Reportable

IN THE SUPREME COURT OF INDIA

CIVIL ORIGINAL JURISDICTION

Writ Petition (Civil) No. 607 of 2021

JACOB PULIYEL …..PETITIONER

Versus

UNION OF INDIA & ORS. …..RESPONDENTS

J U D G M E N T

L. NAGESWARA RAO, J.

1.The Petitioner was a member of the National Technical

Advisory Group on Immunization (NTAGI) and was advising

the Government of India on vaccines. He has filed this Writ

Petition in public interest seeking the following reliefs:

“(a) Direct the respondents to release the entire

segregated trial data for each of the phases of trials

that have been undertaken with respect to the vaccines

being administered in India; and

(b) Direct the respondent No 2 to disclose the detailed

minutes of the meetings of the Subject Expert

Committee and the NTGAI with regard to the vaccines

as directed by the 59

th

Parliamentary Standing

Committee Report and the members who constituted

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the committee for the purpose of each approval

meeting; and

(c) Direct the respondent No.2 to disclose the reasoned

decision of the DCGI granting approval or rejecting an

application for emergency use authorization of vaccines

and the documents and reports submitted to the DCGI

in support of such application; and

(d) Direct the respondents to disclose the post

vaccination data regarding adverse events, vaccinees

who got infected with Covid, those who needed

hospitalization and those who died after such infection

post vaccination and direct the respondents to widely

publicize the data collection of such adverse event

through the advertisement of toll free telephone

numbers where such complaints can be registered; and

(e) Declare that vaccine mandates, in any manner

whatsoever, even by way of making it a precondition for

accessing any benefits or services, is a violation of

rights of citizens and unconstitutional; and

(f) Pass any other orders as this Hon'ble Court deems

fit.”

2.In the Writ Petition, the Petitioner highlighted the

adverse consequences of emergency approval of vaccines in

India, the need for transparency in publishing segregated

clinical trial data of vaccines, the need for disclosure of

clinical data, lack of transparency in regulatory approvals,

minutes and constitution of the expert bodies, imperfect

evaluation of Adverse Events Following Immunisation (AEFIs)

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and vaccine mandates in the absence of informed consent

being unconstitutional. The Petitioner further stated in the

Writ Petition that coercive vaccination would result in

interfering with the principle of informed self-determination

of individuals, protected by Article 21 of the Constitution of

India.

3.Notice was issued in the Writ Petition on 09.08.2021. An

additional affidavit was filed by the Petitioner on 03.09.2021

raising additional grounds. It was averred in the additional

affidavit that natural immunity is long-lasting and robust in

comparison to vaccine immunity and that vaccines do not

prevent infection or transmission of COVID-19. The Petitioner

further stated that vaccines are not effective in preventing

against infection from new variants of COVID-19. The

Petitioner relied on news articles on the fourth nationwide

serological survey conducted by Indian Council of Medical

Research (ICMR) in June and July, 2021, according to which

up to two-thirds of the Indian population above the age of 6

years had already been infected with COVID-19 and had

antibodies specific to the SARS-CoV-2 virus. The Petitioner

relied upon other news articles and research studies

conducted to state that there had been breakthrough

infections even amongst vaccinated people. Urging that

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research has shown that vaccinated people also transmit the

virus, the Petitioner contended that vaccine mandates are

meaningless.

4.The Petitioner filed an Interlocutory Application seeking

a direction to restrain all authorities and institutions, public

and private, from mandating the vaccine in any manner

whatsoever, on a precondition of accessing any service or on

pain of any penalty. The Petitioner has drawn the attention

of this Court to various restrictions that were placed by State

Governments, other employers and educational institutions

on unvaccinated individuals. The Petitioner contended that

mandating vaccination for access to resources, public places

and means of earning livelihood would be in violation of their

fundamental rights, especially so, when scientific studies

have shown that unvaccinated persons do not pose more

danger of transmission of the virus when compared to

vaccinated persons.

5.Respondent No. 1, the Union of India, has raised a

preliminary objection regarding the maintainability of the

Writ Petition. The Union of India has further contended that

the serious threat posed by the unprecedented pandemic

which had devastating effects on the entire world called for

emergency measures. It is accepted world over that

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vaccination for COVID-19 is necessary to avoid infection.

India was one of the few countries in the world which

succeeded in manufacturing vaccines for protection from

COVID-19, one of which was COVAXIN, India’s indigenous

vaccine and the other being COVISHIELD, which was

manufactured by Serum Institute of India with technology

transfer from AstraZeneca / Oxford University. The country

started one of the largest inoculation programmes in the

world in larger public interest, while tackling challenges of

vaccine hesitancy, effect of the second wave of the

pandemic and other such adverse circumstances. The Union

of India expressed serious doubts about the intention of the

Petitioner in filing this Writ Petition. As we have not seen the

end of the pandemic caused due to the COVID-19 virus, any

interference with the steps taken by the Union on the basis of

the advice given by the NTAGI and other expert bodies would

provide impetus to the already prevailing vaccine hesitancy

in certain sections of the society. In their counter-affidavit,

the Union of India reminded us that decisions of domain

experts should not normally be interfered with in judicial

review and that this Court should not sit in appeal over a

scientific process undertaken by domain experts on a subject

which is not the expertise of any judicial forum. The long-

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drawn procedure for making applications for issuance of

licenses for manufacturing vaccines and the statutory regime

governing the same have been referred to in the counter-

affidavit to emphasize that the Union of India has not been

remiss in grant of emergency licences. There is a detailed

procedure for approval with checks at every stage which has

been followed for grant of emergency approval. In so far as

disclosure of clinical trial data is concerned, the Union of

India referred to the National Ethical Guidelines for

Biomedical and Health Research involving Human

Participants published by the ICMR, which require privacy

and confidentiality of human participants to be maintained.

Accordingly, the Union of India contended that such details

pertaining to identity and records of the participants in the

clinical trial data cannot be disclosed to the public as per the

prevailing statutory regime. It was asserted by the Union of

India that the remaining data has already been made

available in the public domain.

6.On the subject of monitoring of AEFIs, the Union of India

brought to our attention established procedures and

protocols in place for surveillance of AEFIs established under

the National Adverse Event Following Immunisation

Surveillance Guideline. Further, the multi-tier structure

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comprising AEFI Committees at the state and national levels,

providing guidance, carrying out investigation and causality

assessment was elaborated upon. Details of the procedures

followed in accordance with globally accepted practices were

highlighted in the counter-affidavit. According to the Union

of India, all cases of serious and severe AEFI, including

reported deaths, are subjected to scientific and technical

review process with causality assessments done at the state

and national levels by trained experts to ascertain whether a

particular AEFI can be attributed to the vaccine. In the

counter-affidavit, it was also made clear that COVID-19

vaccination is voluntary and that the Government of India

encourages all individuals to take vaccination in the interest

of public health, as the individual’s ill health has a direct

effect on the society. It was also made clear that COVID-19

vaccination is not linked to any benefits or services.

7.Counter-affidavits have been filed by other

Respondents as well. The vaccine manufacturers, i.e.,

Respondents Nos. 4 and 5, have brought to the notice of this

Court that approval to their vaccines was granted after strict

compliance of the procedure prescribed. The States of Tamil

Nadu, Maharashtra, Delhi and Madhya Pradesh have also

filed counter-affidavits, justifying the restrictions that were

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placed on unvaccinated persons in public interest. The

details of the restrictions have been discussed later.

8.We have heard Mr. Prashant Bhushan, learned counsel

for the Petitioner, Mr. Tushar Mehta, learned Solicitor General

of the Union of India, Mr. S. Guru Krishnakumar, learned

Senior Counsel for Respondent No. 4, Mr. Amit Anand Tiwari,

learned Additional Advocate General for the State of Tamil

Nadu, Mr. Rahul Chitnis, learned counsel for the State of

Maharashtra, Ms. Mrinal Gopal Elker, learned counsel for the

State of Madhya Pradesh and Ms. Shyel Trehan, learned

counsel for Respondent No. 5.

Preliminary Issues

I. Maintainability

9.The learned Solicitor General raised a preliminary

objection as to the maintainability of the Writ Petition which

is filed in public interest. He stated that this Writ Petition, if

entertained, would harm public interest, as any observation

made by this Court against vaccination would result in

potential threat of vaccine hesitancy.

10. The Petitioner is a paediatrician, who was a member

of the NTAGI earlier. It has been stated in the Writ Petition

that he has a number of publications in internationally peer-

reviewed medical journals to his credit. The Petitioner

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strongly believes that there cannot be coercive vaccination,

especially of inadequately tested vaccines, which amounts to

an intrusion into the individual’s personal autonomy. He is

also of the firm opinion that an individual is deprived of the

opportunity to give informed consent in the absence of

availability of segregated data of clinical trials of the

vaccines. He has also aired further grievances pertaining to

poor evaluation and reporting of AEFIs.

11.This Court is entitled to entertain a public interest

litigation moved by a person having knowledge in the

subject-matter of the lis and, thus, having an interest therein,

as contradistinguished from a busybody, in the welfare of

people

1

. The Union of India has objected to the

maintainability of the Writ Petition on the ground that the

questions raised by the Petitioner may result in raising

doubts in the minds of the citizenry about the vaccination,

adding to the already existing vaccine hesitancy in the

country. The consequence would be a debilitating effect on

public health and therefore, the petition cannot be said to be

in public interest. In other words, the maintainability of the

Writ Petition is raised on the ground that the sensitive issue

of vaccination should not be dealt with by this Court, as it

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

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has the propensity of fuelling doubts about the efficacy of the

vaccines.

12.From the rejoinder affidavit submitted by the Petitioner,

we note that a petition had been filed by the Petitioner

earlier, during his tenure as a member of the NTAGI, with

respect to the Rotavac vaccine claiming that adequate data

from the clinical trials had not been provided to the NTAGI.

The rejoinder affidavit further states that the petition was

dismissed by this Court, on the ground that the Petitioner

could not have filed the said petition while being a member

of the NTAGI. The enthusiasm of the Petitioner in

approaching this Court has not gone unobserved. However,

as the issues raised by the Petitioner have a bearing on

public health and pertain to the fundamental rights of the

country’s populace, we are of the opinion that they warrant

due consideration by this Court. Therefore, we are not

inclined to entertain the challenge mounted by the Union of

India to the maintainability of the Writ Petition.

II. Judicial review of executive decisions based on expert

opinion

13.Yet another ground taken by the Union of India is that

this Court has to yield to executive decision and action in the

matter of administration of drugs / vaccines. The existence

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of any other possible view cannot enable this Court to

interfere in matters relating to opinion of domain experts by

sitting in appeal over such decisions, while adjudicating a

writ petition filed under Article 32 of the Constitution. The

learned Solicitor General supported the stand of the Union of

India with reference to the law laid down by this Court in

Academy of Nutrition Improvement v. Union of 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

Supreme Court of the United States (hereinafter, the “ US

Supreme Court ”) in Henning Jacobson v.

Commonwealth of Massachusetts

5

, Zucht v. King

6

and

in Docket No. 21A240 titled Joseph R. Biden v. Missouri

dated 13.01.2022 and the judgment of the Supreme Court of

New South Wales (hereinafter, the “NSW Supreme Court ”)

in Kassam v. Hazzard; Henry v. Hazzard

7

to bolster his

submissions that courts should not lightly interfere with

matters of policy concerning the safety and health of the

people and it is not the court’s function to determine the

2 (2011) 8 SCC 274

3 (2013) 6 SCC 620

4 (1990) 3 SCC 223

5 197 US 11 (1905)

6 260 US 174 (1922)

7 [2021] NSWSC 1320

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merits of the exercise of power by the executive. The

learned Solicitor General was joined by Mr. Amit Anand

Tiwari, learned Additional Advocate General for the State of

Tamil Nadu, in emphasising the limited scope of judicial

review in matters of policy framed on the basis of expert

opinion.

14.In opposition, the Petitioner argued that matters of

public importance involving invasion of fundamental rights of

individuals cannot be brushed aside by this Court on the

ground that they are beyond the jurisdiction of this Court.

This Court has a duty to safeguard the fundamental rights of

individuals and issues raised herein are of seminal

importance which ought to be decided after assessing the

relevant material placed before this Court by both sides. Mr.

Bhushan referred to the judgement of the High Court of New

Zealand in Ryan Yardley v. Minister for Workplace

Relations and Safety

8

in support of his submission that the

scientific data and evidence that was produced before the

High Court of New Zealand was assessed to adjudge the

efficacy of vaccines in preventing transmission of the COVID-

19 virus.

8 [2022] NZHC 291

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15.It was further argued by Mr. Bhushan that the

judgments relied upon by the Union of India are not

applicable to the facts of this case. He relied upon the

judgments of this Court in Delhi Development Authority

v. Joint Action Committee, Allottee of SFS Flats

9

,

Directorate of Film Festivals v. Gaurav Ashwin Jain

10

and an order of this Court in Distribution of Essential

Supplies and Services During Pandemic, In re

11

and

submitted that policy decisions taken by the executive are

not beyond the scope of judicial review, if they are manifestly

arbitrary or unreasonable.

16.Before examining the parameters of judicial review in

this case, it is profitable to refer to judgments from beyond

our borders which have dealt with the scope of judicial

review in matters relating to public health and vaccinations,

in particular. Compulsory vaccination against small pox was

the subject-matter of Jacobson (supra) decided in 1905. The

US Supreme Court was of the opinion that the mandate of

the local government for compulsory vaccination was binding

on every individual. The safety and health of the people has

to be protected by the government and the judiciary is not

9 (2008) 2 SCC 672

10 (2007) 4 SCC 737

11 (2021) 7 SCC 772

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competent to interfere with decisions taken in the interest of

public health. The Court can interfere by way of judicial

review of legislative action in matters of public health only

when there is no real or substantial relation to the object of

the legislation or when there is plain, palpable invasion of

rights secured by fundamental law and thereby, give effect

to the Constitution.

17.In the wake of the COVID-19 pandemic, restrictions on

attendance at religious services in areas classified as ‘red’ or

‘orange’ zones were imposed by an executive order issued

by the Governor of New York. The said restrictions were

challenged on the ground that they violate the free exercise

clause of the First Amendment of the Constitution of the

United States. By a majority of 6:3, the US Supreme Court in

Roman Catholic Diocese v. Cuomo

12

granted injunctive

relief on being satisfied that the executive order struck at the

very heart of the First Amendment’s guarantee of religious

liberty. While doing so, the US Supreme Court observed that

the members of the Court are not public health experts and

they should respect the judgment of those with special

expertise and responsibility in this area. However, the

Constitution cannot be put away and forgotten even in a

12 141 S. Ct. 63 (2020)

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pandemic. Gorsuch, J., who wrote a concurring opinion,

observed that Jacobson (supra) hardly supports cutting the

Constitution loose during a pandemic. Jacobson (supra)

was distinguished by Gorsuch, J., who held that the Court did

not interfere with the challenged law in Jacobson (supra)

only because it did not “contravene the Constitution of the

United States” or “infringe any right granted or secured by”

it. A word of caution sounded by Gorsuch, J. is to the effect

that the Court cannot stay out of the way in times of crisis,

when the Constitution is under attack. In his dissent,

Roberts, C.J. held that the injunction sought would not be in

public interest, especially when it concerns public health and

safety needs which calls for swift government action in

everchanging circumstances. He relied upon the earlier

order passed by the US Supreme Court in South Bay

United Pentecostal Church v. Newsom

13

wherein it was

recognised that courts must grant elected representatives

broad discretion when they undertake to act in areas fraught

with medical and scientific uncertainties.

