.”

C(b)A study conducted by researchers of Christian MedicalCollege, Vellore[25], wherein it has been concluded as follows:“Among symptomatic COVID-19 patients, priorvaccination with either Covishield™ or Covaxin®impacted the severity of illness and reduced mortalityDwhen compared with unvaccinated patients. Fullvaccination conferred substantially higher protectiveeffect over partial vaccination.” The results of the studyalso indicate that compared with unvaccinated patients,partially vaccinated patients had milder disease, reducedrequirement of oxygen, hospital admission, ICU admissionEand mortality. Again, when fully vaccinated patients werecompared with unvaccinated individuals, full vaccination wasassociated with significantly less disease severity,requirement of respiratory supports, hospital admission, ICUadmission and mortality. The study further showed thatFmajority of the patients screened who required hospitalisationwere unvaccinated.

(c)A study conducted by researchers of All India Institute ofMedical Sciences (AIIMS), New Delhi[26], which states that:“We evaluated the association between COVID-19

G25 Abhilash, Kundavaram Paul Prabhakar et al. “Impact of prior vaccination withCovishieldTM and Covaxin® on mortality among symptomatic COVID-19 patientsduring the second wave of the pandemic in South India during April and May 2021: acohort study.” Vaccine vol. 40,13 (2022): 2107-2113

26 Aakashneel Bhattacharya, Piyush Ranjan, Tamoghna Ghosh, Harsh Agarwal, SukritiSeth, Ganesh Tarachand Maher, Ashish Datt Upadhyay, Arvind Kumar, UpendraBaitha, Gaurav Gupta, Bindu Prakash, Sada Nand Dwivedi, Naveet Wig “Evaluation ofH

vaccination status (the number of vaccine shots receivedand time interval since the last dose) and the vaccines’clinical efficacy in India in preventing the disease andits severity. This study has several noteworthy findings.Firstly, both the Indian vaccines provided significantprotective role in preventing the disease among peoplewho had clinical suspicion of COVID-19. Secondly,These vaccines protected from progression to severeform of the disease among the patients who turned RT-PCR positive despite getting vaccinated. The probabilityof hospitalisation was about eight times less, and ICUadmission/death was about fourteen times lesser amongfully vaccinated patients in comparison to unvaccinatedRT-PCR positive patients. Thirdly, the protective efficacyof the vaccines had dose-dependent effect. Theeffectiveness is maximum among individuals whoreceived both doses of vaccination at least two weeksbefore the onset of their symptoms.”

(d)A study conducted by researchers of AIIMS, Patna[27],which concludes as follows: “COVID-19 vaccination wasfound to be effective in infection prevention. One outof two and four out of five individuals were found to beprotected against SARS-CoV-2 infection followingpartial and full vaccination, respectively. Thevaccinated individuals had lesser LOS compared tounvaccinated ones. Additionally, the fully vaccinatedindividuals were less likely to develop severe disease.”LOS herein refers to the length of hospital stays.

30. On behalf of the State of Tamil Nadu, Mr. Amit Anand Tiwari,learned Additional Advocate General, submitted that the restrictionsplaced by way of the circular dated 18.11.2021 are within the competenceof the State in exercise of its powers under the Disaster Management

the dose-effect association between the number of doses and duration since the lastdose of COVID-19 vaccine, and its efficacy in preventing the disease and reducingdisease severity: single centre, cross-sectional analytical study from India” Diabetes& Metabolic Syndrome: Clinical Research & Reviews Volume 15, Issue 5 (2021), 10223827 Singh C, Naik BN, Pandey S, et al. “Effectiveness of COVID-19 vaccine in preventinginfection and disease severity: case-control study from an Eastern State of India.”Epidemiology and Infection. 2021;149:e224

AAct, 2005 (hereinafter, the “DM Act”) and the Tamil Nadu Public HealthAct, 1939. Section 76(2)(b) thereof empowers the State Government tomake vaccinations compulsory, in the event of declaration by theGovernment of an outbreak of notified disease. He submitted that therestrictions placed by the circular dated 18.11.2021 are in larger publicinterest and cannot be said to be unreasonable restrictions, as theseBwere an essential facet of the precautionary approach adopted by theState of Tamil Nadu in dealing with the unprecedented pandemic.According to Mr. Tiwari, these restrictions were in furtherance of theState realising the importance of curtailing the spread of COVID-19.The unchecked spread of the virus could lead to further dangerousCmutations. While referring to opinions of experts in the field of health,including that of the World Health Organization (WHO), the UnitedNations International Children’s Emergency Fund (UNICEF) and theOxford Vaccine group, as well as scientific studies published in the NewEngland Journal of Medicine, the Lancet and the International Journalof Scientific Studies, it was submitted on behalf of the State of TamilDNadu that vaccination prevents severe disease and significantly reduceshospitalisation and mortality and that vaccines continued to be highlyeffective in preventing severe disease and death. The measures werejustified on the ground that they were not only aimed for the safety of aparticular individual but also served greater purpose of ensuring safetyEof the community at large.

31. Mr. Rahul Chitnis, learned counsel appearing for the State ofMaharashtra, referred to the information provided by the WHO to contendthat vaccines save infected individuals from “life threateningcomplications, … and consequential untimely death” and therefore,Fvaccine mandate issued by the State of Maharashtra is in the interest ofgeneral public. The restrictions that are imposed are reasonable andcannot be said to “manifestly arbitrary” as they are issued only for atemporary period with exclusions and are reviewed periodically by theState to assess if relaxations can be granted. He submitted that there is

no compulsion to get vaccinated, however, in view of the serious threatGthat not being vaccinated poses to the right of life and personal liberty ofthe larger population, certain unavoidable restrictions have been imposed,especially given that strict adherence to social distancing and masking issignificantly compromised in bigger cities.

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

to ration not being provided to unvaccinated persons through the publicdistribution system. We were informed by the learned counsel for theState of Madhya Pradesh that the order dated 08.11.2021, by whichvaccination was made mandatory for receiving ration from fair priceshops, was not implemented and was eventually withdrawn on 07.01.2022.

33. In the counter-affidavit filed on behalf of the Government ofNCT of Delhi, it was submitted that the order dated 08.10.2021 wasissued by the Delhi Disaster Management Authority after due applicationof mind, to control the spread of COVID-19 and mitigate its effects.Under Section 6(2)(i) of the DM Act, the National Disaster ManagementAuthority has been issuing orders from time to time directing StateGovernments and Union Territories, amongst other authorities, to takeeffective measures to prevent the spread of COVID-19, and infurtherance of this, also permitted States to impose further localrestrictions. The Delhi Disaster Management Authority, in meetingheld on 29.09.2021, decided to ensure 100 per cent vaccination of allGovernment employees, frontline workers, healthcare workers as wellas teachers and staff working in schools and colleges, on the advice ofmedical and other experts. It was considered necessary as theseindividuals have frequent interaction with the general public andvulnerable sections of the society and therefore, pose greater risk ofspreading the virus. While an individual may have right to decide againstgetting vaccinated, the State, however, has statutory duty to regulatethe interaction of unvaccinated persons within the society in the interestof public health.

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

APetitioner relied upon the opinion of Dr. Aditi Bhargava, who is aprofessor at University of California, San Francisco and molecularbiologist with 33 years of research experience, from her presentationmade before the US Senate on 02.11.2021. Her opinion is to the effectthat vaccines do not prevent infection and transmission. She is of thefurther belief that natural immunity is the gold standard. According toBDr. Bhargava, there has been no documented case of naturally immuneperson getting reinfected with severe disease or hospitalised, despite thefirst case reported nearly two years ago, whereas, there have beenthousands of cases of severe infection, hospitalisation, and deaths infully vaccinated people. Mr. Bhushan concluded by submitting that anyCrestrictions placed on personal autonomy of individuals would be violativeof Article 21, unless the criteria laid down in K. S. Puttaswamy (supra)is met.

B. Evolution of COVID-19 and vaccines

35. COVID-19 emerged in late 2019. The WHO officially declaredDthe novel coronavirus outbreak as pandemic on 11.03.2020. The viruswas detected in the country in the last week of January, 2020 and spreadrapidly. As the threat of infections from the virus loomed large, anunprecedented national lockdown was announced on 24.03.2020, whichextended for few months, with restrictions being removed thereafterEin phased manner. India was not alone in this; several countries imposedlockdowns to arrest the spread of the deadly disease, which has led to adrastic loss of human life worldwide and presented threat ofextraordinary proportions to public health, food systems, economic andsocial conditions. Scientific studies and research for manufacture ofvaccines to prevent severe infections were undertaken on an emergencyFbasis. Towards the end of 2020, emergency vaccines came to beadministered in the western part of the world. However, by then, thespread of COVID-19 around the globe was considerable. Around thesame period, variant called B.1.1.7 was found in the United Kingdom.The said variant was renamed as Alpha, as per the naming schemeGrecommended by the expert group convened by the WHO, which alsoincludes scientists from the WHO’s Technical Advisory Group on VirusEvolution (TAG-VE). Another variant, called B.1.351 and later renamedas Beta, was found to be linked to second wave of infections in SouthAfrica. Both these variants were identified as Variants of Concern (VOC)by the WHO on 18.12.2020, meaning that they were variants with geneticH

changes that would affect virus characteristics such as transmissibility,disease severity or immune escape and through comparativeassessment, are found to be associated with an increase of transmissionor increase in virulence or decrease in effectiveness of public healthmeasures such as vaccines, therapeutics etc. Soon thereafter, the highlytransmissible variant called Gamma was found in Brazil and was identifiedas VOC by the WHO on 11.01.2021.[28]

36. In the first half of 2021, the Delta variant was identified as thepredominant variant in India and was believed to be 60 per cent moretransmissible than the Alpha variant. Thereafter, Delta rapidly spreadbeyond the borders to other countries. Another variant, Omicron, surfacedin November, 2021, whose spread was much more accelerated thanearlier variants, including that of Delta. On the basis of the evidenceavailable as on 21.01.2022, the WHO was of the opinion that the Omicronhas significant growth advantage over Delta, leading to rapid spread inthe community with higher levels of incidence than previously seen inthe pandemic. It was further observed that despite lower risk of severedisease and death following infection, the very high levels of transmissionnevertheless have resulted in significant increases in hospitalisation andcontinue to pose overwhelming demands on health care systems in mostcountries. It was found that because of the 26-32 mutations that it has inthe spike protein, Omicron has infected even those who have beenpreviously infected or vaccinated.[29] Though the infections andtransmission from Omicron at present within the country are not as seriousas they were in the first two months of 2022, expert opinion is to theeffect that Omicron might not be the last of the variants, as we havesince witnessed.

