JACOB PULIYEL versus UNION OF INDIA & ORS.
[2022] 3 S.C.R. 471, Supreme Court of India, 2022
Outcome: Disposed off
Segment: Issues
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JACOB PULIYEL
v.
UNION OF INDIA & ORS.
(Writ Petition (Civil) No. 607 of 2021)
MAY 02, 2022
[L. NAGESWARA RAO AND B. R. GAVAI, JJ.]
Public health – COVID-19 pandemic – Vaccines and other
public health measures – Fundamental rights of individuals – Bodily
integrity and personal autonomy of an individual – Held: Bodily
integrity is protected under Art. 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 Art. 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 case, 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 – Constitution of India, 1950 – Art. 21.
Public health – COVID-19 pandemic – Vaccines and other
public health measures – Vaccination policy –
Restrictions on
unvaccinated individuals –Challenge to – Held: Substantial material
filed before the Court reflecting the near-unanimous views of experts
on 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 –
Current vaccination policy of the Union of India is informed by
relevant considerations and cannot be said to be unreasonable or
manifestly arbitrary – However, no data placed by Union of India
or the States, controverting the material placed by the Petitioner in
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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,
it is suggested 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 however clarified that in the context of the
rapidly-evolving situation presented by the COVID-19 pandemic,
the suggestion to review the vaccine mandates imposed by States /
Union Territories, is limited to the present situation alone and is 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 – The suggestion also does not extend
to any other directions requiring maintenance of COVID-appropriate
behaviour issued by the Union or
the State Governments.
Public health – COVID-19 pandemic – Clinical trials of
vaccines – Non-disclosure of segregated clinical data – Held: The
results of Phase III clinical trials of the vaccines in question have
been published, in line with the requirement under the statutory
regime in place, Good Clinical Practices (GCP) guidelines and the
WHO Statement on Clinical Trials – Material provided by 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 meetings of Subject Expert Committee (SEC) [the body which
sends recommendations to the Central Drugs Standard Control
Organisation] and National Technical Advisory Group on
Immunization (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, subject to the
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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.
Public health – Immunisation – Adverse Events Following
Immunisation (AEFI) – Central Drugs Standard Control
Organisation (CDSCO) – Sweeping challenge to the monitoring
system of AEFIs being faulty and not reflecting accurate figures of
those with severe reactions or deaths from vaccines, not acceptable
– Role of the Pharmacovigilance Programme of India – CDSCO, as
elaborated upon by Union of India, collates and studies previously
unknown reactions seen during monitoring of AEFIs at the time of
vaccine administration – 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.
Public health – Immunisation – Adverse effects following
immunisation – Information relating to – Held: Such information is
crucial for creating awareness around vaccines and their efficacy,
apart from being instrumental in further scientific studies around
the pandemic – Imperative need for collection of requisite data of
adverse events and wider participation in terms of reporting – Union
of India 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.
Public health – Vaccination – Paediatric vaccination – Policy
decision – Scope of review – Held: Decision taken by Union of
India to vaccinate children in the country is in tune with global
scientific consensus and expert bodies like the WHO, the UNICEF
and the CDC – It is beyond the scope of review for the 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
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on Clinical Trials and the extant statutory regime, Union of India
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, if not already done.
Public Health – Policy decisions based on expert opinion –
Judicial review – Scope – Held: Court would be slow in interfering
with matters of policy, especially those connected to public health –
Wide latitude is provided to the executive in matters involving policy
decisions based on expert opinion – 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 – Constitution of
India, 1950 – Art. 14.
Evidence – News item published in newspaper – Admissibility
– Held: The 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 – Judicial
Notice.
Public interest litigation – 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 – Maintainability of.
Disposing the writ petition, the Court
HELD: Judicial review of public policies relating to health
- Ambit of
1.1. 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. It is neither within the domain of the
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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. 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
arbitrary. [Para 21][497-B-E]
1.2. The courts should not rush in where even scientists
and medical experts are careful to tread. The rule of prudence is
that courts will be reluctant to interfere with policy decisions
taken by the Government, in matters of public health, after
collecting and analysing inputs from surveys and research. Nor
will courts attempt to substitute their own views as to what is
wise, safe, prudent or proper, in relation to technical issues
relating to public health in preference to those formulated by
persons said to possess technical expertise and rich experience.
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. One
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
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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. [Para 22][497-E-G;
498-A-D]
1.3. The 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. [Para 25][499-E-F]
Vaccine mandates – If violative of Art.21 of the Constitution
2.1. Bodily integrity is protected under Article 21 of the
Constitution of India and no individual can be forced to be
vaccinated. 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. 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. [Para 49][516-B-F]
2.2. The Union of India is justified in centering its
vaccination policy around the health of the population at large,
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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. [Para 56]
[520-D-F]
2.3. While there is abundant data to show that getting
vaccinated continues to be the dominant expert advice even in
the face of new variants, no submission nor any data has been put
forth to justify restrictions only on unvaccinated individuals when
emerging scientific evidence appears to indicate that the risk of
transmission of the virus from unvaccinated individuals is almost
on par with that from vaccinated persons. To put it differently,
neither the Union of India nor the State Governments have
produced any material before this Court to justify the
discriminatory treatment of unvaccinated individuals in public
places by imposition of vaccine mandates. No doubt that when
COVID-19 vaccines came into the picture, they were expected
to address, and were
indeed found to be successful in dealing
with, the risk of infection from the variants in circulation at the
time. However, with the virus mutating, one has 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, 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.
[Para 58][522-D-G; 523-A-B]
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2.4. 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, it is suggested 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. [Para 59][523-D-F]
2.5. However, 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, the 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. [Para 61]
[524-C-E]
Judicial notice of news item
published in a newspaper
3. The 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. In the
absence of anything on record in the present case to substantiate
the statement made by a member of the NTAGI, this Court is 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. Also, the evidence relating to the
approval process of the Rotavac vaccine has no relevance to the
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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. [Para 70][530-G-H;
531-A-B]
Non-disclosure of segregated clinical trial data in public
domain
4. It is seen 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. It cannot be said that emergency
approvals to the vaccines were given in haste, without properly
reviewing the data from clinical trials. Also, the Parliamentary
Standing Committee report relied upon by the Petitioner 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. 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
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with the procedure prescribed under the Drugs and Cosmetics
Act, 1940 and the New Drugs and Clinical Trials Rules, 2019
framed under the said Act, 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.
[Para 76][535-E-H; 536-A-D]
Improper collection and reporting of Adverse Events
Following Immunisations (AEFIs).
5. 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. [Para 84][541-F-H; 542-A]
Vaccination of children
6.1. This Court cannot sit in judgment of leading scientific
analysis relating to the safety of paediatric vaccination. Experts
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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 jurisdiction of this Court but also hazardous if
this Court were to examine the accuracy of such expert opinion,
based on competing medical opinions. The scope of judicial review
does not entail the Court embarking upon such misadventures.
Therefore, the contention of the Petitioner, that this Court has
to intervene in paediatric vaccination on the ground that it is
unscientific, is rejected. [Para 87][543-C-F]
6.2. With respect to results of clinical trials, it is noted that
the Union of India has stated that the results of clinical trials of
COVAXIN for paediatric population have already been published.
It is further noted that for the age group of 12 to 14 years,
Biological E’s Corbevax is being administered. Keeping in line
with the WHO Statement on Clinical Trials, the Declaration of
Helsinki and the GCP guidelines, the Union of India is directed
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. [Para 88]
[543-F-H]
7. Conclusion
(i) Given the issues urged by the Petitioner have a bearing
on public health and concern the fundamental rights of individuals
in this country, this Court is 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
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scientific issues on the basis of divergent medical opinion.
However, this does not bar the Court from scrutinising whether
the policy in question can be held to be beyond the pale of
unreasonableness and manifest arbitrariness and to be in
furtherance of the right to life of all persons, bearing in mind the
material on record.
