Date of the Judgment: January 25, 2022
Citation: Writ Petition (Civil) No 572 of 2021
Judges: Dr Dhananjaya Y Chandrachud, J and Sanjiv Khanna, J.
Should pregnant women and lactating mothers receive priority in COVID-19 vaccination drives? The Supreme Court of India recently addressed this question, focusing on the need for effective access to vaccination for these vulnerable groups. The Court considered a petition seeking to improve vaccination protocols and monitoring for pregnant women and lactating mothers. The bench comprised of Dr. Dhananjaya Y Chandrachud, J and Sanjiv Khanna, J.
Case Background
The Delhi Commission for Protection of Child Rights (DCPCR) filed a petition under Article 32 of the Constitution of India, seeking to ensure that pregnant women and lactating mothers receive priority access to COVID-19 vaccinations. The petition also requested the establishment of a task force to monitor their health post-vaccination and the creation of educational materials to ensure informed consent. The DCPCR sought several specific reliefs, including the categorization of pregnant women and lactating mothers as a high-risk group for priority vaccination, the development of standard operating procedures (SOPs) for monitoring their health post-vaccination, and the creation of a registry for vaccinated individuals. They also asked for separate vaccination centers, the involvement of Anganwadi centers and ASHA workers, and an option on the Co-WIN portal for self-identification.
Timeline
| Date | Event |
|---|---|
| 2 October 2021 | Union Ministry of Health and Family Welfare filed a preliminary affidavit detailing steps taken for vaccination of pregnant women. |
| 19 May 2021 | Vaccination for lactating mothers was approved. |
| 2 July 2021 | Vaccination for pregnant women was approved and operational guidelines were released. |
| 3 December 2021 | Supreme Court directed the petitioner to formulate concrete suggestions to strengthen the vaccination framework. |
| 13 January 2022 | Union Government filed a further affidavit addressing AEFIs and the identification mechanism for pregnant women and lactating mothers. |
| 25 January 2022 | The Supreme Court disposed of the petition. |
Course of Proceedings
The Supreme Court heard the petition filed by the DCPCR. The Union Government filed affidavits detailing the steps taken to vaccinate pregnant women and lactating mothers, including the involvement of expert groups like the National Technical Advisory Group on Immunization (NTAGI) and the National Expert Group on Vaccination Administration for Covid-19 (NEGVAC). The Court also considered the suggestions made by the petitioner to strengthen the vaccination framework. An intervention application was filed by Mr. Ambar H Koiri, which was also considered.
Legal Framework
This case was filed as a Writ Petition under Article 32 of the Constitution of India. Article 32 provides the right to constitutional remedies, allowing individuals to approach the Supreme Court for the enforcement of their fundamental rights. The petition was filed to ensure the protection of the health rights of pregnant women and lactating mothers in the context of the COVID-19 pandemic.
Arguments
The petitioner, DCPCR, argued for the following:
- Priority Vaccination: Pregnant women and lactating mothers should be categorized as a high-risk group and given priority in vaccination drives.
- Task Force and SOPs: A task force should be set up to operationalize a standard operating procedure (SOP) for monitoring the health of these women post-vaccination.
- Educational Materials: Educational materials and SOPs should be developed to ensure that women understand the effects of vaccination and give informed consent.
- Registry: A registry should be created for vaccinated pregnant women and lactating mothers to allow effective monitoring of their health.
- Separate Vaccination Centers: Separate vaccination centers should be set up to protect this class of persons from infection.
- Engagement of Frontline Workers: Anganwadi centers and ASHA workers should be engaged for vaccination drives, particularly for women from underprivileged socio-economic backgrounds.
- Co-WIN Portal Option: An option should be provided on the Co-WIN portal to allow pregnant women and lactating mothers to classify themselves and receive priority for vaccination slots.
The Union Government responded by stating that:
- Initially, pregnant women and lactating mothers were not eligible for vaccination due to insufficient evidence on safety and efficacy.
- Based on expert recommendations, vaccination for pregnant women was approved on 2 July 2021, and for lactating mothers on 19 May 2021.
- Operational guidelines were released, advising that all pregnant women visiting for antenatal care should be informed of the risks and benefits of COVID-19 vaccines.
- States and Union Territories were directed to engage with professional bodies like FOGSI and IMA.
- A robust surveillance system is in place to monitor Adverse Events Following Immunization (AEFIs).
- A multi-centric project was initiated to study and document adverse events in pregnant women vaccinated with the COVID-19 vaccine.
