Supreme Court Approves Union's Decision To Vaccinate Children Against COVID; Directs To Ensure Publication Of Clinical Trial Data

Dr. Jacob Puliyel, a former member of the National Technical Advisory Group of Immunization, the petitioner herein sought the Court's indulgence in the issue of non-disclosure of clinical trial data for the vaccines that are being administered to children in India and beseeched it for a stay on the coercive COVID-19 vaccine mandates introduced in various states and by private establishments for children in the age group 15-18 years. The petitioner had also impelled the Court to consider that administering experimental vaccines, the long term side effects of which are unknown, to healthy children is unethical and irresponsible.

A Bench comprising Justices L. Nageswara Rao and B.R. Gavai refrained from entering into the domain of the scientific experts to interfere with their decision to carry out paediatric vaccination on the ground that the same was unscientific.

"On paediatric vaccination, we recognise that the decision taken by the Union of India to vaccinate children in this country is in tune with global scientific consensus and expert bodies like the WHO, the UNICEF and the CDC and it is beyond the scope of review for this Court to second- guess expert opinion, on the basis of which the Government has drawn up its policy. Keeping in line with he WHO Statement on Clinical Trials and the extant statutory regime, we direct the Union of India to ensure that key findings and results of the relevant phases of clinical trials of vaccines already approved by the regulatory authorities for administration to children, be made public at the earliest, if not already done".

Advocate, Mr. Prashant Bhushan, appearing on behalf of the petitioner, had submitted that the children are at almost no risk from the COVID-19 virus. He had opined that there are only rare cases wherein children were hospitalised due to COVID-19. He had also questioned the small size of the trial population and its ability to capture anything other than the most obvious risks of the vaccine. Relying on articles published in Nature and Lancet, he had further argued that the risks of administering vaccines to the children outweigh its benefits. The risk of myocarditis associated with mRNA vaccines had also been highlighted.

Controverting the submissions put forth by the petitioner, the Solicitor General, Mr. Tushar Mehta appearing on behalf of the Union Government submitted that the global agencies like the WHO (World Health Organisation), the UNICEF (United Nations International Children's Emergency Fund)and the CDC (Centre for Disease Control and Prevention) have recommended paediatric vaccination. It was refuted that the vaccines pose a greater threat than the virus itself. As on 12.02.2022, 8,91,39,455 doses of COVAXIN have already been administered to children in the age group of 15-18 years. Out of all these cases there were 1739 complaints of minor effects, 81 of serious effects and 6 for severe ones. The size of the trial population was also, argued to be in consonance with the expert approved protocol. Mr. Mehta submitted that paediatric vaccination are always preventive in nature and administered to avoid any risk of infection and of prolonged clinical symptoms.

The Apex Court noted that though domain experts can have differing opinions with respect to child vaccination, Courts need to exercise caution to sit in scrutiny of the expert opinion which was the basis of the policy decision of the Government. It was of the view that the child vaccination policy adopted by the Union Government is in harmony with global scientific consensus and expert bodies like the WHO, the UNICEF and the CDC. It observed -

"It would not only be beyond our jurisdiction but also hazardous if this Court were to examine the accuracy of such expert opinion, based on competing medical opinions."

The Court was of the view that as the vaccines administered in India are inactivated virus vaccines and not mRNA vaccines, the apprehension of the petitioner with respect to the risk associated with the mRNA do not warrant consideration in the present case.

Addressing the issue of publication of the results of the clinical trial for the paediatric population, it noted that the Union Government had stated that data for COVAXIN has been published. Considering the fact that apart from COVAXIN, for children of the age group of 12-14 years, Biological E's Corbevax is also being administered, the Court directed the Union Government to ensure that the key findings and result of the clinical trials of Corbevax are made public at the earliest, in terms of the WHO Statement on Clinical Trials, the Declaration of Helsinki and the GCP guidelines.

Jacob Puliyel vs Union Of India | 2022 LiveLaw (SC) 439 | WP(C) 607 of 2021 | 2 May 2022

Coram: Justices L Nageswara Rao and BR Gavai

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