(iii) With respect to the infringement of bodily integrity and
personal autonomy of an individual considered in the light of
vaccines and other public health measures introduced to deal
with the COVID-19 pandemic, this Court is 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
case, 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.
(v) However, no data has been placed by the Union of India
or the States, 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
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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, it is suggested 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, the 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.
The 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,
it is found that the results of Phase III clinical trials of the vaccines
in question have been
published, in line with the requirement
under the statutory regime in place, the GCP guidelines and the
WHO Statement on Clinical Trials. The material provided by the
Union of India, comprising of minutes of the meetings of the SEC,
do not warrant the conclusion that restricted emergency use
approvals had been granted to COVISHIELD and COVAXIN in
haste, without thorough review of the relevant data. Relevant
information relating to the meetings of the SEC and the NTAGI
are available in public domain and therefore, challenge to the
procedures adopted by the expert bodies while granting
regulatory approval to the vaccines on the ground of lack of
transparency cannot be entertained. However, 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
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under the extant statutory regime must be made available to the
public without undue delay.
(vii) One cannot 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. 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 one trusts 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) 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, this Court recognises 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, 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
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authorities for administration to children, be made public at the
earliest, if not already done. [Para 89 (ii) to (ix)][544-A-H; 545-
A-H; 546-A-H; 574-A-E]
Delhi Development Authority v. Joint Action Committee,
Allottee of SFS Flats (2008) 2 SCC 672 : [2007]
13 SCR 811; In re: Distribution of Essential Supplies
and Services During Pandemic, (2021) 7 SCC 772;
Ugar Sugar Works Ltd. v. Delhi Administration (2001)
3 SCC 635; Villianur Iyarkkai Padukappu Maiyam v.
Union of India (2009) 7SCC 561; Directorate of Film
Festivals v. Gaurav Ashwin Jain (2007) 4 SCC 737:
[2007] 5 SCR 7; Pyarali K.Tejani v. Mahadeo
Ramchandra Dange (1974) 1 SCC 167 : [1974]
2 SCR 154; Union of India v. Dinesh Engineering
Corporation (2001) 8 SCC 491; Common Cause (A
Registered Society) v. Union of India (2018) 5 SCC 1 :
[2018] 6 SCR 1; K. S. Puttaswamy v. Union of India
(2017) 10 SCC 1 : [2017] 10 SCR 569 and Ashwani
Kumar v. Union of India (2019) 2 SCC 636 : [2018]
13 SCR 1286 – relied on
Indian Banks’ Association, Bombay v. Devkala
Consultancy Service (2004) 11 SCC 1 : [2004] 1 Suppl.
SCR 225; Academy of NutritionImprovement v. Union
of India, (2011) 8 SCC 274: [ 2011] 8 SCR 680; G.
Sundarrajan v. Union of India (2013) 6 SCC 620 :
[2013] 8 SCR 631; Shri Sitaram Sugar Company Ltd.
v. Union of India (1990) 3 SCC 223 : [1990] 1 SCR 
909; Aruna Ramachandra Shanbaug v. Union of India
(2011) 4 SCC 454 : [2011] 4 SCR 1057;  National
Legal Services Authority v. Union of India (2014) 5 SCC
438 : [2014] 5 SCR 119;  X v. Hospital ‘Z’ (1998) 8
SCC 296 : [1998] 1 Suppl. SCR 723; Kharak Singh v
State of U.P., [1964] 1 SCR 332; Gobind v. State of
M.P. (1975) 2 SCC 148 : [1975] 3 SCR  946;
Association of Medical Super Speciality Aspirants and
Residents v. Union of India (2019) 8 SCC 607 : [2019]
12 SCR 1011; Vincent Panikurlangara v. Union of
India (1987) 2 SCC 165; ArunaRodrigues (4) v. Union
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of India (2011) 12 SCC 481; and Laxmi Raj Shetty v.
State of Tamil Nadu (1988) 3 SCC 319 : [1988] 3 SCR 
706 – referred to.
Henning Jacobson v. Commonwealth of Massachusetts
197 US 11 (1905); Zucht v. King, 260 US 174 (1922);
Henry v. Hazzard [2021] NSWSC 1320; Ryan Yardley
v. Minister for Workplace Relations and Safety [2022]
NZHC 291; Roman Catholic Diocese v. Cuomo 141 S.
Ct. 63 (2020); South Bay United Pentecostal Church v.
Newsom 140 S. Ct. 1613 (2020); Kassam v. Hazzard;
Henry v. Hazzard [2021] NSWCA 299; Ministry of
Health v. Atkinson [2012] NZCA 184; Jane Roe v.
Henry Wade 410 US 113 (1973); Four Aviation Security
Service Employees v. Minister of COVID-19 Response
[2021] NZHC 3012 and Spencer v. Attorney General
of Canada [2021] FC 361 – referred to.
Case Law Reference
[2004] 1 Suppl. SCR 225
referred to
Para 11
[2011] 8 SCR 680
referred to
Para 13
[2013] 8 SCR 631
referred to
Para 13
[1990] 1 SCR  909
referred to
Para 13
[2007] 5 SCR 7
relied on
Para 14
[2007] 13 SCR 811
relied on
Para 15
(2021) 7 SCC 772
relied on
Para 15
(2001) 3 SCC 635
relied on
Para 21
(2009) 7 SCC 561
relied on
Para 21
[1974] 2 SCR 154
relied on
Para 22
(2001) 8 SCC 491
relied on
Para 23
[2018] 6 SCR 1
referred to
Para 28
[2011] 4 SCR 1057
referred to
Para 28
[2017] 10 SCR 569
referred to
Para 28
[2014] 5 SCR 119
referred to
Para 41
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[1998] 1 Suppl. SCR 723
referred to
Para 41
[1964] 1 SCR 332
referred to
Para 41
[1975] 3 SCR  946
referred to
Para 41
[2019] 12 SCR 1011
referred to
Para 43
(1987) 2 SCC 165
referred to
Para 55
[2018] 13 SCR 1286
referred to
Para 55
(2011) 12 SCC 481
referred to
Para 62
[1988] 3 SCR  706 
referred to
Para 70
CIVIL ORIGINAL JURISDICTION : Writ Petition (Civil) No.607
of 2021.
(Under Article 32 of The Constitution of India)
Prashant Bhushan, Ms. Cheryl Dsouza, Advs. for the Petitioner.
Tushar Mehta, SG, K. M. Nataraj, Ms. Aishwarya Bhati, ASGs,
Amit Anand Tiwari, AAG, S. Guru Krishnakumar, Sr. Adv., Rajat Nair,
Kanu Agrawal, Ketan Paul, Mayank Pandey, Gurmeet Singh Makker,
Vipin Nair, P. B. Suresh, Sughosh Subramanyam, Arindam Ghosh, Agnish
Aditya, Shyel Trehan, Ms. Malvika Kapila, Ms. Bhagya Yadav, Ms.
Tanwangi Shukla, Shailesh Madiyal, Ms. Mrinal Gopal Elker, Kameshwar
Nath Mishra, Ms. Pratibha Yadav, Rahul Chitnis, Sachin Patil, Aaditya
A. Pande, Geo Joseph, Ms. Shwetal Shepal, Ms. Jyoti Mendiratta, Dr.
Joseph Aristotle S., Ms. Mary Mitzy, Ms. Devyani Gupta, Advs. for the
Respondents.
Ms. Meenakshi S. Kamble, Hitesh Kumar Sharma, Akhileshwar
Jha, Ms. Kavita S. More, Advs. for the Intervenors.
The Judgment of the Court was delivered by
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
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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
59thParliamentary Standing Committee Report and the
members who constituted the committee for the purpose of
each approval meeting; and
(c) Direct the respondent No.2 to disclose the reasoned
decision of the DCGI granting approval or rejecting an
application for emergency use authorization of vaccines and
the documents and reports submitted to the DCGI in support
of such application; and
(d) Direct the respondents to disclose the post vaccination
data regarding adverse events, vaccinees who got infected
with Covid, those who needed hospitalization and those who
died after such infection post vaccination and direct the
respondents to widely publicize the data collection of such
adverse event through the advertisement of toll free telephone
numbers where such complaints can be registered; and
(e) Declare that vaccine mandates, in any manner whatsoever,
even by way of making it a precondition for accessing any
benefits or services, is a violation of rights of citizens and
unconstitutional; and
(f) Pass any other orders as this Hon’ble Court deems fit.”