37. The WHO established the Technical Advisory Group onCOVID-19 Vaccine Composition (TAG-CO-VAC) in September, 2021.According to the statement made by the said group on 11.01.2022 in thecontext of circulation of the Omicron variant, the group reviews andassesses the public health implications of emerging VOCs on theperformance of COVID-19 vaccines and provides recommendations

28 Tracking SARS-CoV-2 variants, World Health Organization, available at https://www.who.int/en/activities/tracking-SARS-CoV-2-variants/ (last accessed on 01.05.2022)29 Statement by Dr Hans Henri P. Kluge, WHO Regional Director for Europe,11.01.2011, available at https://www.euro.who.int/en/media-centre/sections/statements/2022/statement-update-on-covid-19-omicron-wave-threatening-to-overcome-health-workforce (last accessed on 01.05.2022)

Aon COVID-19 vaccine composition. The said group is developing aframework to analyse the evidence on emerging VOCs in the context ofcriteria that would trigger recommendation to change COVID-19vaccine strain composition and will advise the WHO on updated vaccinecompositions, as required. The group has spelt out in their statement thatat present, with the available COVID-19 vaccines, the focus is onBreducing severe disease and death, as well as protecting health systems.According to the TAG-CO-VAC, vaccines, which have received WHOEmergency Use Listing across several vaccine platforms, provide highlevel of protection against severe disease and death caused by VOCs.The group takes note of data which indicates that vaccine effectivenessCwill be reduced against symptomatic disease caused by the Omicronvariant but at the same time, it was of the opinion that protection againstsevere disease is more likely to be preserved. Along with the StrategicAdvisory Group of Experts on Immunization (SAGE) and its WorkingGroup on COVID-19 vaccines, TAG-CO-VAC has recommendedCOVID-19 vaccines for priority populations worldwide to provideDprotection against severe disease and death globally and, in the longerterm, to mitigate the emergence and impact of new VOCs by reducingthe burden of infection.[30]

38. With the outbreak of the devastating pandemic, as many as5,23,843 lives have been lost in this country, as per the latest data availableEon the website of the Ministry of Health and Family Welfare (MoHFW).Initially, efforts made by the Government of India were to protect peopleby arresting serious infection. With treatment protocol and clinicalmanagement protocol for COVID-19 being revised periodically as moreand more data and research on the virus came to be known, personsFaffected by the virus were treated with the information that was availableat the point. Using whatever little was known about the virus in the initialstages, dedicated efforts have been made to save countless lives in thiscountry. With the approval of vaccines on an emergency basis in January,2021, there was some hope about preventing infections from the virus.Inoculation, which commenced slowly in view of the non-availability ofG30 Interim Statement on COVID-19 vaccines in the context of the circulation of theOmicron SARS-CoV-2 Variant from the WHO Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC), 11.01.2022, available at https://www.who.int/news/item/11-01-2022-interim-statement-on-covid-19-vaccines-in-the-context-of-the-circulation-of-the-omicron-sars-cov-2-variant-from-the-who-technical-Hadvisory-group-on-covid-19-vaccine-composition (last accessed on 01.05.2022)

sufficient doses of vaccines, gained pace with the increase in manufactureby Respondent Nos. 4 and 5. With the Government embarking uponextensive awareness drives encouraging vaccination, more than 189 croredoses of vaccine have been administered within the country till date, asper the data available on the website of the MoHFW.

39. With the introduction of vaccines, it was understood thatvaccines would aid in preventing infections. To protect their populacefrom infection, countries worldwide promoted vaccination as, needlessto say, an uninfected person will not transmit the disease. Thereafter,with the mutation of the virus eventually resulting in multiple VOCs,breakthrough infections were noticed. Vaccinated people were found tobe infected with the virus and could also act as carriers, transmitting thevirus to others. Even in such situation, there is no question of whethervaccination for COVID-19 should be continued. The recommendationsof the WHO’s TAG-CO-VAC and SAGE make it amply clear thatvaccines, which have received emergency use approvals, provide strongprotection against serious illness, hospitalisation and death and gettingvaccinated is one of the most crucial steps towards protecting oneselffrom COVID-19, stopping new variants from emerging and helping endthe pandemic. It should be noted that the advice of the WHO with respectto COVID-19 has been consistent since the time vaccines becameavailable, even after recognising that it was still possible to get infectedand spread the infection to others despite being vaccinated, as is evidentfrom the latest version of the WHO’s ‘COVID-19 advice for the public:Getting vaccinated’ as of 13.04.2022[31]. The Union of India has placedconsiderable material on record in terms of scientific briefs and publishedstudies which stand testimony to the significance of vaccination as acrucial public health intervention in this pandemic and its continuedbenefits to individual health as well as public health infrastructure.Vaccination of majority of the population of this country has undoubtedlybeen instrumental in preventing severe disease, hospitalisation and deaths,and benefited the community at large, especially those members withco-morbidities, the elderly and sick persons. Even the Petitioner is notopposed to the vaccination programme and does not challenge thevaccination drive of the Government of India, as has been reiterated byhim during the course of his arguments. Exception to the vaccinationprogramme taken by the Petitioner is only to coercive vaccination through

31 Available at https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-

19-vaccines/advice(last accessed on 01.05.2022)

DEF

Avaccine mandates, which place unjustifiable restrictions on those whowish to not be vaccinated.

40. In light of the virulent mutations of the COVID-19 virus andadvice of experts from the WHO as well as common findings of severalstudies on this subject, the vaccination drive that is being undertaken byBthe Government of India in the interest of public health cannot be faultedwith.

C. Personal autonomy and public health

41. Before dealing with the issue of coercive vaccination, it isnecessary to consider whether the right of privacy of individuals canCoverride public health, more so, when the submission on behalf of theRespondents is that steps taken to restrict the rights of individuals are inthe larger interest of public health. It is true that to be vaccinated or notis entirely the choice of the individual. Nobody can be forcefullyvaccinated as it would result in bodily intrusion and violation of theindividual’s right to privacy, protected under Article 21 of the ConstitutionDof India. Personal autonomy was read into Article 21 by this Court inCommon Cause (supra), by placing reliance on National LegalServices Authority v. Union of India[32], and Aruna RamachandraShanbaug (supra). This Court, in Common Cause (supra), emphasizedthe right of an individual to choose how he should live his own life, withoutany control or interference by others. It recognised the right of anEindividual to refuse unwanted medical treatment and to not be forced totake any medical treatment that is not desired. In view of the categoricstatement of the Union of India that vaccination of COVID-19 isvoluntary, the question of any intrusion into bodily integrity does not arisefor consideration in this case. However, the Petitioner has asserted thatFlimitations placed on access to public places and public resources forunvaccinated persons result in coercive vaccination, and therefore, limitthe right of unvaccinated persons to refuse medical treatment.

42. Disclosure of data of patient suffering from AIDS was thesubject matter of decision of this Court in X v. Hospital ‘Z’[33]. PlacingGreliance on Kharak Singh v State of U.P.[34], Gobind v. State of M.P.[35]and judgment of the US Supreme Court in Jane Roe v. Henry Wade[36],32 (2014) 5 SCC 43833 (1998) 8 SCC 29634 (1964) 1 SCR 33235 (1975) 2 SCC 148H36 410 US 113 (1973)

this Court held that though non-disclosure of medical information of anindividual can be traced to the right to privacy protected under Article21, it is not absolute and is subject to action lawfully taken for protectionof health or morals or protection of rights and freedoms of others.

43. In Association of Medical Super Speciality Aspirants andResidents v. Union of India[37], to which one of us was party (LNageswara Rao, J.), this Court, while considering validity of servicebonds to be executed at the time of admission to postgraduate andsuperspeciality courses in medical science, held as follows:

“33. The above discussion leads us to the conclusion that rightto life guaranteed by Article 21 means right to life with humandignity. Communitarian dignity has been recognised by thisCourt. While balancing communitarian dignity vis-à-vis thedignity of private individuals, the scales must tilt in favour ofcommunitarian dignity. The laudable objective with which theState Governments have introduced compulsory service bondsis to protect the fundamental right of the deprived sections ofthe society guaranteed to them under Article 21 of theConstitution of India. The contention of the appellants thattheir rights guaranteed under Article 21 of the Constitutionof India have been violated is rejected.”44. Strong reliance was placed by the Petitioner on the judgmentof the High Court of New Zealand in Ryan Yardley (supra). Theprincipal contention of the applicants therein was that the impugned order,requiring police and defence force personnel to be vaccinated, placedunjustified limitation on the rights protected by the New Zealand Bill ofRights Act 1990 (hereinafter, the “NZ Bill of Rights”), particularly theright to refuse to undergo medical treatment, the right to manifest religion,the right to be free from discrimination and other rights under Section 28of the said Act (including the right to work, and of minority groups toenjoy their culture and practice their religion). The purpose of the order,as clarified by the Minister by way of an amendment order in February,2022 is as below:

“(a) avoid, mitigate, or remedy the actual or potentialadverse effects of the COVID-19 outbreak (whether director indirect); and

512SUPREME COURT REPORTS

A(b) ensure continuity of services that are essential for publicsafety, national defence, or crisis response; and

(c) maintain trust in public services.”

45. Considering the submissions of the applicants therein that theorder placed unjustified limitations on fundamental rights protected byBthe NZ Bill of Rights, the NZ High Court held that the impugned orderlimits the right of affected workers to refuse to undergo medicaltreatment as well as the right (or significant interest) to retain employment.While examining the question of whether the limitation of the said rightswas justified, the NZ High Court noted that the order mandatingCvaccinations for the police and defence personnel was imposed to ensurethe continuity of services that are essential for public safety, nationaldefence, or crisis response, and to promote public confidence in thoseservices, rather than to stop the spread of COVID-19. The NZ HighCourt further took note of the fact that by October, 2021, 83.1 per centof police personnel had received at least one or more doses of theDvaccination, and 70.1 per cent had received both doses. By the time theorder took effect on 17.01.2022, there were only 164 unvaccinated staffmembers in an overall workforce of 15,682 staff. It was found that theposition within the New Zealand Defence Forces (NZDF) was similar.From total of 15,480 NZDF personnel, 3,048 are civil staff. As onE01.02.2022, 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 fullyvaccinated, leaving 40 who were not. The NZ High Court was of theview that the relatively low number of unvaccinated police and NZDFpersonnel impacted by the order may not, by itself, mean that the orderwas not reasonable limit on rights that can be demonstrably justified, ifFthere was evidence to establish that the presence of unvaccinatedpersonnel, even in small numbers, created materially higher risk to theremaining workforce. While observing that the evidence on this issue issparse, the NZ High Court referred to the evidence of Dr. Petrovsky,who deposed that vaccination has potential benefit in reducing the severityGof disease, even with the Omicron variant. However, in his view,mandatory vaccination did not assist in preventing workers in affectedroles from contracting COVID-19, or transmitting it to others. The NZHigh Court further considered the evidence of Dr. Town, the Ministry’sChief Science Adviser, who, according to the NZ High Court, did notdirectly respond to Dr. Petrovsky’s analysis of the effectiveness of theH

vaccine to inhibit the spread of COVID-19 in workforce, but insteadprovided his more generalised opinions. In his evidence, Dr. Town statedthat vaccines show reduced effectiveness compared with Delta in termsof becoming infected with and transmitting Omicron.