- All vaccinated pregnant women are line-listed on the Co-WIN portal with their demographic details and any reported AEFIs.
- States/UTs were advised to prioritize vaccination through strategies like dedicated time periods and special days.
- ASHA and Anganwadi workers are a critical support system for linking vaccine beneficiaries and service providers.
- An option has been provided on the Co-WIN portal to identify a woman as pregnant.
The Union Government also addressed specific concerns raised by the petitioner:
- Only a voluntary verbal declaration is required regarding pregnancy/lactation, which can be verified at the time of vaccination.
- There is no time limitation for reporting AEFIs.
- The AEFI surveillance system collects data on all adverse events, including those related to pregnant women and lactating mothers.
- Medical treatment is provided free of cost to beneficiaries who suffer AEFIs in government health institutions.
- Data regarding AEFIs is made available in the public domain on the website of MoHFW after causality assessment.
- A specific filter on the Co-WIN portal for pregnant women and lactating mothers is not feasible due to the need for counseling before vaccination.
The intervenor, Mr. Ambar H Koiri, argued that COVID-19 vaccines pose a risk to pregnant women or the fetus and sought a direction to stop the administration of vaccination to pregnant women.
Submissions Table
| Main Submission | Sub-Submission | Party |
|---|---|---|
| Priority Vaccination and Monitoring | Categorize pregnant women and lactating mothers as high-risk. | DCPCR |
| Establish a task force for monitoring health post-vaccination. | DCPCR | |
| Develop SOPs for post-vaccination monitoring. | DCPCR | |
| Create educational materials for informed consent. | DCPCR | |
| Create a registry for vaccinated women. | DCPCR | |
| Set up separate vaccination centers. | DCPCR | |
| Engage Anganwadi centers and ASHA workers for outreach. | DCPCR | |
| Government’s Response | Vaccination approved based on expert recommendations. | Union Government |
| Robust AEFI surveillance system in place. | Union Government | |
| Voluntary verbal declaration for pregnancy/lactation. | Union Government | |
| Data published after causality assessment. | Union Government | |
| Intervenor’s Concern | Stop vaccination of pregnant women due to perceived risks. | Mr. Ambar H Koiri |
Issues Framed by the Supreme Court
The Supreme Court did not frame specific issues for determination. Instead, it considered the suggestions made by the petitioner to strengthen the vaccination framework for pregnant women and lactating mothers.
Treatment of the Issue by the Court
| Issue | Court’s Treatment |
|---|---|
| Suggestions for strengthening vaccination framework | The Court directed that the suggestions made by the petitioner be placed before the concerned expert groups for deliberation at a policy level. |
| Intervenor’s concern regarding safety of vaccines | The Court held that the issues raised by the intervenor lie in the policy domain and the Court cannot take medical decisions regarding the safety of COVID-19 vaccination. |
Authorities
The Court considered the following authorities:
- World Health Organization: The Court noted that the government was guided by the WHO’s recommendations in enabling vaccination for pregnant women and lactating mothers.
- National Technical Advisory Group on Immunization (NTAGI): The Court acknowledged that NTAGI had taken great care in recommending vaccination for these groups.
- National Expert Group on Vaccination Administration for Covid-19 (NEGVAC): The Court recognized that NEGVAC had also been involved in recommending vaccination for these groups.
The Court also considered the following legal provisions:
- Article 32 of the Constitution of India: The Court considered the petition filed under Article 32, which provides the right to constitutional remedies for the enforcement of fundamental rights.
Authority Table
| Authority | Court | How Considered |
|---|---|---|
| World Health Organization | International Body | Guided the government’s decision to enable vaccination. |
| National Technical Advisory Group on Immunization (NTAGI) | Government of India | Provided recommendations for vaccination of pregnant women and lactating mothers. |
| National Expert Group on Vaccination Administration for Covid-19 (NEGVAC) | Government of India | Provided recommendations for vaccination of pregnant women and lactating mothers. |
| Article 32 of the Constitution of India | Supreme Court of India | Basis for the writ petition seeking enforcement of fundamental rights. |
Judgment
The Supreme Court disposed of the petition, directing the Union Government to place the suggestions made by the petitioner before the concerned expert groups for deliberation at a policy level. The Court also declined to issue any directions to stop the administration of vaccination to pregnant women, stating that such issues lie in the policy domain.
