MANU/SC/0566/2022

Equivalent/Neutral Citation: 2022 INSC 503, 2022(7)SC ALE256, 2022 (3) SC J 631, [2022]3SC R471

IN THE SUPREME COURT OF INDIA

Writ Petition (Civil) No. 607 of 2021
Decided On: 02.05.2022
Jacob Puliyel Vs. Union of India (UOI) and Ors.
Hon'ble Judges/Coram:
L. Nageswara Rao and B.R. Gavai, JJ.
Counsels:
For Appellant/Petitioner/Plaintiff: Prashant Bhushan, AOR Cheryl D'souza, Adv.
For Respondents/Defendant: Tushar Mehta, SGI, Aishwarya Bhati, Ld. ASG, Ketan Paul,
Aman Sharma, Shivika Mehra, Ameyavikrama Thanvi, Rajat Nair, Kanu Aggarwal, Mayank
Pandey, Advs., Gurmeet Singh Makker, AOR, S. Guru Krishna Kumar, Sr. Adv., Vipin
Nair, AOR, P.B. Suresh, Sughosh Subramanyam, Arindam Ghosh, Agnish Aditya, Karthik
Jayshankar, Prakash Baghel, Advs., Malvika Kapila, AOR, Shyel Trehan, Hitesh Jain,
Monisha Mane Bhangale, Warisha Parkar, Bhagya Yadav, Tanwangi Shukla, Advs., Mrinal
Gopal Elker, AOR, Rahul Chintis, Adv., Sachin Patil, AOR, Aaditya A. Pande, Geo Joseph,
Advs., Jyoti Mendiratta, AOR, Amit Anand Tiwari, AAG, Joseph Aristotle S., AOR, Mary
Mitzy, Devyani Gupta, Tanvi Anand, Nupur Sharma, Shobhit Dwivedi, Sanjeev Kumar
Mahara, Advs., Shailesh Madiyal, AOR, Meenakshi S. Kamble, Hitesh Kumar Sharma, S.K.
Rajora, Akhileshwar Jha, Kavita S. More, Advs., Amit Kumar, AOR, Ajay Bansal, Gaurav
Yadava and Veena Bansal, Advs.
Case Category:
LETTER PETITION AND PIL MATTER
Case Note:
Civil - Vaccination - Trial data - Release - Article 21 of the Constitution of
India, 1950 - The Petitioner has filed present Writ Petition in public interest
seeking to 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 direct the Respondent No. 2 to
disclose the detailed minutes of the meetings of the Subject Expert
Committee and the NTGAI with regard to the vaccines as directed by the 59th
Parliamentary Standing Committee Report and the members who constituted
the committee for the purpose of each approval meeting - Whether Union of
India is directed 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?
Facts:
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

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constitution of the expert bodies, imperfect evaluation of Adverse Events
Following Immunisation (AEFIs) 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. 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 to 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 direct the
Respondent No. 2 to disclose the detailed minutes of the meetings of the
Subject Expert Committee and the NTGAI with regard to the vaccines as
directed by the 59th Parliamentary Standing Committee Report and the
members who constituted the committee for the purpose of each approval
meeting; and 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 direct the Respondents to disclose
the post vaccination data regarding adverse events, vaccines 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 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
Held, while disposing of the petition
1. 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.[40]
2. With regard to 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. With respect to the infringement of
bodily integrity and personal autonomy of an individual considered in the light
of vaccines and other public health measures introduced to deal with the
COVID-19 pandemic, we are of the opinion that bodily integrity is protected
under Article 21 of the Constitution and no individual can be forced to be
vaccinated. Further, personal autonomy of an individual, which is a
recognised facet of the protections guaranteed under Article 21, encompasses
the right to refuse to undergo any medical treatment in the sphere of
individual health. However, in the interest of protection of communitarian
health, the Government is entitled to regulate issues of public health concern

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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 Justice K.S.
Puttaswamy and Ors. v. Union of India (UOI) and Ors., 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. 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. 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. On paediatric vaccination, the decision taken by the Union of India to
vaccinate children in this country is in tune with global scientific consensus
and expert bodies like the WHO, the UNICEF and the CDC and it is beyond the
scope of review for this Court to second-guess expert opinion, on the basis of
which the Government has drawn up its policy. Keeping in line with the WHO
Statement on Clinical Trials and the extant statutory regime, the Union of
India is directed 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. [89]
3. Writ Petition disposed of. [91]

JUDGMENT
L. Nageswara Rao, J.
1 . The Petitioner was a member of the National Technical Advisory Group on
Immunization (NTAGI) and was advising the Government of India on vaccines. He has
filed this Writ Petition in public interest seeking the following reliefs:
(a) Direct the Respondents to release the entire segregated trial data for each of
the phases of trials that have been undertaken with respect to the vaccines
being administered in India; and
(b) Direct the Respondent No. 2 to disclose the detailed minutes of the
meetings of the Subject Expert Committee and the NTGAI with regard to the
vaccines as directed by the 59th Parliamentary Standing Committee Report and

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 the members who constituted the committee for the purpose of each approval
meeting; and
(c) Direct the Respondent No. 2 to disclose the reasoned decision of the DCGI
granting approval or rejecting an application for emergency use authorization of
vaccines and the documents and reports submitted to the DCGI in support of
such application; and
(d) Direct the Respondents to disclose the post vaccination data regarding
adverse events, vaccines 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)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 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