46. After weighing the evidence, the NZ High Court was of theview that vaccination may still be effective in limiting infection andtransmission, but at significantly lower level than was the case withthe earlier variants. It was further concluded that vaccination does notprevent persons contracting and spreading COVID-19, particularly withthe Omicron variant. The NZ High Court referred to an earlier judgmentin Four Aviation Security Service Employees v. Minister of COVID-19 Response[38], where the precautionary principle had been applied, tomake the point that even modest vaccination protection on modestnumber of personnel needs to be considered in the context of potentialeffects of pandemic. The NZ High Court referred to judgment of theFederal Court of Ontario in Spencer v. Attorney General of Canada[39]to elaborate on the precautionary principle, as “a foundational approachto decision-making under uncertainty, that points to the importanceof 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, theNZ High Court held that even though the applicants therein were notbeing forcibly treated, they were required to be vaccinated as conditionof their employment, refusal of which led to termination. Observing thata right does not need to be taken away in its entirety before it is regardedas having been limited, the NZ High Court opined that the level of pressurein that case was significant and amounted 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 evidenceadduced before the NZ High Court, it concluded that the vaccine waseffective at reducing the transmission of the earlier variants of the virusand that it was also effective at reducing symptomatic infection anddetrimental effects of the Delta variant. As the applicants were borderworkers interacting with international travellers who may be carryingthe virus and given the likelihood of vaccines contributing to preventingthe risk of transmission, the NZ High Court held that precautionaryapproach, in doing everything that can be reasonably done to minimise

38 [2021] NZHC 3012

39 [2021] FC 361

Arisk of the outbreak or spread in strong public interest, is justified. Further,the curtailment of the right to refuse to undergo medical treatment wasfound to be proportionate to the objective, as the applicants, who workedas aviation workers, were situated in key location where COVID-19might enter New Zealand.B47. In Ryan Yardley (supra), the NZ High Court held that theprinciple in Four Aviation Security Service Employees (supra) is notdirectly applicable as the order was not promulgated to contain the spreadof the virus but for the purpose of ensuring continuity of, and confidencein, essential services. Additionally, there was no evidence of threat tothe continuity of the police and NZDF services, which would enable theCNZ High Court to give the benefit of the doubt to the New ZealandCrown in imposing measures to address that risk. Placing reliance onthe evidence adduced as well as the public health advice which was tothe effect that vaccine mandates were not considered necessary foraddressing the risk of the outbreak or spread of COVID-19, the HighDCourt made it clear that while vaccination significantly improved theprospects of avoiding illness and death even with the Omicron variant,given the variant’s propensity to break through vaccination barriers, itconcluded that there was no real threat to the continuity of these essentialservices that the impugned order sought to address. Further, finding thatsuspension of the unvaccinated would address any potential problems,Ethe terminations arising from the order in light of the temporary, albeitsignificant, period of peak impact of the infection, were found to bedisproportionate and unjustified. While the Petitioner has sought supportfrom this judgment to demonstrate how courts in other jurisdictions havestruck down vaccine mandates taking into account Omicron’s impact on

Fthe effectiveness of vaccines in addressing spread, we believe that thisjudgment may not be of much assistance to us for determining the issueat hand for two reasons. First, the judgment expressly recognised thatthe impugned vaccine mandate was not brought about to suppress thespread of the virus but to ensure continuity of, and confidence in, essential

services, such as the police and the defence personnel, which we areGnot concerned with in the present case. Second, while the NZ HighCourt looked into depositions of expert witnesses to come to its ownconclusion on efficacy of vaccines vis-à-vis the Omicron variant, thescope of our review does not entail assessment of competing scientificopinions, as the judiciary is not equipped to decide issues of medicalHexpertise and epidemiology.

48. The crucial point that requires to be considered by us is whetherlimitations placed by the Government on personal autonomy of anindividual can be justified in the interest of public health in the wake ofthe devastating COVID-19 pandemic. As stated, personal autonomyhas been recognized as critical facet of the right to life and right toself-determination under Article 21 of the Constitution, by this Court inCommon Cause (supra). In K.S. Puttaswamy (supra), this Court laiddown three requirements to be fulfilled by the State while placing restraintson the right to privacy to protect legitimate State interests. It was held:“310. … The first requirement that there must be law inexistence to justify an encroachment on privacy is an expressrequirement of Article 21. For, no person can be deprived ofhis life or personal liberty except in accordance with theprocedure established by law. The existence of law is anessential requirement. Second, the requirement of need, interms of legitimate State aim, ensures that the nature andcontent of the law which imposes the restriction falls withinthe zone of reasonableness mandated by Article 14, which isa guarantee against arbitrary State action. The pursuit of alegitimate State aim ensures that the law does not suffer frommanifest arbitrariness. Legitimacy, as postulate, involves avalue judgment. Judicial review does not reappreciate orsecond guess the value judgment of the legislature but is fordeciding whether the aim which is sought to be pursued suffersfrom palpable or manifest arbitrariness. The third requirementensures that the means which are adopted by the legislatureare proportional to the object and needs sought to be fulfilledby the law. Proportionality is an essential facet of theguarantee against arbitrary State action because it ensuresthat the nature and quality of the encroachment on the rightis not disproportionate to the purpose of the law. Hence, thethreefold requirement for valid law arises out of the mutualinterdependence between the fundamental guarantees againstarbitrariness on the one hand and the protection of life andpersonal liberty, on the other. The right to privacy, which isan intrinsic part of the right to life and liberty, and thefreedoms embodied in Part III is subject to the same restraintswhich apply to those freedoms.”

AWhile the judgment is in context of the right to privacy, the analysiswith respect to the threefold requirement for curtailment of such right ison the anvil of the protection guaranteed to fundamental freedoms underArticle 21, and therefore, would also be the litmus test for invasion of anindividual’s bodily autonomy under Article 21.

B49. The upshot of the above discussion leads to the followingconclusions:

a)Bodily integrity is protected under Article 21 of theConstitution of India and no individual can be forced to bevaccinated.

b)Personal autonomy of an individual involves the right of anindividual to determine how they should live their own life,which consequently encompasses the right to refuse toundergo any medical treatment in the sphere of individualhealth.

Dc)Persons who are keen to not be vaccinated on account ofpersonal beliefs or preferences, can avoid vaccination,without anyone physically compelling them to be vaccinated.However, if there is likelihood of such individuals spreadingthe infection to other people or contributing to mutation ofEthe virus or burdening of the public health infrastructure,thereby affecting communitarian health at large, protectionof which is undoubtedly legitimate State aim of paramountsignificance in this collective battle against the pandemic,the Government can regulate such public health concernsby imposing certain limitations on individual rights that areFreasonable and proportionate to the object sought to befulfilled.

50. The submission made on behalf of the Petitioner is that theDelta and Omicron variants have shown breakthrough infections and itis clear from the scientific data that, an unvaccinated person does notGpose greater risk than vaccinated person in terms of transmission ofthe infection. While this submission has been dealt with subsequently,we believe that as long as there is risk of spreading the disease, therecan be restrictions placed on individuals’ rights in larger public interest.Further, extensive material from experts has been placed before thisCourt, which extol the benefits of vaccination in tackling the severe andHlife-threatening impact of the infection, specifically in terms of reductionin oxygen requirement, hospitalisation, ICU admissions and mortality,thereby easing the disproportionate burden from the upsurge of severecases on the health infrastructure, which has already been witnessed bythe country during the second wave of the pandemic where resourceswere woefully inadequate to stem the impact of the Delta variant on athen scarcely vaccinated population. We hasten to add that restrictionsthat are placed by the Government should not be unreasonable and areopen to scrutiny by constitutional courts. It is difficult for us to envisagethe myriad situations in dealing with the evolving pandemic that may callfor restraint on individual rights in larger public interest and therefore, asand when such limitations are challenged, they can be assessed byconstitutional courts to see whether they meet the threefold requirementlaid down in K.S. Puttaswamy (supra).

D. Assessment of the vaccine mandates imposed by StateGovernments

51. The grievance of the Petitioner pertains to the vaccinemandates imposed by various State Governments and privateorganisations, resulting in restrictions on fundamental freedoms of personswho have chosen not to be vaccinated. The Petitioner has alleged dualityin the stand of the Respondents, as on one hand, the Union of India hascategorically stated that vaccines are voluntary and on the other, theState Governments have imposed and defended restrictions on accessto public places and resources for persons who are unvaccinated. ThePetitioner contested the vaccine mandates on the following grounds:

(a)Natural immunity acquired from COVID-19 infection ismore long-lasting and robust as compared to vaccineFimmunity.

(b)Serological studies show that more than 75 per cent of theIndian population has already been infected and isseropositive and therefore, has better immunity to theinfection than that which can be provided by the vaccine.

(c)Vaccines do not prevent infection from or transmission ofCOVID-19 and are especially ineffective in preventingagainst infection from new variants.

52. In support of the above grounds, other than on the aspect oftransmission of the virus, the Petitioner has relied on individual opinions

Aof doctors and other advisors, news articles and findings from researchstudies, some of which are preprints meaning they have not been peer-reviewed and report new medical research which has yet to be evaluatedand therefore, should not be used to guide clinical practice, as explainedby medRxiv, platform where several preprint articles in the field ofhealth sciences are published. Some of the material relied on by theBPetitioner has been listed below:

(a)An article in the scientific journal Nature[40], which statesthat “studies have shown that memory plasma cellssecreted antibody specific for the spike protein encodedin SARS-CoV-2 even 11 months after the infection andCfurther that, immune memory to many viruses is stableover decades, if not for lifetime”.

(b)A study published in the European Journal ofEpidemiology[41], which has analysed data from 68 countriesavailable as of 03.09.2021 and has found that “at theDcountry level, there appears to be no discerniblerelationship between percentage of population fullyvaccinated and new COVID-19 cases”. It is further statedtherein that in fact higher percentage of population fullyvaccinated have higher COVID-19 per 1 million people.

E(c)The United Kingdom’s COVID-19 vaccine surveillancereport, Week 40, which appears to indicate negativeefficacy against infection amongst all ages above 30 years,on the basis of data between week 36 and week 39 in 2021.

