DELHI COMMISSION FOR PROTECTION OF CHILD RIGHTSversusUNION OF INDIA AND ANOTHER

908            SUPREME COURT
                         [2022]REPORTS
                                2 S.C.R. 908                   [2022] 2 S.C.R.


A     DELHI COMMISSION FOR PROTECTION OF CHILD RIGHTS
                                        v.
                     UNION OF INDIA AND ANOTHER
                      (Writ Petition (Civil) No 572 of 2021)
B                              JANUARY 25, 2022
              [DR. DHANANJAYA Y CHANDRACHUD AND
                       SANJIV KHANNA, JJ.]
             Covid-19 vaccination: Vaccination of Pregnant Women and
      Lactating Mothers – Petitioner seeking categorization of pregnant
C
      women and lactating mothers as belonging to the high risk category
      for the purposes of vaccination – Certain suggestions made by
      petitioner raised issues of policy – The same required the government
      to take decision, bearing in mind welfare, safety and dignity of
      such class of women – The suggestions made by the petitioner
D     involved application of domain knowledge by experts in the area –
      Court not in a position to take the decision unaided by an expert
      determination – Union Government to place the matter before duly
      constituted expert group to evaluate the suggestions – Writ petition
      disposed of.
E           CIVIL ORIGINAL JURISDICTION: Writ Petition (Civil) No.
      572 of 2021.
            (UNDER ARTICLE 32 OF THE CONSTITUTION OF INDIA)
            Ms. Vrinda Grover, Kumar Shanu, Soutik Banerjee, Ms. Ayushi
      Rajput, Ms. Rangoli Seth, Prateek K Chadha, Advs. for the Petitioner.
F
           Ms. Aishwarya Bhati, ASG, Gurmeet Singh Makker, Rajat Nair,
      Kanu Agrawal, Ms. Deepabali Dutta, Ketan Paul, Advs. for the
      Respondents.
            Nilesh C. Ojha, Prem Sunder Jha, Ishwarlal S. Agarwal, Ms. Dipali
G     N. Ojha, Pratik Jain Saklecha, Shivam Mehra, Abhishek Mishra, Ms.
      Sidhi A. Dhamnaskar, Ms. Snehal S. Surve, Ms. Poonam S. Rajbhar,
      Ms. Deepika G. Jaiswal, Mangesh B. Dongre, Pritam Bishwas, Anant
      Misra, Advs. for the Intervener.


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                                       908
DELHI COMMISSION FOR PROTECTION OF CHILD RIGHTS v. UNION OF                    909
                   INDIAAND ANOTHER

      The Judgment of the Court was delivered by                               A
      DR. DHANANJAYA Y CHANDRACHUD, J.
       1. These proceedings under Article 32 of the Constitution have
been instituted by the Delhi Commission for Protection of Child Rights 1.
The specific reliefs which have been sought concern the need to provide
effective access to vaccination to pregnant women and lactating mothers.       B
These reliefs can broadly be summarized as follows:
      (i)     Categorization of pregnant women and lactating mothers
              as belonging to the high risk category to be given priority in
              vaccination;
                                                                               C
      (ii)    Their inclusion in the vaccination drives and setting up of a
              task force to operationalize a standard operating procedure 2
              for monitoring of their health post vaccination;
      (iii)   Developing educational materials and SOPs for women
              belonging to this group to understand the effects of             D
              vaccination and ensure informed consent;
      (iv)    Creation of a registry for vaccinated pregnant women and
              lactating mothers to allow effective and constant monitoring
              of their health;
      (v)     Setting up of separate vaccination centers to protect this       E
              class of persons from untoward infection;
      (vi)    Engaging Anganwadi centres and ASHA workers for
              vaccination drives as a method of outreach particularly for
              women belonging to underprivileged socio economic
              backgrounds; and                                                 F
      (vii)   Providing an option on the Co-WIN portal so as to allow
              pregnant women and lactating mothers to classify and
              identify themselves such that they can be given priority while
              providing slots for vaccination.
      2. Initially, a preliminary affidavit was filed on 2 October 2021 by     G
the Additional Commissioner in the Union Ministry of Health and Family
Welfare3. The affidavit has detailed out steps taken for (i) constituting
1
  “DCPCR”
2
  “SOP”
3
  “MoHFW”                                                                      H
910                SUPREME COURT REPORTS                          [2022] 2 S.C.R.


