Jacob Puliyel, MD, a pediatrician in India for more than 40 years, brought suit in the Supreme Court of India against the Union of India and COVID-19 vaccine manufacturers in a legal challenge to the country’s COVID vaccine program.1 Dr. Puliyel, who has served as Director of Research and Projects at Holy Family Hospital in Delhi and is a former member of the National Technical Advisory Group (NTAG) on immunizations in India, sued the government and COVID vaccine manufacturers seeking release of information related to the COVID vaccine approval process, as well as arguing for a policy change that allows unvaccinated persons to enter public spaces and access resources.
Specifically, Dr. Puliyel asked the Supreme Court of India for the release of each phase of clinical trial data for the COVID vaccines administered in India; disclosure of minutes from the meeting of the Subject Expert Committee and the NTGAI with regard to vaccines; release of information surrounding the approval or rejection of emergency use applications of vaccines by the Drugs Controller General of India (DCGI); and disclosure of post vaccination data related to COVID. He also asked the court to declare that all COVID vaccine mandates are unconstitutional and a violation of h2citizen’s rights.
Dr. Puliyel: COVID Vaccines Do Not Prevent Infection or Transmission
In support of his request, Dr. Puliyel submitted affidavits to the court stating that natural immunity from SARS-CoV-2 is superior to vaccine acquired immunity and that vaccines do not prevent infection or transmission of COVID. News articles were submitted to show that two-thirds of the population in India had already been infected with SARS-CoV-2 and have antibodies to the virus, and that the vaccinated were susceptible to breakthrough infections. Dr. Puliyel also argued that vaccine mandates and restrictions on the unvaccinated are meaningless because the virus is transmitted by the vaccinated and unvaccinated alike.
The government maintained that the COVID vaccines administered in India, Covaxin and Covishield, are needed to combat the global pandemic threat. They also maintained that trial data cannot be released to the public due to privacy concerns; that information regarding adverse events has already been released; that vaccination remains voluntary for all citizens, and that restrictions on the unvaccinated were necessary to protect the public health.
Respondent COVID vaccine manufacturers argued that they followed strict guidelines for government approval of their COVID vaccines.
The Union of India strongly opposed this lawsuit, claiming that the publicity could increase vaccine hesitancy and endanger the public health, and that public health matters should not be interfered with by the court. However, because Dr. Puliyel brought this lawsuit in the interest of the public and because he is considered a subject matter expert, the Court determined the case would be heard for the welfare of the public.
The Supreme Court of India Looked to High Courts in Other Countries
The government made their argument relying on prominent cases in India, as well as U.S. cases, such as Jacobson v. Commonwealth of Massachusetts, Zucht v. King; Biden vs. Missouri, and Roman Catholic Diocese v. Cuomo. The court also looked to New South Wales for guidance, finding that the Supreme Court in Assam v. Hazzard held that it was not the court’s role to determine the effectiveness of the government’s regulations or whether the regulations were the best response to the risks COVID posed to the public, instead the New South Whales Supreme Court emphasized that their only role was to determine the legal validity of the Minister’s orders.
Reviewing India’s case history, the Court summarized its role in reviewing policy decisions:
to check whether it violates the fundamental rights of the citizens or is opposed to the provisions of the Constitution, or opposed to any statutory provision or manifestly arbitrary” but not to, “substitute their own views as to what is wise, safe, prudent or proper. 2
In Distribution of Essential Supplies & Services during Pandemic, the Court determined that it would not, “second guess” the policy experts, but would “exercise jurisdiction to determine if the chosen policy measure conforms to the standards of reasonableness, militates against manifest arbitrariness and protects the right to life of all persons.”3
Court Found Forced Vaccination Violates the Constitution of India
In considering the global pandemic, the court said that it could not find fault with the government’s vaccination drive, citing the highly transmissible Delta and Omicron variants of SARS-CoV-2; the approximate loss of 5,23,843 lives from the virus in India; and the recommendations of the World Health Organization (WHO), TAG-CO-VAC and SAGE that vaccination would provide strong protection against serious illness, hospitalization and death.
However, regarding the issue of the right of individual privacy verses the government restricting individual rights in the name of public health, the Supreme Court of India found that forced vaccination is a violation of Article 21 of the Constitution of India. The Court previously found in Article 21 a right to personal autonomy, which extends to the right to refuse medical treatment.