2. In the Writ Petition, the Petitioner highlighted the adverse
consequences of emergency approval of vaccines in India, the need
for
transparency in publishing segregated clinical trial data of vaccines, the
need for disclosure of clinical data, lack of transparency in regulatory
approvals, minutes and constitution of the expert bodies, imperfect
evaluation of Adverse Events Following Immunisation (AEFIs) 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.
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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 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
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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,
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including reported deaths, are subjected to scientific and technical review
process with causality assessments done at the state and national levels
by trained experts to ascertain whether a particular AEFI can be
attributed to the vaccine. In the counter-affidavit, it was also made clear
that COVID-19 vaccination is voluntary and that the Government of
India encourages all individuals to take vaccination in the interest of
public health, as the individual’s ill health has a direct effect on the society.
It was also made clear that COVID-19 vaccination is not linked to any
benefits or services.
7. Counter-affidavits have been filed by other Respondents as
well. The vaccine manufacturers, i.e.,Respondents Nos. 4 and 5, have
brought to the notice of this Court that approval to their vaccines was
granted after strict compliance of the procedure prescribed. The States
of Tamil Nadu, Maharashtra, Delhi and Madhya Pradesh have also filed
counter-affidavits, justifying the restrictions that were 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
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to an intrusion into the individual’s personal autonomy. He is also of the
firm opinion that an individual is deprived of the opportunity to give
informed consent in the absence of availability of segregated data of
clinical trials of the vaccines. He has also aired further grievances
pertaining to poor evaluation and reporting of AEFIs.
11. This Court is entitled to entertain a public interest litigation
moved by a person having knowledge in the subject-matter of the lis
and, thus, having an interest therein, as contradistinguished from a
busybody, in the welfare of people1. The Union of India has objected to
the maintainability of the Writ Petition on the ground that the questions
raised by the Petitioner may result in raising doubts in the minds of the
citizenry about the vaccination, adding to the already existing vaccine
hesitancy in the country. The consequence would be a debilitating effect
on public health and therefore, the petition cannot be said to be in public
interest. In other words, the maintainability of the Writ Petition is raised
on the ground that the sensitive issue of vaccination should not be dealt
with by this Court, as it has the propensity of fuelling doubts about the
efficacy of the vaccines.
12. From the rejoinder affidavit submitted by the Petitioner, we
note that a petition had been filed by the Petitioner earlier, during his
tenure as a member of the NTAGI, with respect to the Rotavac
vaccine
claiming that adequate data from the clinical trials had not been provided
to the NTAGI. The rejoinder affidavit further states that the petition
was dismissed by this Court, on the ground that the Petitioner could not
have filed the said petition while being a member of the NTAGI. The
enthusiasm of the Petitioner in approaching this Court has not gone
unobserved. However, as the issues raised by the Petitioner have a bearing
on public health and pertain to the fundamental rights of the country’s
populace, we are of the opinion that they warrant due consideration by
this Court. Therefore, we are not inclined to entertain the challenge
mounted by the Union of India to the maintainability of the Writ Petition.
II. Judicial review of executive decisions based on expert
opinion
13. Yet another ground taken by the Union of India is that this
Court has to yield to executive decision and action in the matter of
administration of drugs / vaccines. The existence of any other possible
1 Indian Banks’ Association, Bombay v. Devkala Consultancy Service (2004) 11 SCC 1
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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 India2, G. Sundarrajan v. Union of India3
and Shri Sitaram Sugar Company Ltd. v. Union of India4. Further,
the learned Solicitor General relied upon the judgments of the Supreme
Court of the United States (hereinafter, the “US Supreme Court”) in
HenningJacobson v. Commonwealth of Massachusetts5, Zucht v.
King6and 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. Hazzard7 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.
14. In opposition, the Petitioner argued that matters of public
importance involving
invasion of fundamental rights of individuals cannot
be brushed aside by this Court on the ground that they are beyond the
jurisdiction of this Court. This Court has a duty to safeguard the
fundamental rights of individuals and issues raised herein are of seminal
importance which ought to be decided after assessing the relevant
material placed before this Court by both sides. Mr. Bhushan referred to
the judgement of the High Court of New Zealand in Ryan Yardley v.
Minister for Workplace Relations and Safety8 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.
2 (2011) 8 SCC 274
3 (2013) 6 SCC 620
4 (1990) 3 SCC 223
5 197 US 11 (1905)
6 260 US 174 (1922)
7 [2021] NSWSC 1320
8 [2022] NZHC 291
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15. It was further argued by Mr. Bhushan that the judgments
relied upon by the Union of India are not applicable to the facts of this
case. He relied upon the judgments of this Court in Delhi Development
Authority v. Joint Action Committee, Allottee of SFS Flats9,
Directorate of Film Festivals v. Gaurav Ashwin Jain10and an order
of this Court in Distribution of Essential Supplies and Services During
Pandemic, In re11 and submitted that policy decisions taken by the
executive are not beyond the scope of judicial review, if they are
manifestly arbitrary or unreasonable.
16. Before examining the parameters of judicial review in this
case, it is profitable to refer to judgments from beyond our borders which
have dealt with the scope of judicial review in matters relating to public
health and vaccinations, in particular. Compulsory vaccination against
small pox was the subject-matter of Jacobson (supra) decided in 1905.
The US Supreme Court was of the opinion that the mandate of the local
government for compulsory vaccination was binding on every individual.
The safety and health of the people has to be protected by the government
and the judiciary is not competent to interfere with decisions taken in the
interest of public health. The Court can interfere by way of judicial review
of legislative action in matters of public health only when there is no real
or substantial relation to the object of the legislation or when
there is
plain, palpable invasion of rights secured by fundamental law and thereby,
give effect to the Constitution.
17. In the wake of the COVID-19 pandemic, restrictions on
attendance at religious services in areas classified as ‘red’ or ‘orange’
zones were imposed by an executive order issued by the Governor of
New York. The said restrictions were challenged on the ground that
they violate the free exercise clause of the First Amendment of the
Constitution of the United States. By a majority of 6:3, the US Supreme
Court in Roman Catholic Diocese v. Cuomo12 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
9 (2008) 2 SCC 672
10 (2007) 4 SCC 737
11 (2021) 7 SCC 772
12 141 S. Ct. 63 (2020)
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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. Newsom13 wherein it was recognised that courts
must grant elected representatives broad discretion when they undertake
to act in areas fraught with medical and scientific uncertainties.
18. Biden v. Missouri (supra) related to vaccine mandates for
healthcare providers. The Secretary of Health and Human Services issued
a rule on being convinced that vaccination of healthcare workers in
facilities in the Medicare and Medicaid Programs against COVID–19
was “necessary for the health and safety of individuals to whom
care and services are
furnished”. The said rule was challenged and
the US District Courts for the Western District of Louisiana and the
Eastern District of Missouri each entered preliminary injunctions against
its enforcement. The appeals filed against the said injunction were
rejected by the Fifth Circuit in Louisiana and the Eighth Circuit in Missouri.
Aggrieved thereby, the Government moved the US Supreme Court
seeking for a stay on the preliminary injunctions passed by the US District
Courts. While granting stay of the preliminary injunctions, by its plural
opinion the US Supreme Court held that the role of courts in reviewing
decisions taken by the executive should be to ensure that the executive
“has acted within a zone of reasonableness”.
