In 2009, several schools for tribal children in Khammam district in Telangana, India became the sites for observation studies for a cervical cancer vaccine.
Thousands of girls aged between nine and 15 were administered the Human Papilloma Virus (HPV) vaccine in three rounds, under the supervision of state health department officials.
However, months later, many of these girls started falling ill and by 2010, five of them had died. Two more deaths were reported in Vadodara, Gujarat, where another brand of HPV vaccine was administered to an estimated 14,000 children.
These shocking events led to an investigation by a standing committee on health and family welfare, which revealed a number of irregularities in the trials. Consent for conducting the studies was taken from hostel wardens rather than the parents or guardians of the girls, and many of the consent forms had thumbprint impressions instead of signatures.
The committee also found that the girls had no knowledge about the nature of the disease or the vaccine. The investigation report stated that a large number of parents or guardians were illiterate and could not even write in their local languages.
In response to the deaths of the tribal girls, the Supreme Court asked the Drug Controller General of India (DCGI) and the Indian Council of Medical Research (ICMR) to explain how permissions were given for these trials. The court also asked for relevant files pertaining to the grant of licenses for the trials and requested an update on the steps taken on the report of the parliamentary committee.
The observation studies in India were carried out by an American NGO named Program for Appropriate Technology in Health (PATH). The objective of these studies was to collect data on the effect of the vaccines on the minor subjects and to help authorities make an informed opinion on introducing the vaccine into India's immunization program. The studies were sponsored by the Bill & Melinda Gates Foundation (BMGF), which has been involved in numerous healthcare projects around the world, including vaccination programs.
The involvement of BMGF in funding these controversial studies has raised concerns among healthcare activists in India. They argue that it is unethical for those championing vaccine use to also invest in vaccine development. Additionally, BMGF has funded two organizations, GAVI and Public Health Foundation of India (PHFI), which are both under fire for conflict of interest.
GAVI, a global aid organization specializing in vaccination, has representatives from pharmaceutical companies on its board. PHFI, a public-private partnership society co-founded by BMGF, has accepted grants from pharma companies.
Critics argue that these organizations have a working relationship with pharma companies, which raises questions about their influence over public health policies and vaccine recommendations. They also question the safety testing criteria and the time allocated for observation studies, pointing to the controversial Pentavalent vaccine as an example. The deaths of infants soon after being immunized with Pentavalent have caused anxiety and led to calls for a reevaluation of the vaccine.