In balancing the state’s interest in public health and an individual’s right to personal autonomy, the court found that Article 21 of the Indian Constitution grants individuals the right to determine how they should live their own life, which includes the right to refuse medical treatment such as vaccination. However, when there is a likelihood that an individual could spread the virus to other people, the state’s interest in protecting the public allows the government to impose certain restrictions on individual rights, as long as such restrictions are reasonable, in proportion to the objective sought, and reviewable by the courts. Accordingly, the Court found that the government’s restrictions are a valid exercise of power, despite evidence that an unvaccinated person is no more likely to spread the Delta or Omicron variants of the SARS-CoV-2 virus than a vaccinated person.
The Court: COVID Vaccination Policy in India Not Unreasonable
In support of his case, Dr. Puliyel presented scientific journals showing that patients who recovered from COVID still had antibodies 11 months after infection. He also pointed out that countries with a higher percent of the population vaccinated have a higher rate of COVID per one million people. He said that a vaccine surveillance report in the United Kingdom showed that, in week 40, there was a negative efficacy of the vaccine in those over the age of 30.
The court confirmed that its only role is to determine whether the Union of India took into consideration scientific research when establishing its policy advocating COVID vaccination for the entire country. The court acknowledged that large portions of the public cannot be considered healthy because they suffer from chronic disease and lack of nutrition, especially the elderly population, and that the Union of India’s vaccination policy was rightly centered around large segments of more vulnerable people, rather than a minority who are healthy as the subjects in the scientific articles that Dr. Puliyel presented to support the efficacy of natural immunity. Accordingly, the court found that the COVID vaccination policy of India was made in the interest of public health and is not unreasonable.
The Court: Vaccinated Population a Source of Virus Transmission
Considering the fact that the vaccinated and the unvaccinated pose nearly the same risk of transmitting the virus, the court looked at whether the Union of India’s vaccination policy of restricting unvaccinated persons from accessing public resources amounted to discrimination. Dr. Puliyel presented a letter published in the Lancet finding that peak viral load of COVID did not differ either by vaccination status or by variant; that the secondary infection rate of vaccinated and unvaccinated households only differed by two percent, and that four of the five most vaccinated countries were categorized by the U.S. Centers for Disease Control and Prevention (CDC) as high transmission countries. In addition, he submitted a study conducted in Massachusetts in July 2021 demonstrating that, after attending public gatherings, 346 out of 469 COVID cases (74 percent) were among vaccinated persons.
Presented with this data, the court concluded:
It appears to be grossly negligent to ignore the vaccinated population as a possible and relevant source of transmission when deciding about public health control measures.4
The court admitted that vaccine mandates may have been found to be constitutional prior to the emergence of SARS-CoV-2 variants that do not appear to respond to COVID vaccines. However, now that vaccinated persons present nearly the same risk of transmission as unvaccinated persons, the court said that restrictions placed on the unvaccinated are not in proportion to the risk they pose to public health.4
The court wrote:
While there is abundant data to show that getting vaccinated continues to be the dominant expert advice even in the face of new variants, no submission nor any data has been put forth to justify restrictions only on unvaccinated individuals when emerging scientific evidence appears to indicate that the risk of transmission of the virus from unvaccinated individuals is almost on par with that from vaccinated persons. To put it differently, neither the Union of India nor the State Governments have produced any material before this court to justify the discriminatory treatment of unvaccinated individuals in public places by imposition of vaccine mandates”5
The court suggested that all authorities, public, private and educational, review their current orders that restrict an unvaccinated person’s access to public services and resources.
The Court: Government Followed Approval Process for COVID Vaccines
Dr. Puliyel asserted that the government rushed the approval of COVID vaccines in, “a hurried and opaque manner.”6 He said that the trial data, regulatory approvals, and minutes from meetings approving the vaccine have not been publicly disclosed, which demonstrates a lack of transparency in the approval process, and that, while the complete data sets may not be available yet, releasing preliminary COVID vaccine adverse event data would allow individuals to make an informed vaccination decision.
