DELHI COMMISSION FOR PROTECTION OF CHILD RIGHTS versus UNION OF INDIA AND ANOTHER on 25 January 2022

1. These proceedings under Article 32 of the Constitution havebeen instituted by the Delhi Commission for Protection of Child Rights[1].The specific reliefs which have been sought concern the need to provideeffective access to vaccination to pregnant women and lactating mothers.These reliefs can broadly be summarized as follows:

(i) Categorization of pregnant women and lactating mothersas belonging to the high risk category to be given priority invaccination;

(ii) Their inclusion in the vaccination drives and setting up of atask force to operationalize a standard operating procedure[2]for monitoring of their health post vaccination;

(iii) Developing educational materials and SOPs for womenbelonging to this group to understand the effects ofvaccination and ensure informed consent;

(iv) Creation of a registry for vaccinated pregnant women andlactating mothers to allow effective and constant monitoringof their health;

(v) Setting up of separate vaccination centers to protect thisclass of persons from untoward infection;

(vi) Engaging Anganwadi centres and ASHA workers forvaccination drives as a method of outreach particularly forwomen belonging to underprivileged socio economicbackgrounds; and

(vii) Providing an option on the Co-WIN portal so as to allowpregnant women and lactating mothers to classify andidentify themselves such that they can be given priority whileproviding slots for vaccination.

2. Initially, a preliminary affidavit was filed on 2 October 2021 bythe Additional Commissioner in the Union Ministry of Health and FamilyWelfare[3]. The affidavit has detailed out steps taken for (i) constituting 1 “DCPCR”2 “SOP”3 “MoHFW”

A

B

C

D

E

F

G

H

Athe National Technical Advisory Group on Immunization[4] and NationalExpert Group on Vaccination Administration for Covid-19[5]; (ii) stepstaken for supporting the vaccination of pregnant women; (iii) steps takenfor tracking Adverse Events Following Immunization[6]; and (iv) supportprovided through vaccination centres and ASHA and Anganwadi workers.The affidavit states that:B

(i) Initially, pregnant women and lactating mothers were noteligible for the COVID-19 vaccination as there was nosufficient evidence regarding its safety and efficacy.Subsequently, the World Health Organization and otherexperts recommended that the benefits of the vaccine forCthis group outweigh its potential risks;

(ii) Based on the recommendations of experts, a nationalconsultation was held on the subject with representativesof State Governments, medical colleges, Federation ofObstetric and Gynecological Societies of India (FOGSI),DNGOs, among others, to gain consensus on the subject ofvaccinating pregnant women and lactating mothers andspreading awareness regarding the vaccination drive;

(iii) The MoHFW approved the vaccination of pregnant womenon 2 July 2021 and vaccination for lactating mothers wasEapproved on 19 May 2021. Operational guidelines forvaccination of pregnant women were released on 2 July2021, which recommended that all pregnant women visitingfor antenatal care should be informed of the risks and benefitsof COVID-19 vaccines and their likely side effects; F(iv)The MoHFW has directed all States and Union Territoriesto engage with professional bodies such as FOGSI, IndianMedical Association, Indian Academy of Paediatrics,National Neonatology Forum;

(v) Since the full impact of the vaccines on pregnancy outcomesGfor the woman and the fetus are unclear, all AEFIs aremonitored through a well-structured and robust surveillance 4 “NTAGI”

5 “NEGVAC”H6 “AEFI”

DELHI COMMISSION FOR PROTECTION OF CHILD RIGHTS v. UNION OFINDIA AND ANOTHER [DR. DHANANJAYA Y CHANDRACHUD, J.]

system. For this purpose, National AEFI SurveillanceOperational Guidelines and COVID-19 OperationalGuidelines have been formulated; A

(vi) A causality assessment is conducted by the designated AEFIcommittee and AEFI amongst the beneficiaries ofvaccination are reported by the vaccinator or DistrictBImmunization Officer through the Co-WIN portal;

(vii) A multi-centric project to study and document the adverseevents occurring in pregnant women vaccinated with theCOVID-19 vaccine is being initiated across the country;

(viii) All pregnant women who are vaccinated are line-listed onthe Co-WIN portal with their demographic details and anyAEFI reported is also entered on the portal to ensure that atracking mechanism is maintained; C

(ix) As regards the vaccination drive for pregnant women andlactating mothers, States/UTs have been advised that theymay prioritize vaccination through strategies like dedicatedtime period for vaccination of pregnant women and lactatingmothers, designate special days for their vaccination, andidentify centres for vaccination of this group; D

(x) ASHA and Anganwadi workers form a critical supportsystem as frontline workers by linking the vaccinebeneficiaries and the service providers. Thus, dedicatedInformation Education Communication material has beendeveloped for frontline workers (including ASHA andAnganwadi workers and vaccinators); and E

F

(xi) An option has been provided on the Co-WIN portal toidentify a woman as pregnant to ensure the woman can getvaccinated at the nearest centre.

