Supreme Court Dismisses Plea for Clinical Trial Data of Rotavac Vaccine

The Supreme Court rejected a plea demanding centre-wise data of Rotavac vaccine clinical trials, asserting it cannot override the expert committee's decision. The trial, involving 6,799 infants across three centres, aimed to assess vaccine safety and efficacy. The petition sought public disclosure of this data.

The Supreme Court has dismissed a plea seeking the release of centre-wise clinical trial data for the anti-diarrhoea vaccine Rotavac. The court stated it would not challenge the decision made by an expert committee on the matter.

Rotavac, a rotavirus vaccine, aims to protect children from severe diarrhoea-causing viruses. A bench of justices B R Gavai and K V Viswanathan passed the order while hearing the plea, which called for the Centre and others to disclose segregated data from the third phase of the clinical trial involving 6,799 infants.

The plea argued that the trials, held in Delhi, Pune, and Vellore, should have their data examined by the National Technical Advisory Group on Immunization (NTAGI) in public interest. However, the bench questioned, "How can we sit in appeal over the decision of an expert committee?" and maintained they would not override the NTAGI's decision.