Trials of imported HPV vaccines end as six girls die

The death of six tribal girls who were administered imported brands of the human papilloma vaccine (HPV) has forced the government to stop clinical trials of the vaccine, though the deaths have not been directly linked to the vaccine.

States have been advised not to carry out any more vaccinations, parliament was informed on Friday.
"Two imported brands of the Human Papilloma Virus (HPV) vaccines, namely Gardasil and Cervarix, were allowed to undergo clinical trial (Phase III) in India, before being granted permission for import and market authorisation," said S Gandhiselvan, minister of state for health and family welfare, in a statement to the Lok Sabha.

"To assess the need of health services and the preparedness for introducing the Human Papilloma Virus (HPV) vaccines in the future, Path, an international NGO, was given permission for a post-licensure observational study of HPV vaccination in Khammam district (Andhra Pradesh) and Vadodara district (Gujarat). The study by Path was recommended by the Ethical Committee and Advisory Groups at the state and central level," he said.

According to the minister, the trial was "provided technical support for the development of protocols and advised on ethical issues" by the Indian Council of Medical Research, an autonomous research agency under the health ministry.

"Four deaths in the target of 14,019 in Andhra and two in the target of 10,686 in Gujarat have been reported from among the children who were administered these vaccines. The cause of deaths was determined as viral fever, drowning, suicide, severe anaemia, malaria and suspected snakebite. Based on the concerns on these deaths, states have been advised not to carry out any further vaccinations at present," Gandhiselvan said.

Earlier this month, several enraged public health activists and Communist leader Brinda Karat had asked union health minister Ghulam Nabi Azad to spell out the government's stand on the very same vaccination programme, alleging that there were murky practices being followed by Path and pharmaceutical companies.
They slammed the programme for being unethical and also because the trials were being conducted on poor and socio-economically marginal tribals, who were being treated as "guinea pigs".