3. On 3 December 2021, this Court directed the petitioner toformulate concrete suggestions to strengthen the existing framework ofvaccination of pregnant women and lactating mothers and share it withthe Union Government. The petitioner shared these suggestions andthereafter, a further affidavit dated 13 January 2022 has been filed bythe Union Government which has particularly dealt with AEFIs and themechanism for identification of pregnant women and lactating mothers,in response to the petitioner’s suggestions. The affidavit states that:

G

H

912SUPREME COURT REPORTS

A(i)Regarding the declaration and identification of pregnantwomen and lactating mothers at the time of vaccination,only a verbal declaration, on a purely voluntary basis, isrequired regarding the status of pregnancy/lactation, whichcan be verified at the time of vaccination. Once thedeclaration is made, the vaccinator provides the beneficiaryBwith information about risks of COVID-19 infection inpregnancy, the benefits and side-effects of vaccination;

(ii) The guidelines issued by MoHFW require reporting of anysuspected AEFI irrespective of the time interval betweenthe day of vaccination and the day of onset of symptoms.CThus, there is no time limitation for reporting AEFIs;

(iii) The current AEFI surveillance system collects data of alladverse events related to COVID-19 vaccine beneficiaries,including pregnant women or lactating mothers. Under thissystem, (a) the District Immunization Officers have beenDinstructed to set up a network with private hospitals to reportAEFIs; (b) training has been given to State officers, medicalofficers, private practitioners and frontline health workerson their role in AEFI surveillance; (c) Auxiliary NurseMidwifes at block/planning unit have been instructed toEnotify all AEFIs and medical officers have been instructedto look for any patterns; (d) pregnant women are beinggiven antenatal care services through government or privatehealth care facilities;

(iv) Medical treatment is being provided free of cost toFbeneficiaries who suffer AEFIs in all government healthinstitutions. States/UTs have been asked to identify at leastone AEFI management centre in each block. Additionally,MoHFW has established a patient to doctor telemedicineplatform; G(v)Regarding the publication of data, the affidavit states thatonce the causality assessment is done, the data regardingAEFIs is made available in public domain on the website ofMoHFW. Since all AEFIs following vaccination may notbe causally linked to the vaccination, publication of datawithout causality assessment is inappropriate as it mayHincrease vaccination hesitancy; and

(vi) Regarding the creation of the specific filter on the Co-WINportal for pregnant women and lactating mothers, theaffidavit states that this group has to be identified andcounselled before the vaccination and there is no methodof verification at the time of booking of slots.

4. We have heard Ms Vrinda Grover, learned counsel appearingon behalf of the petitioner and Ms Aishwarya Bhati, learned AdditionalSolicitor General. An intervention application has been filed by Mr AmbarH Koiri, who is represented by Mr Nilesh Ojha.

5. During the course of her submissions, Ms Vrinda Grover, learnedcounsel has submitted that the affidavits which have been filed by theUnion of India would substantially resolve the concerns which have beenraised in the petition. Learned counsel submitted that DCPCR institutedthese proceedings with the object of ensuring that vaccination forpregnant women and lactating mothers is taken up on a priority.

6. The decision to enable vaccination for lactating mothers wastaken on 19 May 2021 while the decision to permit vaccination forpregnant women was announced on 2 July 2021. The Court has beenapprised of the fact that in taking these decisions, the Government hasbeen guided by its own expert groups as well as by a consensus whichhas evolved at the international level through the World HealthOrganization.

7. Learned counsel appearing on behalf of the petitioners hashighlighted three concerns which, according to the petitioners, remainand which may be addressed at a suitable level by the government. Weshall outline the concerns which have been presented during the courseof the oral submissions by Ms Vrinda Grover, seriatim:

Firstly, it has been submitted that the framework for vaccinationof pregnant women and lactating mothers envisages a voluntary verbaldeclaration by the person who seeks vaccination, at the time of registration.In this context, it has been submitted that the woman who visits avaccination centre may not necessarily be aware of the need to makesuch a declaration and in the event that she is not informed by thepersonnel at the vaccination centre, the recording of her status either asa pregnant woman or lactating mother may remain to be incorporated inthe data set. Hence, it has been submitted that if the Co-WIN portal issuitably modified so as to incorporate a declaration at the time of A

B

C

D

E

F

G

H

Aregistration, this would facilitate the monitoring of the health of thevaccinated woman or mother, as the case may be.

