The lack of transparency in assessing scientific evidence for the approval and administration of vaccines has been the subject of dispute with regard to India’s vaccine policy. One such issue, which claimed that the policy violated constitutionally guaranteed freedoms and rights of individuals without adequate justification from a public health perspective, was taken to the Supreme Court. The petitioner, Jacob Puliyel, a former member of the Central government’s National Technical Advisory Group on Immunisation (NTAGI), sought the release of vaccine trial data for all phases, detailed minutes of the NTAGI, the composition and minutes of subject expert committees (SEC), disclosure of the Drugs Controller of India’s decisions on Emergency Use Authorisation (EUA) of vaccines, post-vaccination data relating to adverse events, deaths after vaccination, and the number of those who became infected after vaccination.
His petition had three main points. One, without relevant data on vaccine trials and information about the process of approvals, it cannot be ensured that vaccination is based on ‘informed consent’. Information on the scale of breakthrough infections (infections after vaccination), post-vaccination deaths, adverse-events-related mortality, and data pertaining to all phases of vaccine trials were hard to come by. Apart from the lack of segregated data on vaccine trials, the petitioner highlighted insufficient reporting and evaluation of adverse events following immunisation (AEFIs).
The second contention was that without conclusive evidence that the vaccinated were less likely to transmit the infection than the unvaccinated, there was no justification from a public health perspective to restrict the latter alone to specific places and services. Jacob Puliyel argued that natural immunity that developed from exposure to COVID-19 was more robust than vaccine-induced immunity and that a large majority of Indians had acquired such natural immunity. The existing vaccines, he argued, were not effective against new variants of the virus. According to sero surveys conducted by the Indian Council of Medical Research, two-thirds of the Indian population had been infected with COVID-19. In such circumstances, vaccine mandates placed restrictions on livelihoods without any justification.
The third contention was about the validity of the vaccination programme for children, as in their case the potential benefits did not outweigh the risks.
Government’s defence
The Union government questioned the maintainability of the petition and argued that the decisions were reached on the basis of relevant inputs from experts and through due procedure mandated by law. It contended that courts should not sit in appeal over a scientific process by domain experts.
The government maintained that emergency measures were required given the scale of the pandemic, and vaccination as a means to prevent infection was recognised the world over. India, it said, had one of the largest inoculation programmes in the world and any interference with the government’s efforts would only encourage vaccine hesitancy. The governments of Tamil Nadu, Madhya Pradesh, Delhi and Maharashtra too filed counter-afffidavits in which they cited public interest to justify the restrictions placed on unvaccinated persons.
On the court’s purview
In its order on May 2, the bench of Justices L. Nageswara Rao and B.R. Gavai said the petitioner was not just another “busybody” and that the issues he had raised were public health concerns and pertained to fundamental rights. On the question whether the exercise of power by the executive was beyond judicial review, it referred to several national and international pronouncements in which courts refrained from entering the domain of executive policymaking, but cited a 2001 Supreme Court order which said “this does not mean that courts have to abdicate their right to scrutinise whether the policy in question is formulated keeping in mind all the relevant facts and [whether] the said policy can be held to be beyond the pale of discrimination or reasonableness...”.
It also referred to a court order involving the Delhi Development Authority, which stated that an executive order termed as a policy decision was subject to judicial review for test of constitutionality, limits of power, and conflict with a statutory or larger policy.
The court, however, maintained that it was not within its remit to adjudicate on scientific disputes. As such, it avoided the debate over natural immunity versus vaccine-induced immunity. It also refused to examine the scientific validity of paediatric vaccination, stating that the policy was in line with global scientific consensus.
On the basis of the government’s submissions on vaccine efficacy in preventing deaths and reducing hospitalisation numbers, the court concluded that the government’s policy was on the right track. The state had an obligation under Article 47 of the Constitution to improve public health and to create and sustain the conditions conducive to good health, the court observed.
Even as the court appeared to accept the government’s argument that it had followed due procedure at every stage of vaccine approval, the fact remained that much of the evidence was not in the public domain. According to the government, clinical trial data could not be released as it was bound by the National Ethical Guidelines for Biomedical and Health Research involving human participants to maintain confidentiality. The government argued that all cases of serious and severe AEFI, including reported deaths, were subject to scientific and technical review process and that causalty assessments were done at State and national levels by trained experts.
On the petitioner’s claim that clinical trials would be completed only in 2023, that vaccines were only for emergency use, and that disclosure of data was necessary to assess adverse effects across age groups, the government argued that the Central Drugs Standard Control Organisation (CDSCO) in consultation with the subject expert committees had granted EUA for the two vaccines, Covaxin and Covishield, under the accelerated approval process rules (a policy move made by the government in 2019).
Emergency approvals
The court did not agree with the reasoning that emergency approvals were given in a hurry, as these were necessary to keep the infection at bay. It, however, made it clear that “subject to the protection of privacy of individuals and to the extent permissible by the 2019 rules, the relevant data required to be published under the statutory regime and the WHO statement on Clinical Trials shall be made public without undue delay”.
The court also did not buy the petitioner’s argument that the AEFI surveillance system was faulty. According to him, the percentage of AEFIs in India was 0.004 per cent of total vaccinations; even Europe had a larger percentage of AEFIs. He also contended that individuals and doctors ought to have the right to report AEFIs as it was in the U.S. rather than leaving it to the vaccinators. The court agreed with this and directed the government to make it easy for individuals and doctors to report adverse events on an online platform, the results of which should be made public without disclosing identities.
The court did consider the scientific evidence presented by the petitioner in relation to the impact of vaccination on transmission and the constitutional validity of restrictions on the unvaccinated. He cited a letter published in Lancet stating that the risk of transmission from vaccinated people could not be underestimated. The letter referred to the United States’ Centres for Disease and Control maintaining that “four out of top five countries with the highest percentage of fully vaccinated population [were] high transmission countries.”
The government cited several hospital-based research studies to show that vaccines prevented hospitalisation, severe infection and death. Even while acknowledging that the vaccination programme was voluntary, the court held that the government could impose reasonable and proportionate limitations on individual rights if there was a risk of spreading the infection, contributing to virus mutation or burdening the health infrastructure. It also said that restrictions placed by the government should not be unreasonable and would be subject to scrutiny by constitutional courts.
The court concluded that “restrictions on unvaccinated individuals imposed through various vaccine mandates by State governments/Union Territories cannot be said to be proportionate” and asked all governments and organisations to ‘review’ their vaccine mandates. Even this direction, it said, “is limited to the present situation alone and is not to be construed as interfering with the lawful exercise of power by the executive to take suitable measures for prevention of infection and transmission of the virus”.
With the overwhelming majority of Indians, including those in the 15-18 age group, already vaccinated, the Supreme Court’s order may not have the scope to affect the vaccination programme. It remains to be seen whether its relatively muted push for greater transparency and accountability in public health measures will have any long-term effects.
