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.
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According to World Health Organisation (WHO) statistics, India registers over 130,000 new cervical cancer cases each year with 74,000 women dying annually from the disease in the country. Developing countries account for nearly 80 per cent of the 510,000 cases of cervical cancer reported worldwide each year.
In an emailed response, a GSK spokesperson said the company believed that the demonstration projects would help reduce the huge burden of cervical cancer in India.
“To date, no deaths have been causally associated with Human Papilloma Virus (HPV) vaccination in India or elsewhere. Experience with our HPV vaccines used in the post-licensure observational study confirms the good safety profile reported in clinical trials”, she stated.
MSD also clarified that the study was designed and implemented in accordance with all local ethical guidelines and followed the regulatory approvals.
Not all agree. Delhi-based women’s group Sama has criticised the demonstration trials and said their attempts to get the study design or protocol of the trials through the Right to Information Act filing did not succeed, as the health ministry denied access to the information terming it as “trade secret and commercial confidence”.