A     the National Technical Advisory Group on Immunization4 and National
      Expert Group on Vaccination Administration for Covid-195; (ii) steps
      taken for supporting the vaccination of pregnant women; (iii) steps taken
      for tracking Adverse Events Following Immunization6; and (iv) support
      provided through vaccination centres and ASHA and Anganwadi workers.
      The affidavit states that:
B
            (i)      Initially, pregnant women and lactating mothers were not
                     eligible for the COVID-19 vaccination as there was no
                     sufficient evidence regarding its safety and efficacy.
                     Subsequently, the World Health Organization and other
                     experts recommended that the benefits of the vaccine for
C                    this group outweigh its potential risks;
            (ii)     Based on the recommendations of experts, a national
                     consultation was held on the subject with representatives
                     of State Governments, medical colleges, Federation of
                     Obstetric and Gynecological Societies of India (FOGSI),
D                    NGOs, among others, to gain consensus on the subject of
                     vaccinating pregnant women and lactating mothers and
                     spreading awareness regarding the vaccination drive;
            (iii)    The MoHFW approved the vaccination of pregnant women
                     on 2 July 2021 and vaccination for lactating mothers was
E                    approved on 19 May 2021. Operational guidelines for
                     vaccination of pregnant women were released on 2 July
                     2021, which recommended that all pregnant women visiting
                     for antenatal care should be informed of the risks and benefits
                     of COVID-19 vaccines and their likely side effects;
F           (iv)     The MoHFW has directed all States and Union Territories
                     to engage with professional bodies such as FOGSI, Indian
                     Medical Association, Indian Academy of Paediatrics,
                     National Neonatology Forum;
            (v)      Since the full impact of the vaccines on pregnancy outcomes
G                    for the woman and the fetus are unclear, all AEFIs are
                     monitored through a well-structured and robust surveillance

      4
        “NTAGI”
      5
        “NEGVAC”
      6
H       “AEFI”
DELHI COMMISSION FOR PROTECTION OF CHILD RIGHTS v. UNION OF                  911
  INDIAAND ANOTHER [DR. DHANANJAYA Y CHANDRACHUD, J.]

              system. For this purpose, National AEFI Surveillance           A
              Operational Guidelines and COVID-19 Operational
              Guidelines have been formulated;
      (vi)    A causality assessment is conducted by the designated AEFI
              committee and AEFI amongst the beneficiaries of
              vaccination are reported by the vaccinator or District         B
              Immunization Officer through the Co-WIN portal;
      (vii)   A multi-centric project to study and document the adverse
              events occurring in pregnant women vaccinated with the
              COVID-19 vaccine is being initiated across the country;
      (viii) All pregnant women who are vaccinated are line-listed on        C
             the Co-WIN portal with their demographic details and any
             AEFI reported is also entered on the portal to ensure that a
             tracking mechanism is maintained;
      (ix)    As regards the vaccination drive for pregnant women and
              lactating mothers, States/UTs have been advised that they      D
              may prioritize vaccination through strategies like dedicated
              time period for vaccination of pregnant women and lactating
              mothers, designate special days for their vaccination, and
              identify centres for vaccination of this group;
      (x)     ASHA and Anganwadi workers form a critical support
                                                                             E
              system as frontline workers by linking the vaccine
              beneficiaries and the service providers. Thus, dedicated
              Information Education Communication material has been
              developed for frontline workers (including ASHA and
              Anganwadi workers and vaccinators); and
      (xi)    An option has been provided on the Co-WIN portal to            F
              identify a woman as pregnant to ensure the woman can get
              vaccinated at the nearest centre.
       3. On 3 December 2021, this Court directed the petitioner to
formulate concrete suggestions to strengthen the existing framework of
vaccination of pregnant women and lactating mothers and share it with        G
the Union Government. The petitioner shared these suggestions and
thereafter, a further affidavit dated 13 January 2022 has been filed by
the Union Government which has particularly dealt with AEFIs and the
mechanism for identification of pregnant women and lactating mothers,
in response to the petitioner’s suggestions. The affidavit states that:      H
912          SUPREME COURT REPORTS                          [2022] 2 S.C.R.


