Notwithstanding the findings by the expert team about deficiencies in the trials of Human Papilloma Virus (HPV) vaccine in Andhra Pradesh and Gujarat, the health Ministry has allowed the ongoing third phase of the clinical trials in India, but without further vaccinations.

Turning down the demand by many public interest groups, the Centre also ruled out bringing in any new legislation that would cover all bio-medical and health research in the light of the findings of the panel.

Sources said the Ministry had studied the final report of the panel that was submitted recently, and allowed the continuation of the third phase trials in accordance with the panel recommendation. The committee had recommended that 3rd phase of operational research could be continued as it would provide useful information and did not involve any further vaccination, sources said.

PATH (Programme for Appropriate Technology in Health), an International NGO, was granted permission to carry out a post licensure (operational research) study of HPV vaccination in 3 blocks each of Khammam district of Andhra Pradesh and Vadodara district of Gujarat, with the permission of State Governments of Gujarat and Andhra Pradesh.  The study utilized both the brands of HPV vaccine available in the market (Gardasil by Merck in Andhra Pradesh and Cervirix by GSK in Gujarat).

Following the alleged deaths of six children, the trials were suspended and the Union Health Minister appointed a Committee comprising of Dr S S Agarwal, former director, Advanced Centre for Training, Research, Education on Cancer, Dr  S P Aggarwal, former DGHS and Dr Sunita Mittal, HoD, Obstetrics & Gynaecology, AIIMS to investigate ethical issues raised in this matter.

The final report of the panel had ruled out direct linkage between the deaths and the trials held in Khammam (where 13, 791 girls were vaccinated) and Gujarat’s Vadodara (where 9,637 were vaccinated). But at the same time, it said “the reported deaths were most probably unrelated to the vaccine. However, the cause of death in all cases could not be established with certainty.”

The inquiry voiced concern over the supply of vaccines, free of cost from pharma giants GlaxoSmithKline and Merck. It also found serious lapses in the conduct of the trials, mainly in planning and implementation of the project. It was most unusual for a large observational study to not have diary card-based reporting of Serious Adverse Events (SAE) and for it to target “vulnerable” girls despite directions that no research would be done on tribals unless of specific use to them. The project design didn’t take the issue of SAE seriously nor appointed an independent monitoring agency which caused unacceptable delays in the reporting of deaths. It resulted in gross under reporting of adverse events and didn’t provide insurance to girls though PATH had a cover, according to the report.

The committee also found serious discrepancies in consent forms of the vaccinated girls. Of the 100 forms from Andhra Pradesh she studied, witness signatures were missing in 69. Over 2,763 forms out of 14,253 in Andhra had been signed by wardens/principals on the behalf of children (by the state government’s order).  The inquiry report also came down on the ICMR’s role as it sided with PATH to call the project an observational study and no clinical trial.

Following the report, the public interest groups have called for overhauling the existing laws to bring in stricter rules and regulations and reign on the multinationals who were eyeing the huge market in the country, at the cost of precious lives. Contentions were also raised about the nature of the study whether it was operational study as claimed by PATH or clinical trials.