The Supreme Court Today (August 6th) dismissed a plea seeking centre-wise data of the clinical trial of anti-diarrhoea vaccine Rotavac, saying it cannot sit in appeal over the decision taken by an expert committee on the issue. Rotavirus vaccine, Rotavac, claims that it protects children from viruses, which are the leading cause of severe diarrhoea among them.
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NEW DELHI: The Supreme Court on Tuesday dismissed a plea seeking center-wise data from the clinical trial of the anti-diarrhoea vaccine Rotavac, stating it cannot overrule the decision made by an expert committee on the matter. The Rotavirus vaccine, Rotavac, claims to protect children from viruses that are the leading cause of severe diarrhea.
A bench comprising Justices B R Gavai and K V Viswanathan passed the order while hearing the plea, which sought directives for the Centre and others to disclose the “segregated data” from the third phase of the clinical trial of Rotavac, involving 6,799 infants. The trials were conducted at three centers: Delhi, Pune, and Vellore, to assess the safety and efficacy of the vaccine.
The plea asserted that the data should have been reviewed by the National Technical Advisory Group on Immunization (NTAGI) in the “public interest” but claimed that secrecy surrounded the data, preventing even this apex body from accessing it.
During the hearing, the bench remarked,
“How can we sit in appeal over the decision of an expert committee?” It further reiterated, “We will not sit in appeal over the decision of the NTAGI.”
Advocate Prashant Bhushan, representing the petitioner, argued,
“What is the harm in the release of this data?”
An advocate for one of the respondents countered that the petition was “half-baked” and that the petitioner had not conducted proper research before filing the public interest litigation (PIL).
The bench concluded the hearing with,
“Thank you. Dismissed.”
In July 2016, the apex court had sought responses from the Centre and others on the PIL, which argued that the segregated data was crucial to determine if the vaccine was safe across all areas or if certain groups were more “susceptible to adverse effects of the vaccine.”
The court had also sought directives for the Centre and others to provide the petitioner with the complete segregated results of the clinical trial conducted at all three centers, including the number of intussusceptions during the two-year trial period at each center.
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