Secondly, it has been suggested that in order to further supportthe surveillance measures which have been instituted by the governmentfor monitoring AEFIs, targeted tracking of pregnant women and lactatingBmothers can be considered so as to bolster the process of monitoring.

Thirdly, it has been emphasized that when adequate data setsbecome available, the publication of data will enhance the confidence inthe process of vaccination.

8. Ms Aishwarya Bhati, learned Additional Solicitor General whileCresponding to the above suggestions submitted that each of the threesuggestions has been carefully evaluated by experts within the UnionGovernment. The Additional Solicitor General submits that in the ongoingprocess where decisions are being continuously evolved, the governmenthas certain concerns over implementing the suggestions at the presentDstage but, is open to further deliberation with the expert bodies.

9. On the first aspect in particular, it has been submitted that withthe process of walk-in-registration, the registration on the Co-WIN portalhas become subsidiary. However, it has been submitted that the reasonwhy it was believed that a verbal declaration at the time of vaccinationEwould suffice was to ensure that no person is dissuaded from seekingvaccination by introducing an additional column at the time of registration.On targeted tracking, it has been submitted that a robust mechanism hasalready been put into place by the Union Government. As regards thepublication of data, it has been submitted that at this stage, such a proposalmay be premature, but the Union Government is seized of the issue.FMoreover, it has been submitted that the publication of raw data may notbe appropriate and the data is published after due scrutiny and assessmentby experts.

10. This Court is cognizant that the suggestions which have beenmade on behalf of the petitioners do raise issues of policy. For instance,Gany mandate for disclosure at the stage of registration has to factor inand balance concerns over the privacy of the person. There may wellnot be one answer or a single acceptable solution particularly becausepregnant women and lactating mothers belong to different social andeconomic strata. The government has to take a decision bearing mindtheir welfare, safety and dignity. Likewise, the need to further enhanceH

DELHI COMMISSION FOR PROTECTION OF CHILD RIGHTS v. UNION OFINDIA AND ANOTHER [DR. DHANANJAYA Y CHANDRACHUD, J.]

the existing protocols for monitoring AEFIs can be carefully evaluatedby the expert groups. The Additional Solicitor General has already statedthat data is placed in the public domain after being scrutinized at anexpert level within the government. The suggestions made before theCourt have emanated from a statutory body. They can be consideredwith the same sense of cooperation which has pervaded the judicialprocess during the hearing of the present petition.

11. The three suggestions which have been made by the petitionerswould undoubtedly involve an application of domain knowledge by expertsin the area. The Court may not be in the best position to take a decisionunaided by an expert determination. Hence, we are of the view thathaving regard to the inclination which has been shown by the UnionGovernment, it would be appropriate if the three suggestions which havebeen outlined earlier are duly placed before the concerned expert groupsas set out in the affidavit of the Union Government so that the suggestionscan be deliberated upon at a policy level at an appropriate stage. ThisCourt has constituted a National task Force previously comprised ofeminent experts from across the country and the Union Governmentmay engage with them as well to seek suggestions for eliciting its viewsand suggestions in the area. We appreciate the steps which have beentaken by DCPCR in moving these proceedings and equally, the sense ofresponsibility with which suggestions have been made and discussedboth by Ms Vrinda Grover appearing for DCPCR and by Ms AishwaryaBhati, Additional Solicitor General appearing for the Union Governmentin the course of these proceedings.

12. Leaving it open to the Union of India to take a consideredview after evaluating the suggestions, we dispose of the petition.

13. We further note that Mr Nilesh Ojha, counsel appearing onbehalf of the intervenor, has urged before this Court that the intervenorhas conducted studies which reflect that COVID-19 vaccines pose arisk to pregnant women or the fetus. On this basis, the intervenor hassought a direction from this Court to stop the administration of vaccinationto pregnant women. The issues raised by the intervenor clearly lie in thepolicy domain and this Court cannot take medical decisions regardingthe safety of COVID-19 vaccination among pregnant and lactatingpersons. The affidavits of the Union of India indicate that NTAGI andNEGVAC have taken great care in recommending vaccination for thesegroups only after receiving guidance from the World Health Organization A

B

C

D

E

F

G

H

[2022] 2 S.C.R.

Aand other domain experts. Thus, we do not find it necessary to issue anydirections to the Union Government as regards this interventionapplication.

14. Pending applications, if any, stand disposed of.

BDevika Gujral

(Assisted by : Mahendra Yadav, LCRA)

Petition disposed of.

C

D

E

F

G

H