Jacob Puliyel vs Union of India - Supreme Court Judgment 2022

Dr. Jacob Puliyel vs Union of India - Supreme Court Judgment 2022 (Judgment on Vaccination) Dr. Jacob Puliyel vs Union of India - Supreme Court Judgment 2022 (Judgment given below)


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 long5 | P a g e
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 counteraffidavit 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 peerreviewed 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
people1
. 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 COVID19 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. Newsom13 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 unconstitutional16
. 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 logical17. 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 arbitrary18
.
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 experience19. 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
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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 adhoc 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
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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 nittygritty 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
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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,
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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
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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
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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, Vellore25, 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 Delhi26, 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 RTPCR 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 doseeffect 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, Patna27
,
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 (TAGVE). 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 COVID19 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/mediacentre/sections/statements/2022/statement-update-on-covid-19-omicron-wavethreatening-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 COVID19 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-inthe-context-of-the-circulation-of-the-omicron-sars-cov-2-variant-from-the-whotechnical-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 13.04.202231. The Union of India
has placed considerable material on record in terms of
31 Available at https://www.who.int/emergencies/diseases/novel-coronavirus2019/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
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“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 COVID19, 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
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effect that vaccine mandates were not considered necessary
for addressing the risk of the outbreak or spread of COVID19, 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
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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
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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
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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
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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 lifethreatening 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
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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
Epidemiology41, which has analysed data from 68
countries available as of 03.09.2021 and has found that
“at the country level, there appears to be no discernible
relationship between percentage of population fully
vaccinated and new COVID-19 cases”. It is further
stated therein that in fact higher percentage of
population fully vaccinated have higher COVID-19 per 1
million people.
(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)
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53. While we are aware that courts cannot decide whether
natural immunity is more resilient as compared to vaccineacquired 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 reexamined, 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
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on the basis of the National Family Health Survey – 5 (2019-
21) shows that (i) in the age group of 15-49 years, 57 per
cent of women and 25 per cent of men are anaemic, (ii)
amongst individuals aged above 15 years, 13.5 per cent of
women and 15.6 per cent of men have high or very high
blood sugar level or take medicines to control blood sugar
level, (iii) amongst individuals aged above 15 years, 21.3 per
cent of women and 24 per cent of men have hypertension or
elevated blood pressure or take medicines to control blood
pressure. Further, as per the 75th Round National Sample
Survey (NSS), conducted from July 2017 to June 2018, the
average age of the elderly population in India was 67.5
years, with 67.1 per cent of India’s elderly living in rural
areas. A study was conducted43 on the basis of the data
from the NSS, aiming to highlight the vulnerability of the
aged amidst the COVID-19 pandemic. According to the
study, out of every 100 elderly, 27.7 persons reported
ailments 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)
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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 care44
.
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
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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
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(b) A study conducted on breakthrough infection in
Massachusetts in July, 2021 and reported in the
Morbidity and Mortality Weekly Report46, which
investigated 469 COVID-19 cases that had been
identified among the Massachusetts residents who had
travelled to a town where multiple large public events
had been held and 346 cases, i.e., 74 per cent of the
infections occurred in fully vaccinated individuals.
Findings from the investigation suggest that even
jurisdictions without substantial or high COVID-19
transmission might consider expanding prevention
strategies, including masking in indoor public settings
regardless of vaccination status, given the potential risk
of infection during attendance at large public gatherings
that include travelers from many areas with differing
levels of transmission.
The Petitioner has also cited various news articles reporting
instances of breakthrough infections in fully vaccinated
people, carrying as much virus as those who were
unvaccinated, abroad as well as within India.
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
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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
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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
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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
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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 rapidlychanging 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
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and the Subject Expert Committee (SEC), the body which
sends recommendations to the Central Drugs Standard
Control Organisation, while deliberating on the applications
and data of the vaccine manufacturers, and the names and
institutional relationships of the experts who participated in
each of these meetings. Mr. Bhushan relied on the 59th
Report of the Parliamentary Standing Committee on Health
and Family Welfare, in support of his submission on a need
for transparency in the decision-making of the CDSCO and
other regulatory authorities.
63. In response, the Union of India submitted that the
procedure prescribed under the statutory regime was
scrupulously followed before granting emergency approval of
the vaccines manufactured by Respondent Nos. 4 and 5. As
per the extant statutory regime, permission to import or
manufacture new drugs including vaccines or to undertake
clinical trials is granted by the Central Drugs Standard
Control Organisation (CDSCO). The CDSCO, in consultation
with the SEC, evaluates the applications for grant of such
permission, which are to be accompanied with data as
required under the Second Schedule to the New 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
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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.
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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
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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 COVID19 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 COVID19 (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 wellestablished 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 welldefined 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 secondguess 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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