53. While we are aware that courts cannot decide whether naturalFimmunity is more resilient as compared to vaccine-acquired immunityand we do not seek to substitute our own views in matters of differencesin scientific opinion, we cannot help but notice that in the first articlereferred to above, published in Nature, it has been noted that immunityin convalescent individuals (i.e., those who have recovered from COVID-G19) can be boosted further by vaccinating them after year. Accordingto 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 toCovid” Nature 595, 359-360 (2021)

41 Subramanian, S.V., Kumar, A. “Increases in COVID-19 are unrelated to levels ofvaccination across 68 countries and 2947 counties in the United States” Eur J Epidemiol36, 1237–1240 (2021)H

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

54. In any event, what we have to assess, in accordance with thelaw laid down by this Court, is whether the Union of India has takennote of scientific and medical inputs and research findings in puttingtogether its policy advocating vaccination for the entire eligible population.Article 47 of the Constitution of India imposes an obligation on the Unionof India to improve public health. It is the obligation of the State to ensurethe creation and the sustaining of conditions congenial to good health.From the several obligations of the State enshrined in Part IV of theConstitution, maintenance and improvement of public health rank highas these are indispensable to the very physical existence of thecommunity.[42]

55. It should be noted that the submission made on behalf of thePetitioner championing natural immunity is from the perspective of ahealthy person. Even the Petitioner does not dispute the fact that thesame standard is not applicable to persons with co-morbidities, the sickand elderly people. cursory glance at the data recorded in the IndiaFact 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 womenand 25 per cent of men are anaemic, (ii) amongst individuals aged above15 years, 13.5 per cent of women and 15.6 per cent of men have high orvery high blood sugar level or take medicines to control blood sugarlevel, (iii) amongst individuals aged above 15 years, 21.3 per cent ofwomen and 24 per cent of men have hypertension or elevated bloodpressure or take medicines to control blood pressure. Further, as per the

42 Vincent Panikurlangara v. Union of India (1987) 2 SCC 165

ABC

A75[th] Round National Sample Survey (NSS), conducted from July 2017to June 2018, the average age of the elderly population in India was 67.5years, with 67.1 per cent of India’s elderly living in rural areas. studywas conducted[43] on the basis of the data from the NSS, aiming to highlightthe vulnerability of the aged amidst the COVID-19 pandemic. Accordingto the study, out of every 100 elderly, 27.7 persons reported ailmentsBduring the previous 15 days, with cardiovascular conditions includinghypertension (32.0%), endocrine conditions including diabetes (22.5%),musculoskeletal conditions (13.9%), infectious diseases (10.0%), andrespiratory ailments (7.3%) being the top five conditions for seekingoutpatient care among the elderly in the preceding 15 days. TheCConstitution, through Article 41, mandates the State to make available tothe elderly the right to live with dignity and to provide the elderly, ill anddisabled with assistance, medical facilities and geriatric care[44].

56. Surely, the Union of India is justified in centering its vaccinationpolicy around the health of the population at large, with emphasis onDinsulating the weaker and more vulnerable sections from the risk ofsevere infection and its consequences, as opposed to basing its decisionkeeping in mind the interests of healthy few. Given the considerablematerial filed before this Court reflecting the near-unanimous views ofexperts on the benefits of vaccination in dealing with severe disease,reduction in oxygen requirement, hospital and ICU admissions andEmortality and stopping new variants from emerging, this Court is satisfiedthat the current vaccination policy of the Union of India, formulated inthe interest of public health, is informed by relevant considerations andcannot be said to be unreasonable. Whether there is contrasting scientificopinion supporting the argument of natural immunity offering betterFprotection against infection from COVID-19 and whether these scientificopinions can be substantiated are not pertinent for determination of theissue before this Court.

57. We now come to the crux of the challenge against coercivevaccine mandates, with respect to which the Petitioner has argued thatGthey amount to restrictions on the fundamental rights of unvaccinatedindividuals and cannot be said to be proportionate, as according to the

43 Ranjan, A., Muraleedharan, V.R. “Equity and elderly health in India: reflections from75th round National Sample Survey, 2017–18, amidst the COVID-19 pandemic” GlobalHealth 16, 93 (2020)44 Ashwani Kumar v. Union of India (2019) 2 SCC 636H

Petitioner, with the prevalence of the Omicron variant, unvaccinatedpeople pose no greater danger to the transmission of the virus incomparison to vaccinated persons. It was claimed by the Petitioner thateven if the vaccines reduced the severity of the disease, it was up to theindividual to decide whether they wanted to be the beneficiary of vaccines.The State’s lookout was the protection of larger public health and withboth the vaccinated and unvaccinated posing nearly equal risks intransmission of the infection to others around them, the State cannotimpose restrictions targeting only the unvaccinated and impeding theirright to access public resources. The Petitioner has thus, allegeddiscrimination against the unvaccinated, who in the present situation, areplaced more or less on the same footing as vaccinated individuals withrespect to the transmission of the virus. In support of his submissions,the Petitioner has relied on scientific studies and reports, some of whichare listed below:

(a)A letter published in the Lancet, Regional Health[45], whichstates: “In the UK it was described that secondary attackDrates among household contacts exposed to fullyvaccinated index cases was similar to householdcontacts exposed to unvaccinated index cases (25% forvaccinated vs 23% for unvaccinated). 12 of 31infections in fully vaccinated household contacts (39%)Earose from fully vaccinated epidemiologically linkedindex cases. Peak viral load did not differ byvaccination status or variant type….The US Centres forDisease Control and Prevention (CDC) identifies fourof the top five counties with the highest percentage offully vaccinated population (99.9–84.3%) as “high”Ftransmission counties. Many decisionmakers assumethat the vaccinated can be excluded as source oftransmission. It appears to be grossly negligent to ignorethe vaccinated population as possible and relevantsource of transmission when deciding about public”Ghealth control measures.

(b)A study conducted on breakthrough infection inMassachusettsin July, 2021 and reported in the Morbidity45 Gunter Kampf, Letter titled “The Epidemiological relevance of the COVID-19vaccinated population is increasing” Lancet Regional Health Vol. 11, 100272, December01, 2021

Aand Mortality Weekly Report[46], which investigated 469COVID-19 cases that had been identified among theMassachusetts residents who had travelled to town wheremultiple large public events had been held and 346 cases,i.e., 74 per cent of the infections occurred in fully vaccinatedindividuals. Findings from the investigation suggest that evenBjurisdictions without substantial or high COVID-19transmission might consider expanding prevention strategies,including masking in indoor public settings regardless ofvaccination status, given the potential risk of infection duringattendance at large public gatherings that include travelersCfrom many areas with differing levels of transmission.

The Petitioner has also cited various news articles reportinginstances of breakthrough infections in fully vaccinated people, carryingas much virus as those who were unvaccinated, abroad as well as withinIndia.

58. We have already referred to the material placed by the Unionof India and the States appearing before this Court. While there isabundant data to show that getting vaccinated continues to be the dominantexpert advice even in the face of new variants, no submission nor anydata has been put forth to justify restrictions only on unvaccinatedEindividuals when emerging scientific evidence appears to indicate thatthe risk of transmission of the virus from unvaccinated individuals isalmost on par with that from vaccinated persons. To put it differently,neither the Union of India nor the State Governments have producedany material before this Court to justify the discriminatory treatment ofunvaccinated individuals in public places by imposition of vaccineFmandates. No doubt that when COVID-19 vaccines came into the picture,they were expected to address, and were indeed found to be successfulin dealing with, the risk of infection from the variants in circulation at thetime. However, with the virus mutating, we have seen more potentvariants surface which have broken through the vaccination barrier toGsome extent. While vaccination mandates in the era of prevalence ofthe variants prior to the Delta variant may have withstood constitutionalscrutiny, 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 PublicGatherings — Barnstable County, Massachusetts, July 2021". MMWR Morb MortalHWkly Rep 2021;70:1059-1062

been controverted by the Union of India as well as the State Governments,we are of the opinion that the restrictions on unvaccinated individualsimposed through vaccine mandates cannot be considered to beproportionate, especially since both vaccinated and unvaccinatedindividuals presently appear to be susceptible to transmission of the virusat similar levels.

59. Details of the vaccine mandates passed by the States ofMaharashtra, Tamil Nadu, Madhya Pradesh and Delhi have beendiscussed earlier. It has come to our knowledge that since the judgmentin this matter was reserved, the National Disaster Management Authoritytook decision that there may not be any further need to invoke provisionsof the DM Act for COVID-19 containment measures, taking intoconsideration the overall improvement in the situation. Further, the Statesof Maharashtra and Tamil Nadu, taking into account the present situationin which near-normalcy has been restored, have rolled back therestrictions placed on unvaccinated persons. The State of MadhyaPradesh had withdrawn the restrictions imposed on unvaccinatedindividuals in terms of withholding distribution of food grains from fairprice 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 anynew development or research finding comes to light which provides theGovernment due justification to impose reasonable and proportionaterestrictions on the rights of unvaccinated individuals in furtherance ofthe continuing efforts to combat this pandemic, we suggest that allauthorities in this country, including private organisations and educationalinstitutions, review the relevant orders and instructions imposingrestrictions on unvaccinated individuals in terms of access to public places,services and resources.

60. While we appreciate that it is the domain of the executive todetermine how best to encourage vaccination without unduly encroachinginto the fundamental rights of unvaccinated individuals, we wish tohighlight the mechanism of the “health pass” employed in France, as anapt example of proportionate measure intended to cope with the perilsof the spread of the virus. We understand that “health pass” may takethe form of either the results of viral screening test not concluding thata person has been infected with COVID-19, or proof of vaccinationstatus, or certificate of recovery following an infection. In referralby the Prime Minister to review the law on managing the public health

Astate of emergency, the Constitutional Council in France, in Decision no.2021-824 DC dated 05.08.2021, determined that the “health pass” didnot infringe the right to personal privacy guaranteed by Article 2 of theDeclaration of Human and Civic Rights of 1789 as the requirement didnot introduce an obligation to vaccinate.

B61. Having expressed our opinion on the vaccine mandates in theprevailing context, we reiterate that vaccines effectively address severedisease arising from COVID-19 infections, are instrumental in reducingoxygen requirement, hospital and ICU admissions and mortality andcontinue to be the solution to stopping new variants from emerging, asper the advice of the WHO. Since the time arguments were heard in theCmatter, we have come to know of more variants that have now comeinto circulation. Given the rapidly-changing nature of the virus and theclear purpose served by the approved vaccines in terms of restorationand protection of public health, our suggestions with respect to reviewof vaccine mandates are limited to the present situation alone. ThisDjudgment is not to be construed as impeding, in any manner, the lawfulexercise of power by the executive to take suitable measures forprevention of infection and transmission of the virus in public interest,which may also take the form of restrictions on unvaccinated people inthe future, if the situation so warrants. Such restrictions will be subjectto constitutional scrutiny to examine if they meet the threefoldErequirement for intrusion into rights of individuals, as discussed earlier.II. Non-disclosure of segregated clinical trial data in publicdomain

62. It is the complaint of the Petitioner that the COVID-19 vaccines,Fmanufactured by Respondent Nos. 4 and 5, have been given restrictedemergency approval by the Drugs Controller General of India (DCGI)in hurried and opaque manner. Mr. Bhushan argued that clinical trialsin respect of the vaccines had not been completed and at present, thevaccines are only authorised for emergency use. According to thePetitioner, while clinical trials are scheduled to be completed in the yearG2023, even the full dataset from the interim analysis conducted has notbeen made public. The disclosure of segregated data of clinical trials isessential to determine the adverse effects, if any, across various agegroups and diverse populations and accordingly, enable individuals tomake more informed decisions on whether to be vaccinated. Reliance

was placed on an order of this Court in Aruna Rodrigues (4) v. Unionof India[47 ]and judgment of the Delhi High Court dated 15.01.2019 inW.P. (C) No. 343 of 2019 titled Master Hridaan Kumar (minor) v.Union of India with respect to the importance of disclosure of relevanttechnical data and informed consent. Additionally, the last amendedversion of the Declaration of Helsinki – Ethical principles from medicalresearch involving human subjects (hereinafter, the “Declaration ofHelsinki”) and statement by the WHO dated 09.04.2015 on ‘publicdisclosure of clinical trial results’ (hereinafter, the “WHO Statementon Clinical Trials”) were pressed into service to establish thesignificance of disclosure of data of clinical trials, so as to enable thedata to be assessed independently, and not only by the vaccinemanufacturer who has commercial interest in production of thevaccines. Mr. Bhushan submitted that there would be no invasion ofprivacy of individuals, if personal identification data and past medicalhistory of the trial participants was redacted and the raw data pertainingto clinical trials is made public. The further grievance of the Petitionerpertained to lack of transparency in regulatory approvals, minutes ofmeetings and constitution of expert bodies. The Petitioner has soughtfor clear detailing of the information furnished before, and evidence reliedon by, the expert bodies such as the NTAGI and the Subject ExpertCommittee (SEC), the body which sends recommendations to the CentralDrugs Standard Control Organisation, while deliberating on theapplications and data of the vaccine manufacturers, and the names andinstitutional relationships of the experts who participated in each of thesemeetings. Mr. Bhushan relied on the 59[th] Report of the ParliamentaryStanding Committee on Health and Family Welfare, in support of hissubmission on need for transparency in the decision-making of theCDSCO and other regulatory authorities.