19. Having been aggrieved by certain orders of the Minister for
Health and Medical Research that required people working in the
construction, aged care and education sectors to be compulsorily
vaccinated, Al-Munir Kassamand three others, along with Natasha Henry
and five others, approached the NSW Supreme Court challenging the
13 140 S. Ct. 1613 (2020)
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constitutional validity of the decision. While considering the grounds of
challenge, the NSW Supreme Court in Kassam v. Hazzard (supra)
was of the view that “it is not the Court’s function to determine the
merits of the exercise of the power by the Minister to make the
impugned orders, much less for the court to choose between plausible
responses to the risks to the public health posed by the Delta
variant”. The NSW Supreme Court further observed that it is not the
court’s function to conclusively determine the effectiveness of some of
the alleged treatments for those infected or the effectiveness of COVID-
19 vaccines, especially their capacity to inhibit the spread of the disease,
which are all matters of merits, policy and fact for the decision maker
and not the court. The NSW Supreme Court emphasised that its only
function is to determine the legal validity of the impugned orders. The
said view of the NSW Supreme Court was approved by the New South
Wales Court of Appeal in Kassam v. Hazzard; Henry v. Hazzard14.
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. Atkinson15, the NZ High Court held that the Crown has the
burden to demonstrate that a limitation of a fundamental right is
14 [2021] NSWCA 299
15 [2012] NZCA 184
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demonstrably justified. We have come to know that in the time since the
judgment in this matter was reserved, the decision of the NZ High Court
in Ryan Yardley (supra) has been appealed by the Government of
New Zealand before the New Zealand Court of Appeal.
21. We shall now proceed to analyse the precedents of this Court
on the ambit of judicial review of public policies relating to health. It is
well settled that the Courts, in exercise of their power of judicial review,
do not ordinarily interfere with the policy decisions of the executive unless
the policy can be faulted on grounds of mala fide, unreasonableness,
arbitrariness or unfairness etc. Indeed, arbitrariness, irrationality,
perversity and mala fide will render the policy unconstitutional16.It is
neither within the domain of the courts nor the scope of judicial review
to embark upon an enquiry as to whether a particular public policy is
wise or whether better public policy can be evolved. Nor are the courts
inclined to strike down a policy at the behest of a petitioner merely because
it has been urged that a different policy would have been fairer or wiser
or more scientific or more logical17. Courts do not and cannot act as
appellate authorities examining the correctness, suitability and
appropriateness of a policy, nor are courts advisors to the executive on
matters of policy which the executive is entitled to formulate. The scope
of judicial review when examining a policy of the Government
is to check
whether it violates the fundamental rights of the citizens or is opposed to
the provisions of the Constitution, or opposed to any statutory provision
or manifestly arbitrary18.
22. This Court in a series of decisions has reiterated that courts
should not rush in where even scientists and medical experts are careful
to tread. The rule of prudence is that courts will be reluctant to interfere
with policy decisions taken by the Government, in matters of public health,
after collecting and analysing inputs from surveys and research. Nor
will courts attempt to substitute their own views as to what is wise, safe,
prudent or proper, in relation to technical issues relating to public health
in preference to those formulated by persons said to possess technical
expertise and rich experience19. Where expertise of a complex nature is
expected of the State in framing rules, the exercise of that power not
16 Ugar Sugar Works Ltd. v. Delhi Administration (2001) 3 SCC 635
17 Villianur Iyarkkai Padukappu Maiyam v. Union of India (2009) 7 SCC 561
18 Directorate of Film Festivals v. Gaurav Ashwin Jain (2007) 4 SCC 737
19 Academy of Nutrition Improvement v. Union of India (2011) 8 SCC 274
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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.20
23. There is no doubt that this Court has held in more than one
judgment that where the decision of the authority is in regard to a policy
matter, this Court will not ordinarily interfere since decisions on policy
matters are taken based on expert knowledge of the persons concerned
and courts are normally not equipped to question the correctness of a
policy decision. However, this does not mean that courts have to abdicate
their right to scrutinise whether the policy in question is formulated keeping
in mind all the relevant facts and the said policy can be held to be beyond
the pale of discrimination or unreasonableness, bearing in mind the material
on record.21 In Delhi Development Authority (supra), this Court held
that an executive order termed as a policy decision is not beyond the
pale of judicial review. Whereas the superior courts may not interfere
with the nitty-gritty of the policy, or substitute one by the other but it will
not be correct to contend that the court shall lay its judicial hands off,
when a plea is raised that the impugned decision is a policy decision.
Interference therewith on the part of the superior court would not be
without jurisdiction as it is subject to judicial review. It was further held
therein that the policy decision is subject to judicial review on the following
grounds:
a)
if it is unconstitutional;
20 Pyarali K. Tejani v. Mahadeo Ramchandra Dange (1974) 1 SCC 167
21 Union of India v. Dinesh Engineering Corporation (2001) 8 SCC 491
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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.
24. During the second wave of COVID-19 pandemic, this Court
in Distribution of Essential Supplies & Services during Pandemic
(supra), to which one of us was a party (L Nageswara Rao, J.), dealt
with issues of vaccination policy, pricing and other connected issues.
While doing so, this Court held that policy-making continues to be the
sole domain of the executive and the judiciary does not possess the
authority or competence to assume the role of the executive. It was
made clear that the Court cannot second guess the wisdom of the
executive when it chooses between two competing and efficacious policy
measures. However, it continues to exercise jurisdiction to determine if
the chosen policy measure conforms to the standards of reasonableness,
militates against manifest arbitrariness and protects the right to life of all
persons.
25. There can be no ambiguity in the principles of law relating to
judicial review laid down by this Court. A perusal of the judgments referred
to above would clearly show that this Court would be slow in interfering
with matters of policy, 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.
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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 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
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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 India22, Aruna
Ramachandra Shanbaug v. Union of India23 and K. S. Puttaswamy
v. Union of India24. 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
22 (2018) 5 SCC 1
23 (2011) 4 SCC 454
24 (2017) 10 SCC 1
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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, Vellore25, wherein it has been concluded as follows:
“Among symptomatic COVID-19 patients, prior
vaccination with either Covishield™ or Covaxin®
impacted the severity of illness and reduced mortality
when compared with unvaccinated patients. Full
vaccination conferred a substantially higher protective
effect over partial vaccination.” The results of the study
also indicate that compared with unvaccinated patients,
partially vaccinated patients had milder disease, reduced
requirement of oxygen, hospital admission, ICU admission
and mortality. Again, when fully vaccinated patients were
compared with unvaccinated individuals, full vaccination was
associated with significantly less disease severity,
requirement of respiratory supports, hospital admission, ICU
admission and mortality. The
study further showed that
majority of the patients screened who required hospitalisation
were unvaccinated.
(c)
A study conducted by researchers of All India Institute of
Medical Sciences (AIIMS), New Delhi26, which states that:
“We evaluated the association between COVID-19
25 Abhilash, Kundavaram Paul Prabhakar et al. “Impact of prior vaccination with
CovishieldTM and Covaxin® on mortality among symptomatic COVID-19 patients
during the second wave of the pandemic in South India during April and May 2021: a
cohort study.” Vaccine vol. 40,13 (2022): 2107-2113
26 Aakashneel Bhattacharya, Piyush Ranjan, Tamoghna Ghosh, Harsh Agarwal, Sukriti
Seth, Ganesh Tarachand Maher, Ashish Datt Upadhyay, Arvind Kumar, Upendra
Baitha, Gaurav Gupta, Bindu Prakash, Sada Nand Dwivedi, Naveet Wig “Evaluation of
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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, Patna27,
which concludes as follows: “COVID-19 vaccination was
found to be effective in infection prevention. One out
of two and four out of five individuals were found to be
protected against SARS-CoV-2 infection following
partial and full vaccination, respectively. The
vaccinated individuals had lesser LOS compared to
unvaccinated ones. Additionally, the fully vaccinated
individuals were less likely to develop severe disease.”
LOS herein refers to the
length of hospital stays.
30. On behalf of the State of Tamil Nadu, Mr. Amit Anand Tiwari,
learned Additional Advocate General, submitted that the restrictions
placed by way of the circular dated 18.11.2021 are within the competence
of the State in exercise of its powers under the Disaster Management
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
27 Singh C, Naik BN, Pandey S, et al. “Effectiveness of COVID-19 vaccine in preventing
infection and disease severity: a case-control study from an Eastern State of India.”