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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
vaccination for COVID-19 is necessary to avoid infection. India was one of the few
countries in the world which succeeded in manufacturing vaccines for protection from
COVID-19, one of which was COVAXIN, India's indigenous vaccine and the other being
COVISHIELD, which was manufactured by Serum Institute of India with technology
transfer from AstraZeneca/Oxford University. The country started one of the largest
inoculation programmes in the world in larger public interest, while tackling challenges
of vaccine hesitancy, effect of the second wave of the pandemic and other such adverse
circumstances. The Union of India expressed serious doubts about the intention of the
Petitioner in filing this Writ Petition. As we have not seen the end of the pandemic
caused due to the COVID-19 virus, any interference with the steps taken by the Union
on the basis of the advice given by the NTAGI and other expert bodies would provide
impetus to the already prevailing vaccine hesitancy in certain Sections of the society. In
their counter-affidavit, the Union of India reminded us that decisions of domain experts
should not normally be interfered with in judicial review and that this Court should not
sit in appeal over a scientific process undertaken by domain experts on a subject which
is not the expertise of any judicial forum. The long-drawn procedure for making
applications for issuance of licenses for manufacturing vaccines and the statutory
regime governing the same have been referred to in the counter-affidavit to emphasize
that the Union of India has not been remiss in grant of emergency licences. There is a
detailed procedure for approval with checks at every stage which has been followed for
grant of emergency approval. In so far as disclosure of clinical trial data is concerned,
the Union of India referred to the National Ethical Guidelines for Biomedical and Health
Research involving Human Participants published by the ICMR, which require privacy
and confidentiality of human participants to be maintained. Accordingly, the Union of
India contended that such details pertaining to identity and records of the participants
in the clinical trial data cannot be disclosed to the public as per the prevailing statutory
regime. It was asserted by the Union of India that the remaining data has already been
made available in the public domain.
6 . On the subject of monitoring of AEFIs, the Union of India brought to our attention
established procedures and protocols in place for surveillance of AEFIs established
under the National Adverse Event Following Immunisation Surveillance Guideline.
Further, the multi-tier structure 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

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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 placed on unvaccinated
persons in public interest. The details of the restrictions have been discussed later.
8. We have heard Mr. Prashant Bhushan, learned Counsel for the Petitioner, Mr. Tushar
Mehta, learned Solicitor General of the Union of India, Mr. S. Guru Krishnakumar,
learned Senior Counsel for Respondent No. 4, Mr. Amit Anand Tiwari, learned Additional
Advocate General for the State of Tamil Nadu, Mr. Rahul Chitnis, learned Counsel for the
State of Maharashtra, Ms. Mrinal Gopal Elker, learned Counsel for the State of Madhya
Pradesh and Ms. Shyel Trehan, learned Counsel for Respondent No. 5.
Preliminary Issues
I. Maintainability
9. The learned Solicitor General raised a preliminary objection as to the maintainability
of the Writ Petition which is filed in public interest. He stated that this Writ Petition, if
entertained, would harm public interest, as any observation made by this Court against
vaccination would result in potential threat of vaccine hesitancy.
10. The Petitioner is a paediatrician, who was a member of the NTAGI earlier. It has
been stated in the Writ Petition that he has a number of publications in internationally
peer-reviewed medical journals to his credit. The Petitioner strongly believes that there
cannot be coercive vaccination, especially of inadequately tested vaccines, which
amounts to an intrusion into the individual's personal autonomy. He is also of the firm
opinion that an individual is deprived of the opportunity to give informed consent in the
absence of availability of segregated data of clinical trials of the vaccines. He has also
aired further grievances pertaining to poor evaluation and reporting of AEFIs.
11. This Court is entitled to entertain a public interest litigation moved by a person
having knowledge in the subject-matter of the lis and, thus, having an interest therein,
as contradistinguished from a busybody, in the welfare of people 1. The Union of India
has objected to the maintainability of the Writ Petition on the ground that the questions
raised by the Petitioner may result in raising doubts in the minds of the citizenry about
the vaccination, adding to the already existing vaccine hesitancy in the country. The
consequence would be a debilitating effect on public health and therefore, the petition
cannot be said to be in public interest. In other words, the maintainability of the Writ
Petition is raised on the ground that the sensitive issue of vaccination should not be
dealt with by this Court, as it 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

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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 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
MANU/SC/0805/2011 : (2011) 8 SCC 274, G. Sundarrajan v. Union of India
MANU/SC/0466/2013 : (2013) 6 SCC 620 and Shri Sitaram Sugar Co. Ltd. v. Union of
India MANU/SC/0249/1990 : (1990) 3 SCC 223. 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
MANU/USSC/0257/1905 : 197 US 11 (1905), Zucht v. King MANU/USSC/0031/1922 :
260 US 174 (1922) 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 [2021] NSWSC
1320 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 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.
1 4 . 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 judgment of the High Court
of New Zealand in Ryan Yardley v. Minister for Workplace Relations and Safety [2022]
NZHC 291 in support of his submission that the scientific data and evidence that was
produced before the High Court of New Zealand was assessed to adjudge the efficacy of
vaccines in preventing transmission of the COVID-19 virus.
15. It was further argued by Mr. Bhushan that the judgments relied upon by the Union
of India are not applicable to the facts of this case. He relied upon the judgments of this
Court in Delhi Development Authority v. Joint Action Committee, Allottee of SFS Flats
MANU/SC/0202/2008 : (2008) 2 SCC 672, Directorate of Film Festivals v. Gaurav
Ashwin Jain MANU/SC/1778/2007 : (2007) 4 SCC 737 and an order of this Court in
Distribution of Essential Supplies and Services During Pandemic, In re
MANU/SC/0365/2021 : (2021) 7 SCC 772 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

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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
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.
1 7 . 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 MANU/USSC/0007/2020 : 141 S. Ct. 63 (2020) 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 pandemic.
Gorsuch, J., who wrote a concurring opinion, observed that Jacobson (supra) hardly
supports cutting the Constitution loose during a pandemic. Jacobson (supra) was
distinguished by Gorsuch, J., who held that the Court did not interfere with the
challenged law in Jacobson (supra) only because it did not "contravene the Constitution
of the United States" or "infringe any right granted or secured by" it. A word of caution
sounded by Gorsuch, J. is to the effect that the Court cannot stay out of the way in
times of crisis, when the Constitution is under attack. In his dissent, Roberts, C.J. held
that the injunction sought would not be in public interest, especially when it concerns
public health and safety needs which calls for swift government action in everchanging
circumstances. He relied upon the earlier order passed by the US Supreme Court in
South Bay United Pentecostal Church v. Newsom 140 S. Ct. 1613 (2020) wherein it was
recognised that courts must grant elected representatives broad discretion when they
undertake to act in areas fraught with medical and scientific uncertainties.
18. Biden v. Missouri (supra) related to vaccine mandates for healthcare providers. The
Secretary of Health and Human Services issued a Rule on being convinced that
vaccination of healthcare workers in facilities in the Medicare and Medicaid Programs
against COVID-19 was "necessary for the health and safety of individuals to whom care
and services are furnished". The said Rule was challenged and the US District Courts for
the Western District of Louisiana and the Eastern District 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".
1 9 . 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
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

