SC ON VACCINES

lows the global practices.”

The court directed the Centre to maintain transparency in sharing findings and reports on approved vaccines. It suggested a virtual platform for sharing information on adverse effects due to vaccination with due regard to the right to privacy.

The bench said information on adverse effects is crucial to understanding the efficacy of vaccines. “...publish reports on adverse events of vaccines from public and doctors on a publicly accessible system without compromising with the privacy of citizens,” said the bench. It referred to the segregation of vaccine trial data and added subject to the privacy of individuals, the data of all trials conducted and being conducted must be made available to the public without delay.

The court directed the Centre that all clinical trials, key findings and results of vaccines approved for children be made public.

The petitioner asked the government and the Drug Controller General of India to provide segregated data for each of the phases of clinical trials of the vaccines administered in India. The court also heard the vaccine manufacturers – Covaxin’s Bharat Biotech and Covishield’s Serum Institute of India (SII) – before reserving its order in March.

The petition quoted the World Medical Association’s Helsinki Declaration of 2013 on Ethical Principles for Medical Research involving human subjects, which mandates researchers to publicly disclose all negative, inconclusive and positive results of their research.

The Centre, Maharashtra, Tamil Nadu and Madhya Pradesh defended their vaccine mandates saying they fulfil the test of proportionality and are meant to create more awareness about vaccination.

SII told the court that all necessary data was with the regulator. Bharat Biotech denied allegations of non-disclosure of information and said the data related to the phase III trial has been published.

The Centre told the court all documents related to Covid-19 vaccines and their compositions are available in the public domain, and the vaccines has proved to be very effective and safe