18.Biden v. Missouri (supra) related to vaccine mandates

for healthcare providers. The Secretary of Health and Human

Services issued a rule on being convinced that vaccination of

13 140 S. Ct. 1613 (2020)

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healthcare workers in facilities in the Medicare and Medicaid

Programs against COVID–19 was “ necessary for the health

and safety of individuals to whom care and services are

furnished”. The said rule was challenged and the US District

Courts for the Western District of Louisiana and the Eastern

District of Missouri each entered preliminary injunctions

against its enforcement. The appeals filed against the said

injunction were rejected by the Fifth Circuit in Louisiana and

the Eighth Circuit in Missouri. Aggrieved thereby, the

Government moved the US Supreme Court seeking for a stay

on the preliminary injunctions passed by the US District

Courts. While granting stay of the preliminary injunctions,

by its plural opinion the US Supreme Court held that the role

of courts in reviewing decisions taken by the executive

should be to ensure that the executive “has acted within a

zone of reasonableness”.

19.Having been aggrieved by certain orders of the Minister

for Health and Medical Research that required people

working in the construction, aged care and education sectors

to be compulsorily vaccinated, Al-Munir Kassam and three

others, along with Natasha Henry and five others,

approached the NSW Supreme Court challenging the

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constitutional validity of the decision. While considering the

grounds of challenge, the NSW Supreme Court in Kassam v.

Hazzard (supra) was of the view that “it is not the Court’s

function to determine the merits of the exercise of the power

by the Minister to make the impugned orders, much less for

the court to choose between plausible responses to the risks

to the public health posed by the Delta variant”. The NSW

Supreme Court further observed that it is not the court’s

function to conclusively determine the effectiveness of some

of the alleged treatments for those infected or the

effectiveness of COVID-19 vaccines, especially their capacity

to inhibit the spread of the disease, which are all matters of

merits, policy and fact for the decision maker and not the

court. The NSW Supreme Court emphasised that its only

function is to determine the legal validity of the impugned

orders. The said view of the NSW Supreme Court was

approved by the New South Wales Court of Appeal in

Kassam v. Hazzard; Henry v. Hazzard

14

.

20.The Minister for Workplace Relations and Safety passed

COVID-19 Public Health Response (Specified Work

Vaccinations) Order 2021, by which it was determined that

work carried out by certain police and defence force

14 [2021] NSWCA 299

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personnel could only be undertaken by workers who have

been vaccinated. Three police and defence force workers

who did not wish to be vaccinated sought judicial review of

the said order before the High Court of New Zealand

(hereinafter, the “NZ High Court”). While adjudicating the

dispute, the NZ High Court in Ryan Yardley (supra)

expressed its opinion that the choices made by governments

on their response to COVID-19 involve wide policy questions,

including decisions on the use of border closures, lockdowns,

isolation requirements, vaccine mandates and many other

measures, which are decisions for the elected

representatives to make. The NZ High Court made it clear

that the Court addresses narrower legal questions and the

Court’s function is not to address the wider policy questions.

While referring to the evidence of experts, the NZ High Court

stressed on the institutional limitations on the Court’s ability

to reach definitive conclusions but clarified that the Court

must exercise its constitutional responsibility to ensure that

decisions are made lawfully. While relying upon a judgment

of the Court of Appeal of New Zealand in Ministry of Health

v. Atkinson

15

, the NZ High Court held that the Crown has

the burden to demonstrate that a limitation of a fundamental

15 [2012] NZCA 184

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right is demonstrably justified. We have come to know that

in the time since the judgment in this matter was reserved,

the decision of the NZ High Court in Ryan Yardley (supra)

has been appealed by the Government of New Zealand

before the New Zealand Court of Appeal.

21.We shall now proceed to analyse the precedents of this

Court on the ambit of judicial review of public policies

relating to health. It is well settled that the Courts, in

exercise of their power of judicial review, do not ordinarily

interfere with the policy decisions of the executive unless the

policy can be faulted on grounds of mala fide,

unreasonableness, arbitrariness or unfairness etc. Indeed,

arbitrariness, irrationality, perversity and mala fide will

render the policy unconstitutional

16

. It is neither within the

domain of the courts nor the scope of judicial review to

embark upon an enquiry as to whether a particular public

policy is wise or whether better public policy can be evolved.

Nor are the courts inclined to strike down a policy at the

behest of a petitioner merely because it has been urged that

a different policy would have been fairer or wiser or more

scientific or more logical

17

. Courts do not and cannot act as

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

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appellate authorities examining the correctness, suitability

and appropriateness of a policy, nor are courts advisors to

the executive on matters of policy which the executive is

entitled to formulate. The scope of judicial review when

examining a policy of the Government is to check whether it

violates the fundamental rights of the citizens or is opposed

to the provisions of the Constitution, or opposed to any

statutory provision or manifestly arbitrary

18

.

22.This Court in a series of decisions has reiterated that

courts should not rush in where even scientists and medical

experts are careful to tread. The rule of prudence is that

courts will be reluctant to interfere with policy decisions

taken by the Government, in matters of public health, after

collecting and analysing inputs from surveys and research.

Nor will courts attempt to substitute their own views as to

what is wise, safe, prudent or proper, in relation to technical

issues relating to public health in preference to those

formulated by persons said to possess technical expertise

and rich experience

19

. Where expertise of a complex nature

is expected of the State in framing rules, the exercise of that

power not demonstrated as arbitrary must be presumed to

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

20 | P a g e

be valid as a reasonable restriction on the fundamental right

of the citizen and judicial review must halt at the frontiers.

The Court cannot re-weigh and substitute its notion of

expedient solution. Within the wide judge-proof areas of

policy and judgment open to the government, if they make

mistakes, correction is not in court but elsewhere. That is

the comity of constitutional jurisdictions in our jurisprudence.

We cannot evolve a judicial policy on medical issues. All

judicial thought, Indian and Anglo-American, on the judicial

review power where rules under challenge relate to a

specialised field and involve sensitive facets of public

welfare, has warned courts of easy assumption of

unreasonableness of subordinate legislation on the strength

of half-baked studies of judicial generalists aided by the ad-

hoc learning of counsel. However, the Court certainly is the

constitutional invigilator and must act to defend the citizen in

the assertion of his fundamental rights against executive

tyranny draped in disciplinary power.

20

23.There is no doubt that this Court has held in more than

one judgment that where the decision of the authority is in

regard to a policy matter, this Court will not ordinarily

interfere since decisions on policy matters are taken based

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

21 | P a g e

on expert knowledge of the persons concerned and courts

are normally not equipped to question the correctness of a

policy decision. However, this does not mean that courts

have to abdicate their right to scrutinise whether the policy

in question is formulated keeping in mind all the relevant

facts and the said policy can be held to be beyond the pale of

discrimination or unreasonableness, bearing in mind the

material on record.

21

In Delhi Development Authority

(supra), this Court held that an executive order termed as a

policy decision is not beyond the pale of judicial review.

Whereas the superior courts may not interfere with the nitty-

gritty of the policy, or substitute one by the other but it will

not be correct to contend that the court shall lay its judicial

hands off, when a plea is raised that the impugned decision

is a policy decision. Interference therewith on the part of

the superior court would not be without jurisdiction as it is

subject to judicial review. It was further held therein that the

policy decision is subject to judicial review on the following

grounds:

a)if it is unconstitutional;

b)if it is dehors the provisions of the Act and the

regulations;

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

22 | P a g e

c)if the delegatee has acted beyond its power of

delegation;

d)if the executive policy is contrary to the statutory or a

larger policy.

24.During the second wave of COVID-19 pandemic, this

Court in Distribution of Essential Supplies & Services

during Pandemic (supra), to which one of us was a party (L

Nageswara Rao, J.), dealt with issues of vaccination policy,

pricing and other connected issues. While doing so, this

Court held that policy-making continues to be the sole

domain of the executive and the judiciary does not possess

the authority or competence to assume the role of the

executive. It was made clear that the Court cannot second

guess the wisdom of the executive when it chooses between

two competing and efficacious policy measures. However, it

continues to exercise jurisdiction to determine if the chosen

policy measure conforms to the standards of reasonableness,

militates against manifest arbitrariness and protects the right

to life of all persons.

25. There can be no ambiguity in the principles of law

relating to judicial review laid down by this Court. A perusal

of the judgments referred to above would clearly show that

this Court would be slow in interfering with matters of policy,

23 | P a g e

especially those connected to public health. There is also no

doubt that wide latitude is given to executive opinion which

is based on expert advice. However, it does not mean that

this Court will not look into cases where violation of

fundamental rights is involved and the decision of the

executive is manifestly arbitrary or unreasonable. It is true

that this Court lacks the expertise to arrive at conclusions

from divergent opinions of scientific issues but that does not

prevent this Court from examining the issues raised in this

Writ Petition, especially those that concern violation of Article

21 of the Constitution of India.

26. Identifying the issues in the present matter, they can

be divided as follows:

I.Vaccine mandates being violative of Article 21 of the

Constitution of India.

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

domain.

III.Improper collection and reporting of AEFIs.

IV.Vaccination of children.

I. Vaccine Mandates

A. Submissions

27.Mr. Bhushan submitted that there is nothing wrong in

the Government encouraging the people to get vaccinated.

However, coercive vaccination from the pain of denial of

essential services is plainly unconstitutional, being violative

24 | P a g e

of the principle of bodily autonomy and the right to access

one’s means of livelihood. Though the Union of India has

made a categorical submission that vaccines are voluntary,

the State Governments have been placing restrictions on

unvaccinated people by denying them access to public

places and services. He referred to: (i) an order passed by

the Government of NCT of Delhi on 08.10.2021 by which

government employees, including frontline workers and

healthcare workers, as well as teachers and staff working in

schools and colleges were not to be allowed to attend their

respective offices and institutions without the first dose of

vaccination with effect from 16.10.2021; (ii) a directive

issued by the Government of Madhya Pradesh on 08.11.2021

stating that it was mandatory to be vaccinated with two

doses of the vaccine to get food grains at fair price shops;

(iii) an order passed by the Government of Maharashtra

dated 27.11.2021 requiring persons to be fully vaccinated if

they are connected with any program, event, shop,

establishment, mall and for utilising public transport; (iv) an

order issued by the Government of Tamil Nadu dated

18.11.2021 permitting only vaccinated people into open,

public places, schools, colleges, hostels, boarding houses,

factories and shops; and other instances where students in

25 | P a g e

the age group of 15 to 18 years were not permitted to appear

for their examinations without being vaccinated.

28. Mr. Bhushan contended that there is need to balance

individuals’ rights with public interest concerning health.

According to him, vaccine mandates can be on the basis of

efficacy and safety of vaccination and prevention of

transmission. He submitted that there is sufficient evidence

to the effect that natural immunity acquired from a COVID-19

infection is long-lasting and robust in comparison to vaccine

immunity. Studies also indicate that vaccines do not prevent

infection from the virus or transmission amongst people.

Vaccines are also ineffective in preventing infection from new

variants. According to serological studies, 75 per cent of the

Indian population has already been infected and is

seropositive and, therefore, they have better immunity to

infection than what is provided by the vaccines. The

vaccines which are being administered in this country are

only authorised for emergency use and the procedure for

clinical trials of such vaccines has not been fully complied

with. In view of the lack of transparency in disclosure of trial

data resulting in absence of informed consent, any vaccine

mandate would be unconstitutional. Mr. Bhushan contended

that every individual has personal autonomy and cannot be

26 | P a g e

forced to be vaccinated against his will. For the said

proposition, he relied on the judgments of Common Cause

(A Registered Society) v. Union of India

22

, Aruna

Ramachandra Shanbaug v. Union of India

23

and K. S.

Puttaswamy v. Union of India

24

. Imposing restrictions on

the rights of persons who are unvaccinated is totally

unwarranted as there is no basis for discriminating against

unvaccinated persons. He relied upon scientific studies,

opinions of experts and news articles to contend that

vaccinated people are also prone to infection and there is no

difference between a vaccinated individual and an

unvaccinated person with respect to transmission of the

virus. As there is no serious threat of spread of the virus by

an unvaccinated person in comparison to a vaccinated

person, placing restrictions on unvaccinated persons is

meaningless.

29.Per contra, the learned Solicitor General of India

contended that more than 180 crore doses had been

administered, resulting in a substantial number of individuals

in the country being vaccinated. He submitted that the

vaccines have proved to be effective and safe and any

indulgence by this Court would result in vaccine hesitancy.

22 (2018) 5 SCC 1

23 (2011) 4 SCC 454

24 (2017) 10 SCC 1

27 | P a g e

The Government had taken extra care to appoint various

committees to examine the efficacy, safety, immunogenicity,

pharmacodynamics of the vaccines before granting

approvals. Some of the material placed before this Court to

bolster the Union of India’s submissions have been listed

below:

(a)‘Science Brief: SARS-CoV-2 Infection-induced and

Vaccine-induced immunity’ of the United States Centers

for Disease Control and Prevention (CDC) updated as on

29.10.2021, which in its conclusion states that:

“Numerous immunologic studies and a growing number

of epidemiologic studies have shown that vaccinating

previously infected individuals significantly enhances

their immune response and effectively reduces the risk

of subsequent infection, including in the setting of

increased circulation of more infectious variants.

Although the Delta variant and some other variants have

shown increased resistance to neutralization by both

post-infection and post-vaccination sera in laboratory

studies, observed reduction in effectiveness has been

modest, with continued strong protection against

hospitalization, severe disease and death.”

28 | P a g e

(b)A study conducted by researchers of Christian Medical

College, Vellore

25

, wherein it has been concluded as

follows: “Among symptomatic COVID-19 patients, prior

vaccination with either Covishield™ or Covaxin®

impacted the severity of illness and reduced mortality

when compared with unvaccinated patients. Full

vaccination conferred a substantially higher protective

effect over partial vaccination.” The results of the study

also indicate that compared with unvaccinated patients,

partially vaccinated patients had milder disease, reduced

requirement of oxygen, hospital admission, ICU

admission and mortality. Again, when fully vaccinated

patients were compared with unvaccinated individuals,

full vaccination was associated with significantly less

disease severity, requirement of respiratory supports,

hospital admission, ICU admission and mortality. The

study further showed that majority of the patients

screened who required hospitalisation were

unvaccinated.

25 Abhilash, Kundavaram Paul Prabhakar et al. “Impact of prior vaccination with

CovishieldTM and Covaxin® on mortality among symptomatic COVID-19 patients

during the second wave of the pandemic in South India during April and May 2021: a

cohort study.” Vaccine vol. 40,13 (2022): 2107-2113

29 | P a g e

(c)A study conducted by researchers of All India Institute of

Medical Sciences (AIIMS), New Delhi

26

, which states that:

“We evaluated the association between COVID-19

vaccination status (the number of vaccine shots received

and time interval since the last dose) and the vaccines’

clinical efficacy in India in preventing the disease and its

severity. This study has several noteworthy findings.