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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 [2021] NSWCA 299.
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 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 MANU/NZCA/0056/2012 : [2012] NZCA 184, the NZ High
Court held that the Crown has the burden to demonstrate that a limitation of a
fundamental right is demonstrably justified. We have come to know that in the time
since the 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.
2 1 . We shall now proceed to analyse the precedents of this Court on the ambit of
judicial review of public policies relating to health. It is well settled that the Courts, in
exercise of their power of judicial review, do not ordinarily interfere with the policy
decisions of the executive unless the policy can be faulted on grounds of mala fide,
unreasonableness, arbitrariness or unfairness etc. Indeed, arbitrariness, irrationality,
perversity and mala fide will render the policy unconstitutional 2. It is neither within the
domain of the courts nor the scope of judicial review to embark upon an enquiry as to
whether a particular public policy is wise or whether better public policy can be
evolved. Nor are the courts inclined to strike down a policy at the behest of a Petitioner
merely because it has been urged that a different policy would have been fairer or wiser
or more scientific or more logical 3. Courts do not and cannot act as 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
arbitrary4.

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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 experience5.
Where expertise of a complex nature is expected of the State in framing rules, the
exercise of that power not demonstrated as arbitrary must be presumed to be valid as a
reasonable restriction on the fundamental right of the citizen and judicial review must
halt at the frontiers. The Court cannot re-weigh and substitute its notion of expedient
solution. Within the wide judge-proof areas of policy and judgment open to the
government, if they make mistakes, correction is not in court but elsewhere. That is the
comity of constitutional jurisdictions in our jurisprudence. We cannot evolve a judicial
policy on medical issues. All judicial thought, Indian and Anglo-American, on the
judicial review power where Rules under challenge relate to a specialised field and
involve sensitive facets of public welfare, has warned courts of easy assumption of
unreasonableness of subordinate legislation on the strength of half-baked studies of
judicial generalists aided by the ad-hoc learning of counsel. However, the Court
certainly is the constitutional invigilator and must act to defend the citizen in the
assertion of his fundamental rights against executive tyranny draped in disciplinary
power.6
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 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.7 In Delhi Development
Authority (supra), this Court held that an executive order termed as a policy decision is
not beyond the pale of judicial review. Whereas the superior courts may not interfere
with the nitty-gritty of the policy, or substitute one by the other but it will not be
correct to contend that the court shall lay its judicial hands of, 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;
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.
2 4 . 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

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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, 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 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 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

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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 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 MANU/SC/0232/2018 : (2018) 5 SCC 1, Aruna Ramachandra Shanbaug
v. Union of India MANU/SC/0176/2011 : (2011) 4 SCC 454 and K.S. Puttaswamy v.
Union of India MANU/SC/1044/2017 : (2017) 10 SCC 1. 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.
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."
(b) A study conducted by researchers of Christian Medical College, Vellore8,
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

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 partial vaccination." The results of the study also indicate that compared with
unvaccinated patients, partially vaccinated patients had milder disease, reduced
requirement of oxygen, hospital admission, ICU admission and mortality. Again,
when fully vaccinated patients were compared with unvaccinated individuals,
full vaccination was associated with significantly less disease severity,
requirement of respiratory supports, hospital admission, ICU admission and
mortality. The study further showed that majority of the patients screened who
required hospitalisation were unvaccinated.
(c) A study conducted by researchers of All India Institute of Medical Sciences
(AIIMS), New Delhi9, which states that: "We evaluated the association between
COVID-19 vaccination status (the number of vaccine shots received and time
interval since the last dose) and the vaccines' clinical efficacy in India in
preventing the disease and its severity. This study has several noteworthy
findings. Firstly, both the Indian vaccines provided a significant protective role
in preventing the disease among people who had a clinical suspicion of COVID-
19. Secondly, These vaccines protected from progression to a severe form of
the disease among the patients who turned RT-PCR positive despite getting
vaccinated. The probability of hospitalisation was about eight times less, and
ICU admission/death was about fourteen times lesser among fully vaccinated
patients in comparison to unvaccinated RT-PCR positive patients. Thirdly, the
protective efficacy of the vaccines had a dose-dependent effect. The
effectiveness is maximum among individuals who received both doses of
vaccination at least two weeks before the onset of their symptoms."
(d) A study conducted by researchers of AIIMS, Patna10, 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 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

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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.
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.
3 2 . 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 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 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,

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San Francisco and a molecular biologist with 33 years of research experience, 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; several countries imposed lockdowns to
arrest the spread of the deadly disease, which has led to a drastic loss of human life
worldwide and presented a threat of extraordinary proportions to public health, food
systems, economic and social conditions. Scientific studies and research for
manufacture of vaccines to prevent severe infections were undertaken on an emergency
basis. Towards the end of 2020, emergency vaccines came to be administered in the
western part of the world. However, by then, the spread of COVID-19 around the globe
was considerable. Around the same period, a variant called B.1.1.7 was found in the
United Kingdom. The said variant was renamed as Alpha, as per the naming scheme
recommended by the expert group convened by the WHO, which also includes scientists
from the WHO's Technical Advisory Group on Virus Evolution (TAG-VE). Another
variant, called B.1.351 and later renamed as Beta, was found to be linked to a second
wave of infections in South Africa. Both these variants were identified as Variants of
Concern (VOC) by the WHO on 18.12.2020, meaning that they were variants with
genetic changes that would affect virus characteristics such as transmissibility, disease
severity or immune escape and through a comparative assessment, are found to be
associated with an 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 11.01.2021.11
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 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.12 Though the

