HC urged to restrain centre from clinical trials of rotavirus

A PIL was today filed in the Delhi High Court seeking direction to restrain the Centre from conducting any further clinical trials of rotavirus 116E vaccine in India until complete data from the previous trials were disclosed.
A rotavirus vaccine protects children from rotaviruses, which are the leading cause of severe diarrhoea among infants and young children.
The petition came up for hearing before a bench of Chief Justice G Rohini and Justice Jayant Nath which fixed the PIL for further hearing on July 27.
The petition was filed by Dr Jacob Puliyel, working at St Stephen's Hospital here, who also sought a direction to be provided complete data of the results of a multi-centre clinical trial of rotavirus vaccine done on infants.

Advocate Prashant Bhushan, appearing for the petitioner, said that the plea was filed in public interest "on behalf of millions of infants who are likely to be administered this vaccine in near future and also in his (Puliyel) personal capacity as a pediatrician and as a member of National Technical Advisory Group on Immunization (NTAGI)".
"The disclosure of complete and segregated data for all the centres of this study (is necessary) as it is on the basis of this data that the vaccine is intended to be taken to Phase IV of the study exposing it to nearly 1,00,000 infants.

"Concealing of this vital data also does severe injustice to the thousands of infants who participated in this study, the researchers who painstakingly conducted the trials and the medical/scientific community who depend on this vital data in their work," the plea said.
The petitioner said that complete disclosure of clinical trials of a vaccine such as "rotavirus 116E is especially important because the government plans to take the research to Phase IV which will expose vaccine to approximately another 1,00,000 infants in different regions of the country."
While seeking a direction to the Ministry of Health and Family Welfare, Ministry of Science and Technology, Christian Medical College (Vellore) and NTAGI, the petition said that guidelines should be framed "regarding publication of complete and segregated research results in clinical trials on humans, in accordance with the WHO statement of April 2015 on the issue.