Firstly, both the Indian vaccines provided a significant

protective role in preventing the disease among people

who had a clinical suspicion of COVID-19. Secondly,

These vaccines protected from progression to a severe

form of the disease among the patients who turned RT-

PCR positive despite getting vaccinated. The probability

of hospitalisation was about eight times less, and ICU

admission/death was about fourteen times lesser among

fully vaccinated patients in comparison to unvaccinated

RT-PCR positive patients. Thirdly, the protective efficacy

of the vaccines had a dose-dependent effect. The

effectiveness is maximum among individuals who

26 Aakashneel Bhattacharya, Piyush Ranjan, Tamoghna Ghosh, Harsh Agarwal, Sukriti

Seth, Ganesh Tarachand Maher, Ashish Datt Upadhyay, Arvind Kumar, Upendra Baitha,

Gaurav Gupta, Bindu Prakash, Sada Nand Dwivedi, Naveet Wig “Evaluation of the dose-

effect association between the number of doses and duration since the last dose of

COVID-19 vaccine, and its efficacy in preventing the disease and reducing disease

severity: A single centre, cross-sectional analytical study from India” Diabetes &

Metabolic Syndrome: Clinical Research & Reviews Volume 15, Issue 5 (2021), 102238

30 | P a g e

received both doses of vaccination at least two weeks

before the onset of their symptoms.”

(d)A study conducted by researchers of AIIMS, Patna

27

,

which concludes as follows: “COVID-19 vaccination was

found to be effective in infection prevention. One out of

two and four out of five individuals were found to be

protected against SARS-CoV-2 infection following partial

and full vaccination, respectively. The vaccinated

individuals had lesser LOS compared to unvaccinated

ones. Additionally, the fully vaccinated individuals were

less likely to develop severe disease.” LOS herein refers

to the length of hospital stays.

30.On behalf of the State of Tamil Nadu, Mr. Amit Anand

Tiwari, learned Additional Advocate General, submitted that

the restrictions placed by way of the circular dated

18.11.2021 are within the competence of the State in

exercise of its powers under the Disaster Management Act,

2005 (hereinafter, the “DM Act”) and the Tamil Nadu Public

Health Act, 1939. Section 76(2)(b) thereof empowers the

State Government to make vaccinations compulsory, in the

event of a declaration by the Government of an outbreak of a

27 Singh C, Naik BN, Pandey S, et al. “Effectiveness of COVID-19 vaccine in preventing

infection and disease severity: a case-control study from an Eastern State of India.”

Epidemiology and Infection. 2021;149:e224

31 | P a g e

notified disease. He submitted that the restrictions placed

by the circular dated 18.11.2021 are in larger public interest

and cannot be said to be unreasonable restrictions, as these

were an essential facet of the precautionary approach

adopted by the State of Tamil Nadu in dealing with the

unprecedented pandemic. According to Mr. Tiwari, these

restrictions were in furtherance of the State realising the

importance of curtailing the spread of COVID-19. The

unchecked spread of the virus could lead to further

dangerous mutations. While referring to opinions of experts

in the field of health, including that of the World Health

Organization (WHO), the United Nations International

Children’s Emergency Fund (UNICEF) and the Oxford Vaccine

group, as well as scientific studies published in the New

England Journal of Medicine, the Lancet and the International

Journal of Scientific Studies, it was submitted on behalf of the

State of Tamil Nadu that vaccination prevents severe disease

and significantly reduces hospitalisation and mortality and

that vaccines continued to be highly effective in preventing

severe disease and death. The measures were justified on

the ground that they were not only aimed for the safety of a

particular individual but also served a greater purpose of

ensuring safety of the community at large.

32 | P a g e

31.Mr. Rahul Chitnis, learned counsel appearing for the

State of Maharashtra, referred to the information provided by

the WHO to contend that vaccines save infected individuals

from “life threatening complications, … and consequential

untimely death” and therefore, vaccine mandate issued by

the State of Maharashtra is in the interest of general public.

The restrictions that are imposed are reasonable and cannot

be said to “manifestly arbitrary” as they are issued only for a

temporary period with exclusions and are reviewed

periodically by the State to assess if relaxations can be

granted. He submitted that there is no compulsion to get

vaccinated, however, in view of the serious threat that not

being vaccinated poses to the right of life and personal

liberty of the larger population, certain unavoidable

restrictions have been imposed, especially given that strict

adherence to social distancing and masking is significantly

compromised in bigger cities.

32.The complaint of the Petitioner in relation to prevention

of access to essential resources in the State of Madhya

Pradesh pertains to ration not being provided to

unvaccinated persons through the public distribution system.

We were informed by the learned counsel for the State of

33 | P a g e

Madhya Pradesh that the order dated 08.11.2021, by which

vaccination was made mandatory for receiving ration from

fair price shops, was not implemented and was eventually

withdrawn on 07.01.2022.

33.In the counter-affidavit filed on behalf of the

Government of NCT of Delhi, it was submitted that the order

dated 08.10.2021 was issued by the Delhi Disaster

Management Authority after due application of mind, to

control the spread of COVID-19 and mitigate its effects.

Under Section 6(2)(i) of the DM Act, the National Disaster

Management Authority has been issuing orders from time to

time directing State Governments and Union Territories,

amongst other authorities, to take effective measures to

prevent the spread of COVID-19, and in furtherance of this,

also permitted States to impose further local restrictions.

The Delhi Disaster Management Authority, in a meeting held

on 29.09.2021, decided to ensure 100 per cent vaccination of

all Government employees, frontline workers, healthcare

workers as well as teachers and staff working in schools and

colleges, on the advice of medical and other experts. It was

considered necessary as these individuals have frequent

interaction with the general public and vulnerable sections of

the society and therefore, pose greater risk of spreading the

34 | P a g e

virus. While an individual may have a right to decide

against getting vaccinated, the State, however, has a

statutory duty to regulate the interaction of unvaccinated

persons within the society in the interest of public health.

34.In his rejoinder, Mr. Bhushan, while reiterating his

submissions, took exception to the contradictory stand taken

by the Union of India on COVID-19 vaccination being

voluntary and not mandatory. On one hand, the Union of

India made it clear in the counter-affidavit that vaccination is

voluntary and on the other, a series of advisories and

material had been filed by the Union of India, supporting the

claim of vaccination being mandatory. Mr. Bhushan

submitted that the Union of India has not provided any

material to the Court contrary to what has been supplied by

the Petitioner furthering his scientific and legal contention

that unvaccinated people pose no greater danger than

vaccinated individuals in the matter of transmission of the

COVID-19 virus, and therefore, there is no public health

rationale in vaccine mandates. In addition to the various

points raised in his submissions, the learned counsel for the

Petitioner relied upon the opinion of Dr. Aditi Bhargava, who

is a professor at University of California, San Francisco and a

molecular biologist with 33 years of research experience,

35 | P a g e

from her presentation made before the US Senate on

02.11.2021. Her opinion is to the effect that vaccines do not

prevent infection and transmission. She is of the further

belief that natural immunity is the gold standard. According

to Dr. Bhargava, there has been no documented case of a

naturally immune person getting reinfected with severe

disease or hospitalised, despite the first case reported nearly

two years ago, whereas, there have been thousands of cases

of severe infection, hospitalisation, and deaths in fully

vaccinated people. Mr. Bhushan concluded by submitting

that any restrictions placed on personal autonomy of

individuals would be violative of Article 21, unless the criteria

laid down in K. S. Puttaswamy (supra) is met.

B. Evolution of COVID-19 and vaccines

35.COVID-19 emerged in late 2019. The WHO officially

declared the novel coronavirus outbreak as a pandemic on

11.03.2020. The virus was detected in the country in the

last week of January, 2020 and spread rapidly. As the threat

of infections from the virus loomed large, an unprecedented

national lockdown was announced on 24.03.2020, which

extended for a few months, with restrictions being removed

thereafter in a phased manner. India was not alone in this;

36 | P a g e

several countries imposed lockdowns to arrest the spread of

the deadly disease, which has led to a drastic loss of human

life worldwide and presented a threat of extraordinary

proportions to public health, food systems, economic and

social conditions. Scientific studies and research for

manufacture of vaccines to prevent severe infections were

undertaken on an emergency basis. Towards the end of

2020, emergency vaccines came to be administered in the

western part of the world. However, by then, the spread of

COVID-19 around the globe was considerable. Around the

same period, a variant called B.1.1.7 was found in the United

Kingdom. The said variant was renamed as Alpha, as per the

naming scheme recommended by the expert group

convened by the WHO, which also includes scientists from

the WHO’s Technical Advisory Group on Virus Evolution (TAG-

VE). Another variant, called B.1.351 and later renamed as

Beta, was found to be linked to a second wave of infections

in South Africa. Both these variants were identified as

Variants of Concern (VOC) by the WHO on 18.12.2020,

meaning that they were variants with genetic changes that

would affect virus characteristics such as transmissibility,

disease severity or immune escape and through a

comparative assessment, are found to be associated with an

37 | P a g e

increase of transmission or increase in virulence or decrease

in effectiveness of public health measures such as vaccines,

therapeutics etc. Soon thereafter, the highly transmissible

variant called Gamma was found in Brazil and was identified

as a VOC by the WHO on 11.01.2021.

28

36. In the first half of 2021, the Delta variant was identified

as the predominant variant in India and was believed to be

60 per cent more transmissible than the Alpha variant.

Thereafter, Delta rapidly spread beyond the borders to other

countries. Another variant, Omicron, surfaced in November,

2021, whose spread was much more accelerated than earlier

variants, including that of Delta. On the basis of the

evidence available as on 21.01.2022, the WHO was of the

opinion that the Omicron has a significant growth advantage

over Delta, leading to rapid spread in the community with

higher levels of incidence than previously seen in the

pandemic. It was further observed that despite a lower risk

of severe disease and death following infection, the very high

levels of transmission nevertheless have resulted in

significant increases in hospitalisation and continue to pose

overwhelming demands on health care systems in most

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)

38 | P a g e

countries. It was found that because of the 26-32 mutations

that it has in the spike protein, Omicron has infected even

those who have been previously infected or vaccinated.

29

Though the infections and transmission from Omicron at

present within the country are not as serious as they were in

the first two months of 2022, expert opinion is to the effect

that Omicron might not be the last of the variants, as we

have since witnessed.

37. The WHO established the Technical Advisory Group on

COVID-19 Vaccine Composition (TAG-CO-VAC) in September,

2021. According to the statement made by the said group on

11.01.2022 in the context of circulation of the Omicron

variant, the group reviews and assesses the public health

implications of emerging VOCs on the performance of COVID-

19 vaccines and provides recommendations on COVID-19

vaccine composition. The said group is developing a

framework to analyse the evidence on emerging VOCs in the

context of criteria that would trigger a recommendation to

change COVID-19 vaccine strain composition and will advise

the WHO on updated vaccine compositions, as required. The

group has spelt out in their statement that at present, with

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)

39 | P a g e

the available COVID-19 vaccines, the focus is on reducing

severe disease and death, as well as protecting health

systems. According to the TAG-CO-VAC, vaccines, which

have received WHO Emergency Use Listing across several

vaccine platforms, provide a high level of protection against

severe disease and death caused by VOCs. The group takes

note of data which indicates that vaccine effectiveness will

be reduced against symptomatic disease caused by the

Omicron variant but at the same time, it was of the opinion

that protection against severe disease is more likely to be

preserved. Along with the Strategic Advisory Group of

Experts on Immunization (SAGE) and its Working Group on

COVID-19 vaccines, TAG-CO-VAC has recommended COVID-

19 vaccines for priority populations worldwide to provide

protection against severe disease and death globally and, in

the longer term, to mitigate the emergence and impact of

new VOCs by reducing the burden of infection.

30

38.With the outbreak of the devastating pandemic, as

many as 5,23,843 lives have been lost in this country, as per

the latest data available on the website of the Ministry of

30 Interim Statement on COVID-19 vaccines in the context of the circulation of the

Omicron SARS-CoV-2 Variant from the WHO Technical Advisory Group on COVID-19

Vaccine Composition (TAG-CO-VAC), 11.01.2022, available at

https://www.who.int/news/item/11-01-2022-interim-statement-on-covid-19-vaccines-in-

the-context-of-the-circulation-of-the-omicron-sars-cov-2-variant-from-the-who-

technical-advisory-group-on-covid-19-vaccine-composition (last accessed on

01.05.2022)

40 | P a g e

Health and Family Welfare (MoHFW). Initially, efforts made

by the Government of India were to protect people by

arresting serious infection. With treatment protocol and

clinical management protocol for COVID-19 being revised

periodically as more and more data and research on the virus

came to be known, persons affected by the virus were

treated with the information that was available at the point.

Using whatever little was known about the virus in the initial

stages, dedicated efforts have been made to save countless

lives in this country. With the approval of vaccines on an

emergency basis in January, 2021, there was some hope

about preventing infections from the virus. Inoculation,

which commenced slowly in view of the non-availability of

sufficient doses of vaccines, gained pace with the increase in

manufacture by Respondent Nos. 4 and 5. With the

Government embarking upon extensive awareness drives

encouraging vaccination, more than 189 crore doses of

vaccine have been administered within the country till date,

as per the data available on the website of the MoHFW.

39.With the introduction of vaccines, it was understood

that vaccines would aid in preventing infections. To protect

their populace from infection, countries worldwide promoted

41 | P a g e

vaccination as, needless to say, an uninfected person will not

transmit the disease. Thereafter, with the mutation of the

virus eventually resulting in multiple VOCs, breakthrough

infections were noticed. Vaccinated people were found to be

infected with the virus and could also act as carriers,

transmitting the virus to others. Even in such a situation,

there is no question of whether vaccination for COVID-19

should be continued. The recommendations of the WHO’s

TAG-CO-VAC and SAGE make it amply clear that vaccines,

which have received emergency use approvals, provide

strong protection against serious illness, hospitalisation and

death and getting vaccinated is one of the most crucial steps

towards protecting oneself from COVID-19, stopping new

variants from emerging and helping end the pandemic. It

should be noted that the advice of the WHO with respect to

COVID-19 has been consistent since the time vaccines

became available, even after recognising that it was still

possible to get infected and spread the infection to others

despite being vaccinated, as is evident from the latest

version of the WHO’s ‘COVID-19 advice for the public:

Getting vaccinated’ as of 13.04.2022

31

. The Union of India

has placed considerable material on record in terms of

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

2019/covid-19-vaccines/advice (last accessed on 01.05.2022)

42 | P a g e

scientific briefs and published studies which stand testimony

to the significance of vaccination as a crucial public health

intervention in this pandemic and its continued benefits to

individual health as well as public health infrastructure.

Vaccination of a majority of the population of this country has

undoubtedly been instrumental in preventing severe disease,

hospitalisation and deaths, and benefited the community at

large, especially those members with co-morbidities, the

elderly and sick persons. Even the Petitioner is not opposed

to the vaccination programme and does not challenge the

vaccination drive of the Government of India, as has been

reiterated by him during the course of his arguments.