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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.
3 7 . The WHO established the Technical Advisory Group on COVID-19 Vaccine
Composition (TAG-CO-VAC) in September, 2021. According to the statement made by
the said group on 11.01.2022 in the context of circulation of the Omicron variant, the
group reviews and assesses the public health implications of emerging VOCs on the
performance of COVID-19 vaccines and provides recommendations on COVID-19
vaccine composition. The said group is developing a framework to analyse the evidence
on emerging VOCs in the context of criteria that would trigger a recommendation to
change COVID-19 vaccine strain composition and will advise the WHO on updated
vaccine compositions, as required. The group has spelt out in their statement that at
present, with the available COVID-19 vaccines, the focus is on reducing severe disease
and death, as well as protecting health systems. According to the TAG-CO-VAC,
vaccines, which have received WHO Emergency Use Listing across several vaccine
platforms, provide a high level of protection against severe disease and death caused by
VOCs. The group takes note of data which indicates that vaccine effectiveness will be
reduced against symptomatic disease caused by the Omicron variant but at the same
time, it was of the opinion that protection against severe disease is more likely to be
preserved. Along with the Strategic Advisory Group of Experts on Immunization (SAGE)
and its Working Group on COVID-19 vaccines, TAG-CO-VAC has recommended COVID-
19 vaccines for priority populations worldwide to provide protection against severe
disease and death globally and, in the longer term, to mitigate the emergence and
impact of new VOCs by reducing the burden of infection.13
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 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 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

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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 13.04.202214. The Union of India has placed considerable material on record in
terms of scientific briefs and published studies which stand testimony to the
significance of vaccination as a crucial public health intervention in this pandemic and
its continued benefits to individual health as well as public health infrastructure.
Vaccination of a majority of the population of this country has undoubtedly been
instrumental in preventing severe disease, hospitalisation and deaths, and 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
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 MANU/SC/0309/2014 : (2014) 5 SCC 438, 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. 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' MANU/SC/0733/1998 : (1998) 8 SCC 296.
Placing reliance on Kharak Singh v. State of U.P. ( MANU/SC/0085/1962 : 1964) 1 SCR
332, Gobind v. State of M.P. MANU/SC/0119/1975 : (1975) 2 SCC 148 and a
judgment of the US Supreme Court in Jane Roe v. Henry Wade MANU/USSC/0177/1972
: 410 US 113 (1973), this Court held that though non-disclosure of medical information
of an individual can be traced to the right to privacy protected Under Article 21, it is not
absolute and is subject to action lawfully taken for protection of health or morals or

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protection of rights and freedoms of others.
43. In Association of Medical Super Speciality Aspirants and Residents v. Union of India
MANU/SC/1112/2019 : (2019) 8 SCC 607, to which one of us was a party (L.
Nageswara Rao, J.), this Court, while considering validity of service bonds to be
executed at the time of admission to postgraduate and superspeciality courses in
medical science, held as follows:
3 3 . 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 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.
4 5 . Considering the submissions of the applicants therein that the order placed
unjustified limitations on fundamental rights protected by the NZ Bill of Rights, the NZ
High Court held that the impugned order limits the right of affected workers to refuse to
undergo a medical treatment as well as the right (or significant interest) to retain
employment. While examining the question of whether the limitation of the said rights
was justified, the NZ High Court noted that the order mandating vaccinations for the
police and defence personnel was imposed to ensure the continuity of services that are
essential for public safety, national defence, or crisis response, and to promote public
confidence in those services, rather than to stop the spread of COVID-19. The NZ High
Court further took note of the fact that by October, 2021, 83.1 per cent of police
personnel had received at least one or more doses of the vaccination, and 70.1 per cent
had received both doses. By the time the order took effect on 17.01.2022, there were
only 164 unvaccinated staff members in an overall workforce of 15,682 staff. It was
found that the position within the New Zealand Defence Forces (NZDF) was similar.
From a total of 15,480 NZDF personnel, 3,048 are civil staff. As on 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

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Court was of the view that the relatively low number of unvaccinated police and NZDF
personnel impacted by the order may not, by itself, mean that the order was not a
reasonable limit on rights that can be demonstrably justified, if there was evidence to
establish that the presence of unvaccinated personnel, even in small numbers, created a
materially higher risk to the remaining workforce. While observing that the evidence on
this issue is sparse, the NZ High Court referred to the evidence of Dr. Petrovsky, who
deposed that vaccination has potential benefit in reducing the severity of disease, even
with the Omicron variant. However, in his view, mandatory vaccination did not assist in
preventing workers in affected roles from contracting COVID-19, or transmitting it to
others. The NZ High Court further considered the evidence of Dr. Town, the Ministry's
Chief Science Adviser, who, according to the NZ High Court, did not directly respond to
Dr. Petrovsky's analysis of the effectiveness of the 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[2021] NZHC
3012, where the precautionary principle had been applied, to make the point that even a
modest vaccination protection on a modest number of personnel needs to be considered
in the context of potential effects of a pandemic. The NZ High Court referred to a
judgment of the Federal Court of Ontario in Spencer v. Attorney General of Canada
[2021] FC 361 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 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

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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 effect that vaccine mandates were not considered
necessary for addressing the risk of the outbreak or spread of COVID-19, the High Court
made it clear that while vaccination significantly improved the prospects of avoiding
illness and death even with the Omicron variant, given the variant's propensity to break
through vaccination barriers, it concluded that there was no real threat to the continuity
of these essential services that the impugned order sought to address. Further, finding
that suspension of the unvaccinated would address any potential problems, the
terminations arising from the order in light of the temporary, albeit significant, period
of peak impact of the infection, were found to be disproportionate and unjustified.
While the Petitioner has sought support from this judgment to demonstrate how courts
in other jurisdictions have struck down vaccine mandates taking into account Omicron's
impact on the effectiveness of vaccines in addressing spread, we believe that this
judgment may not be of much assistance to us for determining the issue at hand for two
reasons. First, the judgment expressly recognised that the impugned vaccine mandate
was not brought about to suppress the spread of the virus but to ensure continuity of,
and confidence in, essential services, such as the police and the 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 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