Epidemiology and Infection. 2021;149:e224
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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 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.
32. The complaint of the Petitioner in relation to prevention of
access to essential resources in the State of Madhya Pradesh pertains
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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
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Petitioner relied upon the opinion of Dr. Aditi Bhargava, who is a
professor at University of California, San Francisco and a molecular
biologist with 33 years of research experience, 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
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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 11.01.2021.28
36. In the first half of 2021, the Delta variant was identified as the
predominant variant in India and was believed to be 60 per cent more
transmissible than the Alpha variant. Thereafter, Delta rapidly spread
beyond the borders to other countries. Another variant, Omicron, surfaced
in November, 2021, whose spread was much more accelerated than
earlier variants, including that of Delta. On the basis of the evidence
available as on 21.01.2022, the WHO was of the opinion that the Omicron
has a significant growth advantage over Delta, leading to rapid spread in
the community with higher levels of incidence than previously seen in
the pandemic. It was further observed that despite a lower risk of severe
disease and death following infection, the very high levels of transmission
nevertheless have resulted in significant increases in hospitalisation and
continue to pose overwhelming demands on health care systems in most
countries. It was found that because of the 26-32 mutations that it has in
the spike
protein, Omicron has infected even those who have been
previously infected or vaccinated.29 Though the infections and
transmission from Omicron at present within the country are not as serious
as they were in the first two months of 2022, expert opinion is to the
effect that Omicron might not be the last of the variants, as we have
since witnessed.
37. The WHO established the Technical Advisory Group on
COVID-19 Vaccine Composition (TAG-CO-VAC) in September, 2021.
According to the statement made by the said group on 11.01.2022 in the
context of circulation of the Omicron variant, the group reviews and
assesses the public health implications of emerging VOCs on the
performance of COVID-19 vaccines and provides recommendations
28 Tracking SARS-CoV-2 variants, World Health Organization, available at https://
www.who.int/en/activities/tracking-SARS-CoV-2-variants/ (last accessed on 01.05.2022)
29 Statement by Dr Hans Henri P. Kluge, WHO Regional Director for Europe,
11.01.2011, available at https://www.euro.who.int/en/media-centre/sections/statements/
2022/statement-update-on-covid-19-omicron-wave-threatening-to-overcome-health-
workforce (last accessed on 01.05.2022)
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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.30
38. With the outbreak of the devastating pandemic, as many as
5,23,843 lives have been lost in this country, as per the
latest data available
on the website of the Ministry of 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
30 Interim Statement on COVID-19 vaccines in the context of the circulation of the
Omicron SARS-CoV-2 Variant from the WHO Technical Advisory Group on COVID-
19 Vaccine Composition (TAG-CO-VAC), 11.01.2022, available at https://
www.who.int/news/item/11-01-2022-interim-statement-on-covid-19-vaccines-in-the-
context-of-the-circulation-of-the-omicron-sars-cov-2-variant-from-the-who-technical-
advisory-group-on-covid-19-vaccine-composition (last accessed on 01.05.2022)
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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 variants from emerging and helping end
the pandemic. It should be noted that the advice of the WHO with respect
to COVID-19 has been consistent since the time vaccines became
available, even after recognising
that it was still possible to get infected
and spread the infection to others despite being vaccinated, as is evident
from the latest version of the WHO’s ‘COVID-19 advice for the public:
Getting vaccinated’ as of 13.04.202231. The Union of India has placed
considerable material on record in terms of 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
31 Available at https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-
19-vaccines/advice (last accessed on 01.05.2022)
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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 India32, 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’33. Placing
reliance on Kharak Singh v State of U.P.34, Gobind v. State of M.P.35
and a judgment of the US Supreme Court in Jane Roe v. Henry Wade36,
32 (2014) 5 SCC 438
33 (1998) 8 SCC 296
34 (1964) 1 SCR 332
35 (1975) 2 SCC 148
36 410 US 113 (1973)
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this Court held that though non-disclosure of medical information of an
individual can be traced to the right to privacy protected under Article
21, it is not absolute and is subject to action lawfully taken for protection
of health or morals or protection of rights and freedoms of others.
43. In Association of Medical Super Speciality Aspirants and
Residents v. Union of India37, to which one of us was a party (L
Nageswara Rao, J.), this Court, while considering validity of service
bonds to be executed at the time of admission to postgraduate and
superspeciality courses in medical science, held as follows:
“33. The above discussion leads us to the conclusion that right
to life guaranteed by Article 21 means right to life with human
dignity. Communitarian dignity has been recognised by this
Court. 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
37 (2019) 8 SCC 607
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(b) ensure continuity of services that are essential for public
safety, national defence, or crisis response; and
(c) maintain trust in public services.”
45. Considering the submissions of the applicants therein that the
order placed unjustified limitations on fundamental rights protected by
the NZ Bill of Rights, the NZ High Court held that the impugned order
limits the right of affected workers to refuse to undergo a medical
treatment as well as the right (or significant interest) to retain employment.
While examining the question of whether the limitation of the said rights
was justified, the NZ High Court noted that the order mandating
vaccinations for the police and defence personnel was imposed to ensure
the continuity of services that are essential for public safety, national
defence, or crisis response, and to promote public confidence in those
services, rather than to stop the spread of COVID-19. The NZ High
Court further took note of the fact that by October, 2021, 83.1 per cent
of police personnel had received at least one or more doses of the
vaccination, and 70.1 per cent had received both doses. By the time the
order took effect on 17.01.2022, there were only 164 unvaccinated staff
members in an overall workforce of 15,682 staff. It was found that the
position within the New Zealand Defence Forces (NZDF) was similar.
From a total of 15,480 NZDF personnel, 3,048 are civil staff. As on
01.02.2022, 99.2 per
cent of the regular forces were fully vaccinated,
leaving aside 75 members and 98.7 per cent of the civil staff were fully
vaccinated, leaving 40 who were not. The NZ High Court was of the
view that the relatively low number of unvaccinated police and NZDF
personnel impacted by the order may not, by itself, mean that the order
was not a reasonable limit on rights that can be demonstrably justified, if
there was evidence to establish that the presence of unvaccinated
personnel, even in small numbers, created a materially higher risk to the
remaining workforce. While observing that the evidence on this issue is
sparse, the NZ High Court referred to the evidence of Dr. Petrovsky,
who deposed that vaccination has potential benefit in reducing the severity
of disease, even with the Omicron variant. However, in his view,
mandatory vaccination did not assist in preventing workers in affected
roles from contracting COVID-19, or transmitting it to others. The NZ
High Court further considered the evidence of Dr. Town, the Ministry’s
Chief Science Adviser, who, according to the NZ High Court, did not
directly respond to Dr. Petrovsky’s analysis of the effectiveness of the
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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 Response38, 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 Canada39
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
38 [2021] NZHC 3012
39 [2021] FC 361
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risk of the outbreak or spread in strong public interest, is justified. Further,
the curtailment of the right to refuse to undergo medical treatment was
found to be proportionate to the objective, as the applicants, who worked
as aviation workers, were situated in a key location where COVID-19
might enter New Zealand.
47. In Ryan Yardley (supra), the NZ High Court held that the
principle in Four Aviation Security Service Employees (supra) is not
directly applicable as the order was not promulgated to contain the spread
of the virus but for the purpose of ensuring continuity of, and confidence
in, essential services. Additionally, there was no evidence of a threat to
the continuity of the police and NZDF services, which would enable the
NZ High Court to give the benefit of the doubt to the New Zealand
Crown in imposing measures to address that risk. Placing reliance on
the evidence adduced as well as the public health advice which was to
the 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.
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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 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.”