Exception to the vaccination programme taken by the

Petitioner is only to coercive vaccination through vaccine

mandates, which place unjustifiable restrictions on those who

wish to not be vaccinated.

40. In light of the virulent mutations of the COVID-19 virus

and advice of experts from the WHO as well as common

findings of several studies on this subject, the vaccination

drive that is being undertaken by the Government of India in

the interest of public health cannot be faulted with.

C. Personal autonomy and public health

43 | P a g e

41. Before dealing with the issue of coercive vaccination, it

is necessary to consider whether the right of privacy of

individuals can override public health, more so, when the

submission on behalf of the Respondents is that steps taken

to restrict the rights of individuals are in the larger interest of

public health. It is true that to be vaccinated or not is

entirely the choice of the individual. Nobody can be

forcefully vaccinated as it would result in bodily intrusion and

violation of the individual’s right to privacy, protected under

Article 21 of the Constitution of India. Personal autonomy

was read into Article 21 by this Court in Common Cause

(supra), by placing reliance on National Legal Services

Authority v. Union of India

32

, and Aruna Ramachandra

Shanbaug (supra). This Court, in Common Cause (supra),

emphasized the right of an individual to choose how he

should live his own life, without any control or interference by

others. It recognised the right of an individual to refuse

unwanted medical treatment and to not be forced to take

any medical treatment that is not desired. In view of the

categoric statement of the Union of India that vaccination of

COVID-19 is voluntary, the question of any intrusion into

bodily integrity does not arise for consideration in this case.

32 (2014) 5 SCC 438

44 | P a g e

However, the Petitioner has asserted that limitations placed

on access to public places and public resources for

unvaccinated persons result in coercive vaccination, and

therefore, limit the right of unvaccinated persons to refuse

medical treatment.

42. Disclosure of data of a patient suffering from AIDS was

the subject matter of a decision of this Court in X v.

Hospital ‘Z’

33

. Placing reliance on Kharak Singh v State

of U.P.

34

, Gobind v. State of M.P.

35

and a judgment of the

US Supreme Court in Jane Roe v. Henry Wade

36

, this Court

held that though non-disclosure of medical information of an

individual can be traced to the right to privacy protected

under Article 21, it is not absolute and is subject to action

lawfully taken for protection of health or morals or protection

of rights and freedoms of others.

43.In Association of Medical Super Speciality

Aspirants and Residents v. Union of India

37

, to which

one of us was a party (L Nageswara Rao, J.), this Court, while

considering validity of service bonds to be executed at the

time of admission to postgraduate and superspeciality

courses in medical science, held as follows:

33 (1998) 8 SCC 296

34 (1964) 1 SCR 332

35 (1975) 2 SCC 148

36 410 US 113 (1973)

37 (2019) 8 SCC 607

45 | P a g e

“33. The above discussion leads us to the conclusion

that right to life guaranteed by Article 21 means right to

life with human dignity. Communitarian dignity has been

recognised by this Court. While balancing communitarian

dignity vis-à-vis the dignity of private individuals, the

scales must tilt in favour of communitarian dignity. The

laudable objective with which the State Governments

have introduced compulsory service bonds is to protect

the fundamental right of the deprived sections of the

society guaranteed to them under Article 21 of the

Constitution of India. The contention of the appellants

that their rights guaranteed under Article 21 of the

Constitution of India have been violated is rejected.”

44.Strong reliance was placed by the Petitioner on the

judgment of the High Court of New Zealand in Ryan Yardley

(supra). The principal contention of the applicants therein

was that the impugned order, requiring police and defence

force personnel to be vaccinated, placed unjustified

limitation on the rights protected by the New Zealand Bill of

Rights Act 1990 (hereinafter, the “NZ Bill of Rights”),

particularly the right to refuse to undergo medical treatment,

the right to manifest religion, the right to be free from

discrimination and other rights under Section 28 of the said

Act (including the right to work, and of minority groups to

enjoy their culture and practice their religion). The purpose of

46 | P a g e

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 potential

adverse effects of the COVID-19 outbreak (whether

direct or indirect); and

(b) ensure continuity of services that are essential for

public safety, national defence, or crisis response; and

(c) maintain trust in public services.”

45.Considering the submissions of the applicants therein

that the order placed unjustified limitations on fundamental

rights protected by the NZ Bill of Rights, the NZ High Court

held that the impugned order limits the right of affected

workers to refuse to undergo a medical treatment as well as

the right (or significant interest) to retain employment. While

examining the question of whether the limitation of the said

rights was justified, the NZ High Court noted that the order

mandating vaccinations for the police and defence personnel

was imposed to ensure the continuity of services that are

essential for public safety, national defence, or crisis

response, and to promote public confidence in those

services, rather than to stop the spread of COVID-19. The

NZ High Court further took note of the fact that by October,

2021, 83.1 per cent of police personnel had received at least

one or more doses of the vaccination, and 70.1 per cent had

received both doses. By the time the order took effect on

47 | P a g e

17.01.2022, there were only 164 unvaccinated staff

members in an overall workforce of 15,682 staff. It was

found that the position within the New Zealand Defence

Forces (NZDF) was similar. From a total of 15,480 NZDF

personnel, 3,048 are civil staff. As on 01.02.2022, 99.2 per

cent of the regular forces were fully vaccinated, leaving aside

75 members and 98.7 per cent of the civil staff were fully

vaccinated, leaving 40 who were not. The NZ High Court

was of the view that the relatively low number of

unvaccinated police and NZDF personnel impacted by the

order may not, by itself, mean that the order was not a

reasonable limit on rights that can be demonstrably justified,

if there was evidence to establish that the presence of

unvaccinated personnel, even in small numbers, created a

materially higher risk to the remaining workforce. While

observing that the evidence on this issue is sparse, the NZ

High Court referred to the evidence of Dr. Petrovsky, who

deposed that vaccination has potential benefit in reducing

the severity of disease, even with the Omicron variant.

However, in his view, mandatory vaccination did not assist in

preventing workers in affected roles from contracting COVID-

19, or transmitting it to others. The NZ High Court further

considered the evidence of Dr. Town, the Ministry’s Chief

48 | P a g e

Science Adviser, who, according to the NZ High Court, did not

directly respond to Dr. Petrovsky’s analysis of the

effectiveness of the vaccine to inhibit the spread of COVID-19

in a workforce, but instead provided his more generalised

opinions. In his evidence, Dr. Town stated that vaccines

show reduced effectiveness compared with Delta in terms of

becoming infected with and transmitting Omicron.

46.After weighing the evidence, the NZ High Court was of

the view that vaccination may still be effective in limiting

infection and transmission, but at a significantly lower level

than was the case with the earlier variants. It was further

concluded that vaccination does not prevent persons

contracting and spreading COVID-19, particularly with the

Omicron variant. The NZ High Court referred to an earlier

judgment in Four Aviation Security Service Employees

v. Minister of COVID-19 Response

38

, where the

precautionary principle had been applied, to make the point

that even a modest vaccination protection on a modest

number of personnel needs to be considered in the context

of potential effects of a pandemic. The NZ High Court

referred to a judgment of the Federal Court of Ontario in

38 [2021] NZHC 3012

49 | P a g e

Spencer v. Attorney General of Canada

39

to elaborate on

the precautionary principle, as “a foundational approach to

decision-making under uncertainty, that points to the

importance of acting on the best available information to

protect the health of” the citizens. In Four Aviation

Security Service Employees (supra), which dealt with

restrictions placed on aviation security workers, the NZ High

Court held that even though the applicants therein were not

being forcibly treated, they were required to be vaccinated

as a condition of their employment, refusal of which led to

termination. Observing that a right does not need to be

taken away in its entirety before it is regarded as having

been limited, the NZ High Court opined that the level of

pressure in that case was significant and amounted to

coercion, and therefore, the applicants’ right to refuse to

undergo medical treatment was limited. However, the said

limitation was held to be justified. From the evidence

adduced before the NZ High Court, it concluded that the

vaccine was effective at reducing the transmission of the

earlier variants of the virus and that it was also effective at

reducing symptomatic infection and detrimental effects of

the Delta variant. As the applicants were border workers

39 [2021] FC 361

50 | P a g e

interacting with international travellers who may be carrying

the virus and given the likelihood of vaccines contributing to

preventing the risk of transmission, the NZ High Court held

that a precautionary approach, in doing everything that can

be reasonably done to minimise risk of the outbreak or

spread in strong public interest, is justified. Further, the

curtailment of the right to refuse to undergo medical

treatment was found to be proportionate to the objective, as

the applicants, who worked as aviation workers, were

situated in a key location where COVID-19 might enter New

Zealand.

47.In Ryan Yardley (supra), the NZ High Court held that

the principle in Four Aviation Security Service

Employees (supra) is not directly applicable as the order

was not promulgated to contain the spread of the virus but

for the purpose of ensuring continuity of, and confidence in,

essential services. Additionally, there was no evidence of a

threat to the continuity of the police and NZDF services,

which would enable the NZ High Court to give the benefit of

the doubt to the New Zealand Crown in imposing measures

to address that risk. Placing reliance on the evidence

adduced as well as the public health advice which was to the

51 | P a g e

effect that vaccine mandates were not considered necessary

for addressing the risk of the outbreak or spread of COVID-

19, the High Court made it clear that while vaccination

significantly improved the prospects of avoiding illness and

death even with the Omicron variant, given the variant’s

propensity to break through vaccination barriers, it

concluded that there was no real threat to the continuity of

these essential services that the impugned order sought to

address. Further, finding that suspension of the

unvaccinated would address any potential problems, the

terminations arising from the order in light of the temporary,

albeit significant, period of peak impact of the infection, were

found to be disproportionate and unjustified. While the

Petitioner has sought support from this judgment to

demonstrate how courts in other jurisdictions have struck

down vaccine mandates taking into account Omicron’s

impact on the effectiveness of vaccines in addressing spread,

we believe that this judgment may not be of much assistance

to us for determining the issue at hand for two reasons. First,

the judgment expressly recognised that the impugned

vaccine mandate was not brought about to suppress the

spread of the virus but to ensure continuity of, and

confidence in, essential services, such as the police and the

52 | P a g e

defence personnel, which we are not concerned with in the

present case. Second, while the NZ High Court looked into

depositions of expert witnesses to come to its own

conclusion on efficacy of vaccines vis-à-vis the Omicron

variant, the scope of our review does not entail assessment

of competing scientific opinions, as the judiciary is not

equipped to decide issues of medical expertise and

epidemiology.

48.The crucial point that requires to be considered by us is

whether limitations placed by the Government on personal

autonomy of an individual can be justified in the interest of

public health in the wake of the devastating COVID-19

pandemic. As stated, personal autonomy has been

recognized as a critical facet of the right to life and right to

self-determination under Article 21 of the Constitution, by

this Court in Common Cause (supra). In K.S. Puttaswamy

(supra), this Court laid down three requirements to be

fulfilled by the State while placing restraints on the right to

privacy to protect legitimate State interests. It was held:

“310. … The first requirement that there must be a law

in existence to justify an encroachment on privacy is an

express requirement of Article 21. For, no person can be

deprived of his life or personal liberty except in

accordance with the procedure established by law. The

53 | P a g e

existence of law is an essential requirement. Second, the

requirement of a need, in terms of a legitimate State

aim, ensures that the nature and content of the law

which imposes the restriction falls within the zone of

reasonableness mandated by Article 14, which is a

guarantee against arbitrary State action. The pursuit of a

legitimate State aim ensures that the law does not suffer

from manifest arbitrariness. Legitimacy, as a postulate,

involves a value judgment. Judicial review does not

reappreciate or second guess the value judgment of the

legislature but is for deciding whether the aim which is

sought to be pursued suffers from palpable or manifest

arbitrariness. The third requirement ensures that the

means which are adopted by the legislature are

proportional to the object and needs sought to be

fulfilled by the law. Proportionality is an essential facet of

the guarantee against arbitrary State action because it

ensures that the nature and quality of the encroachment

on the right is not disproportionate to the purpose of the

law. Hence, the threefold requirement for a valid law

arises out of the mutual interdependence between the

fundamental guarantees against arbitrariness on the one

hand and the protection of life and personal liberty, on

the other. The right to privacy, which is an intrinsic part

of the right to life and liberty, and the freedoms

embodied in Part III is subject to the same restraints

which apply to those freedoms.”

While the judgment is in context of the right to privacy, the

analysis with respect to the threefold requirement for

curtailment of such right is on the anvil of the protection

guaranteed to fundamental freedoms under Article 21, and

54 | P a g e

therefore, would also be the litmus test for invasion of an

individual’s bodily autonomy under Article 21.

49.The upshot of the above discussion leads to the

following conclusions:

a)Bodily integrity is protected under Article 21 of the

Constitution of India and no individual can be forced to

be vaccinated.

b)Personal autonomy of an individual involves the right of

an individual to determine how they should live their

own life, which consequently encompasses the right to

refuse to undergo any medical treatment in the sphere

of individual health.

c)Persons who are keen to not be vaccinated on account

of personal beliefs or preferences, can avoid

vaccination, without anyone physically compelling them

to be vaccinated. However, if there is a likelihood of

such individuals spreading the infection to other people

or contributing to mutation of the virus or burdening of

the public health infrastructure, thereby affecting

communitarian health at large, protection of which is

undoubtedly a legitimate State aim of paramount

significance in this collective battle against the

pandemic, the Government can regulate such public

55 | P a g e

health concerns by imposing certain limitations on

individual rights that are reasonable and proportionate

to the object sought to be fulfilled.

50.The submission made on behalf of the Petitioner is that

the Delta and Omicron variants have shown breakthrough

infections and it is clear from the scientific data that, an

unvaccinated person does not pose a greater risk than a

vaccinated person in terms of transmission of the infection.

While this submission has been dealt with subsequently, we

believe that as long as there is a risk of spreading the

disease, there can be restrictions placed on individuals’

rights in larger public interest. Further, extensive material

from experts has been placed before this Court, which extol

the benefits of vaccination in tackling the severe and life-

threatening impact of the infection, specifically in terms of

reduction in oxygen requirement, hospitalisation, ICU

admissions and mortality, thereby easing the

disproportionate burden from the upsurge of severe cases on

the health infrastructure, which has already been witnessed

by the country during the second wave of the pandemic

where resources were woefully inadequate to stem the

impact of the Delta variant on a then scarcely vaccinated

population. We hasten to add that restrictions that are

56 | P a g e

placed by the Government should not be unreasonable and

are open to scrutiny by constitutional courts. It is difficult for

us to envisage the myriad situations in dealing with the

evolving pandemic that may call for restraint on individual

rights in larger public interest and therefore, as and when

such limitations are challenged, they can be assessed by

constitutional courts to see whether they meet the threefold

requirement laid down in K.S. Puttaswamy (supra).

D. Assessment of the vaccine mandates imposed by State

Governments

51.The grievance of the Petitioner pertains to the vaccine

mandates imposed by various State Governments and

private organisations, resulting in restrictions on fundamental

freedoms of persons who have chosen not to be vaccinated.

