Supreme Court Dismisses Plea for Release of Detailed Clinical Trial Data on Anti-Diarrhoea Vaccine, Rotavac

The Supreme Court of India, on Tuesday, dismissed a public interest litigation (PIL) seeking the release of centre-wise data from the clinical trials of the Rotavac vaccine, which is aimed at preventing severe diarrhoea in children caused by rotavirus infections. The bench, comprising Justices B R Gavai and K V Viswanathan, ruled that it cannot override the decisions made by expert committees such as the National Technical Advisory Group on Immunization (NTAGI).

The petition, which called for detailed transparency regarding the third phase of the Rotavac clinical trials involving 6,799 infants across Delhi, Pune, and Vellore, raised concerns about the safety and efficacy of the vaccine. The petitioner argued that the segregated data was essential for public interest and accused the authorities of maintaining unnecessary secrecy around the results, even withholding them from NTAGI.

During the proceedings, advocate Prashant Bhushan, representing the petitioner, emphasized the importance of public access to the trial data, questioning, “What is the harm in the release of this data?”

However, the bench responded firmly, highlighting their limitation in questioning the judgments of specialized bodies, stating, “How can we sit in appeal over the decision of an expert committee? We will not sit in appeal over the decision of the NTAGI.”

An advocate for the respondent criticized the petition as “half-baked” and argued that the petitioner had not conducted thorough research before filing the PIL. Following this, the bench concluded the hearing with a succinct, “Thank you. Dismissed.”

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The plea for transparency had initially gained some traction when the Supreme Court, in July 2016, sought responses from the Centre and other stakeholders on the necessity of the data to assess if the vaccine posed different risks to various demographic groups. The petitioner had also demanded the complete results from all three trial centers, specifically the occurrences of intussusceptions (a bowel obstruction) during the two-year trial period.