A     (i)      Regarding the declaration and identification of pregnant
               women and lactating mothers at the time of vaccination,
               only a verbal declaration, on a purely voluntary basis, is
               required regarding the status of pregnancy/lactation, which
               can be verified at the time of vaccination. Once the
               declaration is made, the vaccinator provides the beneficiary
B
               with information about risks of COVID-19 infection in
               pregnancy, the benefits and side-effects of vaccination;
      (ii)     The guidelines issued by MoHFW require reporting of any
               suspected AEFI irrespective of the time interval between
               the day of vaccination and the day of onset of symptoms.
C              Thus, there is no time limitation for reporting AEFIs;
      (iii)    The current AEFI surveillance system collects data of all
               adverse events related to COVID-19 vaccine beneficiaries,
               including pregnant women or lactating mothers. Under this
               system, (a) the District Immunization Officers have been
D              instructed to set up a network with private hospitals to report
               AEFIs; (b) training has been given to State officers, medical
               officers, private practitioners and frontline health workers
               on their role in AEFI surveillance; (c) Auxiliary Nurse
               Midwifes at block/planning unit have been instructed to
E              notify all AEFIs and medical officers have been instructed
               to look for any patterns; (d) pregnant women are being
               given antenatal care services through government or private
               health care facilities;
      (iv)     Medical treatment is being provided free of cost to
F              beneficiaries who suffer AEFIs in all government health
               institutions. States/UTs have been asked to identify at least
               one AEFI management centre in each block. Additionally,
               MoHFW has established a patient to doctor telemedicine
               platform;

G     (v)      Regarding the publication of data, the affidavit states that
               once the causality assessment is done, the data regarding
               AEFIs is made available in public domain on the website of
               MoHFW. Since all AEFIs following vaccination may not
               be causally linked to the vaccination, publication of data
               without causality assessment is inappropriate as it may
H              increase vaccination hesitancy; and
DELHI COMMISSION FOR PROTECTION OF CHILD RIGHTS v. UNION OF                     913
  INDIAAND ANOTHER [DR. DHANANJAYA Y CHANDRACHUD, J.]

      (vi)   Regarding the creation of the specific filter on the Co-WIN        A
             portal for pregnant women and lactating mothers, the
             affidavit states that this group has to be identified and
             counselled before the vaccination and there is no method
             of verification at the time of booking of slots.
       4. We have heard Ms Vrinda Grover, learned counsel appearing             B
on behalf of the petitioner and Ms Aishwarya Bhati, learned Additional
Solicitor General. An intervention application has been filed by Mr Ambar
H Koiri, who is represented by Mr Nilesh Ojha.
       5. During the course of her submissions, Ms Vrinda Grover, learned
counsel has submitted that the affidavits which have been filed by the          C
Union of India would substantially resolve the concerns which have been
raised in the petition. Learned counsel submitted that DCPCR instituted
these proceedings with the object of ensuring that vaccination for
pregnant women and lactating mothers is taken up on a priority.
      6. The decision to enable vaccination for lactating mothers was           D
taken on 19 May 2021 while the decision to permit vaccination for
pregnant women was announced on 2 July 2021. The Court has been
apprised of the fact that in taking these decisions, the Government has
been guided by its own expert groups as well as by a consensus which
has evolved at the international level through the World Health
Organization.                                                                   E

       7. Learned counsel appearing on behalf of the petitioners has
highlighted three concerns which, according to the petitioners, remain
and which may be addressed at a suitable level by the government. We
shall outline the concerns which have been presented during the course
of the oral submissions by Ms Vrinda Grover, seriatim:                          F
       Firstly, it has been submitted that the framework for vaccination
of pregnant women and lactating mothers envisages a voluntary verbal
declaration by the person who seeks vaccination, at the time of registration.
In this context, it has been submitted that the woman who visits a
vaccination centre may not necessarily be aware of the need to make             G
such a declaration and in the event that she is not informed by the
personnel at the vaccination centre, the recording of her status either as
a pregnant woman or lactating mother may remain to be incorporated in
the data set. Hence, it has been submitted that if the Co-WIN portal is
suitably modified so as to incorporate a declaration at the time of
                                                                                H
914             SUPREME COURT REPORTS                            [2022] 2 S.C.R.