The Petitioner has alleged duality in the stand of the

Respondents, as on one hand, the Union of India has

categorically stated that vaccines are voluntary and on the

other, the State Governments have imposed and defended

restrictions on access to public places and resources for

persons who are unvaccinated. The Petitioner contested the

vaccine mandates on the following grounds:

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(a)Natural immunity acquired from COVID-19 infection is

more long-lasting and robust as compared to vaccine

immunity.

(b)Serological studies show that more than 75 per cent of

the Indian population has already been infected and is

seropositive and therefore, has better immunity to the

infection than that which can be provided by the

vaccine.

(c)Vaccines do not prevent infection from or transmission of

COVID-19 and are especially ineffective in preventing

against infection from new variants.

52. In support of the above grounds, other than on the

aspect of transmission of the virus, the Petitioner has relied

on individual opinions of doctors and other advisors, news

articles and findings from research studies, some of which

are preprints meaning they have not been peer-reviewed and

report new medical research which has yet to be evaluated

and therefore, should not be used to guide clinical practice,

as explained by medRxiv, a platform where several preprint

articles in the field of health sciences are published. Some

of the material relied on by the Petitioner has been listed

below:

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(a)An article in the scientific journal Nature

40

, which states

that “studies have shown that memory plasma cells

secreted antibody specific for the spike protein encoded

in SARS-CoV-2 even 11 months after the infection and

further that, immune memory to many viruses is stable

over decades, if not for a lifetime”.

(b)A study published in the European Journal of

Epidemiology

41

, which has analysed data from 68

countries available as of 03.09.2021 and has found that

“at the country level, there appears to be no discernible

relationship between percentage of population fully

vaccinated and new COVID-19 cases”. It is further

stated therein that in fact higher percentage of

population fully vaccinated have higher COVID-19 per 1

million people.

(c)The United Kingdom’s COVID-19 vaccine surveillance

report, Week 40, which appears to indicate negative

efficacy against infection amongst all ages above 30

years, on the basis of data between week 36 and week

39 in 2021.

40 Andreas Radbruch and Hyun-Dong Chang, “A long-term perspective on immunity to

Covid” Nature 595, 359-360 (2021)

41 Subramanian, S.V., Kumar, A. “Increases in COVID-19 are unrelated to levels of

vaccination across 68 countries and 2947 counties in the United States” Eur J

Epidemiol 36, 1237–1240 (2021)

59 | P a g e

53.While we are aware that courts cannot decide whether

natural immunity is more resilient as compared to vaccine-

acquired immunity and we do not seek to substitute our own

views in matters of differences in scientific opinion, we

cannot help but notice that in the first article referred to

above, published in Nature, it has been noted that immunity

in convalescent individuals (i.e., those who have recovered

from COVID-19) can be boosted further by vaccinating them

after a year. According to the said article, this results in the

generation of more plasma cells, together with an increase in

the level of SARS-CoV-2 antibodies that was up to 50 times

greater than before vaccination. In the second article

referred to above, published in the European Journal of

Epidemiology, it has been mentioned therein that the

interpretation of the findings should be as follows: “The sole

reliance on vaccination as a primary strategy to mitigate

COVID-19 and its adverse consequences needs to be re-

examined, especially considering the Delta (B.1.617.2)

variant and the likelihood of future variants. Other

pharmacological and non-pharmacological interventions may

need to be put in place alongside increasing vaccination

rates.” We do not see how these conclusions and

interpretations are in favour of an argument that natural

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immunity has proven to be better in protection against

COVID-19 infection, as compared to vaccine-acquired

immunity.

54.In any event, what we have to assess, in accordance

with the law laid down by this Court, is whether the Union of

India has taken note of scientific and medical inputs and

research findings in putting together its policy advocating

vaccination for the entire eligible population. Article 47 of

the Constitution of India imposes an obligation on the Union

of India to improve public health. It is the obligation of the

State to ensure the creation and the sustaining of conditions

congenial to good health. From the several obligations of the

State enshrined in Part IV of the Constitution, maintenance

and improvement of public health rank high as these are

indispensable to the very physical existence of the

community.

42

55. It should be noted that the submission made on behalf

of the Petitioner championing natural immunity is from the

perspective of a healthy person. Even the Petitioner does

not dispute the fact that the same standard is not applicable

to persons with co-morbidities, the sick and elderly people.

A cursory glance at the data recorded in the India Fact Sheet

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

61 | P a g e

on the basis of the National Family Health Survey – 5 (2019-

21) shows that (i) in the age group of 15-49 years, 57 per

cent of women and 25 per cent of men are anaemic, (ii)

amongst individuals aged above 15 years, 13.5 per cent of

women and 15.6 per cent of men have high or very high

blood sugar level or take medicines to control blood sugar

level, (iii) amongst individuals aged above 15 years, 21.3 per

cent of women and 24 per cent of men have hypertension or

elevated blood pressure or take medicines to control blood

pressure. Further, as per the 75

th

Round National Sample

Survey (NSS), conducted from July 2017 to June 2018, the

average age of the elderly population in India was 67.5

years, with 67.1 per cent of India’s elderly living in rural

areas. A study was conducted

43

on the basis of the data

from the NSS, aiming to highlight the vulnerability of the

aged amidst the COVID-19 pandemic. According to the

study, out of every 100 elderly, 27.7 persons reported

ailments during the previous 15 days, with cardiovascular

conditions including hypertension (32.0%), endocrine

conditions including diabetes (22.5%), musculoskeletal

conditions (13.9%), infectious diseases (10.0%), and

43 Ranjan, A., Muraleedharan, V.R. “Equity and elderly health in India: reflections from

75th round National Sample Survey, 2017–18, amidst the COVID-19 pandemic” Global

Health 16, 93 (2020)

62 | P a g e

respiratory ailments (7.3%) being the top five conditions for

seeking outpatient care among the elderly in the preceding

15 days. The Constitution, through Article 41, mandates the

State to make available to the elderly the right to live with

dignity and to provide the elderly, ill and disabled with

assistance, medical facilities and geriatric care

44

.

56. Surely, the Union of India is justified in centering its

vaccination policy around the health of the population at

large, with emphasis on insulating the weaker and more

vulnerable sections from the risk of severe infection and its

consequences, as opposed to basing its decision keeping in

mind the interests of a healthy few. Given the considerable

material filed before this Court reflecting the near-unanimous

views of experts on the benefits of vaccination in dealing

with severe disease, reduction in oxygen requirement,

hospital and ICU admissions and mortality and stopping new

variants from emerging, this Court is satisfied that the

current vaccination policy of the Union of India, formulated in

the interest of public health, is informed by relevant

considerations and cannot be said to be unreasonable.

Whether there is contrasting scientific opinion supporting the

argument of natural immunity offering better protection

44 Ashwani Kumar v. Union of India (2019) 2 SCC 636

63 | P a g e

against infection from COVID-19 and whether these scientific

opinions can be substantiated are not pertinent for

determination of the issue before this Court.

57. We now come to the crux of the challenge against

coercive vaccine mandates, with respect to which the

Petitioner has argued that they amount to restrictions on the

fundamental rights of unvaccinated individuals and cannot

be said to be proportionate, as according to the Petitioner,

with the prevalence of the Omicron variant, unvaccinated

people pose no greater danger to the transmission of the

virus in comparison to vaccinated persons. It was claimed

by the Petitioner that even if the vaccines reduced the

severity of the disease, it was up to the individual to decide

whether they wanted to be the beneficiary of vaccines. The

State’s lookout was the protection of larger public health and

with both the vaccinated and unvaccinated posing nearly

equal risks in transmission of the infection to others around

them, the State cannot impose restrictions targeting only the

unvaccinated and impeding their right to access public

resources. The Petitioner has thus, alleged discrimination

against the unvaccinated, who in the present situation, are

placed more or less on the same footing as vaccinated

individuals with respect to the transmission of the virus. In

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support of his submissions, the Petitioner has relied on

scientific studies and reports, some of which are listed below:

(a)A letter published in the Lancet, Regional Health

45

, which

states: “In the UK it was described that secondary attack

rates among household contacts exposed to fully

vaccinated index cases was similar to household

contacts exposed to unvaccinated index cases (25% for

vaccinated vs 23% for unvaccinated). 12 of 31 infections

in fully vaccinated household contacts (39%) arose from

fully vaccinated epidemiologically linked index cases.

Peak viral load did not differ by vaccination status or

variant type….The US Centres for Disease Control and

Prevention (CDC) identifies four of the top five counties

with the highest percentage of fully vaccinated

population (99.9–84.3%) as “high” transmission

counties. Many decisionmakers assume that the

vaccinated can be excluded as a source of transmission.

It appears to be grossly negligent to ignore the

vaccinated population as a possible and relevant source

of transmission when deciding about public health

control measures.”

45 Gunter Kampf, Letter titled “The Epidemiological relevance of the COVID-19

vaccinated population is increasing” Lancet Regional Health Vol. 11, 100272,

December 01, 2021

65 | P a g e

(b)A study conducted on breakthrough infection in

Massachusetts in July, 2021 and reported in the

Morbidity and Mortality Weekly Report

46

, which

investigated 469 COVID-19 cases that had been

identified among the Massachusetts residents who had

travelled to a town where multiple large public events

had been held and 346 cases, i.e., 74 per cent of the

infections occurred in fully vaccinated individuals.

Findings from the investigation suggest that even

jurisdictions without substantial or high COVID-19

transmission might consider expanding prevention

strategies, including masking in indoor public settings

regardless of vaccination status, given the potential risk

of infection during attendance at large public gatherings

that include travelers from many areas with differing

levels of transmission.

The Petitioner has also cited various news articles reporting

instances of breakthrough infections in fully vaccinated

people, carrying as much virus as those who were

unvaccinated, abroad as well as within India.

46 Brown CM, Vostok J, Johnson H, et al. “Outbreak of SARS-CoV-2 Infections, Including

COVID-19 Vaccine Breakthrough Infections, Associated with Large Public Gatherings —

Barnstable County, Massachusetts, July 2021”. MMWR Morb Mortal Wkly Rep

2021;70:1059-1062

66 | P a g e

58. We have already referred to the material placed by the

Union of India and the States appearing before this Court.

While there is abundant data to show that getting vaccinated

continues to be the dominant expert advice even in the face

of new variants, no submission nor any data has been put

forth to justify restrictions only on unvaccinated individuals

when emerging scientific evidence appears to indicate that

the risk of transmission of the virus from unvaccinated

individuals is almost on par with that from vaccinated

persons. To put it differently, neither the Union of India nor

the State Governments have produced any material before

this Court to justify the discriminatory treatment of

unvaccinated individuals in public places by imposition of

vaccine mandates. No doubt that when COVID-19 vaccines

came into the picture, they were expected to address, and

were indeed found to be successful in dealing with, the risk

of infection from the variants in circulation at the time.

However, with the virus mutating, we have seen more potent

variants surface which have broken through the vaccination

barrier to some extent. While vaccination mandates in the

era of prevalence of the variants prior to the Delta variant

may have withstood constitutional scrutiny, in light of the

data presented by the Petitioner, which has not been

67 | P a g e

controverted by the Union of India as well as the State

Governments, we are of the opinion that the restrictions on

unvaccinated individuals imposed through vaccine mandates

cannot be considered to be proportionate, especially since

both vaccinated and unvaccinated individuals presently

appear to be susceptible to transmission of the virus at

similar levels.

59. Details of the vaccine mandates passed by the States

of Maharashtra, Tamil Nadu, Madhya Pradesh and Delhi have

been discussed earlier. It has come to our knowledge that

since the judgment in this matter was reserved, the National

Disaster Management Authority took a decision that there

may not be any further need to invoke provisions of the DM

Act for COVID-19 containment measures, taking into

consideration the overall improvement in the situation.

Further, the States of Maharashtra and Tamil Nadu, taking

into account the present situation in which near-normalcy

has been restored, have rolled back the restrictions placed

on unvaccinated persons. The State of Madhya Pradesh had

withdrawn the restrictions imposed on unvaccinated

individuals in terms of withholding distribution of food grains

from fair price shops and had notified this Court of the same

during the hearing. Till the infection rate and spread

68 | P a g e

remains low, as it is currently, and any new development or

research finding comes to light which provides the

Government due justification to impose reasonable and

proportionate restrictions on the rights of unvaccinated

individuals in furtherance of the continuing efforts to combat

this pandemic, we suggest that all authorities in this country,

including private organisations and educational institutions,

review the relevant orders and instructions imposing

restrictions on unvaccinated individuals in terms of access to

public places, services and resources.

60. While we appreciate that it is the domain of the

executive to determine how best to encourage vaccination

without unduly encroaching into the fundamental rights of

unvaccinated individuals, we wish to highlight the

mechanism of the “health pass” employed in France, as an

apt example of a proportionate measure intended to cope

with the perils of the spread of the virus. We understand

that a “health pass” may take the form of either the results

of a viral screening test not concluding that a person has

been infected with COVID-19, or proof of vaccination status,

or a certificate of recovery following an infection. In a

referral by the Prime Minister to review the law on managing

the public health state of emergency, the Constitutional

69 | P a g e

Council in France, in Decision no. 2021-824 DC dated

05.08.2021, determined that the “health pass” did not

infringe the right to personal privacy guaranteed by Article 2

of the Declaration of Human and Civic Rights of 1789 as the

requirement did not introduce an obligation to vaccinate.

61. Having expressed our opinion on the vaccine mandates

in the prevailing context, we reiterate that vaccines

effectively address severe disease arising from COVID-19

infections, are instrumental in reducing oxygen requirement,

hospital and ICU admissions and mortality and continue to be

the solution to stopping new variants from emerging, as per

the advice of the WHO. Since the time arguments were

heard in the matter, we have come to know of more variants

that have now come into circulation. Given the rapidly-

changing nature of the virus and the clear purpose served by

the approved vaccines in terms of restoration and protection

of public health, our suggestions with respect to review of

vaccine mandates are limited to the present situation alone.

This judgment is not to be construed as impeding, in any

manner, the lawful exercise of power by the executive to

take suitable measures for prevention of infection and

transmission of the virus in public interest, which may also

take the form of restrictions on unvaccinated people in the

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future, if the situation so warrants. Such restrictions will be

subject to constitutional scrutiny to examine if they meet the

threefold requirement for intrusion into rights of individuals,

as discussed earlier.

II. Non-disclosure of segregated clinical trial data in

public domain

62.It is the complaint of the Petitioner that the COVID-19

vaccines, manufactured by Respondent Nos. 4 and 5, have

been given restricted emergency approval by the Drugs

Controller General of India (DCGI) in a hurried and opaque

manner. Mr. Bhushan argued that clinical trials in respect of

the vaccines had not been completed and at present, the

vaccines are only authorised for emergency use. According

to the Petitioner, while clinical trials are scheduled to be

completed in the year 2023, even the full dataset from the

interim analysis conducted has not been made public. The

disclosure of segregated data of clinical trials is essential to

determine the adverse effects, if any, across various age

groups and diverse populations and accordingly, enable

individuals to make more informed decisions on whether to

be vaccinated. Reliance was placed on an order of this

Court in Aruna Rodrigues (4) v. Union of India

47

and a

47 (2011) 12 SCC 481

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judgment of the Delhi High Court dated 15.01.2019 in W.P.