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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
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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
51. The grievance of the Petitioner pertains to the vaccine
mandates imposed by various State Governments and private
organisations, resulting in restrictions on fundamental freedoms of persons
who have chosen not to be vaccinated. The Petitioner has alleged duality
in the stand of the Respondents, as on one hand, the Union of India has
categorically stated that vaccines are voluntary and on the other, the
State Governments have
imposed and defended restrictions on access
to public places and resources for persons who are unvaccinated. The
Petitioner contested the vaccine mandates on the following grounds:
(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
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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 Nature40, which states
that “studies have shown that memory plasma cells
secreted antibody specific for the spike protein encoded
in SARS-CoV-2 even 11 months after the infection and
further that, immune memory to many viruses is stable
over decades, if not for a lifetime”.
(b)
A study published in the European Journal of
Epidemiology41, which has analysed data from 68 countries
available as of 03.09.2021 and has found that “at the
country level, there appears to be no discernible
relationship between percentage of population fully
vaccinated and new COVID-19 cases”. It is further stated
therein that in fact higher percentage of population fully
vaccinated have higher COVID-19 per 1 million people.
(c)
The United Kingdom’s COVID-19 vaccine surveillance
report, Week 40, which appears to indicate negative
efficacy against infection amongst all ages above 30 years,
on the basis of data between week 36 and week 39 in 2021.
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,
40 Andreas Radbruch and Hyun-Dong Chang, “A long-term perspective on immunity to
Covid” Nature 595, 359-360 (2021)
41 Subramanian, S.V., Kumar, A. “Increases in COVID-19 are unrelated to levels of
vaccination across 68 countries and 2947 counties in the United States” Eur J Epidemiol
36, 1237–1240 (2021)
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together with an increase in the level of SARS-CoV-2 antibodies that
was up to 50 times greater than before vaccination. In the second article
referred to above, published in the European Journal of Epidemiology, it
has been mentioned therein that the interpretation of the findings should
be as follows: “The sole reliance on vaccination as a primary strategy
to mitigate COVID-19 and its adverse consequences needs to be re-
examined, especially considering the Delta (B.1.617.2) variant and
the likelihood of future variants. Other pharmacological and non-
pharmacological interventions may need to be put in place alongside
increasing vaccination rates.” We do not see how these conclusions
and interpretations are in favour of an argument that natural immunity
has proven to be better in protection against COVID-19 infection, as
compared to vaccine-acquired immunity.
54. In any event, what we have to assess, in accordance with the
law laid down by this Court, is whether the Union of India has taken
note of scientific and medical inputs and research findings in putting
together its policy advocating vaccination for the entire eligible population.
Article 47 of the Constitution of India imposes an obligation on the Union
of India to improve public health. It is the obligation of the State to ensure
the creation and the sustaining of conditions congenial to good health.
From the several obligations of the State enshrined in Part IV of the
Constitution, maintenance
and improvement of public health rank high
as these are indispensable to the very physical existence of the
community.42
55. It should be noted that the submission made on behalf of the
Petitioner championing natural immunity is from the perspective of a
healthy person. Even the Petitioner does not dispute the fact that the
same standard is not applicable to persons with co-morbidities, the sick
and elderly people. A cursory glance at the data recorded in the India
Fact Sheet 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
42 Vincent Panikurlangara v. Union of India (1987) 2 SCC 165
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75th Round National Sample Survey (NSS), conducted from July 2017
to June 2018, the average age of the elderly population in India was 67.5
years, with 67.1 per cent of India’s elderly living in rural areas. A study
was conducted43 on the basis of the data from the NSS, aiming to highlight
the vulnerability of the aged amidst the COVID-19 pandemic. According
to the study, out of every 100 elderly, 27.7 persons reported ailments
during the previous 15 days, with cardiovascular conditions including
hypertension (32.0%), endocrine conditions including diabetes (22.5%),
musculoskeletal conditions (13.9%), infectious diseases (10.0%), and
respiratory ailments (7.3%) being the top five conditions for seeking
outpatient care among the elderly in the preceding 15 days. The
Constitution, through Article 41, mandates the State to make available to
the elderly the right to live with dignity and to provide the elderly, ill and
disabled with assistance, medical facilities and geriatric care44.
56. Surely, the Union of India is justified in centering its vaccination
policy around the health of the population at large, with emphasis on
insulating the weaker and more vulnerable sections from the risk of
severe infection and its consequences, as opposed to basing its decision
keeping in mind the interests of a healthy few. Given the considerable
material filed before this Court reflecting the near-unanimous views of
experts on the
benefits of vaccination in dealing with severe disease,
reduction in oxygen requirement, hospital and ICU admissions and
mortality and stopping new variants from emerging, this Court is satisfied
that the current vaccination policy of the Union of India, formulated in
the interest of public health, is informed by relevant considerations and
cannot be said to be unreasonable. Whether there is contrasting scientific
opinion supporting the argument of natural immunity offering better
protection 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
43 Ranjan, A., Muraleedharan, V.R. “Equity and elderly health in India: reflections from
75th round National Sample Survey, 2017–18, amidst the COVID-19 pandemic” Global
Health 16, 93 (2020)
44 Ashwani Kumar v. Union of India (2019) 2 SCC 636
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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 Health45, 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
Massachusettsin July, 2021 and reported in the Morbidity
45 Gunter Kampf, Letter titled “The Epidemiological relevance of the COVID-19
vaccinated population is increasing” Lancet Regional Health Vol. 11, 100272, December
01, 2021
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and Mortality Weekly Report46, which investigated 469
COVID-19 cases that had been identified among the
Massachusetts residents who had travelled to a town where
multiple large public events had been held and 346 cases,
i.e., 74 per cent of the infections occurred in fully vaccinated
individuals. Findings from the investigation suggest that even
jurisdictions without substantial or high COVID-19
transmission might consider expanding prevention strategies,
including masking in indoor public settings regardless of
vaccination status, given the potential risk of infection during
attendance at large public gatherings that include travelers
from many areas with differing levels of transmission.
The Petitioner has also cited various news articles reporting
instances of breakthrough infections in fully vaccinated people, carrying
as much virus as those who were unvaccinated, abroad as well as within
India.
58. We have already referred to the material placed by the Union
of India and the States appearing before this Court. While there is
abundant data to show that getting vaccinated continues to be the dominant
expert advice even in the face of new variants, no submission nor any
data has been put forth to justify restrictions only on unvaccinated
individuals when emerging scientific evidence appears to indicate that
the risk of transmission of the virus from unvaccinated individuals is
almost on par with that from vaccinated
persons. To put it differently,
neither the Union of India nor the State Governments have produced
any material before this Court to justify the discriminatory treatment of
unvaccinated individuals in public places by imposition of vaccine
mandates. No doubt that when COVID-19 vaccines came into the picture,
they were expected to address, and were indeed found to be successful
in dealing with, the risk of infection from the variants in circulation at the
time. However, with the virus mutating, we have seen more potent
variants surface which have broken through the vaccination barrier to
some extent. While vaccination mandates in the era of prevalence of
the variants prior to the Delta variant may have withstood constitutional
scrutiny, in light of the data presented by the Petitioner, which has not
46 Brown CM, Vostok J, Johnson H, et al. “Outbreak of SARS-CoV-2 Infections,
Including COVID-19 Vaccine Breakthrough Infections, Associated with Large Public
Gatherings — Barnstable County, Massachusetts, July 2021". MMWR Morb Mortal
Wkly Rep 2021;70:1059-1062
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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
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state of emergency, the Constitutional Council in France, in Decision no.
2021-824 DC dated 05.08.2021, determined that the “health pass” did
not infringe the right to personal privacy guaranteed by Article 2 of the
Declaration of Human and Civic Rights of 1789 as the requirement did
not introduce an obligation to vaccinate.
