There is no link between the deaths and the vaccination, says an independent committee investigating the death of tribal girls who participated in feasibility studies evaluating the use of cervical cancer vaccines for mass vaccination.

The committee's final report, yet to be made public, comes close to a year after the pilot feasibility projects in Andhra Pradesh and Gujarat were stopped in April last year following the deaths and reports of alleged unethical practices.

The studies, undertaken by non-government organisation PATH, had used cervical cancer vaccines provided by Merck Sharp & Dohme (MSD) in the Andhra Pradesh study, while GlaxoSmithKline (GSK) provided vaccines for the Gujarat study.

About 25,000 young girls had been vaccinated by the two projects.

The Indian Council of Medical Research (ICMR)'s Director General, Dr V.M. Katoch, confirmed that the final report submitted to the Parliamentary Standing Committee on Health and Family Welfare (in mid-February) had concluded there was no link between the deaths and the vaccination.

“It is correct that the committee did not find any lapse in the design or in the regulatory process of these studies and also did not find any link between the deaths and vaccination,” Dr Katoch told Business Line .

While the study stands concluded, PATH has been asked to continue with its surveillance on those who have been vaccinated under the project.

The ICMR had played the role of an advisor to ensure that protocols were adhered to, and the project agreement had been signed in 2007, under a different Director General.

MSD's cervical cancer vaccine Gardasil was launched in India in late 2008, while GSK launched its Cervarix here in early 2009. The products have not been without their share of controversy in the global markets as well, though both companies have stood by the safety of their products.

The final report has been communicated to PATH, investigators of other suspended studies, the Drug Controller General of India and the National Ethics Committee, said Dr Katoch.

The committee has recommended further tightening of processes regarding the implementation of the consent process, used to take the informed consent of any one participating in a human trial of a medical product.

There are suggestions of the inclusion of vulnerable tribal population groups, the need to maintain a distinction between the national immunisation programme and such studies. Further, it added, that free supply of vaccines be considered “covert inducement and indirect coercion”.

Insurance coverage for study participants and the method of monitoring the adverse effects and serious adverse effects and remedial measures for such events, have also been highlighted, Dr Katoch said, adding that details would be available only after the report was made public.

These are generic suggestions that will strengthen the entire process, he added.