A Bad Omen for Public Trust in Vaccines

Context

• Over the past few years, the Indian judiciary has witnessed a surge in petitions related to vaccine approvals and administration.
• While most of these petitions focus on COVID-19 vaccines, concerns have also been raised regarding the rabies and rotavirus vaccines.
• These legal challenges highlight serious issues such as transparency in regulatory processes, informed consent, adverse event monitoring, and compensation for vaccine-related injuries.
• Addressing these concerns through policy reform rather than prolonged litigation is crucial for maintaining public trust in vaccines.

Concerns Raised in Vaccine-Related Petitions

• Lack of Transparency
  • It is incorrect to categorise these petitions as mere offshoots of the global "anti-vax" movement, which often relies on conspiracy theories.
  • Instead, these cases highlight genuine concerns about vaccine safety and regulatory transparency.
  • For instance, a petition from Kerala brought before the Supreme Court alleged deaths due to the failure of an anti-rabies vaccine.
  • Other petitions challenge the lack of publicly available clinical trial data, insufficient disclosure of side effects, poor adverse event monitoring, and the absence of a structured compensation mechanism for those affected by vaccines.
• Declining Trust in CDSCO
  • A significant issue is the public’s declining trust in the Central Drugs Standard Control Organisation (CDSCO), India’s regulatory authority.
  • This lack of trust is evident from petitioners’ demands for independent committees to reassess clinical trial data rather than relying on the CDSCO’s decisions.
  • Additionally, vaccine manufacturers such as Serum Institute and Bharat Biotech have filed defamation lawsuits against critics, with courts granting ex-parte injunctions in some cases.
  • Such actions undermine public confidence and highlight the urgent need for policy intervention rather than judicial proceedings.

Some Other Factors Driving the Petitions

• Transparency Issues in Vaccine Approval
  • One of the primary concerns driving these petitions is the opaque manner in which the CDSCO approves vaccines. Two key transparency-related issues must be addressed.
  • First, while the CDSCO makes regulatory decisions with input from "independent" experts, the identities of these individuals and any conflicts of interest are not disclosed.
  • To restore public confidence, the government must publish details of these experts and provide transcripts of their deliberations.
  • Second, there is no public access to the clinical trial data that forms the basis of vaccine approvals.
  • Currently, pharmaceutical companies submit trial data to the CDSCO, but this information remains confidential.
  • For transparency, the CDSCO should release raw clinical trial data and its internal evaluations, ensuring that patient privacy is protected through necessary redactions.
• Consent and Adverse Event Monitoring
  • Another significant concern raised in petitions is the lack of adequate disclosure about vaccine side effects.
  • Informed consent requires that individuals receive clear and understandable information before vaccination.
  • However, in India, informed consent laws apply only to clinical trials and not to general vaccination programs.
  • The government’s practice of publishing vaccine-related information on obscure websites is inadequate.
  • Instead, information on potential side effects should be made available in accessible formats at vaccination centres.
• Lack of a Strong Legal Framework
  • Furthermore, India’s system for monitoring vaccine-related adverse events, known as Adverse Event Following Immunisation (AEFI), lacks a strong legal framework.
  • Current AEFI guidelines are not legally binding and suffer from poor implementation.
  • Establishing a robust pharmacovigilance system backed by parliamentary legislation would ensure high-quality data collection, independent of pharmaceutical companies’ influence.

The Issue of Compensation for Vaccine-Related Injuries

• A critical issue that remains unresolved is compensation for individuals who suffered severe side effects or lost family members due to COVID-19 vaccines.
• In the case of Sayeeda v. Union of India (2022), the Kerala High Court directed the government to formulate a compensation policy, but the government challenged this order in the Supreme Court, where final arguments are still pending.
• From a legal standpoint, compensation claims should be directed at vaccine manufacturers, as they developed, sold, and profited from the vaccines.
• The government’s role in compensating victims would depend on whether it had agreed to indemnify vaccine manufacturers, but the lack of transparency regarding vaccine purchase agreements makes this unclear.
• Notably, foreign vaccine manufacturers hesitated to enter the Indian market due to the government’s refusal to provide indemnity, allowing Indian manufacturers to dominate the industry and profit significantly.
• Given this, they should also bear responsibility for vaccine-related risks.

The Way Forward: Need for Policy Intervention

• While the compensation issue remains a matter for the courts, other concerns, such as regulatory transparency, informed consent, and adverse event monitoring, should not be left to legal proceedings.
• These are policy matters with significant long-term implications for public trust in vaccines.
• Instead of allowing these issues to be litigated over years with uncertain outcomes, the Ministry of Health should address them proactively through legislative and policy measures.
• The Health Minister should reassure concerned petitioners that their grievances are being taken seriously and commit to implementing reforms.
• A well-drafted law covering vaccine approval transparency, informed consent, and adverse event reporting would be a step in the right direction.
• Such a policy-driven approach would not only improve public confidence in vaccines but also prevent unnecessary litigation that burdens both the courts and the healthcare system.

Conclusion

• The growing number of vaccine-related petitions in India reflects legitimate concerns rather than unfounded scepticism.
• These petitions underscore the need for greater transparency in vaccine approvals, better disclosure of side effects, robust adverse event monitoring, and a fair compensation mechanism for affected individuals.
• Instead of relying on prolonged and often ineffective litigation, policymakers must take responsibility for addressing these issues through legislative reforms.
• Strengthening regulatory transparency and public trust in vaccines is essential for the success of India’s immunization programs and overall public health.

Q1. What is the main concern raised in vaccine-related petitions in India?

Ans. Lack of transparency in vaccine approval, adverse event monitoring, and compensation for vaccine-related injuries.

Q2. Why do petitioners distrust the CDSCO’s regulatory decisions?

Ans. Because key decision-makers and clinical trial data are not disclosed to the public.

Q3. What legal issue is central to the Sayeeda v. Union of India case?

Ans. Compensation for individuals affected by COVID-19 vaccine side effects.

Q4. How can informed consent for vaccination be improved in India?

Ans.  By providing clear and accessible information on vaccine side effects at vaccination centers.

Q5. Why should policymakers address vaccine concerns through policy rather than litigation?

Ans. To ensure timely and effective solutions instead of prolonged court battles with uncertain outcomes 

Source:The Hindu