61. Having expressed our opinion on the vaccine mandates in the
prevailing context, we reiterate that vaccines effectively address severe
disease arising from COVID-19 infections, are instrumental in reducing
oxygen requirement, hospital and ICU admissions and mortality and
continue to be the solution to stopping new variants from emerging, as
per the advice of the WHO. Since the time arguments were heard in the
matter, we have come to know of more variants that have now come
into circulation. Given the rapidly-changing nature of the virus and the
clear purpose served by the approved vaccines in terms of restoration
and protection of public health, our suggestions with respect to review
of vaccine mandates are limited to the present situation alone. This
judgment is not to be 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
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was placed on an order of this Court in Aruna Rodrigues (4) v. Union
of India47 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 NTAGI and the Subject Expert
Committee (SEC),
the body which sends recommendations to the Central
Drugs Standard Control Organisation, while deliberating on the
applications and data of the vaccine manufacturers, and the names and
institutional relationships of the experts who participated in each of these
meetings. Mr. Bhushan relied on the 59th Report of the Parliamentary
Standing Committee on Health and Family Welfare, in support of his
submission on a need for transparency in the decision-making of the
CDSCO and other regulatory authorities.
63. In response, the Union of India submitted that the procedure
prescribed under the statutory regime was scrupulously followed before
granting emergency approval of the vaccines manufactured by
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
47 (2011) 12 SCC 481
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New Drugs and Clinical Trials Rules, 2019 (hereinafter, the “2019
Rules”) framed under the Drugs and Cosmetics Act, 1940. The SEC is
a statutory body, constituted by the CDSCO under Rule 100 of the 2019
Rules, comprising group of experts with specialisation in relevant fields.
According to the Union of India, the SEC looks into the details of trials
and results presented before it and examines them, interacts with the
developers of the vaccines and gives them appropriate directions and
eventually makes recommendations in writing, by way of a resolution,
reflecting the collective opinion of all the domain experts. We were
informed that the trials have been registered on the database of the
Clinical Trials Registry – India, which is hosted at the ICMR’s National
Institute of Medical Statistics. The provisions in relation to ‘Accelerated
Approval Process’ under the Second Schedule to the 2019 Rules were
pointed out to this Court, which stipulate that “accelerated approval
process may be allowed to a new drug for a disease or condition
taking into account its severity, rarity, or prevalence and the
availability or lack of alternative treatments, provided that there is
a prima facie case of the product being of meaningful therapeutic
benefit over the existing treatment”. It is further stated that “After
granting accelerated approval for such drug, the post marketing
trials shall be required to validate the anticipated
clinical benefit.”
It was submitted that applying these provisions on 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
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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.
65. Thereafter, Respondent No. 4 submitted the interim safety
and efficacy data of Phase III clinical trial, which was reviewed by the
SEC in meetings held periodically. In its meeting conducted on 10.03.2021,
the SEC, after detailed deliberation on the updated interim safety and
efficacy data of the phase III clinical trial, recommended omission of
the condition of the use of the vaccine in clinical trial mode. 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
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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.
66. COVISHIELD (ChAdOx1 nCoV-19 Corona Virus Vaccine
(Recombinant)) manufactured by Respondent No. 5 was developed by
the Serum Institute of India in collaboration with Oxford University and
AstraZeneca under technology transfer. As the clinical development of
the said vaccine, including Phase I clinical trial, was conducted in other
countries, Phase II / III clinical trials were conducted by Respondent
No. 5 in the country. Application for permission to manufacture
COVISHIELD for test, examination and analysis was first made by
Respondent No. 5 on 03.05.2020. The safety, immunogenicity and
efficacy data of Phase II / III clinical trials of the AstraZeneca vaccine
carried out in the United Kingdom, Brazil and South Africa were submitted
to the SEC, along with the safety and immunogenicity data from the
ongoing Phase II / III clinical trials in India. On reviewing this data as
well as the approval dated 30.12.2020 granted by the United Kingdom’s
Medicines and Healthcare Products Regulatory Authority (hereinafter,
the “UK-MHRA”) for the
AstraZeneca vaccine along with its conditions
/ restrictions, the SEC, in its meeting dated 01.01.2021, noted that the
safety and immunogenicity data from the Indian study was comparable
with that of the overseas clinical trial data. After detailed deliberation
and taking into account the emerging situation, the SEC recommended
grant of permission for restricted emergency use of the vaccine, subject
to various regulatory provisions and conditions, including requirement to
submit relevant data from the ongoing clinical trials nationally and
internationally at its earliest. Eventually, in its meeting dated 19.01.2022,
the SEC considered the request of Respondent No. 5 to grant permission
to manufacture the vaccine, excluding the conditions for restricted use
in emergency situation and other conditions, on the lines of Marketing
Authorisation by the UK-MHRA for the parent vaccine. After detailed
deliberation and consideration of safety, immunogenicity and efficacy
data from Indian and overseas clinical trials, amongst other data, the
SEC recommended grant of New Drug permission or regular approval,
with conditions that data of ongoing clinical trials and vaccine shall
continue to be supplied and AEFIs shall continue to be monitored.
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67. We were directed to Rule 25 of the 2019 Rules, framed under
the Drugs and Cosmetics Act, 1940, which provides that the clinical trial
shall be conducted in accordance with approved clinical trial protocol
and other related documents as per the requirements of Good Clinical
Practices (GCP) guidelines and the other rules. The expert committee
set up by the CDSCO under Rule 25(vi) in consultation with clinical
experts formulated the GCP guidelines for generation of data on drugs.
The ‘Ethical Principles’, which are part of the said guidelines, protect
principles of privacy and confidentiality of human subjects of research.
The learned Solicitor General also relied upon para 2.4.4 of the GCP
guidelines, which require safeguarding of the confidentiality of research
data that might lead to identification of individual subjects. He further
referred to the important role played by the Ethics Committee under
Rule 11 of the 2019 Rules, which includes safeguarding the rights, safety
and well-being of trial subjects in accordance with the said rules. The
2019 Rules also empower the Ethics Committee to discontinue or suspend
the clinical trial in case it concludes that the trial is likely to compromise
the right, safety or well-being of the trial subject. As per the ICMR’s
National Ethical Guidelines 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
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is in compliance with the WHO Statement on Clinical Trials as the key
outcomes and results of the Phase III clinical trial have been published
in the Lancet. On behalf of Respondent No. 5, it was submitted that the
clinical data generated during the trials had been submitted to the regulatory
authorities for obtaining permissions / licences etc. Further, the peer-
reviewed study of the partial clinical data of Phase II / III trials had
already been published in reputed scientific journals, which included all
the information necessary for safeguarding the public as well as informing
them of the credibility and efficacy of the vaccine. According to
Respondent No. 5, the raw data of the clinical trials served no greater
public purpose than the data which was already available in the public
domain. All applicable medico-legal, scientific and ethical requirements
had been strictly adhered to by Respondent No. 5.
69. In rejoinder, the learned counsel for the Petitioner argued that
there is no transparency in the process of approvals of vaccines and
relevant data is not always placed before the NTAGI. He referred to a
news article in The Wire, according to which Jayaprakash Muliyil, a
member of the NTAGI had stated that the NTAGI had not recommended
vaccination of children in the age group of 12-14 years. He also drew
the attention of this Court to non-supply of relevant data to the NTAGI
at the time of approval of the
Rotavac vaccine against rotavirus. The
Petitioner further complained of the haste shown in grant of emergency
approval to Respondent No. 4. The Petitioner has sought support of a
decision of the United States District Court for the Northern District of
Texas dated 06.01.2022 in Public Health and Medical Professionals
for Transparency v. Food and Drug Administration, which highlighted
the need for transparency in disclosure of clinical trial data. It was
reiterated by the Petitioner that privacy of individuals would not be at
risk as their personal identification data can be redacted before disclosing
segregated data of clinical trials.
70. It is settled law that courts cannot take judicial notice of facts
stated in a news item published in a newspaper. A statement of fact
contained in a newspaper is merely hearsay and therefore, inadmissible
in evidence, unless proved by the maker of the statement appearing in
court and deposing to have perceived the fact reported.48 In the absence
of anything on record in the present case to substantiate the statement
made by Mr. Jayaprakash Muliyil, member of the NTAGI, we are not
48 Laxmi Raj Shetty v. State of Tamil Nadu (1988) 3 SCC 319
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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.