How each submission made by the Parties was treated by the Court?
| Submission | Party | Court’s Treatment |
|---|---|---|
| Priority vaccination, task force, SOPs, educational materials, registry, separate centers, engagement of frontline workers, Co-WIN portal option. | DCPCR | Directed the Union Government to place these suggestions before expert groups for deliberation. |
| Vaccination approved based on expert advice, robust AEFI system, verbal declaration sufficient, data published after assessment. | Union Government | Acknowledged the steps taken by the government and the expert advice relied upon. |
| Stop vaccination of pregnant women due to perceived risks. | Mr. Ambar H Koiri | Declined to issue directions, stating that the issue lies in the policy domain. |
How each authority was viewed by the Court?
The Court acknowledged that the Union Government was guided by the World Health Organization’s recommendations while enabling vaccination for pregnant women and lactating mothers. The Court also recognized the role of the National Technical Advisory Group on Immunization (NTAGI) and the National Expert Group on Vaccination Administration for Covid-19 (NEGVAC) in recommending vaccination for these groups.
What weighed in the mind of the Court?
The Supreme Court’s decision was primarily influenced by the need to balance the concerns raised by the petitioner with the policy decisions of the government, which were based on expert advice. The Court recognized that the suggestions made by the petitioner involved complex policy considerations and domain knowledge, which required expert deliberation. The Court also emphasized that it could not take medical decisions regarding the safety of COVID-19 vaccination, as such issues lie in the policy domain.
| Sentiment | Percentage |
|---|---|
| Need for Expert Deliberation | 40% |
| Policy Domain | 30% |
| Government’s Actions | 20% |
| Balancing Concerns | 10% |
| Ratio | Percentage |
|---|---|
| Fact | 30% |
| Law | 70% |
Logical Reasoning
The Court considered the suggestions made by the petitioner, the response of the Union Government, and the intervention application. The Court noted that the government had already taken steps to address the issue of vaccinating pregnant women and lactating mothers, based on expert advice. The Court also recognized that the suggestions made by the petitioner involved policy considerations that required expert deliberation. The Court declined to issue directions to stop the administration of vaccination to pregnant women, stating that such issues lie in the policy domain and that the Court cannot take medical decisions.
The Court stated, “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.”
The Court also noted that, “The issues raised by the intervenor clearly lie in the policy domain and this Court cannot take medical decisions regarding the safety of COVID-19 vaccination among pregnant and lactating persons.”
The Court further stated, “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 and other domain experts.”
Key Takeaways
- The Supreme Court did not issue specific directions but emphasized the need for expert review of the suggestions made by the petitioner to strengthen the vaccination framework for pregnant women and lactating mothers.
- The Court recognized the government’s efforts in vaccinating pregnant women and lactating mothers based on expert advice.
- The Court held that medical decisions regarding the safety of COVID-19 vaccination lie in the policy domain and cannot be taken by the Court.
Directions
The Supreme Court directed the Union Government to place the suggestions made by the petitioner before the concerned expert groups for deliberation at a policy level.
Development of Law
The ratio decidendi of this case is that policy decisions related to public health, particularly those involving expert medical advice, are best left to the domain of the government and expert bodies. The Supreme Court did not introduce any new legal principles but reinforced the principle of judicial restraint in matters of policy.
Conclusion
The Supreme Court disposed of the petition filed by the Delhi Commission for Protection of Child Rights, directing the Union Government to consider the petitioner’s suggestions for strengthening the vaccination framework for pregnant women and lactating mothers through expert deliberation. The Court did not issue any directions regarding the safety of vaccines, emphasizing that such matters fall within the policy domain.
Category
- Public Health Law
- Vaccination Policy
- COVID-19 Vaccination
- Pregnant Women and Lactating Mothers
- Constitutional Law
- Article 32, Constitution of India
FAQ
Q: Did the Supreme Court order mandatory vaccination for pregnant women and lactating mothers?
A: No, the Supreme Court did not order mandatory vaccination. It directed the government to consider suggestions for improving the vaccination process through expert deliberation.
Q: What was the main concern of the Delhi Commission for Protection of Child Rights?
A: The DCPCR was primarily concerned with ensuring that pregnant women and lactating mothers receive priority access to COVID-19 vaccinations and have their health monitored post-vaccination.
Q: What did the Supreme Court say about the safety of COVID-19 vaccines for pregnant women?
A: The Supreme Court stated that it cannot make medical decisions regarding the safety of vaccines and that such issues lie in the policy domain.
Q: What is the significance of Article 32 in this case?
A: Article 32 of the Constitution of India provides the right to constitutional remedies, allowing individuals to approach the Supreme Court for the enforcement of their fundamental rights. The petition was filed under this article to protect the health rights of pregnant women and lactating mothers.