By: Joe C. Mathew, New Delhi
28 September 2010
The three-member expert committee of the health ministry may give a clean chit to the agencies that conducted observational clinical trials on the safety and efficacy of cervical cancer vaccines marketed by global drug majors GlaxoSmithKline (GSK) and Merck in the country.
The studies, independently initiated by international non-governmental-organization PATH and Indian Council of Medical Research (ICMR) for GSK and Merck vaccines respectively, were called off early this year after six deaths were reported among the girls who were administered these vaccines in Gujarat and Andhra Pradesh.
The committee, formed after the government suspended the vaccine trials, was mandated to find if the trials had indeed caused the deaths and whether it was necessary to allow further trials.
Official sources said the committee had not been able to see any linkage between the administration of vaccines and the deaths. When contacted, Lucknow-based S S Agarwal, the medical expert who heads the committee, declined to comment on the development. He informed that the committee’s views, which are in the final stages of preparation, would be submitted to the health ministry soon.
The vaccine trials were initiated to generate more data in support of the proposals to include cervical cancer vaccination also under national immunisation programme. Both GSK and Merck continue to market their vaccines — branded Cervarix and Gardasil respectively — through the private trade channels.
Any data in favour of universal immunisation can have tremendous impact on the revenues of the two companies as cervical cancer is estimated to be one of the major killer diseases among women in the country.