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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.
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6. Reporting.¯ Report of clinical trial shall be documented in
accordance with the approaches specified in Table 6 of the
Third Schedule. The report shall be certified by the principal
investigator or if no principal investigator is designated then
by each of the participating investigators of the study.”
It is clear from the above, that there are stringent statutory
requirements which have to be complied with by the manufacturers of
vaccines and other participants, during different stages of clinical trials
of vaccines. Further, we also 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
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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.
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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
…
36.  Researchers, authors, sponsors, editors and publishers
all have ethical obligations with regard to the publication
and dissemination of the results of research. Researchers have
a duty to make publicly available the results of their research
on human subjects and are accountable for the completeness
and accuracy of their reports. All parties should adhere to
accepted guidelines for ethical reporting. Negative and
inconclusive as well as positive results must be published or
otherwise made
publicly available. Sources of funding,
institutional affiliations and conflicts of interest must be
declared in the publication. Reports of research not in
accordance with the principles of this Declaration should not
be accepted for publication.”
It is profitable to refer to the relevant portion of the WHO
Statement on Clinical Trials, which is as under: -
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“Reporting timeframes for clinical trials
Clinical trial results are to be reported according to the
timeframes outlined below. Reporting is to occur in BOTH of
the following two modalities.
1. The main findings of clinical trials are to be submitted for
publication in a peer reviewed journal within 12 months of
study completion and are to be published through an open
access mechanism unless there is a specific reason why open
access cannot be used, or otherwise made available publicly
at most within 24 months of study completion.
2. In addition, the key outcomes are to be made publicly
available within 12 months of study completion by posting to
the results section of the primary clinical trial registry. Where
a registry is used without a results database available, the
results should be posted on a free-to-access, publicly
available, searchable institutional website of the Regulatory
Sponsor, Funder or Principal Investigator.”
74. The GCP guidelines are being scrupulously followed, according
to 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
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Court”), we are afraid that the said decision cannot be said to be relevant
for adjudication of the dispute in the present case. The grievance of the
plaintiff in the said case pertained to all data and information for the
Pfizer vaccine, enumerated under the relevant provisions of the Freedom
of Information Act, not being provided by the United States Food and
Drug Administration. The US District Court referred to the Freedom of
Information Act to hold that the citizenry has a right to be provided with
the relevant information pertaining to the Pfizer vaccine and that such
‘information is often useful only if it is timely’. The US District Court
directed expeditious completion of the plaintiff’s request after concluding
that the request under the Freedom of Information Act was of paramount
importance. We note that with respect to COVAXIN and COVISHIELD,
results of clinical trials have been published in accordance with our
statutory regime in place. Reliance placed by the Petitioner on European
Medicines Agency policy on publication of clinical data for medicinal
products for human use is also not relevant as the GCP guidelines relating
to the disclosure of clinical trial data, framed under the 2019 Rules,
currently govern the field of disclosure of clinical trial data in India.
76. An analysis of the submissions made by the learned counsel
appearing for the parties and a close scrutiny of the material placed on
record would show that there is a strict
statutory regime in force for
grant of approvals to vaccines. Specialist bodies established under the
provisions of the Drugs and Cosmetics Act, 1940 and the rules framed
thereunder comprise of domain experts in the relevant field, who conduct
a thorough scrutiny of the material produced by the manufacturers before
granting approval. The information provided on behalf of the Union of
India substantiates that the data provided by the vaccine manufacturers
was considered by the SEC over a period of time and several conditions
were imposed at the time of recommending approvals, which have been
modified or lifted subsequently on availability of further data arising from
the clinical trials before the SEC, as can be seen from the minutes of the
meetings of the SEC, available on the website of the MoHFW. 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
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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
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
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the manner intended, with several members of the original control group
prematurely unblinded and offered the vaccine. The Petitioner contends
that owing to ‘dilution of Phase III control trials prematurely’, there are
no controls to compare against, making it difficult to ascertain which
adverse events are caused by the vaccine. Therefore, reactions which
are not “known reactions” to the vaccine are not considered AEFIs. In
light of this, it is necessary for the authorities to carefully monitor all
vaccine recipients and publicly record all adverse events.
78. Taking this argument further, the Petitioner contended that
the adverse events reporting system in India is not transparent, with
obscure investigation and follow-up of 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
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Following Immunisation surveillance system. It was further strengthened
by the National Adverse Event Following Immunisation Surveillance
Technical Collaborating Centre, comprising of experts from Lady
Hardinge Medical College and Allied Hospitals in New Delhi. Adverse
Event Following Immunisation Committees were formed at the national
and state levels to provide guidance to the National AEFI Surveillance
and carry out documentation, investigation and causality assessment,
besides training and orientation of health care workers and others
involved in AEFI. According to the Union of India, a foolproof protocol
for reporting and causality assessment for any AEFI with Universal
Immunisation Program (UIP) and Non-UIP vaccines has been
established. The National AEFI Committee gets periodical reports
regarding ‘minor AEFIs’, ‘severe AEFIs’ and ‘serious AEFIs’. Online
reporting of all serious and severe AEFIs at the district level to be
communicated to relevant authorities at the state / national level is done
on a web-based portal, SAFEVAC (Surveillance and Action for Events
Following Vaccination). All serious and severe adverse events following
vaccination even at district level are uploaded online on SAFEVAC. It
was submitted on behalf of the Union of India that case details, scanned
copies of reports are uploaded on SAFEVAC, which also has facilities
for generating dashboards and line-lists at different levels.
80.
Further, a similar feature of reporting of all AEFIs (including
minor) by the vaccinator was made available on the Co-WIN portal.
District Immunisation Officers (DIOs) were given the facility to report
AEFI cases about which they have information from such individuals
who do not have access to Co-WIN. Departmental orders and standard
operating procedures have been issued for further investigations and
sharing of hospital records by the DIOs through Co-WIN. The Union of
India has brought to the notice of this Court that an alignment with the
Pharmacovigilance Programme of India (PvPI) under Indian
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
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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 informationin each case and look for trends in reporting
of specific events or unusual cases requiring further early investigation
and assessment. All cases of serious and severe AEFIs, including reported
deaths, are subjected to rapid reviews, analysis and causality assessment
done by a team of
trained subject experts. It was clarified that mere
reporting of AEFI case should not be attributed to the vaccine unless
proved by the causality assessment analysis. The National Expert Group
on Vaccine Administration for COVID-19 (NEGVAC), an additional
body of experts, is also involved in providing guidance on vaccine safety
and surveillance, thus, aiding in the prompt identification of AEFIs for
the purpose of identifying and understanding evolving trends in the disease
and taking prompt action. 2,116 serious and severe AEFIs have been
reported from 1,19,38,44,741 doses of COVID-19 vaccine administered
till 24.11.2021. While a report of rapid review and analysis completed
for 495 cases had been submitted, a further report of 1,356 serious 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
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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
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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.
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
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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 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
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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.
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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 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
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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
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the virus. Our suggestion also does not extend to any other
directions requiring maintenance of COVID-appropriate
behaviour issued by the Union or the State Governments.
(vi)
As regards non-disclosure of segregated clinical data, we
find that the results of Phase III clinical trials of the vaccines
in question have been published, in line with the requirement
under the statutory regime in place, the GCP guidelines and
the WHO Statement on Clinical Trials. The material
provided by the Union of India, comprising of minutes of
the meetings of the SEC, do not warrant the conclusion
that restricted emergency use approvals had been granted
to COVISHIELD and COVAXIN in haste, without thorough
review of the relevant data. Relevant information relating
to the meetings of the SEC and the NTAGI are available in
public domain and therefore, challenge to the procedures
adopted by the expert 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
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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.
90. We express our
gratitude to the learned counsel on either side
for their able assistance in enabling this Court to reach the above
conclusion.
91. The Writ Petition is disposed of accordingly.
Bibhuti Bhushan Bose
Petition disposed.
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