63. In response, the Union of India submitted that the procedureprescribed under the statutory regime was scrupulously followed beforegranting emergency approval of the vaccines manufactured byRespondent Nos. 4 and 5. As per the extant statutory regime, permissionto import or manufacture new drugs including vaccines or to undertakeclinical trials is granted by the Central Drugs Standard ControlOrganisation (CDSCO). The CDSCO, in consultation with the SEC,evaluates the applications for grant of such permission, which are to beaccompanied with data as required under the Second Schedule to the47 (2011) 12 SCC 481

DEF

ANew Drugs and Clinical Trials Rules, 2019 (hereinafter, the “2019Rules”) framed under the Drugs and Cosmetics Act, 1940. The SEC isa statutory body, constituted by the CDSCO under Rule 100 of the 2019Rules, comprising group of experts with specialisation in relevant fields.According to the Union of India, the SEC looks into the details of trialsand results presented before it and examines them, interacts with theBdevelopers of the vaccines and gives them appropriate directions andeventually makes recommendations in writing, by way of resolution,reflecting the collective opinion of all the domain experts. We wereinformed that the trials have been registered on the database of theClinical Trials Registry – India, which is hosted at the ICMR’s NationalCInstitute of Medical Statistics. The provisions in relation to ‘AcceleratedApproval Process’ under the Second Schedule to the 2019 Rules werepointed out to this Court, which stipulate that “accelerated approvalprocess may be allowed to new drug for disease or conditiontaking into account its severity, rarity, or prevalence and theavailability or lack of alternative treatments, provided that there isDa prima facie case of the product being of meaningful therapeuticbenefit over the existing treatment”. It is further stated that “Aftergranting accelerated approval for such drug, the post marketingtrials shall be required to validate the anticipated clinical benefit.”It was submitted that applying these provisions on Accelerated ApprovalEProcess, the CDSCO, in detailed consultation with the SEC and afterexamining the efficacy of the vaccine and its effects, granted permissionfor restricted emergency use of COVAXIN and COVISHIELD, asmanufactured by Respondent Nos. 4 and 5, respectively.

64. As regards COVAXIN (Whole Virion Inactivated Corona Virus

FVaccine), the Union of India stated that application for permission tomanufacture the vaccine was made by Bharat Biotech on 23.04.2020.The CDSCO, in consultation with the SEC, granted permission to BharatBiotech for conducting Phase I/II clinical trials on 29.06.2020 and PhaseIII clinical trials on 23.10.2020. Respondent No. 4 submitted interim

safety and immunogenicity data of Phase I and Phase II clinical trialsGcarried out in the country, along with safety data, including SeriousAdverse Events data, of the ongoing Phase III clinical trial in the country.The data provided by Respondent No.4 from the various phases wereevaluated and analysed by the SEC, which consisted of eminent expertsfrom the fields of microbiology, medicine, pulmonary medicine, paediatricsHand 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 thewebsite of the MoHFW at every stage. In its meeting dated 02.01.2021,observing that on receiving further updated data, justification and requestfor consideration of the proposal in the wake of new mutation of theCOVID-19 virus, and on recognising that the data generated till thenshowed that the vaccine had the potential to target mutated coronavirusstrains, the SEC recommended for grant of permission for restricted usein emergency situation in public interest in clinical trial mode, as anabundant precaution. While granting such permission, Respondent No.4 was directed to continue the ongoing Phase III clinical trial and submitdata from the trial, as and when available. Approval for restricted use inemergency situation in clinical trial mode with various conditions /restrictions was granted by the CDSCO to Respondent No. 4 tomanufacture COVAXIN on 03.01.2021.65. Thereafter, Respondent No. 4 submitted the interim safetyand efficacy data of Phase III clinical trial, which was reviewed by theSEC in meetings held periodically. In its meeting conducted on 10.03.2021,the SEC, after detailed deliberation on the updated interim safety andefficacy data of the phase III clinical trial, recommended omission ofthe condition of the use of the vaccine in clinical trial mode. However, itwas recommended that the vaccine be continued to be used underrestricted use in emergency situation condition. Following expansion ofthe Government’s vaccination drive to include individuals in the age groupof 18-45 years, in its meeting held on 23.04.2021, the SEC consideredBharat Biotech’s proposal to unblind the trial participants in the said agegroup. After detailed deliberations, the SEC recommended the unblindingof the participants in the said age group, upon the request of theparticipants or the principal investigator after completion of two monthsfrom the second dose. Eventually, on consideration of relevant data ofPhase I and Phase II clinical trials along with safety data of 6 months’Phase III clinical trial, including data of serious adverse events till thedate, the SEC in its meeting dated 19.01.2022 noted that there had beenno safety issues and the vaccine maintained its efficacy, specially toavoid hospitalisation and severe infections in the existing situation aswell. Accordingly, the SEC recommended that the status of approval ofCOVAXIN from the restricted use in emergency situation to the NewDrug permission be updated, along with the condition that the firm shallcontinue to submit data of ongoing clinical trial and monitor AEFIs. The

AUnion of India pointed out that Phase I and Phase II clinical trial reportswere published in the Lancet Infectious Diseases Journal, which waspublicly available. Further, to the knowledge of the Union of India, PhaseIII trial publication had been submitted to the Lancet journal byRespondent No. 4 on 02.07.2021, copy of the manuscript of which hasbeen provided to this Court.B

66. COVISHIELD (ChAdOx1 nCoV-19 Corona Virus Vaccine(Recombinant)) manufactured by Respondent No. 5 was developed bythe Serum Institute of India in collaboration with Oxford University andAstraZeneca under technology transfer. As the clinical development ofthe said vaccine, including Phase I clinical trial, was conducted in otherCcountries, Phase II / III clinical trials were conducted by RespondentNo. 5 in the country. Application for permission to manufactureCOVISHIELD for test, examination and analysis was first made byRespondent No. 5 on 03.05.2020. The safety, immunogenicity andefficacy data of Phase II / III clinical trials of the AstraZeneca vaccineDcarried out in the United Kingdom, Brazil and South Africa were submittedto the SEC, along with the safety and immunogenicity data from theongoing Phase II / III clinical trials in India. On reviewing this data aswell as the approval dated 30.12.2020 granted by the United Kingdom’sMedicines and Healthcare Products Regulatory Authority (hereinafter,the “UK-MHRA”) for the AstraZeneca vaccine along with its conditionsE/ restrictions, the SEC, in its meeting dated 01.01.2021, noted that thesafety and immunogenicity data from the Indian study was comparablewith that of the overseas clinical trial data. After detailed deliberationand taking into account the emerging situation, the SEC recommendedgrant of permission for restricted emergency use of the vaccine, subjectFto various regulatory provisions and conditions, including requirement tosubmit relevant data from the ongoing clinical trials nationally andinternationally at its earliest. Eventually, in its meeting dated 19.01.2022,the SEC considered the request of Respondent No. 5 to grant permissionto manufacture the vaccine, excluding the conditions for restricted usein emergency situation and other conditions, on the lines of MarketingGAuthorisation by the UK-MHRA for the parent vaccine. After detaileddeliberation and consideration of safety, immunogenicity and efficacydata from Indian and overseas clinical trials, amongst other data, theSEC recommended grant of New Drug permission or regular approval,with conditions that data of ongoing clinical trials and vaccine shallHcontinue to be supplied and AEFIs shall continue to be monitored.

67. We were directed to Rule 25 of the 2019 Rules, framed underthe Drugs and Cosmetics Act, 1940, which provides that the clinical trialshall be conducted in accordance with approved clinical trial protocoland other related documents as per the requirements of Good ClinicalPractices (GCP) guidelines and the other rules. The expert committeeset up by the CDSCO under Rule 25(vi) in consultation with clinicalexperts formulated the GCP guidelines for generation of data on drugs.The ‘Ethical Principles’, which are part of the said guidelines, protectprinciples of privacy and confidentiality of human subjects of research.The learned Solicitor General also relied upon para 2.4.4 of the GCPguidelines, which require safeguarding of the confidentiality of researchdata that might lead to identification of individual subjects. He furtherreferred to the important role played by the Ethics Committee underRule 11 of the 2019 Rules, which includes safeguarding the rights, safetyand well-being of trial subjects in accordance with the said rules. The2019 Rules also empower the Ethics Committee to discontinue or suspendthe clinical trial in case it concludes that the trial is likely to compromisethe right, safety or well-being of the trial subject. As per the ICMR’sNational Ethical Guidelines for Biomedical and Health Research involvingHuman Participants, the four basic ethical principles for conductingbiomedical and health research are (i) respect for persons (autonomy),(ii) beneficence, (iii) non-malfeasance and (iv) justice. These four basicprinciples have been expanded into 12 general principles, including the‘principle of ensuring privacy and confidentiality’ which requiresmaintaining the privacy of potential participants, her / his identity andrecords, with access given to only those authorised. As regardstransparency of functioning of expert bodies, it was submitted by theUnion of India that recommendations of the SEC in all its meetings areuploaded on the website of the CDSCO. Additionally, the detailed minutesof NTAGI meetings were already available in public domain, which canbe downloaded from both the ICMR and the MoHFW websites.