(C) No. 343 of 2019 titled Master Hridaan Kumar (minor)

v. Union of India with respect to the importance of

disclosure of relevant technical data and informed consent.

Additionally, the last amended version of the Declaration of

Helsinki – Ethical principles from medical research involving

human subjects (hereinafter, the “ Declaration of

Helsinki”) and a statement by the WHO dated 09.04.2015

on ‘public disclosure of clinical trial results’ (hereinafter, the

“WHO Statement on Clinical Trials ”) were pressed into

service to establish the significance of disclosure of data of

clinical trials, so as to enable the data to be assessed

independently, and not only by the vaccine manufacturer

who has a commercial interest in production of the vaccines.

Mr. Bhushan submitted that there would be no invasion of

privacy of individuals, if personal identification data and past

medical history of the trial participants was redacted and the

raw data pertaining to clinical trials is made public. The

further grievance of the Petitioner pertained to lack of

transparency in regulatory approvals, minutes of meetings

and constitution of expert bodies. The Petitioner has sought

for clear detailing of the information furnished before, and

evidence relied on by, the expert bodies such as the NTAGI

72 | P a g e

and the Subject Expert Committee (SEC), the body which

sends recommendations to the Central Drugs Standard

Control Organisation, while deliberating on the applications

and data of the vaccine manufacturers, and the names and

institutional relationships of the experts who participated in

each of these meetings. Mr. Bhushan relied on the 59

th

Report of the Parliamentary Standing Committee on Health

and Family Welfare, in support of his submission on a need

for transparency in the decision-making of the CDSCO and

other regulatory authorities.

63.In response, the Union of India submitted that the

procedure prescribed under the statutory regime was

scrupulously followed before granting emergency approval of

the vaccines manufactured by Respondent Nos. 4 and 5. As

per the extant statutory regime, permission to import or

manufacture new drugs including vaccines or to undertake

clinical trials is granted by the Central Drugs Standard

Control Organisation (CDSCO). The CDSCO, in consultation

with the SEC, evaluates the applications for grant of such

permission, which are to be accompanied with data as

required under the Second Schedule to the New Drugs and

Clinical Trials Rules, 2019 (hereinafter, the “2019 Rules”)

framed under the Drugs and Cosmetics Act, 1940. The SEC

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is a statutory body, constituted by the CDSCO under Rule

100 of the 2019 Rules, comprising group of experts with

specialisation in relevant fields. According to the Union of

India, the SEC looks into the details of trials and results

presented before it and examines them, interacts with the

developers of the vaccines and gives them appropriate

directions and eventually makes recommendations in writing,

by way of a resolution, reflecting the collective opinion of all

the domain experts. We were informed that the trials have

been registered on the database of the Clinical Trials Registry

– India, which is hosted at the ICMR’s National Institute of

Medical Statistics. The provisions in relation to ‘Accelerated

Approval Process’ under the Second Schedule to the 2019

Rules were pointed out to this Court, which stipulate that

“accelerated approval process may be allowed to a new drug

for a disease or condition taking into account its severity,

rarity, or prevalence and the availability or lack of alternative

treatments, provided that there is a prima facie case of the

product being of meaningful therapeutic benefit over the

existing treatment”. It is further stated that “After granting

accelerated approval for such drug, the post marketing trials

shall be required to validate the anticipated clinical benefit.”

It was submitted that applying these provisions on

74 | P a g e

Accelerated Approval Process, the CDSCO, in detailed

consultation with the SEC and after examining the efficacy of

the vaccine and its effects, granted permission for restricted

emergency use of COVAXIN and COVISHIELD, as

manufactured by Respondent Nos. 4 and 5, respectively.

64.As regards COVAXIN (Whole Virion Inactivated Corona

Virus Vaccine), the Union of India stated that application for

permission to manufacture the vaccine was made by Bharat

Biotech on 23.04.2020. The CDSCO, in consultation with the

SEC, granted permission to Bharat Biotech for conducting

Phase I/II clinical trials on 29.06.2020 and Phase III clinical

trials on 23.10.2020. Respondent No. 4 submitted interim

safety and immunogenicity data of Phase I and Phase II

clinical trials carried out in the country, along with safety

data, including Serious Adverse Events data, of the ongoing

Phase III clinical trial in the country. The data provided by

Respondent No.4 from the various phases were evaluated

and analysed by the SEC, which consisted of eminent experts

from the fields of microbiology, medicine, pulmonary

medicine, paediatrics and immunology and immunogenetics.

The resolutions of the various meetings of the SEC, which

also required the presence of the developer / manufacturer

with the necessary information, have been put up on the

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website of the MoHFW at every stage. In its meeting dated

02.01.2021, observing that on receiving further updated

data, justification and request for consideration of the

proposal in the wake of a new mutation of the COVID-19

virus, and on recognising that the data generated till then

showed that the vaccine had the potential to target mutated

coronavirus strains, the SEC recommended for grant of

permission for restricted use in emergency situation in public

interest in clinical trial mode, as an abundant precaution.

While granting such permission, Respondent No. 4 was

directed to continue the ongoing Phase III clinical trial and

submit data from the trial, as and when available. Approval

for restricted use in emergency situation in clinical trial mode

with various conditions / restrictions was granted by the

CDSCO to Respondent No. 4 to manufacture COVAXIN on

03.01.2021.

65.Thereafter, Respondent No. 4 submitted the interim

safety and efficacy data of Phase III clinical trial, which was

reviewed by the SEC in meetings held periodically. In its

meeting conducted on 10.03.2021, the SEC, after detailed

deliberation on the updated interim safety and efficacy data

of the phase III clinical trial, recommended omission of the

condition of the use of the vaccine in clinical trial mode.

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However, it was recommended that the vaccine be continued

to be used under restricted use in emergency situation

condition. Following expansion of the Government’s

vaccination drive to include individuals in the age group of

18-45 years, in its meeting held on 23.04.2021, the SEC

considered Bharat Biotech’s proposal to unblind the trial

participants in the said age group. After detailed

deliberations, the SEC recommended the unblinding of the

participants in the said age group, upon the request of the

participants or the principal investigator after completion of

two months from the second dose. Eventually, on

consideration of relevant data of Phase I and Phase II clinical

trials along with safety data of 6 months’ Phase III clinical

trial, including data of serious adverse events till the date,

the SEC in its meeting dated 19.01.2022 noted that there

had been no safety issues and the vaccine maintained its

efficacy, specially to avoid hospitalisation and severe

infections in the existing situation as well. Accordingly, the

SEC recommended that the status of approval of COVAXIN

from the restricted use in emergency situation to the New

Drug permission be updated, along with the condition that

the firm shall continue to submit data of ongoing clinical trial

and monitor AEFIs. The Union of India pointed out that

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Phase I and Phase II clinical trial reports were published in

the Lancet Infectious Diseases Journal, which was publicly

available. Further, to the knowledge of the Union of India,

Phase III trial publication had been submitted to the Lancet

journal by Respondent No. 4 on 02.07.2021, a copy of the

manuscript of which has been provided to this Court.

66.COVISHIELD (ChAdOx1 nCoV-19 Corona Virus Vaccine

(Recombinant)) manufactured by Respondent No. 5 was

developed by the Serum Institute of India in collaboration

with Oxford University and AstraZeneca under technology

transfer. As the clinical development of the said vaccine,

including Phase I clinical trial, was conducted in other

countries, Phase II / III clinical trials were conducted by

Respondent No. 5 in the country. Application for permission

to manufacture COVISHIELD for test, examination and

analysis was first made by Respondent No. 5 on 03.05.2020.

The safety, immunogenicity and efficacy data of Phase II / III

clinical trials of the AstraZeneca vaccine carried out in the

United Kingdom, Brazil and South Africa were submitted to

the SEC, along with the safety and immunogenicity data from

the ongoing Phase II / III clinical trials in India. On reviewing

this data as well as the approval dated 30.12.2020 granted

by the United Kingdom’s Medicines and Healthcare Products

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Regulatory Authority (hereinafter, the “UK-MHRA”) for the

AstraZeneca vaccine along with its conditions / restrictions,

the SEC, in its meeting dated 01.01.2021, noted that the

safety and immunogenicity data from the Indian study was

comparable with that of the overseas clinical trial data.

After detailed deliberation and taking into account the

emerging situation, the SEC recommended grant of

permission for restricted emergency use of the vaccine,

subject to various regulatory provisions and conditions,

including requirement to submit relevant data from the

ongoing clinical trials nationally and internationally at its

earliest. Eventually, in its meeting dated 19.01.2022, the

SEC considered the request of Respondent No. 5 to grant

permission to manufacture the vaccine, excluding the

conditions for restricted use in emergency situation and

other conditions, on the lines of Marketing Authorisation by

the UK-MHRA for the parent vaccine. After detailed

deliberation and consideration of safety, immunogenicity and

efficacy data from Indian and overseas clinical trials,

amongst other data, the SEC recommended grant of New

Drug permission or regular approval, with conditions that

data of ongoing clinical trials and vaccine shall continue to be

supplied and AEFIs shall continue to be monitored.

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67.We were directed to Rule 25 of the 2019 Rules, framed

under the Drugs and Cosmetics Act, 1940, which provides

that the clinical trial shall be conducted in accordance with

approved clinical trial protocol and other related documents

as per the requirements of Good Clinical Practices (GCP)

guidelines and the other rules. The expert committee set up

by the CDSCO under Rule 25(vi) in consultation with clinical

experts formulated the GCP guidelines for generation of data

on drugs. The ‘Ethical Principles’, which are part of the said

guidelines, protect principles of privacy and confidentiality of

human subjects of research. The learned Solicitor General

also relied upon para 2.4.4 of the GCP guidelines, which

require safeguarding of the confidentiality of research data

that might lead to identification of individual subjects. He

further referred to the important role played by the Ethics

Committee under Rule 11 of the 2019 Rules, which includes

safeguarding the rights, safety and well-being of trial

subjects in accordance with the said rules. The 2019 Rules

also empower the Ethics Committee to discontinue or

suspend the clinical trial in case it concludes that the trial is

likely to compromise the right, safety or well-being of the

trial subject. As per the ICMR’s National Ethical Guidelines

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for Biomedical and Health Research involving Human

Participants, the four basic ethical principles for conducting

biomedical and health research are (i) respect for persons

(autonomy), (ii) beneficence, (iii) non-malfeasance and (iv)

justice. These four basic principles have been expanded into

12 general principles, including the ‘principle of ensuring

privacy and confidentiality’ which requires maintaining the

privacy of potential participants, her / his identity and

records, with access given to only those authorised. As

regards transparency of functioning of expert bodies, it was

submitted by the Union of India that recommendations of the

SEC in all its meetings are uploaded on the website of the

CDSCO. Additionally, the detailed minutes of NTAGI

meetings were already available in public domain, which can

be downloaded from both the ICMR and the MoHFW websites.

68.The contention of Respondent No. 4 is that COVAXIN

has undergone all clinical trials. In Phase III, trials revealed a

77.8% efficacy against symptomatic COVID-19 disease. The

findings of the clinical trials have been published in reputed

peer-reviewed journals and are readily available on the

website of Respondent No.4. A reference was made by

Respondent No. 4 to the WHO Statement on Clinical Trials, to

submit that it is only the key outcomes and findings which

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are required to be made publicly available. It was

contended that Respondent No. 4 is in compliance with the

WHO Statement on Clinical Trials as the key outcomes and

results of the Phase III clinical trial have been published in

the Lancet. On behalf of Respondent No. 5, it was submitted

that the clinical data generated during the trials had been

submitted to the regulatory authorities for obtaining

permissions / licences etc. Further, the peer-reviewed study

of the partial clinical data of Phase II / III trials had already

been published in reputed scientific journals, which included

all the information necessary for safeguarding the public as

well as informing them of the credibility and efficacy of the

vaccine. According to Respondent No. 5, the raw data of the

clinical trials served no greater public purpose than the data

which was already available in the public domain. All

applicable medico-legal, scientific and ethical requirements

had been strictly adhered to by Respondent No. 5.

69. In rejoinder, the learned counsel for the Petitioner

argued that there is no transparency in the process of

approvals of vaccines and relevant data is not always placed

before the NTAGI. He referred to a news article in The Wire,

according to which Jayaprakash Muliyil, a member of the

NTAGI had stated that the NTAGI had not recommended

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vaccination of children in the age group of 12-14 years. He

also drew the attention of this Court to non-supply of relevant

data to the NTAGI at the time of approval of the Rotavac

vaccine against rotavirus. The Petitioner further complained

of the haste shown in grant of emergency approval to

Respondent No. 4. The Petitioner has sought support of a

decision of the United States District Court for the Northern

District of Texas dated 06.01.2022 in Public Health and

Medical Professionals for Transparency v. Food and

Drug Administration, which highlighted the need for

transparency in disclosure of clinical trial data. It was

reiterated by the Petitioner that privacy of individuals would

not be at risk as their personal identification data can be

redacted before disclosing segregated data of clinical trials.

70. It is settled law that courts cannot take judicial notice of

facts stated in a news item published in a newspaper. A

statement of fact contained in a newspaper is merely

hearsay and therefore, inadmissible in evidence, unless

proved by the maker of the statement appearing in court and

deposing to have perceived the fact reported.

48

In the

absence of anything on record in the present case to

substantiate the statement made by Mr. Jayaprakash Muliyil,

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

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member of the NTAGI, we are not inclined to take judicial

notice of the news article reported in The Wire, even more so

in light of the affidavit filed on behalf of the Union of India

stating that the relevant data was examined by the expert

bodies at all stages before granting emergency use approval

to the vaccines. We are also of the opinion that the evidence

relating to the approval process of the Rotavac vaccine has

no relevance to the dispute in this case. On the basis of the

said two incidents, it cannot be concluded that the

emergency use approval to COVISHIELD and COVAXIN

recommended by the SEC are not in accordance with the

statutory regime.

71. At this stage, it is worthwhile to refer to the statutory

regime in place. According to Rule 19 of the 2019 Rules, no

person, institution or organisation shall conduct clinical trial

of a new drug or investigational new drug, except in

accordance with the permission granted by the Central

Licensing Authority (i.e., the CDSCO) and without following

the protocol approved by the Ethics Committee for clinical

trial, registered in accordance with the provisions of Rule 8.

Rule 19 (2) of the 2019 Rules provides that every person

associated with the conduct of clinical trial of a new drug or

investigational new drug shall follow the general principles

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and practices as specified in the First Schedule. The

methodology to be adopted in a clinical trial is provided for in

the First Schedule to the 2019 Rules, relevant clauses of

which are as under: -

“GENERAL PRINCIPLES AND PRACTICES FOR CLINICAL

TRIAL

1. General Principles.― (1) The principles and guidelines

for protection of trial subjects as described in Third

Schedule as well as Good Clinical Practices guidelines

shall be followed in conduct of any clinical trial.

xxx

4. Conduct of Clinical Trial.― Clinical trial should be

conducted in accordance with the principles as specified

in Third Schedule. Adherence to the clinical trial protocol

is essential and if amendment of the protocol becomes

necessary the rationale for the amendment shall be

provided in the form of a protocol amendment. Serious

adverse events shall be reported during clinical trial in

accordance with these Rules.

xxx

6. Reporting.― Report of clinical trial shall be

documented in accordance with the approaches

specified in Table 6 of the Third Schedule. The report

shall be certified by the principal investigator or if no

principal investigator is designated then by each of the

participating investigators of the study.”

