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libra, justice, law

JACOB PULIYEL VS UNION OF INDIA

Research paper

SUPREME COURT CASE: 2 May, 2022

PETITIONER: Jacob Puliyel

RESPONDENT: Union of India and others

BENCH: L. Nageswara Rao, B.R. Gavai

FACTS OF THE CASE:

A public interest litigation petition was presented by Jacob Puliyel, a former National Advisory Technical Group member. He sought disclosure of clinical trial data on vaccines and declared mandatory vaccination unconstitutional.

He filed a Writ Petition before the Supreme Court of India, contending:

(i) adverse consequences of emergency approval of vaccines in India.

(ii) the need for transparency in publishing segregated clinical trial data of vaccines.

(iii) the need for disclosure of clinical data.

(iv) lack of transparency in regulatory approvals.

(v) minutes and constitution of the expert bodies.

(vi) imperfect evaluation of Adverse Events Following Immunization (AEFIs).

(vii) vaccine mandates in the absence of informed consent being unconstitutional.

It was inter-alia contended that coercive vaccination would interfere with the principle of informed choice of individuals, protected by Article 21 of the Constitution of India.

It was also contended that natural immunity is more robust than immunity generated post-vaccine inoculation. Further, the vaccines available presently are not as effective against the newly mutating variants of Covid-19. The Petitioner urged that vaccinated and unvaccinated people can transmit and get infected by the virus making the vaccine mandates meaningless.

ISSUES:

  1. Are the vaccine mandates being violative of Article 21 of the Constitution of India?
  2. Whether the segregated clinical trial data is disclosed in the public domain?
  3. Was there improper collection and reporting of AEFIs?
  4. Whether the vaccination for children is safe?

CONTENTION:

  1. Vaccine Mandates:

The Petitioner contended that due to the vaccine mandates of the Government (including certain state governments), specific prohibitions are placed against unvaccinated people. It makes them coercive and thus unconstitutional and violative of Article 21 of the Constitution. The Petitioner also emphasized that natural immunity acquired post Covid-19 infection is more robust and long-lasting than the immunity provided by vaccines. It further highlighted that the presently available vaccines are ineffective against variants, and thus both vaccinated and unvaccinated persons can transmit the virus.

However, the UOI contradicted this argument by saying that vaccines are proven to be safe and productive, and any deliberation on the same will increase the already pervasive vaccine hesitancy in the country. It also argued that the approval of emergency authorizations of vaccines, associated clinical trials, etc., are all done within the country’s legal framework. The state governments of Tamil Nadu, Maharashtra, Madhya Pradesh, and NCT of Delhi argued that any vaccine mandate implemented in the said states (which had restrictive provisions against unvaccinated persons) was done keeping in mind the larger public interest and for the health and safety of the community as a whole and regularly revised basis the evolving situation of the pandemic.

  • Non-disclosure of segregated clinical trial data in the public domain:

The Petitioner contended that clinical trial data for COVAXIN and COVISHIELD had not been made public. He urged that the disclosure of segregated data of clinical trials is essential to determine the adverse effects across various age groups and diverse populations and, accordingly, enable individuals to make more informed decisions on whether to be vaccinated.

The UOI responded to the contention, as mentioned earlier, by stating that the emergency use approvals were granted after following due procedure and required expert committees were constituted and consulted for the same.

  • Improper collection and reporting of AEFIs:

It was contended by the Petitioner that there have been several adverse events and deaths post-injection of the vaccines and that the Government lacked an appropriate mechanism for reporting the same.

The UOI contended that the procedures and protocols for monitoring adverse events following immunization, as established under the National Adverse Event Following Immunisation Surveillance Guidelines, were followed carefully. Further, the UOI also stated that the COWIN portal had established mechanisms for reporting all AEFIs. All cases of severe AEFIs, including reported deaths, are subjected to rapid reviews, analysis, and causality assessment by trained subject experts. It clarified that merely saying an AEFI case should not be attributed to the vaccine unless proven by the causality assessment analysis.

  • Vaccination of Children:

The Petitioner contended that scientific evidence shows that the risk of administering vaccines to children outweighs the vaccine’s benefits. He also stated that data shows that several children have already developed Covid-19 antibodies. He also said that there is data to indicate the occurrence of adverse reactions in young persons upon inoculation.

The UOI responded to the same by stating that pediatric vaccination is advised by global agencies such as the WHO, UNICEF, and the CDC. Expert opinion in India is also in sync with such international organizations. The UOI supplemented its argument by showcasing vaccination data, revealing the safety of vaccine use on children.

RATIONALE:

Regarding the first issue, the Court noted the evolving nature of the virus and observed the global mandates regarding the same by international organizations such as WHO. Accordingly, the Court held that the Government of India’s vaccination drive is in the interest of public health and cannot be faulted.

It is pertinent to note that while determining personal autonomy, the Court held that:

  • Bodily integrity is protected under Article 21, and no citizen can be forced to be vaccinated.
  • Bodily integrity includes the right to life and the right to refuse medical treatment within its ambit.
  • Citizens may choose not to get vaccinated. However, if there is data to show that such citizens may transmit the virus and affect public health, then the Government may take reasonable restrictive steps against said people.

Regarding the second issue, the Court noted that there are stringent statutory requirements, which must be complied with by the manufacturers of vaccines and other participants during the different stages of clinical trials of vaccines. Furthermore, the Court disagreed with the submission on behalf of the Petitioner that emergency approvals to the vaccines were given in haste, without adequately reviewing the data from clinical trials. The Court also noted that both vaccines had received consent from WHO.

Dealing with the third issue, the Court noted that as per the data presented by the UOI, a well-defined mechanism exists for collecting data relating to adverse events due to Covid-19 vaccines. Even medical practitioners at private hospitals are associated with reporting adverse events.

Thus, the Court dismissed the Petitioner’s challenge. However, the Court emphasized the need to report adverse and suspected events. It directed the UOI to facilitate the same and establish a mechanism for reporting by individuals and private doctors and making reports related to the same publicly accessible.

For the fourth issue, the Court opined that it could not analyze and provide a judgment regarding the safety and integrity of pediatric vaccination as the said aspect is beyond judicial review and a matter to be determined by concerned subject matter experts. Further, the Court also noted that the decision of the UOI regarding pediatric vaccination meets global scientific consensus. Thus, the Court dismissed the challenge raised by the Petitioner regarding the same.

INFERENCE:

The Court dismissed the said Writ Petition made by the Petitioner. No individual can force to take the vaccination, and the current vaccination policy of the Government regarding the restrictions imposed on individuals is not arbitrary. The Government can regulate individuals’ bodily autonomy, keeping the larger interest of public health. The Court said that as long as the covid numbers are low, should place no restrictions on the individuals from accessing public areas, and if there are any such restrictions in place, they should recall immediately. All the covid vaccine trial data, including future trials, should be made available in the public domain subject to the protection of the privacy of the individuals. Regarding the vaccine for children, the Court said that it’s impossible for it to second guess the opinion of the experts and that vaccination already follows global standards and practices. However, if there is any data on adverse reactions to the same, it should be published at the earliest.

SUBMITTED BY,

SHREEJA DAYANANDA K

4th year Bcom.,LLB – Batch 2023 BMS College of law, Bengaluru

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