68. The contention of Respondent No. 4 is that COVAXIN hasundergone all clinical trials. In Phase III, trials revealed 77.8% efficacyagainst symptomatic COVID-19 disease. The findings of the clinicaltrials have been published in reputed peer-reviewed journals and arereadily available on the website of Respondent No.4. reference wasmade by Respondent No. 4 to the WHO Statement on Clinical Trials, tosubmit that it is only the key outcomes and findings which are requiredto be made publicly available. It was contended that Respondent No. 4

Ais in compliance with the WHO Statement on Clinical Trials as the keyoutcomes and results of the Phase III clinical trial have been publishedin the Lancet. On behalf of Respondent No. 5, it was submitted that theclinical data generated during the trials had been submitted to the regulatoryauthorities for obtaining permissions / licences etc. Further, the peer-reviewed study of the partial clinical data of Phase II / III trials hadBalready been published in reputed scientific journals, which included allthe information necessary for safeguarding the public as well as informingthem of the credibility and efficacy of the vaccine. According toRespondent No. 5, the raw data of the clinical trials served no greaterpublic purpose than the data which was already available in the publicCdomain. All applicable medico-legal, scientific and ethical requirementshad been strictly adhered to by Respondent No. 5.

69. In rejoinder, the learned counsel for the Petitioner argued thatthere is no transparency in the process of approvals of vaccines andrelevant data is not always placed before the NTAGI. He referred to aDnews article in The Wire, according to which Jayaprakash Muliyil, amember of the NTAGI had stated that the NTAGI had not recommendedvaccination of children in the age group of 12-14 years. He also drewthe attention of this Court to non-supply of relevant data to the NTAGIat the time of approval of the Rotavac vaccine against rotavirus. ThePetitioner further complained of the haste shown in grant of emergencyEapproval to Respondent No. 4. The Petitioner has sought support of adecision of the United States District Court for the Northern District ofTexas dated 06.01.2022 in Public Health and Medical Professionalsfor Transparency v. Food and Drug Administration, which highlightedthe need for transparency in disclosure of clinical trial data. It wasFreiterated by the Petitioner that privacy of individuals would not be atrisk as their personal identification data can be redacted before disclosingsegregated data of clinical trials.

70. It is settled law that courts cannot take judicial notice of factsstated in news item published in newspaper. statement of factGcontained in newspaper is merely hearsay and therefore, inadmissiblein evidence, unless proved by the maker of the statement appearing incourt and deposing to have perceived the fact reported.[48] In the absenceof anything on record in the present case to substantiate the statementmade by Mr. Jayaprakash Muliyil, member of the NTAGI, we are not

H48 Laxmi Raj Shetty v. State of Tamil Nadu (1988) 3 SCC 319

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 Indiastating that the relevant data was examined by the expert bodies at allstages before granting emergency use approval to the vaccines. We arealso of the opinion that the evidence relating to the approval process ofthe Rotavac vaccine has no relevance to the dispute in this case. On thebasis of the said two incidents, it cannot be concluded that the emergencyuse approval to COVISHIELD and COVAXIN recommended by theSEC are not in accordance with the statutory regime.71. At this stage, it is worthwhile to refer to the statutory regimein place. According to Rule 19 of the 2019 Rules, no person, institutionor organisation shall conduct clinical trial of new drug or investigationalnew drug, except in accordance with the permission granted by the CentralLicensing Authority (i.e., the CDSCO) and without following the protocolapproved by the Ethics Committee for clinical trial, registered inaccordance with the provisions of Rule 8. Rule 19 (2) of the 2019 Rulesprovides that every person associated with the conduct of clinical trial ofa new drug or investigational new drug shall follow the general principlesand practices as specified in the First Schedule. The methodology to beadopted in clinical trial is provided for in the First Schedule to the 2019Rules, relevant clauses of which are as under: -

“GENERAL PRINCIPLES AND PRACTICES FOR CLINICALTRIAL

1. General Principles.¯ (1) The principles and guidelines forprotection of trial subjects as described in Third Schedule aswell as Good Clinical Practices guidelines shall be followedin conduct of any clinical trial.

xxx

4. Conduct of Clinical Trial.¯ Clinical trial should beconducted in accordance with the principles as specified inThird Schedule. Adherence to the clinical trial protocol isessential and if amendment of the protocol becomes necessarythe rationale for the amendment shall be provided in the formof protocol amendment. Serious adverse events shall bereported during clinical trial in accordance with these Rules.xxx

6. Reporting.¯ Report of clinical trial shall be documented inaccordance with the approaches specified in Table 6 of theThird Schedule. The report shall be certified by the principalinvestigator or if no principal investigator is designated thenby each of the participating investigators of the study.”

BIt is clear from the above, that there are stringent statutoryrequirements which have to be complied with by the manufacturers ofvaccines and other participants, during different stages of clinical trialsof vaccines. Further, we also note that the GCP guidelines are statutorilyrequired to be followed.

C72. The GCP guidelines further elaborate on the role of the EthicsCommittee. According to the GCP guidelines, the Ethics Committee isan independent review board or committee comprising of medical /scientific and non-medical / non-scientific members, whose responsibilityit is to verify the protection of the rights, safety and well-being of humansubjects involved in study. The independent review provides publicDreassurance by objectively, independently and impartially reviewing andapproving the “Protocol”, the suitability of the investigator(s), facilities,methods and material to be used for obtaining and documenting “InformedConsent” of the study subjects and adequacy of confidentiality safeguards.Para 2.4 of the GCP guidelines deal with ethical and safety considerations,Ewhich provide that all research involving human subjects should beconducted in accordance with the ethical principles contained in thecurrent version of the Declaration of Helsinki, as annexed to theguidelines. Amongst the principles to be followed, the GCP guidelinesrequire adherence to the “principles of accountability and transparency”and “principles of public domain”:F

“Principles of accountability and transparency,whereby theresearch or experiment will be conducted in fair, honest,impartial and transparent manner, after full disclosure is madeby those associated with the Study of each aspect of theirinterest in the Study, and any conflict of interest that may exist;Gand whereby, subject to the principles of privacy andconfidentiality and the rights of the researcher, full andcomplete records of the research inclusive of data and notesare retained for such reasonable period as may be prescribedor considered necessary for the purposes of post-researchmonitoring, evaluation of the research, conducting further

research (whether by the initial researcher or otherwise) andin order to make such records available for scrutiny by theappropriate legal and administrative authority, if necessary.

xxx

Principles of public domain, whereby the research and anyfurther research, experimentation or evaluation in responseto, and emanating from such research is brought into thepublic domain so that its results are generally made knownthrough scientific and other publications subject to such rightsas are available to the researcher and those associated withthe research under the law in force at that time.”

73. The GCP guidelines have been formulated following theDeclaration of Helsinki. The relevant portion of the said Declaration isas follows: -

“Privacy and Confidentiality

24. Every precaution must be taken to protect the privacy ofresearch subjects and the confidentiality of their personalinformation.

Research Registration and Publication and Dissemination ofResults

36. Researchers, authors, sponsors, editors and publishersall have ethical obligations with regard to the publicationand dissemination of the results of research. Researchers havea duty to make publicly available the results of their researchon human subjects and are accountable for the completenessand accuracy of their reports. All parties should adhere toaccepted guidelines for ethical reporting. Negative andinconclusive as well as positive results must be published orotherwise made publicly available. Sources of funding,institutional affiliations and conflicts of interest must bedeclared in the publication. Reports of research not inaccordance with the principles of this Declaration should notbe accepted for publication.”

It is profitable to refer to the relevant portion of the WHOStatement on Clinical Trials, which is as under: -

A“Reporting timeframes for clinical trials

Clinical trial results are to be reported according to thetimeframes outlined below. Reporting is to occur in BOTH ofthe following two modalities.

1. The main findings of clinical trials are to be submitted forBpublication in peer reviewed journal within 12 months ofstudy completion and are to be published through an openaccess mechanism unless there is specific reason why openaccess cannot be used, or otherwise made available publiclyat most within 24 months of study completion.

2. In addition, the key outcomes are to be made publiclyavailable within 12 months of study completion by posting tothe results section of the primary clinical trial registry. Wherea registry is used without results database available, theresults should be posted on free-to-access, publiclyDavailable, searchable institutional website of the RegulatorySponsor, Funder or Principal Investigator.”

74. The GCP guidelines are being scrupulously followed, accordingto the Union of India. The principles of “public domain” in the GCPguidelines provide for research, experimentation or evaluation in responseEto the research to be brought into the public domain. The results of theclinical trials are generally to be made known through scientific andother publications. The requirement of publication, according to the WHO,also relates to the main findings of clinical trials to be published in apeer-reviewed journal and the key outcomes to be made publicly available,within 12 months of study completion. The Petitioner complains ofFopaqueness in clinical trials as the general public do not have access to,and the opportunity to be aware of, all the necessary details by segregatedclinical trial data (primary datasets) not being available. There is nochallenge by the Petitioner to the GCP guidelines. As required by theWHO Statement on Clinical Trials and the GCP guidelines, findings ofGthe 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 mandatethe disclosure of primary clinical trial data, when the results and keyfindings of such clinical trials have already been published.75. After examining the judgment of the United States DistrictCourt for the Northern District of Texas (hereinafter, the “US DistrictH

Court”), we are afraid that the said decision cannot be said to be relevantfor adjudication of the dispute in the present case. The grievance of theplaintiff in the said case pertained to all data and information for thePfizer vaccine, enumerated under the relevant provisions of the Freedomof Information Act, not being provided by the United States Food andDrug Administration. The US District Court referred to the Freedom ofInformation Act to hold that the citizenry has right to be provided withthe relevant information pertaining to the Pfizer vaccine and that such‘information is often useful only if it is timely’. The US District Courtdirected expeditious completion of the plaintiff’s request after concludingthat the request under the Freedom of Information Act was of paramountimportance. We note that with respect to COVAXIN and COVISHIELD,results of clinical trials have been published in accordance with ourstatutory regime in place. Reliance placed by the Petitioner on EuropeanMedicines Agency policy on publication of clinical data for medicinalproducts for human use is also not relevant as the GCP guidelines relatingto 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 counselappearing for the parties and close scrutiny of the material placed onrecord would show that there is strict statutory regime in force forgrant of approvals to vaccines. Specialist bodies established under theprovisions of the Drugs and Cosmetics Act, 1940 and the rules framedthereunder comprise of domain experts in the relevant field, who conducta thorough scrutiny of the material produced by the manufacturers beforegranting approval. The information provided on behalf of the Union ofIndia substantiates that the data provided by the vaccine manufacturerswas considered by the SEC over period of time and several conditionswere imposed at the time of recommending approvals, which have beenmodified or lifted subsequently on availability of further data arising fromthe clinical trials before the SEC, as can be seen from the minutes of themeetings of the SEC, available on the website of the MoHFW. We donot agree with the submission on behalf of the Petitioner that emergencyapprovals to the vaccines were given in haste, without properly reviewingthe data from clinical trials. We are also of the opinion that theParliamentary Standing Committee report relied upon by Mr. Bhushanis not relevant and the lapses pointed out therein pertain to the year2011, which have no obvious connection to the grant of approval toRespondent Nos. 4 and 5 for the restricted emergency use of their

Arespective vaccines. As long as the relevant information relating to theminutes of the meetings of the regulatory bodies and the key outcomesand findings of the trials are available in public domain, the Petitionercannot contend that every minute detail relating to clinical trials be placedin public domain to enable an individual to take an informed, consciousdecision to be vaccinated or not. Given the widespread affliction causedBby the virus, there was an imminent need of manufacturing vaccineswhich would keep the infection at bay. We would like to highlight thatboth the vaccines have been approved by the WHO as well. perusalof the material placed on record would show that there is materialcompliance with the procedure prescribed under the Drugs and CosmeticsCAct, 1940 and the 2019 Rules, before grant of approval for the emergencyuse of the two vaccines. However, it is made clear that subject to theprotection of privacy of individual subjects and to the extent permissibleby the 2019 Rules, the relevant data which is required to be publishedunder the statutory regime and the WHO Statement on Clinical Trialsshall be made available to the public without undue delay, with respect toDthe ongoing post-marketing trials of COVAXIN and COVISHIELD aswell as ongoing clinical trials or trials that may be conducted subsequentlyfor approval of other COVID-19 vaccines / vaccine candidates.

