Supreme Court issues notice on Plea seeking center-wise release of data On clinical trials
(Judicial Quest News Network)
Supreme Court today issued notice to the Centre, Department of Bio-Technology (DBT) and Christian Medical College, Vellore in a PIL filed by S. Srinivasan seeking complete centre-wise results of the clinical trial of anti-diarrhea vaccine Rotavac
The clinical trial
of Rotavac was conducted between 2011-2013 on 6799 infants in three centers –
Delhi, Pune and Vellore to ensure its safety in terms of the number of
intussusceptions (a potentially fatak side-effect) in the 2-year trial period.
The aggregated data published in a UK-based journal shows that the number of
cases of intussusceptions in the infants who were administered Rotavac vaccine
in Vellore center were the highest and there was a huge difference in the
number of cases of intusseception between result in Delhi and Vellore
DBT had failed to make available the complete
de-aggregated data (center-wise data) before launching the said vaccine. The
very raison d’etre of such multi-center trials is to compare results among
centers and without data the vaccine should not have been allowed to be
launched. This data should have been examined by the National Technical
Advisory Group on Immunization (NTAGI) in public interest but such is the
secrecy surrounding it, it has not been provided even to this apex advisory body.
As of March 2016, the vaccine is being administered in Haryana, Himachal Pradesh, Orissa and Andhra Pradesh with plans to add it to the Universal Immunization Policy of the Government.
Read the Petition.