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 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 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 health concerns by imposing certain
limitations on individual rights that are reasonable and proportionate to the
object sought to be fulfilled.
50. The submission made on behalf of the Petitioner is that the Delta and Omicron
variants have shown breakthrough infections and it is clear from the scientific data that,
an unvaccinated person does not pose a greater risk than a vaccinated person in terms
of transmission of the infection. While this submission has been dealt with
subsequently, we believe that as long as there is a risk of spreading the disease, there
can be restrictions placed on individuals' rights in larger public interest. Further,
extensive material from experts has been placed before this Court, which extol the
benefits of vaccination in tackling the severe and life-threatening impact of the
infection, specifically in terms of reduction in oxygen requirement, hospitalisation, ICU
admissions and mortality, thereby easing the disproportionate burden from the upsurge
of severe cases on the health infrastructure, which has already been witnessed by the
country during the second wave of the pandemic where resources were woefully
inadequate to stem the impact of the Delta variant on a then scarcely vaccinated
population. We hasten to add that restrictions that are 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
5 1 . The grievance of the Petitioner pertains to the vaccine mandates imposed by

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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:
(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:
(a) An Article in the scientific journal Nature15, 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 Epidemiology16, 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.
53. While we are aware that courts cannot decide whether natural immunity is more
resilient as compared to vaccine-acquired immunity and we do not seek to substitute
our own views in matters of differences in scientific opinion, we cannot help but notice
that in the first Article referred to above, published in Nature, it has been noted that
immunity in convalescent individuals (i.e., those who have recovered from COVID-19)
can be boosted further by vaccinating them after a year. According to the said article,
this results in the generation of more plasma cells, together with an increase in the
level of SARS-CoV-2 antibodies that was up to 50 times greater than before vaccination.
In the second Article referred to above, published in the European Journal of
Epidemiology, it has been mentioned therein that the interpretation of the findings
should be as follows: "The sole reliance on vaccination as a primary strategy to mitigate

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COVID-19 and its adverse consequences needs to be re-examined, especially
considering the Delta (B.1.617.2) variant and the likelihood of future variants. Other
pharmacological and non-pharmacological interventions may need to be put in place
alongside increasing vaccination rates." We do not see how these conclusions and
interpretations are in favour of an argument that natural 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.17
5 5 . It should be noted that the submission made on behalf of the Petitioner
championing natural immunity is from the perspective of a healthy person. Even the
Petitioner does not dispute the fact that the same standard is not applicable to persons
with co-morbidities, the sick and elderly people. A cursory glance at the data recorded
in the India Fact Sheet on the basis of the National Family Health Survey - 5 (2019-21)
shows that (i) in the age group of 15-49 years, 57 per cent of women and 25 per cent
of men are anaemic, (ii) amongst individuals aged above 15 years, 13.5 per cent of
women and 15.6 per cent of men have high or very high blood sugar level or take
medicines to control blood sugar level, (iii) amongst individuals aged above 15 years,
21.3 per cent of women and 24 per cent of men have hypertension or elevated blood
pressure or take medicines to control blood pressure. Further, as per the 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 conducted18 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 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 care19.
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

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scientific opinion supporting the argument of natural immunity offering better protection
against infection from COVID-19 and whether these scientific opinions can be
substantiated are not pertinent for determination of the issue before this Court.
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 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 Health20, 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."
(b) A study conducted on breakthrough infection in Massachusetts in July, 2021
and reported in the Morbidity and Mortality Weekly Report21, 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.
5 8 . 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

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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 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 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 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,

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we reiterate that vaccines effectively address severe disease arising from COVID-19
infections, are instrumental in reducing oxygen requirement, hospital and ICU
admissions and mortality and continue to be the solution to stopping new variants from
emerging, as per the advice of the WHO. Since the time arguments were heard in the
matter, we have come to know of more variants that have now come into circulation.
Given the rapidly-changing nature of the virus and the clear purpose served by the
approved vaccines in terms of restoration and protection of public health, our
suggestions with respect to review of vaccine mandates are limited to the present
situation alone. This judgment is not to be construed as impeding, in any manner, the
lawful exercise of power by the executive to take suitable measures for prevention of
infection and transmission of the virus in public interest, which may also take the form
of restrictions on unvaccinated people in the 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
(2011) 12 SCC 481 and a judgment of the Delhi High Court dated 15.01.2019 in W.P.
(C) No. 343 of 2019 titled Master Hridaan Kumar (minor) v. Union of India with respect
to the importance of disclosure of relevant technical data and informed consent.
Additionally, the last amended version of the Declaration of Helsinki - Ethical principles
from medical research involving human subjects (hereinafter, the "Declaration of
Helsinki") and a statement by the WHO dated 09.04.2015 on 'public disclosure of
clinical trial results' (hereinafter, the "WHO Statement on Clinical Trials") were pressed
into service to establish the significance of disclosure of data of clinical trials, so as to
enable the data to be assessed independently, and not only by the vaccine manufacturer
who has a commercial interest in production of the vaccines. Mr. Bhushan submitted
that there would be no invasion of privacy of individuals, if personal identification data
and past medical history of the trial participants was redacted and the raw data
pertaining to clinical trials is made public. The further grievance of the Petitioner
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
N T A G I 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

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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 SECis 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 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 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.
6 5 . Thereafter, Respondent No. 4 submitted the interim safety and efficacy data of