III. Improper collection and reporting of AEFIs

E77. The contention of the Petitioner is that there have been severaladverse effects from vaccines, including deaths. The Petitioner has soughtto fault the Government’s mechanisms in place for handling of the adverseevents. According to the Petitioner, during Phase III trials, where smallcontrolled trials of limited number of participants are conducted, asignificant increase in adverse events may not be seen. But after licensure,Fwhen the vaccines are administered to the masses, rare reactions showup, which is why Phase IV post-marketing trials are legally mandated. Itwas pointed out by the Petitioner that there has been revision of therules by the WHO for classifying AEFIs in 2018. As per the revisedmechanism, only reactions that are previously acknowledged to be causedGby the vaccine are classified as vaccine-related reactions. Reactionsobserved during post-marketing surveillance are not considered as‘consistent with causal association with vaccine’, if significant increasein such reactions during Phase III trials had not been recorded. Accordingto the Petitioner, this acquires significance in the context of trialsconducted in this country, as the control trial in Phase III did not go on inH

the manner intended, with several members of the original control groupprematurely unblinded and offered the vaccine. The Petitioner contendsthat owing to ‘dilution of Phase III control trials prematurely’, there areno controls to compare against, making it difficult to ascertain whichadverse events are caused by the vaccine. Therefore, reactions whichare not “known reactions” to the vaccine are not considered AEFIs. Inlight of this, it is necessary for the authorities to carefully monitor allvaccine recipients and publicly record all adverse events.78. Taking this argument further, the Petitioner contended thatthe adverse events reporting system in India is not transparent, withobscure investigation and follow-up of deaths and other serious adverseevents after COVID-19 vaccination. The Petitioner relied on letterpublished in The Hindu on 17.03.2021, written by group of experts inpublic health, ethics, medicine, law, and journalism to the Minister forHealth & Family Welfare and the DCGI, appealing for “time-bound andtransparent investigation” following deaths and serious adverse effectsafter COVID-19 vaccination. presentation made by the National AEFICommittee in meeting held on 31.03.2021 was referred to by thePetitioner to claim that complete documentation was not available for allthe severe and serious adverse events (including deaths) that had occurredtill the time. Additionally, it was contended that no data pertaining to theAEFIs already classified nor any analysis of the same had been publishedpublicly till date. The Petitioner also drew the attention of this Court tothe Vaccine Adverse Event Reporting System (VAERS) in place in theUnited States, which published all vaccine injury reports every Friday,received till about week prior to the release date. It was brought to thenotice of this Court that 77,314 adverse events have been reported inIndia as on 12.03.2022, amounting to 0.004% of the total vaccination.The Petitioner has pointed out that the percentage of adverse eventsreported in Europe is much larger than the percentage identified in India,which would show that correct figures are not being published by theGovernment.

79. On behalf of the Union of India, the procedures and protocolsfor monitoring of adverse event following immunisation under the NationalAdverse Event Following Immunisation Surveillance Guideline wereelaborated upon. The National Adverse Event Following ImmunisationSurveillance Secretariat, established in the Immunisation TechnicalSupport Unit in 2012, had staff dedicated for managing Adverse Event

AFollowing Immunisation surveillance system. It was further strengthenedby the National Adverse Event Following Immunisation SurveillanceTechnical Collaborating Centre, comprising of experts from LadyHardinge Medical College and Allied Hospitals in New Delhi. AdverseEvent Following Immunisation Committees were formed at the nationaland state levels to provide guidance to the National AEFI SurveillanceBand carry out documentation, investigation and causality assessment,besides training and orientation of health care workers and othersinvolved in AEFI. According to the Union of India, foolproof protocolfor reporting and causality assessment for any AEFI with UniversalImmunisation Program (UIP) and Non-UIP vaccines has beenCestablished. The National AEFI Committee gets periodical reportsregarding ‘minor AEFIs’, ‘severe AEFIs’ and ‘serious AEFIs’. Onlinereporting of all serious and severe AEFIs at the district level to becommunicated to relevant authorities at the state / national level is doneon web-based portal, SAFEVAC (Surveillance and Action for EventsFollowing Vaccination). All serious and severe adverse events followingDvaccination even at district level are uploaded online on SAFEVAC. Itwas submitted on behalf of the Union of India that case details, scannedcopies of reports are uploaded on SAFEVAC, which also has facilitiesfor generating dashboards and line-lists at different levels.80. Further, similar feature of reporting of all AEFIs (includingEminor) by the vaccinator was made available on the Co-WIN portal.District Immunisation Officers (DIOs) were given the facility to reportAEFI cases about which they have information from such individualswho do not have access to Co-WIN. Departmental orders and standardoperating procedures have been issued for further investigations andFsharing of hospital records by the DIOs through Co-WIN. The Union ofIndia has brought to the notice of this Court that an alignment with thePharmacovigilance Programme of India (PvPI) under IndianPharmacopoeia Commission has been developed for receipt of informationregarding AEFI cases from around 300 Adverse Drug ReactionMonitoring Centers in medical colleges and large hospitals. The UnionGof India has highlighted that information from the PvPI and the CDSCOare collated and studied, in case of any new, previously unknown eventsidentified through AEFI surveillance. press release of the MoHFWdated 17.02.2017 titled ‘Maximum Possible Marks to Indian NRA inWHO Assessment’ has been placed before this Court to state that theHAEFI Surveillance System in India (which is in use for COVID-19

vaccination) has been approved by global experts in an assessmentconducted by the WHO in 2017. Given the novel nature of the virus,membership of the National AEFI Committee has been expanded toinclude neurologists, cardiologists, respiratory medicine specialists andmedical specialists, with even States / Union Territories requested toexpand their AEFI Committees on similar scale to strengthen AEFIsurveillance for COVID-19 vaccines. Causality assessment of AEFIcases is conducted at the state and the national levels by experts trainedas per the causality assessment checklist, based on the definition andalgorithm developed by the WHO. Once approved by experts of theNational AEFI Committee, results of causality assessment of AEFI casesare made available in the public domain and are shared with the CDSCO,amongst other authorities, for appropriate regulatory action.

81. As regards the present status of AEFI surveillance for COVID-19 vaccination, it was submitted that as the causality assessment ofreported AEFI cases is time-consuming process, method of rapidreview and assessment had been initiated at the national level to quicklyreview available informationin each case and look for trends in reportingof specific events or unusual cases requiring further early investigationand assessment. All cases of serious and severe AEFIs, including reporteddeaths, are subjected to rapid reviews, analysis and causality assessmentdone by team of trained subject experts. It was clarified that merereporting of AEFI case should not be attributed to the vaccine unlessproved by the causality assessment analysis. The National Expert Groupon Vaccine Administration for COVID-19 (NEGVAC), an additionalbody of experts, is also involved in providing guidance on vaccine safetyand surveillance, thus, aiding in the prompt identification of AEFIs forthe purpose of identifying and understanding evolving trends in the diseaseand taking prompt action. 2,116 serious and severe AEFIs have beenreported from 1,19,38,44,741 doses of COVID-19 vaccine administeredtill 24.11.2021. While report of rapid review and analysis completedfor 495 cases had been submitted, further report of 1,356 serious andsevere AEFI cases had been presented to the NEGVAC and the rapidreview and analysis of balance cases was underway. Press releasesaround report on bleeding and clotting events following COVID-19vaccination being submitted to the MoHFW by the National AEFICommittee and on clarification on deaths following vaccination andprocess of causality assessment were placed before this Court.Therefore, the Union of India submitted that there was continuous

Amonitoring and examination of AEFI cases in India and there is no basisfor the allegations around AEFIs not being properly collected and lackof transparency in their investigation.

82. From the material placed before us, we note that the NationalAEFI Surveillance Secretariat has been functioning for 10 years and asBhas been pointed out, there is well-established protocol in place foridentification and monitoring of AEFIs. The website of the MoHFWcarries the results of causality assessment of AEFI cases, from whichthe public can obtain relevant information pertaining to AEFIs. We havebeen informed that thorough causality assessment analysis of AEFIsis carried out by experts and not every severe disease and death can beCattributed to vaccination. Reactions are examined by experts specificallytrained to undertake causality analysis before notifying such reactionsas adverse events arising from vaccination. There is well-definedmechanism for collection of data relating to adverse events that occurdue to COVID-19 vaccines and the Government of India has takenDsteps to direct all concerned medical professionals at the ground level toreport adverse events. Even medical practitioners at private hospitalsare associated with reporting of adverse events. Therefore, we are notinclined to accept the broad-strokes challenge mounted by the Petitionerthat the surveillance system of AEFIs in this country is faulty and thecorrect figures of those who have suffered any side effects, severeEreactions or deaths post-inoculation have not been disclosed.

83. As regards the contention of the Petitioner on abandoning ofPhase III trials, we note that unblinding of participants during the PhaseIII trial was done on the recommendation of the SEC. The Union ofIndia has emphasized that at every stage, the deliberations of domainFexperts, which involved discussions with the manufacturers, focused onsafety and immunogenicity of the vaccines and it was only when therewas consensus among domain experts that it was safe to extend theimmunisation drive beyond the category of ‘healthcare workers / frontlineworkers’, the appropriate decisions were taken. In doing so, the availableGtrial data, trajectory of the pandemic, evidence, future contingencies andseveral other factors have always been heeded. There is no challengeto the decision of the SEC, body of domain experts, as beingunreasonable or arbitrary, nor have we been called upon to determinewhether adequate time was devoted to recognise all relevant reactionsas vaccine-related reactions prior to such unblinding. What the PetitionerH

seeks is the monitoring of all adverse events and publication of the resultsof investigation. The Union of India has painstakingly taken this Courtthrough the details of the procedure followed to closely monitor, reviewand escalate the incidence of AEFIs to appropriate authorities. As regardspreviously unknown / unidentified reactions seen during the monitoringof AEFIs at the time of vaccine administration, the Union of India haselaborated on the role of the PvPI and the CDSCO, which collate andstudy such reactions. We believe this adequately addresses thePetitioner’s concerns, as this Court has been informed that previouslyunidentified events are also being taken into consideration and investigated.We trust the Union of India to have the appropriate authorities ensurethat this leg of the AEFI surveillance system is not compromised withwhile meeting the requirements of the rapid review and assessmentsystem followed at the national level.84. The Petitioner had taken issue with the present system to theextent it allows only DIOs or the vaccinators to report AEFIs. Accordingto the Petitioner, the repository of AEFIs should be as detailed as theVAERS in the United State of America. The Petitioner further submittedthat individuals and doctors must be able to report adverse events, withthe reporter being given unique identification number and the reportsbeing openly accessible. The response of the Union of India on thisissue is that the DIOs have been instructed to set up network withprivate hospitals to report AEFIs. Training has been provided to stateofficers, medical officers, private practitioners and frontline healthworkers on their role in AEFI surveillance. Even auxiliary nurse midwiveshave been instructed to notify all AEFIs. However, we are in agreementwith the suggestion made by the Petitioner that there should be amechanism by which individuals and private doctors should be permittedto report suspected adverse events. Information relating to adverseeffects following immunisation is crucial for the purpose of understandingthe safety of the vaccines that are being administered, apart from beinginstrumental in further scientific studies around the pandemic. There isan imminent need for collection of requisite data of adverse events andwider participation of people in reporting the adverse events is necessaryfor the purpose of gathering correct information. Thus, the Union ofIndia is directed to facilitate the reporting of suspected adverse eventsby individuals and private doctors on virtual platform and the reportsso made shall be publicly accessible after being given unique identificationnumbers, without listing any personal or confidential data of the persons

Areporting. 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 ofvaccine administration.