A     registration, this would facilitate the monitoring of the health of the
      vaccinated woman or mother, as the case may be.
             Secondly, it has been suggested that in order to further support
      the surveillance measures which have been instituted by the government
      for monitoring AEFIs, targeted tracking of pregnant women and lactating
B     mothers can be considered so as to bolster the process of monitoring.
            Thirdly, it has been emphasized that when adequate data sets
      become available, the publication of data will enhance the confidence in
      the process of vaccination.
             8. Ms Aishwarya Bhati, learned Additional Solicitor General while
C     responding to the above suggestions submitted that each of the three
      suggestions has been carefully evaluated by experts within the Union
      Government. The Additional Solicitor General submits that in the ongoing
      process where decisions are being continuously evolved, the government
      has certain concerns over implementing the suggestions at the present
D     stage but, is open to further deliberation with the expert bodies.
             9. On the first aspect in particular, it has been submitted that with
      the process of walk-in-registration, the registration on the Co-WIN portal
      has become subsidiary. However, it has been submitted that the reason
      why it was believed that a verbal declaration at the time of vaccination
E     would suffice was to ensure that no person is dissuaded from seeking
      vaccination by introducing an additional column at the time of registration.
      On targeted tracking, it has been submitted that a robust mechanism has
      already been put into place by the Union Government. As regards the
      publication of data, it has been submitted that at this stage, such a proposal
      may be premature, but the Union Government is seized of the issue.
F     Moreover, it has been submitted that the publication of raw data may not
      be appropriate and the data is published after due scrutiny and assessment
      by experts.
             10. This Court is cognizant that the suggestions which have been
      made on behalf of the petitioners do raise issues of policy. For instance,
G     any mandate for disclosure at the stage of registration has to factor in
      and balance concerns over the privacy of the person. There may well
      not be one answer or a single acceptable solution particularly because
      pregnant women and lactating mothers belong to different social and
      economic strata. The government has to take a decision bearing mind
      their welfare, safety and dignity. Likewise, the need to further enhance
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DELHI COMMISSION FOR PROTECTION OF CHILD RIGHTS v. UNION OF                    915
  INDIAAND ANOTHER [DR. DHANANJAYA Y CHANDRACHUD, J.]

the existing protocols for monitoring AEFIs can be carefully evaluated         A
by the expert groups. The Additional Solicitor General has already stated
that data is placed in the public domain after being scrutinized at an
expert level within the government. The suggestions made before the
Court have emanated from a statutory body. They can be considered
with the same sense of cooperation which has pervaded the judicial
                                                                               B
process during the hearing of the present petition.
        11. The three suggestions which have been made by the petitioners
would undoubtedly involve an application of domain knowledge by experts
in the area. The Court may not be in the best position to take a decision
unaided by an expert determination. Hence, we are of the view that
having regard to the inclination which has been shown by the Union             C
Government, it would be appropriate if the three suggestions which have
been outlined earlier are duly placed before the concerned expert groups
as set out in the affidavit of the Union Government so that the suggestions
can be deliberated upon at a policy level at an appropriate stage. This
Court has constituted a National task Force previously comprised of            D
eminent experts from across the country and the Union Government
may engage with them as well to seek suggestions for eliciting its views
and suggestions in the area. We appreciate the steps which have been
taken by DCPCR in moving these proceedings and equally, the sense of
responsibility with which suggestions have been made and discussed
both by Ms Vrinda Grover appearing for DCPCR and by Ms Aishwarya               E
Bhati, Additional Solicitor General appearing for the Union Government
in the course of these proceedings.
      12. Leaving it open to the Union of India to take a considered
view after evaluating the suggestions, we dispose of the petition.
                                                                               F
       13. We further note that Mr Nilesh Ojha, counsel appearing on
behalf of the intervenor, has urged before this Court that the intervenor
has conducted studies which reflect that COVID-19 vaccines pose a
risk to pregnant women or the fetus. On this basis, the intervenor has
sought a direction from this Court to stop the administration of vaccination
to pregnant women. The issues raised by the intervenor clearly lie in the      G
policy domain and this Court cannot take medical decisions regarding
the safety of COVID-19 vaccination among pregnant and lactating
persons. The affidavits of the Union of India indicate that NTAGI and
NEGVAC have taken great care in recommending vaccination for these
groups only after receiving guidance from the World Health Organization        H
916              SUPREME COURT REPORTS                        [2022] 2 S.C.R.


A     and other domain experts. Thus, we do not find it necessary to issue any
      directions to the Union Government as regards this intervention
      application.
             14. Pending applications, if any, stand disposed of.

B     Devika Gujral                                           Petition disposed of.
      (Assisted by : Mahendra Yadav, LCRA)




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