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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. 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 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.
6 6 . COVISHIELD (ChAdOx1 nCoV-19 Corona Virus Vaccine (Recombinant))
manufactured by Respondent No. 5 was developed by the Serum Institute of India in
collaboration with Oxford University and AstraZeneca under technology transfer. As the
clinical development of the said vaccine, including Phase I clinical trial, was conducted
in other countries, Phase II/III clinical trials were conducted by Respondent No. 5 in the
country. Application for permission to manufacture COVISHIELD for test, examination
and analysis was first made by Respondent No. 5 on 03.05.2020. The safety,
immunogenicity and efficacy data of Phase II/III clinical trials of the AstraZeneca
vaccine carried out in the United Kingdom, Brazil and South Africa were submitted to
the SEC, along with the safety and immunogenicity data from the ongoing Phase II/III
clinical trials in India. On reviewing this data as well as the approval dated 30.12.2020
granted by the United Kingdom's Medicines and Healthcare Products Regulatory
Authority (hereinafter, the "UK-MHRA") for the AstraZeneca vaccine along with its
conditions/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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6 7 . We were directed to Rule 25 of the 2019 Rules, framed under the Drugs and
Cosmetics Act, 1940, which provides that the clinical trial shall be conducted in
accordance with approved clinical trial protocol and other related documents as per the
requirements of Good Clinical Practices (GCP) guidelines and the other rules. The expert
committee set up by the CDSCO Under Rule 25(vi) in consultation with clinical experts
formulated the GCP guidelines for generation of data on drugs. The 'Ethical Principles',
which are part of the said guidelines, protect principles of privacy and confidentiality of
human subjects of research. The learned Solicitor General also relied upon para 2.4.4 of
the GCP guidelines, which require safeguarding of the confidentiality of research data
that might lead to identification of individual subjects. He further referred to the
important role played by the Ethics Committee Under Rule 11 of the 2019 Rules, which
includes safeguarding the rights, safety and well-being of trial subjects in accordance
with the said rules. The 2019 Rules also empower the Ethics Committee to discontinue
or suspend the clinical trial in case it concludes that the trial is likely to compromise the
right, safety or well-being of the trial subject. As per the ICMR's National Ethical
Guidelines for Biomedical and Health Research involving Human Participants, the four
basic ethical principles for conducting biomedical and health research are (i) respect for
persons (autonomy), (ii) beneficence, (iii) non-malfeasance and (iv) justice. These four
basic principles have been expanded into 12 general principles, including the '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 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.
6 9 . 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 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

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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.22 In the
absence of anything on record in the present case to substantiate the statement made
by Mr. Jayaprakash Muliyil, member of the NTAGI, we are not inclined to take judicial
notice of the news Article reported in The Wire, even more so in light of the affidavit
filed on behalf of the Union of India stating that the relevant data was examined by the
expert bodies at all stages before granting emergency use approval to the vaccines. We
are also of the opinion that the evidence relating to the approval process of the Rotavac
vaccine has no relevance to the dispute in this case. On the basis of 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 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

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 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 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":
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.
Research Registration and Publication and Dissemination of Results

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 ...
3 6 . 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 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.
7 4 . The GCP guidelines are being scrupulously followed, according to the Union of
India. The principles of "public domain" in the GCP guidelines provide for research,
experimentation or evaluation in response to the research to be brought into the public
domain. The results of the clinical trials are generally to be made known through
scientific and other publications. The requirement of publication, according to the WHO,
also relates to the main findings of clinical trials to be published in a peer-reviewed
journal and the key outcomes to be made publicly available, within 12 months of study
completion. The Petitioner complains of opaqueness in clinical trials as the general
public do not have access to, and the opportunity to be aware of, all the necessary
details by segregated clinical trial data (primary datasets) not being available. There is
no challenge by the Petitioner to the GCP guidelines. As required by the WHO Statement
on Clinical Trials and the GCP guidelines, findings of the clinical trials and the key
outcomes of the trials have been published. In light of the existing statutory regime, we
do not see it fit to mandate the disclosure of primary clinical trial data, when the results
and key findings of such clinical trials have already been published.
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

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case. The grievance of the Plaintiff in the said case pertained to all data and information
for the Pfzer 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 Pfzer
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 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.
7 6 . An analysis of the submissions made by the learned Counsel appearing for the
parties and a close scrutiny of the material placed on record would show that there is a
strict statutory regime in force for grant of approvals to vaccines. Specialist bodies
established under the provisions of the Drugs and Cosmetics Act, 1940 and the Rules
framed thereunder comprise of domain experts in the relevant field, who conduct a
thorough scrutiny of the material produced by the manufacturers before granting
approval. The information provided on behalf of the Union of India substantiates that
the data provided by the vaccine manufacturers was considered by the SEC over a
period of time and several conditions were imposed at the time of recommending
approvals, which have been modified or lifted subsequently on availability of further
data arising from the clinical trials before the SEC, as can be seen from the minutes of
the meetings of the SEC, available on the website of the MoHFW. We do not agree with
the submission on behalf of the Petitioner that emergency approvals to the vaccines
were given in haste, without properly reviewing the data from clinical trials. We are also
of the opinion that the Parliamentary Standing Committee report relied upon by Mr.
Bhushan is not relevant and the lapses pointed out therein pertain to the year 2011,
which have no obvious connection to the grant of approval to Respondent Nos. 4 and 5
for the restricted emergency use of their 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 emergency use of the two vaccines. However, it is made
clear that subject to the protection of privacy of individual subjects and to the extent
permissible by the 2019 Rules, the relevant data which is required to be published
under the statutory regime and the WHO Statement on Clinical Trials shall be made
available to the public without undue delay, with respect to the ongoing post-marketing
trials of COVAXIN and COVISHIELD as well as ongoing clinical trials or trials that may
be conducted subsequently for approval of other COVID-19 vaccines/vaccine
candidates.
III. Improper collection and reporting of AEFIs

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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 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.
7 8 . Taking this argument further, the Petitioner contended that the adverse events
reporting system in India is not transparent, with obscure investigation and follow-up of
deaths and other serious adverse events after COVID-19 vaccination. The Petitioner
relied on a letter 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 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