It is clear from the above, that there are stringent statutory

requirements which have to be complied with by the

manufacturers of vaccines and other participants, during

different stages of clinical trials of vaccines. Further, we also

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note that the GCP guidelines are statutorily required to be

followed.

72.The GCP guidelines further elaborate on the role of the

Ethics Committee. According to the GCP guidelines, the

Ethics Committee is an independent review board or a

committee comprising of medical / scientific and non-medical

/ non-scientific members, whose responsibility it is to verify

the protection of the rights, safety and well-being of human

subjects involved in a study. The independent review

provides public reassurance by objectively, independently

and impartially reviewing and approving the “Protocol”, the

suitability of the investigator(s), facilities, methods and

material to be used for obtaining and documenting “Informed

Consent” of the study subjects and adequacy of

confidentiality safeguards. Para 2.4 of the GCP guidelines

deal with ethical and safety considerations, which provide

that all research involving human subjects should be

conducted in accordance with the ethical principles

contained in the current version of the Declaration of

Helsinki, as annexed to the guidelines. Amongst the

principles to be followed, the GCP guidelines require

adherence to the “principles of accountability and

transparency” and “principles of public domain”:

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“Principles of accountability and transparency,

whereby the research or experiment will be conducted in

a fair, honest, impartial and transparent manner, after

full disclosure is made by those associated with the

Study of each aspect of their interest in the Study, and

any conflict of interest that may exist; and whereby,

subject to the principles of privacy and confidentiality

and the rights of the researcher, full and complete

records of the research inclusive of data and notes are

retained for such reasonable period as may be

prescribed or considered necessary for the purposes of

post-research monitoring, evaluation of the research,

conducting further research (whether by the initial

researcher or otherwise) and in order to make such

records available for scrutiny by the appropriate legal

and administrative authority, if necessary.

xxx

Principles of public domain, whereby the research

and any further research, experimentation or evaluation

in response to, and emanating from such research is

brought into the public domain so that its results are

generally made known through scientific and other

publications subject to such rights as are available to the

researcher and those associated with the research under

the law in force at that time.”

73. The GCP guidelines have been formulated following the

Declaration of Helsinki. The relevant portion of the said

Declaration is as follows: -

“Privacy and Confidentiality

24. Every precaution must be taken to protect the

privacy of research subjects and the confidentiality of

their personal information.

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Research Registration and Publication and

Dissemination of Results

…

36. Researchers, authors, sponsors, editors and

publishers all have ethical obligations with regard to the

publication and dissemination of the results of research.

Researchers have a duty to make publicly available the

results of their research on human subjects and are

accountable for the completeness and accuracy of their

reports. All parties should adhere to accepted guidelines

for ethical reporting. Negative and inconclusive as well

as positive results must be published or otherwise made

publicly available. Sources of funding, institutional

affiliations and conflicts of interest must be declared in

the publication. Reports of research not in accordance

with the principles of this Declaration should not be

accepted for publication.”

It is profitable to refer to the relevant portion of the WHO

Statement on Clinical Trials, which is as under: -

“Reporting timeframes for clinical trials

Clinical trial results are to be reported according to the

timeframes outlined below. Reporting is to occur in BOTH

of the following two modalities.

1. The main findings of clinical trials are to be submitted

for publication in a peer reviewed journal within 12

months of study completion and are to be published

through an open access mechanism unless there is a

specific reason why open access cannot be used, or

otherwise made available publicly at most within 24

months of study completion.

2. In addition, the key outcomes are to be made publicly

available within 12 months of study completion by

posting to the results section of the primary clinical trial

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registry. Where a registry is used without a results

database available, the results should be posted on a

free-to-access, publicly available, searchable institutional

website of the Regulatory Sponsor, Funder or Principal

Investigator.”

74.The GCP guidelines are being scrupulously followed,

according to the Union of India. The principles of “public

domain” in the GCP guidelines provide for research,

experimentation or evaluation in response to the research to

be brought into the public domain. The results of the clinical

trials are generally to be made known through scientific and

other publications. The requirement of publication, according

to the WHO, also relates to the main findings of clinical trials

to be published in a peer-reviewed journal and the key

outcomes to be made publicly available, within 12 months of

study completion. The Petitioner complains of opaqueness in

clinical trials as the general public do not have access to, and

the opportunity to be aware of, all the necessary details by

segregated clinical trial data (primary datasets) not being

available. There is no challenge by the Petitioner to the GCP

guidelines. As required by the WHO Statement on Clinical

Trials and the GCP guidelines, findings of the clinical trials

and the key outcomes of the trials have been published. In

light of the existing statutory regime, we do not see it fit to

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mandate the disclosure of primary clinical trial data, when

the results and key findings of such clinical trials have

already been published.

75.After examining the judgment of the United States

District Court for the Northern District of Texas (hereinafter,

the “US District Court”), we are afraid that the said

decision cannot be said to be relevant for adjudication of the

dispute in the present case. The grievance of the plaintiff in

the said case pertained to all data and information for the

Pfizer vaccine, enumerated under the relevant provisions of

the Freedom of Information Act, not being provided by the

United States Food and Drug Administration. The US District

Court referred to the Freedom of Information Act to hold that

the citizenry has a right to be provided with the relevant

information pertaining to the Pfizer vaccine and that such

‘information is often useful only if it is timely’. The US

District Court directed expeditious completion of the

plaintiff’s request after concluding that the request under the

Freedom of Information Act was of paramount importance.

We note that with respect to COVAXIN and COVISHIELD,

results of clinical trials have been published in accordance

with our statutory regime in place. Reliance placed by the

Petitioner on European Medicines Agency policy on

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publication of clinical data for medicinal products for human

use is also not relevant as the GCP guidelines relating to the

disclosure of clinical trial data, framed under the 2019 Rules,

currently govern the field of disclosure of clinical trial data in

India.

76.An analysis of the submissions made by the learned

counsel appearing for the parties and a close scrutiny of the

material placed on record would show that there is a strict

statutory regime in force for grant of approvals to vaccines.

Specialist bodies established under the provisions of the

Drugs and Cosmetics Act, 1940 and the rules framed

thereunder comprise of domain experts in the relevant field,

who conduct a thorough scrutiny of the material produced by

the manufacturers before granting approval. The information

provided on behalf of the Union of India substantiates that

the data provided by the vaccine manufacturers was

considered by the SEC over a period of time and several

conditions were imposed at the time of recommending

approvals, which have been modified or lifted subsequently

on availability of further data arising from the clinical trials

before the SEC, as can be seen from the minutes of the

meetings of the SEC, available on the website of the MoHFW.

91 | P a g e

We do not agree with the submission on behalf of the

Petitioner that emergency approvals to the vaccines were

given in haste, without properly reviewing the data from

clinical trials. We are also of the opinion that the

Parliamentary Standing Committee report relied upon by Mr.

Bhushan is not relevant and the lapses pointed out therein

pertain to the year 2011, which have no obvious connection

to the grant of approval to Respondent Nos. 4 and 5 for the

restricted emergency use of their respective vaccines. As

long as the relevant information relating to the minutes of

the meetings of the regulatory bodies and the key outcomes

and findings of the trials are available in public domain, the

Petitioner cannot contend that every minute detail relating to

clinical trials be placed in public domain to enable an

individual to take an informed, conscious decision to be

vaccinated or not. Given the widespread affliction caused

by the virus, there was an imminent need of manufacturing

vaccines which would keep the infection at bay. We would

like to highlight that both the vaccines have been approved

by the WHO as well. A perusal of the material placed on

record would show that there is material compliance with the

procedure prescribed under the Drugs and Cosmetics Act,

1940 and the 2019 Rules, before grant of approval for the

92 | P a g e

emergency use of the two vaccines. However, it is made

clear that subject to the protection of privacy of individual

subjects and to the extent permissible by the 2019 Rules, the

relevant data which is required to be published under the

statutory regime and the WHO Statement on Clinical Trials

shall be made available to the public without undue delay,

with respect to the ongoing post-marketing trials of COVAXIN

and COVISHIELD as well as ongoing clinical trials or trials that

may be conducted subsequently for approval of other COVID-

19 vaccines / vaccine candidates.

III. Improper collection and reporting of AEFIs

77.The contention of the Petitioner is that there have been

several adverse effects from vaccines, including deaths.

The Petitioner has sought to fault the Government’s

mechanisms in place for handling of the adverse events.

According to the Petitioner, during Phase III trials, where

small controlled trials of a limited number of participants are

conducted, a significant increase in adverse events may not

be seen. But after licensure, when the vaccines are

administered to the masses, rare reactions show up, which is

why Phase IV post-marketing trials are legally mandated. It

was pointed out by the Petitioner that there has been a

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revision of the rules by the WHO for classifying AEFIs in 2018.

As per the revised mechanism, only reactions that are

previously acknowledged to be caused by the vaccine are

classified as vaccine-related reactions. Reactions observed

during post-marketing surveillance are not considered as

‘consistent with causal association with vaccine’, if a

significant increase in such reactions during Phase III trials

had not been recorded. According to the Petitioner, this

acquires significance in the context of trials conducted in this

country, as the control trial in Phase III did not go on in the

manner intended, with several members of the original

control group prematurely unblinded and offered the vaccine.

The Petitioner contends that owing to ‘dilution of Phase III

control trials prematurely’, there are no controls to compare

against, making it difficult to ascertain which adverse events

are caused by the vaccine. Therefore, reactions which are

not “known reactions” to the vaccine are not considered

AEFIs. In light of this, it is necessary for the authorities to

carefully monitor all vaccine recipients and publicly record all

adverse events.

78.Taking this argument further, the Petitioner contended

that the adverse events reporting system in India is not

transparent, with obscure investigation and follow-up of

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deaths and other serious adverse events after COVID-19

vaccination. The Petitioner relied on a letter published in

The Hindu on 17.03.2021, written by a group of experts in

public health, ethics, medicine, law, and journalism to the

Minister for Health & Family Welfare and the DCGI, appealing

for “time-bound and transparent investigation” following

deaths and serious adverse effects after COVID-19

vaccination. A presentation made by the National AEFI

Committee in a meeting held on 31.03.2021 was referred to

by the Petitioner to claim that complete documentation was

not available for all the severe and serious adverse events

(including deaths) that had occurred till the time.

Additionally, it was contended that no data pertaining to the

AEFIs already classified nor any analysis of the same had

been published publicly till date. The Petitioner also drew

the attention of this Court to the Vaccine Adverse Event

Reporting System (VAERS) in place in the United States,

which published all vaccine injury reports every Friday,

received till about a week prior to the release date. It was

brought to the notice of this Court that 77,314 adverse

events have been reported in India as on 12.03.2022,

amounting to 0.004% of the total vaccination. The Petitioner

has pointed out that the percentage of adverse events

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reported in Europe is much larger than the percentage

identified in India, which would show that correct figures are

not being published by the Government.

79.On behalf of the Union of India, the procedures and

protocols for monitoring of adverse event following

immunisation under the National Adverse Event Following

Immunisation Surveillance Guideline were elaborated upon.

The National Adverse Event Following Immunisation

Surveillance Secretariat, established in the Immunisation

Technical Support Unit in 2012, had staff dedicated for

managing Adverse Event Following Immunisation

surveillance system. It was further strengthened by the

National Adverse Event Following Immunisation Surveillance

Technical Collaborating Centre, comprising of experts from

Lady Hardinge Medical College and Allied Hospitals in New

Delhi. Adverse Event Following Immunisation Committees

were formed at the national and state levels to provide

guidance to the National AEFI Surveillance and carry out

documentation, investigation and causality assessment,

besides training and orientation of health care workers and

others involved in AEFI. According to the Union of India, a

foolproof protocol for reporting and causality assessment for

any AEFI with Universal Immunisation Program (UIP) and

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Non-UIP vaccines has been established. The National AEFI

Committee gets periodical reports regarding ‘minor AEFIs’,

‘severe AEFIs’ and ‘serious AEFIs’. Online reporting of all

serious and severe AEFIs at the district level to be

communicated to relevant authorities at the state / national

level is done on a web-based portal, SAFEVAC (Surveillance

and Action for Events Following Vaccination). All serious and

severe adverse events following vaccination even at district

level are uploaded online on SAFEVAC. It was submitted on

behalf of the Union of India that case details, scanned copies

of reports are uploaded on SAFEVAC, which also has facilities

for generating dashboards and line-lists at different levels.

80.Further, a similar feature of reporting of all AEFIs

(including minor) by the vaccinator was made available on

the Co-WIN portal. District Immunisation Officers (DIOs)

were given the facility to report AEFI cases about which they

have information from such individuals who do not have

access to Co-WIN. Departmental orders and standard

operating procedures have been issued for further

investigations and sharing of hospital records by the DIOs

through Co-WIN. The Union of India has brought to the

notice of this Court that an alignment with the

Pharmacovigilance Programme of India (PvPI) under Indian

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Pharmacopoeia Commission has been developed for receipt

of information regarding AEFI cases from around 300 Adverse

Drug Reaction Monitoring Centers in medical colleges and

large hospitals. The Union of India has highlighted that

information from the PvPI and the CDSCO are collated and

studied, in case of any new, previously unknown events

identified through AEFI surveillance. A press release of the

MoHFW dated 17.02.2017 titled ‘Maximum Possible Marks to

Indian NRA in WHO Assessment’ has been placed before this

Court to state that the AEFI Surveillance System in India

(which is in use for COVID-19 vaccination) has been approved

by global experts in an assessment conducted by the WHO in

2017. Given the novel nature of the virus, membership of

the National AEFI Committee has been expanded to include

neurologists, cardiologists, respiratory medicine specialists

and medical specialists, with even States / Union Territories

requested to expand their AEFI Committees on a similar scale

to strengthen AEFI surveillance for COVID-19 vaccines.

Causality assessment of AEFI cases is conducted at the state

and the national levels by experts trained as per the

causality assessment checklist, based on the definition and

algorithm developed by the WHO. Once approved by experts

of the National AEFI Committee, results of causality

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assessment of AEFI cases are 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 of reported AEFI cases is a time-consuming

process, a method of rapid review and assessment had been

initiated at the national level to quickly review available

information in each case and look for trends in reporting of

specific events or unusual cases requiring further early

investigation and assessment. All cases of serious and

severe AEFIs, including reported deaths, are subjected to

rapid reviews, analysis and causality assessment done by a

team of trained subject experts. It was clarified that mere

reporting of AEFI case should not be attributed to the vaccine

unless proved by the causality assessment analysis. The

National Expert Group on Vaccine Administration for COVID-

19 (NEGVAC), an additional body of experts, is also involved

in providing guidance on vaccine safety and surveillance,

thus, aiding in the prompt identification of AEFIs for the

purpose of identifying and understanding evolving trends in

the disease and taking prompt action. 2,116 serious and

severe AEFIs have been reported from 1,19,38,44,741 doses

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of COVID-19 vaccine administered till 24.11.2021. While a

report of rapid review and analysis completed for 495 cases

had been submitted, a further report of 1,356 serious and

severe AEFI cases had been presented to the NEGVAC and

the rapid review and analysis of balance cases was

underway. Press releases around a report on bleeding and

clotting events following COVID-19 vaccination being

submitted to the MoHFW by the National AEFI Committee and

on clarification on deaths following vaccination and process

of causality assessment were placed before this Court.

