Supreme Court Directs Expert Review of Vaccination Protocols for Pregnant and Lactating Women

Date of the Judgment: 25 January 2022

Citation: Not Available

Judges: Dr Dhananjaya Y Chandrachud, J and Sanjiv Khanna, J

Can the Supreme Court intervene in matters of public health policy, especially concerning vaccination protocols for pregnant women and lactating mothers? The Supreme Court of India addressed this question in a recent public interest litigation. The court considered the need for effective vaccination access for pregnant women and lactating mothers, and the protocols surrounding it. The bench comprised of Justices Dr. Dhananjaya Y Chandrachud and Sanjiv Khanna.

Case Background

The Delhi Commission for Protection of Child Rights (DCPCR) filed a writ petition under Article 32 of the Constitution, seeking to ensure that pregnant women and lactating mothers receive priority access to COVID-19 vaccinations. The DCPCR also sought the implementation of specific measures to support this vulnerable group. These measures included categorizing pregnant women and lactating mothers as high-risk, establishing a task force to monitor their health post-vaccination, developing educational materials, creating a registry for vaccinated women, setting up separate vaccination centers, and engaging Anganwadi and ASHA workers for outreach. The petition was filed in 2021 when the vaccination drive was ongoing.

Timeline:

Course of Proceedings

The Supreme Court took cognizance of the petition filed by the DCPCR. The Union Government, through the MoHFW, filed affidavits detailing the steps taken to facilitate the vaccination of pregnant women and lactating mothers. The court also considered the suggestions made by the DCPCR to strengthen the existing framework. An intervention application was also filed, raising concerns about the safety of COVID-19 vaccines for pregnant women, but the court did not find it necessary to issue any directions on this intervention.

Legal Framework

This case was filed under Article 32 of the Constitution of India, which grants the Supreme Court the power to issue directions or orders for the enforcement of fundamental rights. The petition sought to ensure the right to health and well-being of pregnant women and lactating mothers, particularly in the context of the COVID-19 pandemic. The court did not discuss any specific laws or provisions other than Article 32 of the Constitution.

Arguments

Arguments by the Petitioner (DCPCR):

• The petitioner argued that pregnant women and lactating mothers should be categorized as a high-risk group and given priority in vaccination drives.
• They emphasized the need for a task force to monitor the health of vaccinated women post-vaccination.
• The petitioner suggested the development of educational materials and SOPs for informed consent.
• They proposed the creation of a registry for vaccinated women for effective monitoring.
• The petitioner advocated for separate vaccination centers to protect this group from infection.
• They urged the engagement of Anganwadi centers and ASHA workers for outreach, especially for women from underprivileged backgrounds.
• The petitioner requested an option on the Co-WIN portal for pregnant women and lactating mothers to identify themselves for priority vaccination slots.
• The petitioner highlighted concerns that the current system relies on a voluntary verbal declaration at the time of vaccination, which may not always be captured if the woman is not aware of the need for such a declaration, or if the personnel at the vaccination center do not inform her.
• It was submitted that if the Co-WIN portal is modified to incorporate a declaration at the time of registration, it would facilitate the monitoring of the health of the vaccinated woman or mother.
• The petitioner suggested that targeted tracking of pregnant women and lactating mothers can be considered to bolster the process of monitoring AEFIs.
• The petitioner emphasized that the publication of data would enhance confidence in the vaccination process.

Arguments by the Respondent (Union of India):

• The Union Government stated that initially, pregnant women and lactating mothers were not eligible for vaccination due to insufficient evidence regarding safety and efficacy.
• They highlighted that based on expert recommendations, a national consultation was held to gain consensus on vaccinating this group.
• The government approved vaccination for pregnant women on 2 July 2021 and for lactating mothers on 19 May 2021.
• The government stated that operational guidelines were released, recommending that pregnant women be informed of the risks and benefits of the vaccines.
• The government has directed all States and Union Territories to engage with professional bodies like FOGSI and IMA.
• The government stated that AEFIs are monitored through a robust surveillance system, and a multi-centric project is being initiated to study adverse events in pregnant women vaccinated with COVID-19 vaccines.
• The government stated that all vaccinated pregnant women are line-listed on the Co-WIN portal with their demographic details, and any reported AEFI is also entered to ensure tracking.
• States/UTs have been advised to prioritize vaccination through strategies like dedicated time periods, special days, and identified centers for this group.
• ASHA and Anganwadi workers are engaged as frontline workers to link beneficiaries with service providers.
• An option has been provided on the Co-WIN portal to identify a woman as pregnant.
• The government stated that only a verbal declaration is required regarding pregnancy/lactation, which can be verified at the time of vaccination.
• The government stated that there is no time limitation for reporting AEFIs.
• The government stated that medical treatment is provided free of cost to beneficiaries who suffer AEFIs in government health institutions.
• The government stated that data regarding AEFIs is made available in the public domain on the website of MoHFW after causality assessment.
• The Union Government submitted that each of the suggestions made by the petitioner has been carefully evaluated by experts within the Union Government.
• The Additional Solicitor General submitted that in the ongoing process where decisions are being continuously evolved, the government has certain concerns over implementing the suggestions at the present stage but, is open to further deliberation with the expert bodies.
• The government stated that the reason why a verbal declaration at the time of vaccination was deemed sufficient was to ensure that no person is dissuaded from seeking vaccination by introducing an additional column at the time of registration.
• The government stated that a robust mechanism has already been put into place for targeted tracking.
• The government submitted that the publication of raw data may not be appropriate and the data is published after due scrutiny and assessment by experts.