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out documentation, investigation and causality assessment, besides training and
orientation of health care workers and Ors. involved in AEFI. According to the Union of
India, a foolproof protocol for reporting and causality assessment for any AEFI with
Universal Immunisation Program (UIP) and Non-UIP vaccines has been established. The
National AEFI Committee gets periodical reports regarding 'minor AEFIs', 'severe AEFIs'
and 'serious AEFIs'. Online reporting of all serious and severe AEFIs at the district level
to be communicated to relevant authorities at the state/national level is done on a web-
based portal, SAFEVAC (Surveillance and Action for Events Following Vaccination). All
serious and severe adverse events following vaccination even at district level are
uploaded online on SAFEVAC. It was submitted on behalf of the Union of India that case
details, scanned copies of reports are uploaded on SAFEVAC, which also has facilities
for generating dashboards and line-lists at different levels.
8 0 . Further, a similar feature of reporting of all AEFIs (including minor) by the
vaccinator was made available on the Co-WIN portal. District Immunisation Officers
(DIOs) were given the facility to report AEFI cases about which they have information
from such individuals who do not have access to Co-WIN. Departmental orders and
standard operating procedures have been issued for further investigations and sharing
of hospital records by the DIOs through Co-WIN. The Union of India has brought to the
notice of this Court that an alignment with the Pharmacovigilance Programme of India
(PvPI) under Indian Pharmacopoeia Commission has been developed for receipt of
information regarding AEFI cases from around 300 Adverse Drug Reaction Monitoring
Centers in medical colleges and large hospitals. The Union 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
assessment of AEFI cases are made available in the public domain and are shared with
the CDSCO, amongst other authorities, for appropriate regulatory action.
81. As regards the present status of AEFI surveillance for COVID-19 vaccination, it was
submitted that as the causality assessment of reported AEFI cases is a time-consuming
process, a method of rapid review and assessment had been initiated at the national
level to quickly review available information in each case and look for trends in
reporting of specific events or unusual cases requiring further early investigation and
assessment. All cases of serious and severe AEFIs, including reported deaths, are
subjected to rapid reviews, analysis and causality assessment done by a team of trained
subject experts. It was clarified that mere reporting of AEFI case should not be
attributed to the vaccine unless proved by the causality assessment analysis. The
National Expert Group on Vaccine Administration for COVID-19 (NEGVAC), an additional
body of experts, is also involved in providing guidance on vaccine safety and
surveillance, thus, aiding in the prompt identification of AEFIs for the purpose of
identifying and understanding evolving trends in the disease and taking prompt action.
2,116 serious and severe AEFIs have been reported from 1,19,38,44,741 doses of

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COVID-19 vaccine administered till 24.11.2021. While a report of rapid review and
analysis completed for 495 cases had been submitted, a further report of 1,356 serious
and severe AEFI cases had been presented to the NEGVAC and the rapid review and
analysis of balance cases was underway. Press releases around a report on bleeding and
clotting events following COVID-19 vaccination being submitted to the MoHFW by the
National AEFI Committee and on clarification on deaths following vaccination and
process of causality assessment were placed before this Court. Therefore, the Union of
India submitted that there was continuous monitoring and examination of AEFI cases in
India and there is no basis for the allegations around AEFIs not being properly collected
and lack of transparency in their investigation.
82. From the material placed before us, we note that the National AEFI Surveillance
Secretariat has been functioning for 10 years and as has been pointed out, there is a
well-established protocol in place for identification and monitoring of AEFIs. The
website of the MoHFW carries the results of causality assessment of AEFI cases, from
which the public can obtain relevant information pertaining to AEFIs. We have been
informed that a thorough causality assessment analysis of AEFIs is carried out by
experts and not every severe disease and death can be attributed to vaccination.
Reactions are examined by experts specifically trained to undertake causality analysis
before notifying such reactions as adverse events arising from vaccination. There is a
well-defined mechanism for collection of data relating to adverse events that occur due
to COVID-19 vaccines and the Government of India has taken steps to direct all
concerned medical professionals at the ground level to report adverse events. Even
medical practitioners at private hospitals are associated with reporting of adverse
events. Therefore, we are not inclined to accept the broad-strokes challenge mounted
by the Petitioner that the surveillance system of AEFIs in this country is faulty and the
correct figures of those who have suffered any side effects, severe reactions or deaths
post-inoculation have not been disclosed.
83. As regards the contention of the Petitioner on abandoning of Phase III trials, we
note that unblinding of participants during the Phase III trial was done on the
recommendation of the SEC. The Union of India has emphasized that at every stage, the
deliberations of domain experts, which involved discussions with the manufacturers,
focused on safety and immunogenicity of the vaccines and it 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 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.

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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 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 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 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

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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 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
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 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

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in mind the material on record.
(iii) With respect to the infringement of bodily integrity and personal autonomy
of an individual considered in the light of vaccines and other public health
measures introduced to deal with the COVID-19 pandemic, we are of the
opinion that bodily integrity is protected Under Article 21 of the Constitution
and no individual can be forced to be vaccinated. Further, personal autonomy of
an individual, which is a recognised facet of the protections guaranteed Under
Article 21, encompasses the right to refuse to undergo any medical treatment in
the sphere of individual health. However, in the interest of protection of
communitarian health, the Government is entitled to regulate issues of public
health concern by imposing certain limitations on individual rights, which are
open to scrutiny by constitutional courts to assess whether such invasion into
an individual's right to personal autonomy and right to access means of
livelihood meets the threefold requirement as laid down in K.S. Puttaswamy
(supra), i.e., (i) legality, which presupposes the existence of law; (ii) need,
defined in terms of a legitimate State aim; and (iii) proportionality, which
ensures a rational nexus between the objects and the means adopted to achieve
them.
(iv) On the basis of substantial material filed before this Court reflecting the
near-unanimous views of experts on the benefits of vaccination in addressing
severe disease from the infection, reduction in oxygen requirement, hospital
and ICU admissions, mortality and stopping new variants from emerging, this
Court is satisfied that the current vaccination policy of the Union of India is
informed by relevant considerations and cannot be said to be unreasonable or
manifestly arbitrary. Contrasting scientific opinion coming forth from certain
quarters to the effect that natural immunity offers better protection against
COVID-19 is not pertinent for determination of the issue before us.
(v) However, no data has been placed by the Union of India or the States
appearing before us, controverting the material placed by the Petitioner in the
form of emerging scientific opinion which appears to indicate that the risk of
transmission of the virus from unvaccinated individuals is almost on par with
that from vaccinated persons. In light of this, restrictions on unvaccinated
individuals imposed through various vaccine mandates by State
Governments/Union Territories cannot be said to be proportionate. Till the
infection rate remains low and any new development or research finding
emerges which provides due justification to impose reasonable and
proportionate restrictions on the rights of unvaccinated individuals, we suggest
that all authorities in this country, including private organisations and
educational institutions, review the relevant orders and instructions imposing
restrictions on unvaccinated individuals in terms of access to public places,
services and resources, if not already recalled. It is clarified that in the context
of the rapidly-evolving situation presented by the COVID-19 pandemic, our
suggestion to review the vaccine mandates imposed by States/Union
Territories, is limited to the present situation alone and is not to be construed
as interfering with the lawful exercise of power by the executive to take suitable
measures for prevention of infection and transmission of 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