IV. Vaccination of ChildrenB

85. The opinion of the Petitioner is that children are at almost norisk from COVID-19 and instances of previously healthy childrenrequiring hospitalisation due to COVID-19 are exceedingly rare. Whilereferring to articles in the Nature and the Lancet, the Petitioner contendedthat scientific evidence shows that risk of administering vaccines toCchildren outweigh the benefits offered by the vaccine in children. ThePetitioner further submitted that serological studies would show that alarge number of children have already acquired antibodies to COVID-19. The Petitioner has highlighted the risk of myocarditis associated withthe mRNA vaccines, on the basis of which, several European countrieshave recently stopped the use of Moderna vaccines for those under theDage of 30. He has also pointed out that these risks had not been identifiedin the initial vaccine trials as the trial size was too small to uncover rarerisks, which were discovered after mass vaccination. The Petitioner hassought for results as well as the primary data of clinical trials conductedon the paediatric population to be made public.

86. In response thereto, the Union of India contended that paediatricvaccination is advised by global agencies such as the WHO, the UNICEFand the CDC. Expert opinion in India is in tune with global consensus infavour of vaccination of children. We are informed that 8,91,39,455 dosesof COVAXIN have been administered to individuals in the age group ofF15 to 18 years as on 12.03.2022. The AEFIs reported are 1,739 minorcomplaints, 81 serious complaints and 6 severe. According to the Unionof India, the said data would show that the vaccine does not pose threatto the safety of children. As regards the clinical trials, para 2.4.6.2 of theGCP guidelines were relied on to show that children are not required tobe involved in research that could be carried out equally well with adultsGand further that, for the clinical evaluation of new drug, study in childrenshould be carried out after the Phase III clinical trials in adults. It hasbeen stated that paediatric vaccination was considered at stage wheremore than substantial data on safety and immunogenicity of COVAXINin adults was available. To avoid any risks, clinical trials were alsoHconducted on limited number of children as per the protocol approved

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

87. This Court cannot sit in judgment of leading scientific analysisrelating to the safety of paediatric vaccination. Experts in science maythemselves differ in their opinions while taking decisions on matters relatedto safety and allied aspects, but that does not entitle the Court to second-guess expert opinion, on the basis of which the Government has drawnup its policies. The decision taken by the Union of India to vaccinatepaediatric population in this country is in tune with global scientificconsensus and expert bodies like the WHO, the UNICEF and the CDChave also advised paediatric vaccination. It would not only be beyondour jurisdiction but also hazardous if this Court were to examine theaccuracy of such expert opinion, based on competing medical opinions.As already stated, the scope of judicial review does not entail the Courtembarking upon such misadventures. Therefore, we reject the contentionof the Petitioner that this Court has to intervene in paediatric vaccinationon the ground that it is unscientific.

88. With respect to results of clinical trials, we note that the Unionof India has stated that the results of clinical trials of COVAXIN forpaediatric population have already been published. We also note that forthe age group of 12 to 14 years, Biological E’s Corbevax is beingadministered. Keeping in line with the WHO Statement on Clinical Trials,the Declaration of Helsinki and the GCP guidelines, we direct the Unionof India to ensure that key findings and results of the clinical trials ofCorbevax be published at the earliest, if not already done. Neither vaccineis an mRNA vaccine and to this extent, the apprehensions of the Petitionerwith respect to the associated risks of mRNA vaccines are unfoundedin the present situation.

AConclusion

89. In conclusion, we have summarised our findings on the variousissues considered by us, below:

(i)Given the issues urged by the Petitioner have bearing onpublic health and concern the fundamental rights ofBindividuals in this country, we are not inclined to entertainany challenge to the maintainability of the Writ Petition.

(ii)As far as judicial review of policy decisions based on expertopinion is concerned, there is no doubt that wide latitude isprovided to the executive in such matters and the Courtdoes not have the expertise to appreciate and decide onmerits of scientific issues on the basis of divergent medicalopinion. However, this does not bar the Court fromscrutinising whether the policy in question can be held to bebeyond the pale of unreasonableness and manifestarbitrariness and to be in furtherance of the right to life ofall persons, bearing in mind the material on record.

(iii)With respect to the infringement of bodily integrity andpersonal autonomy of an individual considered in the lightof vaccines and other public health measures introduced todeal with the COVID-19 pandemic, we are of the opinionthat bodily integrity is protected under Article 21 of theConstitution and no individual can be forced to bevaccinated. Further, personal autonomy of an individual,which is recognised facet of the protections guaranteedunder Article 21, encompasses the right to refuse to undergoany medical treatment in the sphere of individual health.However, in the interest of protection of communitarianhealth, the Government is entitled to regulate issues of publichealth concern by imposing certain limitations on individualrights, which are open to scrutiny by constitutional courtsto assess whether such invasion into an individual’s right topersonal autonomy and right to access means of livelihoodmeets the threefold requirement as laid down in K.S.Puttaswamy (supra), i.e., (i) legality, which presupposesthe existence of law; (ii) need, defined in terms of legitimateState aim; and (iii) proportionality, which ensures rational

nexus between the objects and the means adopted to achievethem.

(iv)On the basis of substantial material filed before this Courtreflecting the near-unanimous views of experts on thebenefits of vaccination in addressing severe disease fromthe infection, reduction in oxygen requirement, hospital andICU admissions, mortality and stopping new variants fromemerging, this Court is satisfied that the current vaccinationpolicy of the Union of India is informed by relevantconsiderations and cannot be said to be unreasonable ormanifestly arbitrary. Contrasting scientific opinion comingforth from certain quarters to the effect that natural immunityoffers better protection against COVID-19 is not pertinentfor determination of the issue before us.(v)However, no data has been placed by the Union of India orthe States appearing before us, controverting the materialplaced by the Petitioner in the form of emerging scientificopinion which appears to indicate that the risk of transmissionof the virus from unvaccinated individuals is almost on parwith that from vaccinated persons. In light of this, restrictionson unvaccinated individuals imposed through various vaccinemandates by State Governments / Union Territories cannotbe said to be proportionate. Till the infection rate remainslow and any new development or research finding emergeswhich provides due justification to impose reasonable andproportionate restrictions on the rights of unvaccinatedindividuals, we suggest that all authorities in this country,including private organisations and educational institutions,review the relevant orders and instructions imposingrestrictions on unvaccinated individuals in terms of accessto public places, services and resources, if not alreadyrecalled. 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 byStates / Union Territories, is limited to the present situationalone and is not to be construed as interfering with thelawful exercise of power by the executive to take suitablemeasures for prevention of infection and transmission of

the virus. Our suggestion also does not extend to any otherdirections requiring maintenance of COVID-appropriatebehaviour issued by the Union or the State Governments.

(vi)As regards non-disclosure of segregated clinical data, wefind that the results of Phase III clinical trials of the vaccinesBin question have been published, in line with the requirementunder the statutory regime in place, the GCP guidelines andthe WHO Statement on Clinical Trials. The materialprovided by the Union of India, comprising of minutes ofthe meetings of the SEC, do not warrant the conclusionthat restricted emergency use approvals had been grantedCto COVISHIELD and COVAXIN in haste, without thoroughreview of the relevant data. Relevant information relatingto the meetings of the SEC and the NTAGI are available inpublic domain and therefore, challenge to the proceduresadopted by the expert bodies while granting regulatoryDapproval to the vaccines on the ground of lack oftransparency cannot be entertained. However, we reiteratethat subject to the protection of privacy of individual subjects,with respect to ongoing clinical trials and trials that may beconducted subsequently for COVID-19 vaccines, allrelevant data required to be published under the extantEstatutory regime must be made available to the public withoutundue delay.

(vii)We do not accept the sweeping challenge to the monitoringsystem of AEFIs being faulty and not reflecting accuratefigures of those with severe reactions or deaths fromFvaccines. We note that the role of the PharmacovigilanceProgramme of India and the CDSCO, as elaborated uponby the Union of India, collates and studies previouslyunknown reactions seen during monitoring of AEFIs at thetime of vaccine administration and we trust the Union ofGIndia to ensure that this leg of the AEFI surveillance systemis not compromised with, while meeting the requirementsof the rapid review and assessment system followed at thenational level for AEFIs.

(viii) We are also of the opinion that information relating toHadverse effects following immunisation is crucial for creating

[L. NAGESWARA RAO, J.]

awareness around vaccines and their efficacy, apart frombeing instrumental in further scientific studies around thepandemic. Recognising the imperative need for collectionof requisite data of adverse events and wider participationin terms of reporting, the Union of India is directed tofacilitate reporting of suspected adverse events by individualsand private doctors on an accessible virtual platform. Thesereports shall be made publicly accessible, withoutcompromising on protecting the confidentiality of the personsreporting, with all necessary steps to create awareness ofthe existence of such platform and of the informationrequired to navigate the platform to be undertaken by theUnion of India at the earliest.

(ix)On paediatric vaccination, we recognise that the decisiontaken by the Union of India to vaccinate children in thiscountry is in tune with global scientific consensus and expertbodies like the WHO, the UNICEF and the CDC and it isbeyond the scope of review for this Court to second-guessexpert opinion, on the basis of which the Government hasdrawn up its policy. Keeping in line with the WHO Statementon Clinical Trials and the extant statutory regime, we directthe Union of India to ensure that key findings and results of

the relevant phases of clinical trials of vaccines alreadyapproved by the regulatory authorities for administration tochildren, be made public at the earliest, if not already done.

90. We express our gratitude to the learned counsel on either sidefor their able assistance in enabling this Court to reach the aboveconclusion.

91. The Writ Petition is disposed of accordingly.

Bibhuti Bhushan Bose

Petition disposed.