April 17, 2010
Six children who were administered imported brands of the human papilloma vaccine (HPV) have died, the government told Parliament on Friday. While the causes of death have not been attributed to the vaccine in any of these cases, the States have been advised not to carry out any more vaccinations.
The two imported brands Gardasil and Cervarix “were allowed to undergo clinical trial (Phase III) in India, before granting permission to import and market authorisation,” Minister of State for Health and Family Welfare S. Gandhiselvan told the Lok Sabha on Friday in a written response to a question. “For assessing the health services needs and preparedness for introducing [HPV] vaccines into the health services 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].”
Earlier, PATH-International, which has been conducting the project for American pharmaceutical company Merck, with funding from the Bill and Melinda Gates Foundation, had described it as a “demonstration project.”
Health Minister Ghulam Nabi Azad had reportedly termed it “an operational research study,” in a letter to CPI (M) Member of Parliament Brinda Karat.
In his reply, Mr. Gandhiselvan also said “the study by PATH was recommended by the Ethical Committee and Advisory Groups at State and Central levels.”
He added that the Indian Council of Medical Research had provided technical support for the development of protocols, and advised on ethical issues as per government guidelines.
Six deaths, four in Andhra Pradesh and two in Gujarat, have been reported from among the 24,705 children administered these vaccines, he said. The causes of the deaths were determined as “viral fever, drowning, suicide, severe anaemia with malaria and suspected snake bite.”
Reports of the death of four girls in Andhra Pradesh had initially sparked off complaints from civil society groups.