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 results of Phase III clinical trials of the vaccines in question have been
published, in line with the requirement under the statutory regime in place, the
GCP guidelines and the WHO Statement on Clinical Trials. The material provided
by the Union of India, comprising of minutes of the meetings of the SEC, do not
warrant the conclusion that restricted emergency use approvals had been
granted to COVISHIELD and COVAXIN in haste, without thorough review of the
relevant data. Relevant information relating to the meetings of the SEC and the
NTAGI are available in public domain and therefore, challenge to the
procedures adopted by the expert bodies while granting regulatory approval to
the vaccines on the ground of lack of transparency cannot be entertained.
However, we reiterate that subject to the protection of privacy of individual
subjects, with respect to ongoing clinical trials and trials that may be conducted
subsequently for COVID-19 vaccines, all relevant data required to be published
under the extant statutory regime must be made available to the public without
undue delay.
(vii) We do not accept the sweeping challenge to the monitoring system of
AEFIs being faulty and not reflecting accurate figures of those with severe
reactions or deaths from vaccines. We note that the role of the
Pharmacovigilance Programme of India and the CDSCO, as elaborated upon by
the Union of India, collates and studies previously unknown reactions seen
during monitoring of AEFIs at the time of vaccine administration and we trust
the Union of India to ensure that this leg of the AEFI surveillance system is not
compromised with, while meeting the requirements of the rapid review and
assessment system followed at the national level for AEFIs.
(viii) We are also of the opinion that information relating to adverse effects
following immunisation is crucial for creating awareness around vaccines and
their efficacy, apart from being instrumental in further scientific studies around
the pandemic. Recognising the imperative need for collection of requisite data
of adverse events and wider participation in terms of reporting, the Union of
India is directed to facilitate reporting of suspected adverse events by
individuals and private doctors on an accessible virtual platform. These reports
shall be made publicly accessible, without compromising on protecting the
confidentiality of the persons reporting, with all necessary steps to create
awareness of the existence of such a platform and of the information required
to navigate the platform to be undertaken by the Union of India at the earliest.
(ix) On paediatric vaccination, we recognise that the decision taken by the
Union of India to vaccinate children in this country is in tune with global
scientific consensus and expert bodies like the WHO, the UNICEF and the CDC
and it is beyond the scope of review for this Court to second-guess expert
opinion, on the basis of which the Government has drawn up its policy. Keeping
in line with 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.
9 0 . 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.

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1 Indian Banks' Association, Bombay v. Devkala Consultancy Service
MANU/SC/0355/2004 : (2004) 11 SCC 1
2 Ugar Sugar Works Ltd. v. Delhi Administration MANU/SC/0189/2001 : (2001) 3 SCC
635
3 Villianur Iyarkkai Padukappu Maiyam v. Union of India MANU/SC/0811/2009 : (2009)
7 SCC 561
4 Directorate of Film Festivals v. Gaurav Ashwin Jain MANU/SC/1778/2007 : (2007) 4
SCC 737
5 Academy of Nutrition Improvement v. Union of India MANU/SC/0805/2011 : (2011) 8
SCC 274
6 Pyarali K. Tejani v. Mahadeo Ramchandra Dange MANU/SC/0146/1973 : (1974) 1
SCC 167
7 Union of India v. Dinesh Engineering Corporation MANU/SC/0575/2001 : (2001) 8
SCC 491
8 Abhilash, Kundavaram Paul Prabhakar et al. "Impact of prior vaccination with
Covishield" 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
9 Aakashneel Bhattacharya, Piyush Ranjan, Tamoghna Ghosh, Harsh Agarwal, Sukriti
Seth, Ganesh Tarachand Maher, Ashish Datt Upadhyay, Arvind Kumar, Upendra Baitha,
Gaurav Gupta, Bindu Prakash, Sada Nand Dwivedi, Naveet Wig "Evaluation of the dose-
effect association between the number of doses and duration since the last dose of
COVID-19 vaccine, and its efficacy in preventing the disease and reducing disease
severity: A single centre, cross-sectional analytical study from India" Diabetes &
Metabolic Syndrome: Clinical Research & Reviews Volume 15, Issue 5 (2021), 102238
10 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
11 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)
12 Statement by Dr Hans Henri P. Kluge, WHO Regional Director for Europe, 11.01.2011,
available at https://www.euro.who.int/en/media-
centre/sections/statements/2022/statement-update-on-covid-19-omicron-wave-
threatening-to-overcome-health-workforce (last accessed on 01.05.2022)
13 Interim Statement on COVID-19 vaccines in the context of the circulation of the
Omicron SARS-CoV-2 Variant from the WHO Technical Advisory Group on COVID-19
Vaccine Composition (TAG-CO-VAC), 11.01.2022, available at
https://www.who.int/news/item/11-01-2022-interim-statement-on-covid-19-vaccines-
in-the-context-of-the-circulation-of-the-omicron-sars-cov-2-variant-from-the-who-
technical-advisory-group-on-covid-19-vaccine-composition (last accessed on
01.05.2022)
14 Available at https://www.who.int/emergencies/diseases/novel-coronavirus-
2019/covid-19-vaccines/advice (last accessed on 01.05.2022)
15 Andreas Radbruch and Hyun-Dong Chang, "A long-term perspective on immunity to
Covid" Nature 595, 359-360 (2021)

23-08-2024 (Page 41 of 42) www.manupatra.com Karnavati University

16 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)
17 Vincent Panikurlangara v. Union of India MANU/SC/0985/1987 : (1987) 2 SCC 165
18 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)
19 Ashwani Kumar v. Union of India MANU/SC/1475/2018 : (2019) 2 SCC 636
20 Gunter Kampf, Letter titled "The Epidemiological relevance of the COVID-19
vaccinated population is increasing" Lancet Regional Health Vol. 11, 100272, December
01, 2021
21 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
22 Laxmi Raj Shetty v. State of Tamil Nadu MANU/SC/0252/1988 : (1988) 3 SCC 319

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