April 16, 2010
NEW DELHI – The government Friday said that the cervical cancer HPV vaccination drive in Gujarat and Andhra Pradesh was indeed part of approved clinical trials. But after the death of six tribal girls who were administered the vaccine, the government has told other states not to carry out any further such trials.
“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.
He added: “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 Pradresh) and Vadodara district (Gujarat). The study by PATH was recommended by the Ethical Committee and Advisory Groups at the state and central level.”
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 with malaria and suspected snake bite. 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 the 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 pharma 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”.
All of our reports have stated four deaths….we are trying to confirm the other two as stated in this article.