The court disagreed, finding that the government’s approval for emergency use of the COVID-19 vaccines was properly made in accordance with the statutory regime in place. In India, all new drug trials must follow a certain protocol with stringent statutory requirements as set forth in the Good Clinical Practices guidelines and be approved by the Ethics Committee and the Central Licensing Authority. The Ethics Committee, which is comprised of medical, scientific and non-medical and nonscientific members, is an independent review board that is tasked with providing an objective and independent review of the clinical trials.
The Union of India claimed that these strict clinical trial guidelines were followed for COVID vaccine clinical trials and that the main findings of trials have been published in a peer reviewed journal, in accordance with WHO requirements.
The Court: Ongoing COVID Vaccine Trial Data Must Be Publicly Available
The court agreed with the government and declined to mandate the disclosure of segregated clinical trial data, citing privacy reasons, and also declined to declare that COVID vaccine approvals were granted without proper review of clinical trial data. However, the court ordered that relevant data, which must be published under statutory regimes and WHO requirements for ongoing clinical trials, along with data from COVID vaccine post-marketing trials, be made available to the public without delay.
Dr. Puliyel advised the court that, because clinical trials are made up of a small subset of the population, not all adverse events may be seen during trials and, instead, may only be noticed once the vaccine is available to the public at large. He pointed out that, in 2018, the WHO changed the way it classified adverse events after vaccination to only consider adverse events as vaccine related when that same adverse reaction also occurred during previous smaller, limited clinical trials.
In other words:
Reactions observed during post-marketing surveillance are not considered as ‘consistent with causal association with vaccine’, if a significant increase in such reactions during Phase III trials had not been recorded.7
In the case of the COVID vaccine trials, phase III trials were cut short and then control subjects were offered the vaccine, which had the effect of diluting the control group and ultimately making it impossible to evaluate potential differences in long term health outcomes between the vaccinated and control groups. At the same time, it makes it more possible for doctors to dismiss adverse events that occur post COVID vaccination, as adverse events are less likely to be considered vaccine related events. Therefore, Dr. Puliyel asked that all post marketing adverse event data be made available to the public.
However, the court declined to act, finding that the Phase III trials were cut short on the advice of the SEC, and stating that the government has protocols in place to consider and investigate adverse reactions to COVID vaccine, which only occur during the post-marketing phase.
Dr. Puliyel: India’s Adverse Event Reporting System Should Be More Like VAERS
Dr. Puliyel contended that the vaccine adverse events reporting system in India is not transparent and complete data as on serious adverse events should be published like in the United States though the Vaccine Adverse Event Reporting System (VAERS). The court pointed out that the National AEFI Surveillance Secretariat, which has been in place for a decade, has a protocol in place for identifying and monitoring adverse events to vaccination.
However, Dr. Puliyel argued that the vaccine adverse event reporting system in India needs to be changed to allow individuals, as well as private doctors, to report adverse events like is done in the U.S. with VAERS. The court agreed and directed the Union of India to facilitate the reporting of vaccine adverse events by individuals, as well as private doctors, on a public on-line platform. The court said:
Information relating to adverse effects following immunisation is crucial for the purpose of understanding the safety of the vaccines that are being administered, apart from being instrumental in further scientific studies around the pandemic. There is an imminent need for collection of requisite data of adverse events and wider participation of people in reporting the adverse events is necessary for the purpose of gathering correct information.8
The Court: Pediatric COVID-19 Vaccination Program Will Stand
Dr. Puliyel presented evidence that children are not at high risk of severe illness from COVID and argued that the risk from COVID vaccination outweighs the risk of getting seriously ill from the virus, pointing out that a large number of children in India have already recovered from a SARS-CoV-2 infection.
The court sided with the government, stating that it would not second-guess expert opinion as to the safety of pediatric COVID vaccinations. However, the court ordered the Union of India to immediately release the key findings and clinical trial results of Corbevax, the COVID vaccine that does not use messenger RNA (mRNA) technology, which is being given to children, if that data has not already been released.
The Supreme Court of India acknowledged that citizens have a liberty interest that prohibits forced vaccination; that restrictions placed on unvaccinated persons should be reviewed in light of the fact that the COVID vaccine does not prevent infection and transmission; that ongoing COVID vaccine clinical trial data should be publicly released, and that the government’s vaccine adverse event reporting system should be improved. However, the court did not fully recognize and adequately respond to all of Dr. Puliyel’s legitimate complaints about the government’s COVID vaccination program.
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