Arguments by the Intervenor:

• The intervenor 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

Issues Framed by the Supreme Court

The Supreme Court did not frame specific issues but considered the following concerns raised by the petitioner:

1. Whether the framework for vaccination of pregnant women and lactating mothers, which envisages a voluntary verbal declaration by the person seeking vaccination, is sufficient to ensure that all eligible women are properly identified and their health is monitored?
2. Whether targeted tracking of pregnant women and lactating mothers can be considered to bolster the process of monitoring AEFIs?
3. Whether the publication of data, when adequate data sets become available, will enhance the confidence in the process of vaccination?

Treatment of the Issue by the Court:

Authorities

The Supreme Court relied on the following authorities:

• World Health Organization: The court noted that the government’s decision to enable vaccination for pregnant women and lactating mothers was guided by a consensus evolved at the international level through the World Health Organization.
• National Technical Advisory Group on Immunization (NTAGI): The court noted that the Union of India’s affidavits indicate that NTAGI and NEGVAC have taken great care in recommending vaccination for these groups.
• National Expert Group on Vaccination Administration for Covid-19 (NEGVAC): The court noted that the Union of India’s affidavits indicate that NTAGI and NEGVAC have taken great care in recommending vaccination for these groups.

The Supreme Court also considered the following legal provisions:

• Article 32 of the Constitution of India: This article grants the Supreme Court the power to issue directions or orders for the enforcement of fundamental rights.

Authorities Table

Judgment

What weighed in the mind of the Court?

The Supreme Court’s decision was influenced by a combination of factors. The court recognized the importance of ensuring the health and well-being of pregnant women and lactating mothers during the COVID-19 pandemic. The court also acknowledged the steps taken by the Union Government to facilitate vaccination for this group. However, the court also recognized the need to further strengthen the existing framework based on the suggestions made by the petitioner. The court emphasized that the suggestions made by the petitioner involved policy decisions and required expert determination. The court’s decision was also influenced by the need to balance concerns over privacy and the need to ensure that no person is dissuaded from seeking vaccination. The court’s decision was also influenced by the fact that the suggestions were made by a statutory body, the DCPCR. The court’s decision was also influenced by the fact that the government had shown an inclination to consider the suggestions and had stated that it was open to further deliberation with expert bodies.

Fact:Law Ratio

Logical Reasoning

Key Takeaways

• The Supreme Court acknowledged the steps taken by the Union Government to facilitate vaccination for pregnant women and lactating mothers.
• The court recognized the need to further strengthen the existing framework based on the suggestions made by the petitioner.
• The court emphasized that the suggestions made by the petitioner involved policy decisions and required expert determination.
• The court directed the Union Government to place the suggestions before the concerned expert groups for deliberation at a policy level.
• The court did not intervene in the policy domain regarding the safety of COVID-19 vaccination among pregnant and lactating persons.

Directions

The Supreme Court directed the Union Government to place the three suggestions made by the petitioner before the concerned expert groups for deliberation at a policy level. The three suggestions were:

1. Modification of the Co-WIN portal to incorporate a declaration at the time of registration.
2. Implementation of targeted tracking of pregnant women and lactating mothers for AEFIs.
3. Publication of data to enhance confidence in the vaccination process.

Development of Law

The ratio decidendi of this case is that matters of public health policy, particularly those involving expert medical opinions, are best addressed through expert bodies and policy-level deliberations. The Supreme Court, while acknowledging the importance of the issues raised, refrained from making specific directions, instead directing the government to consider the suggestions through its expert groups. This case reinforces the principle that the judiciary should be cautious in intervening in policy matters and should instead rely on the expertise of the executive and expert bodies.

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 suggestions made by the petitioner to strengthen the vaccination framework for pregnant women and lactating mothers. The court emphasized that the suggestions involved policy decisions and required expert determination. The court’s decision highlights the importance of expert guidance in public health policy and the judiciary’s role in ensuring that policy decisions are made with due consideration of all relevant factors. The court refrained from making specific directions, instead directing the government to consider the suggestions through its expert groups.