Therefore, the Union of India submitted that there was

continuous monitoring and examination of AEFI cases in India

and there is no basis for the allegations around AEFIs not

being properly collected and lack of transparency in their

investigation.

82.From the material placed before us, we note that the

National AEFI Surveillance Secretariat has been functioning

for 10 years and as has been pointed out, there is a well-

established protocol in place for identification and monitoring

of AEFIs. The website of the MoHFW carries the results of

causality assessment of AEFI cases, from which the public

can obtain relevant information pertaining to AEFIs. We have

been informed that a thorough causality assessment analysis

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of AEFIs is carried out by experts and not every severe

disease and death can be attributed to vaccination.

Reactions are examined by experts specifically trained to

undertake causality analysis before notifying such reactions

as adverse events arising from vaccination. There is a well-

defined mechanism for collection of data relating to adverse

events that occur due to COVID-19 vaccines and the

Government of India has taken steps to direct all concerned

medical professionals at the ground level to report adverse

events. Even medical practitioners at private hospitals are

associated with reporting of adverse events. Therefore, we

are not inclined to accept the broad-strokes challenge

mounted by the Petitioner that the surveillance system of

AEFIs in this country is faulty and the correct figures of those

who have suffered any side effects, severe reactions or

deaths post-inoculation have not been disclosed.

83.As regards the contention of the Petitioner on

abandoning of Phase III trials, we note that unblinding of

participants during the Phase III trial was done on the

recommendation of the SEC. The Union of India has

emphasized that at every stage, the deliberations of domain

experts, which involved discussions with the manufacturers,

focused on safety and immunogenicity of the vaccines and it

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was only when there was consensus among domain experts

that it was safe to extend the immunisation drive beyond the

category of ‘healthcare workers / frontline workers’, the

appropriate decisions were taken. In doing so, the available

trial data, trajectory of the pandemic, evidence, future

contingencies and several other factors have always been

heeded. There is no challenge to the decision of the SEC, a

body of domain experts, as being unreasonable or arbitrary,

nor have we been called upon to determine whether

adequate time was devoted to recognise all relevant

reactions as vaccine-related reactions prior to such

unblinding. What the Petitioner seeks is the monitoring of all

adverse events and publication of the results of

investigation. The Union of India has painstakingly taken this

Court through the details of the procedure followed to closely

monitor, review and escalate the incidence of AEFIs to

appropriate authorities. As regards previously unknown /

unidentified reactions seen during the monitoring of AEFIs at

the time of vaccine administration, the Union of India has

elaborated on the role of the PvPI and the CDSCO, which

collate and study such reactions. We believe this adequately

addresses the Petitioner’s concerns, as this Court has been

informed that previously unidentified events are also being

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taken into consideration and investigated. We trust the

Union of India to have the appropriate authorities ensure that

this leg of the AEFI surveillance system is not compromised

with while meeting the requirements of the rapid review and

assessment system followed at the national level.

84. The Petitioner had taken issue with the present system

to the extent it allows only DIOs or the vaccinators to report

AEFIs. According to the Petitioner, the repository of AEFIs

should be as detailed as the VAERS in the United State of

America. The Petitioner further submitted that individuals

and doctors must be able to report adverse events, with the

reporter being given a unique identification number and the

reports being openly accessible. The response of the Union

of India on this issue is that the DIOs have been instructed to

set up a network with private hospitals to report AEFIs.

Training has been provided to state officers, medical officers,

private practitioners and frontline health workers on their

role in AEFI surveillance. Even auxiliary nurse midwives

have been instructed to notify all AEFIs. However, we are in

agreement with the suggestion made by the Petitioner that

there should be a mechanism by which individuals and

private doctors should be permitted to report suspected

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adverse events. Information relating to adverse effects

following immunisation is crucial for the purpose of

understanding the safety of the vaccines that are being

administered, apart from being instrumental in further

scientific studies around the pandemic. There is an imminent

need for collection of requisite data of adverse events and

wider participation of people in reporting the adverse events

is necessary for the purpose of gathering correct information.

Thus, the Union of India is directed to facilitate the reporting

of suspected adverse events by individuals and private

doctors on a virtual platform and the reports so made shall

be publicly accessible after being given unique identification

numbers, without listing any personal or confidential data of

the persons reporting. All necessary steps to create

awareness of, and to navigate, this platform for self-reporting

shall be effectuated by the Government, roping in and

training relevant participants right from the ground level of

vaccine administration.

IV. Vaccination of Children

85.The opinion of the Petitioner is that children are at

almost no risk from COVID-19 and instances of previously

healthy children requiring hospitalisation due to COVID-19

are exceedingly rare. While referring to articles in the Nature

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and the Lancet, the Petitioner contended that scientific

evidence shows that risk of administering vaccines to

children outweigh the benefits offered by the vaccine in

children. The Petitioner further submitted that serological

studies would show that a large number of children have

already acquired antibodies to COVID-19. The Petitioner has

highlighted the risk of myocarditis associated with the mRNA

vaccines, on the basis of which, several European countries

have recently stopped the use of Moderna vaccines for those

under the age of 30. He has also pointed out that these risks

had not been identified in the initial vaccine trials as the trial

size was too small to uncover rare risks, which were

discovered after mass vaccination. The Petitioner has sought

for results as well as the primary data of clinical trials

conducted on the paediatric population to be made public.

86.In response thereto, the Union of India contended that

paediatric vaccination is advised by global agencies such as

the WHO, the UNICEF and the CDC. Expert opinion in India

is in tune with global consensus in favour of vaccination of

children. We are informed that 8,91,39,455 doses of

COVAXIN have been administered to individuals in the age

group of 15 to 18 years as on 12.03.2022. The AEFIs

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reported are 1,739 minor complaints, 81 serious complaints

and 6 severe. According to the Union of India, the said data

would show that the vaccine does not pose threat to the

safety of children. As regards the clinical trials, para 2.4.6.2

of the GCP guidelines were relied on to show that children

are not required to be involved in research that could be

carried out equally well with adults and further that, for the

clinical evaluation of a new drug, study in children should be

carried out after the Phase III clinical trials in adults. It has

been stated that paediatric vaccination was considered at a

stage where more than substantial data on safety and

immunogenicity of COVAXIN in adults was available. To avoid

any risks, clinical trials were also conducted on a limited

number of children as per the protocol approved by domain

experts. Having found no serious adverse event in the said

trials, paediatric vaccination was initiated in a phased

manner, starting from the eldest paediatric age group of 15

to 18 years. On 12.05.2021, on the basis of

recommendations of the SEC, the CDSCO granted permission

to Respondent No. 4 to conduct Phase II / Phase III clinical

trials of COVAXIN for the age group of 2 to 18 years.

Thereafter, Respondent No. 4 had submitted an application

for grant of permission to manufacture COVAXIN paediatric

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vaccines for emergency use, which was subsequently

granted by the CDSCO. It was argued on behalf of the Union

of India that expert opinion is to the effect that paediatric

vaccinations are always preventive in nature and are

administered to avoid any risk of infection and of prolonged

clinical symptoms.

87.This Court cannot sit in judgment of leading scientific

analysis relating to the safety of paediatric vaccination.

Experts in science may themselves differ in their opinions

while taking decisions on matters related to safety and allied

aspects, but that does not entitle the Court to second-guess

expert opinion, on the basis of which the Government has

drawn up its policies. The decision taken by the Union of

India to vaccinate paediatric population in this country is in

tune with global scientific consensus and expert bodies like

the WHO, the UNICEF and the CDC have also advised

paediatric vaccination. It would not only be beyond our

jurisdiction but also hazardous if this Court were to examine

the accuracy of such expert opinion, based on competing

medical opinions. As already stated, the scope of judicial

review does not entail the Court embarking upon such

misadventures. Therefore, we reject the contention of the

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Petitioner that this Court has to intervene in paediatric

vaccination on the ground that it is unscientific.

88.With respect to results of clinical trials, we note that the

Union of India has stated that the results of clinical trials of

COVAXIN for paediatric population have already been

published. We also note that for the age group of 12 to 14

years, Biological E’s Corbevax is being administered. Keeping

in line with the WHO Statement on Clinical Trials, the

Declaration of Helsinki and the GCP guidelines, we direct the

Union of India to ensure that key findings and results of the

clinical trials of Corbevax be published at the earliest, if not

already done. Neither vaccine is an mRNA vaccine and to

this extent, the apprehensions of the Petitioner with respect

to the associated risks of mRNA vaccines are unfounded in

the present situation.

Conclusion

89.In conclusion, we have summarised our findings on the

various issues considered by us, below:

(i)Given the issues urged by the Petitioner have a bearing

on public health and concern the fundamental rights of

individuals in this country, we are not inclined to

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entertain any challenge to the maintainability of the Writ

Petition.

(ii)As far as judicial review of policy decisions based on

expert opinion is concerned, there is no doubt that wide

latitude is provided to the executive in such matters and

the Court does not have the expertise to appreciate and

decide on merits of scientific issues on the basis of

divergent medical opinion. However, this does not bar

the Court from scrutinising whether the policy in

question can be held to be beyond the pale of

unreasonableness and manifest arbitrariness and to be

in furtherance of the right to life of all persons, bearing

in mind the material on record.

(iii)With respect to the infringement of bodily integrity and

personal autonomy of an individual considered in the

light of vaccines and other public health measures

introduced to deal with the COVID-19 pandemic, we are

of the opinion that bodily integrity is protected under

Article 21 of the Constitution and no individual can be

forced to be vaccinated. Further, personal autonomy of

an individual, which is a recognised facet of the

protections guaranteed under Article 21, encompasses

the right to refuse to undergo any medical treatment in

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the sphere of individual health. However, in the interest

of protection of communitarian health, the Government

is entitled to regulate issues of public health concern by

imposing certain limitations on individual rights, which

are open to scrutiny by constitutional courts to assess

whether such invasion into an individual’s right to

personal autonomy and right to access means of

livelihood meets the threefold requirement as laid down

in K.S. Puttaswamy (supra), i.e., (i) legality, which

presupposes the existence of law; (ii) need, defined in

terms of a legitimate State aim; and (iii) proportionality,

which ensures a rational nexus between the objects and

the means adopted to achieve them.

(iv)On the basis of substantial material filed before this

Court reflecting the near-unanimous views of experts on

the benefits of vaccination in addressing severe disease

from the infection, reduction in oxygen requirement,

hospital and ICU admissions, mortality and stopping new

variants from emerging, this Court is satisfied that the

current vaccination policy of the Union of India is

informed by relevant considerations and cannot be said

to be unreasonable or manifestly arbitrary. Contrasting

scientific opinion coming forth from certain quarters to

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the effect that natural immunity offers better protection

against COVID-19 is not pertinent for determination of

the issue before us.

(v)However, no data has been placed by the Union of India

or the States appearing before us, controverting the

material placed by the Petitioner in the form of emerging

scientific opinion which appears to indicate that the risk

of transmission of the virus from unvaccinated

individuals is almost on par with that from vaccinated

persons. In light of this, restrictions on unvaccinated

individuals imposed through various vaccine mandates

by State Governments / Union Territories cannot be said

to be proportionate. Till the infection rate remains low

and any new development or research finding emerges

which provides due justification to impose reasonable

and proportionate restrictions on the rights of

unvaccinated individuals, we suggest that all authorities

in this country, including private organisations and

educational institutions, review the relevant orders and

instructions imposing restrictions on unvaccinated

individuals in terms of access to public places, services

and resources, if not already recalled. It is clarified that

in the context of the rapidly-evolving situation presented

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by the COVID-19 pandemic, our suggestion to review the

vaccine mandates imposed by States / Union Territories,

is limited to the present situation alone and is not to be

construed as interfering with the lawful exercise of

power by the executive to take suitable measures for

prevention of infection and transmission of the virus.

Our suggestion also does not extend to any other

directions requiring maintenance of COVID-appropriate

behaviour issued by the Union or the State

Governments.

(vi)As regards non-disclosure of segregated clinical data, we

find that the results of Phase III clinical trials of the

vaccines in question have been published, in line with

the requirement under the statutory regime in place, the

GCP guidelines and the WHO Statement on Clinical Trials.

The material provided by the Union of India, comprising

of minutes of the meetings of the SEC, do not warrant

the conclusion that restricted emergency use approvals

had been granted to COVISHIELD and COVAXIN in haste,

without thorough review of the relevant data. Relevant

information relating to the meetings of the SEC and the

NTAGI are available in public domain and therefore,

challenge to the procedures adopted by the expert

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bodies while granting regulatory approval to the

vaccines on the ground of lack of transparency cannot

be entertained. However, we reiterate that subject to

the protection of privacy of individual subjects, with

respect to ongoing clinical trials and trials that may be

conducted subsequently for COVID-19 vaccines, all

relevant data required to be published under the extant

statutory regime must be made available to the public

without undue delay.

(vii)We do not accept the sweeping challenge to the

monitoring system of AEFIs being faulty and not

reflecting accurate figures of those with severe reactions

or deaths from vaccines. We note that the role of the

Pharmacovigilance Programme of India and the CDSCO,

as elaborated upon by the Union of India, collates and

studies previously unknown reactions seen during

monitoring of AEFIs at the time of vaccine administration

and we trust the Union of India to ensure that this leg of

the AEFI surveillance system is not compromised with,

while meeting the requirements of the rapid review and

assessment system followed at the national level for

AEFIs.

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(viii)We are also of the opinion that information relating to

adverse effects following immunisation is crucial for

creating awareness around vaccines and their efficacy,

apart from being instrumental in further scientific studies

around the pandemic. Recognising the imperative need

for collection of requisite data of adverse events and

wider participation in terms of reporting, the Union of

India is directed to facilitate reporting of suspected

adverse events by individuals and private doctors on an

accessible virtual platform. These reports shall be made

publicly accessible, without compromising on protecting

the confidentiality of the persons reporting, with all

necessary steps to create awareness of the existence of

such a platform and of the information required to

navigate the platform to be undertaken by the Union of

India at the earliest.

(ix)On paediatric vaccination, we recognise that the decision

taken by the Union of India to vaccinate children in this

country is in tune with global scientific consensus and

expert bodies like the WHO, the UNICEF and the CDC and

it is beyond the scope of review for this Court to second-

guess expert opinion, on the basis of which the

Government has drawn up its policy. Keeping in line with

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the WHO Statement on Clinical Trials and the extant

statutory regime, we direct the Union of India to ensure

that key findings and results of the relevant phases of

clinical trials of vaccines already approved by the

regulatory authorities for administration to children, be

made public at the earliest, if not already done.

90.We express our gratitude to the learned counsel on

either side for their able assistance in enabling this Court to

reach the above conclusion.

91.The Writ Petition is disposed of accordingly.

.....................................J.

[ L. NAGESWARA RAO ]

.....................................J.

[ B. R. GAVAI ]

New Delhi,

May 2, 2022

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