Indian Council of Medical Research (ICMR) Director General V.M. Katoch has asked the nation's Health and Family Welfare Ministry and state governments to immediately suspend the cervical cancer vaccination program after reports of four deaths and 120 complications in girls receiving Merck's Gardasil, according to The Hindu.
The vaccination program is being jointly conducted by PATH, a Seattle-based NGO, ICMR and the two state governments. About 32,000 girls between the ages of 10 and 14 years were to be tested in the study, according to the Daily News & Analysis. "Everything was going fine until we received complaints of violation of guidelines and exploitation of people from civil society groups some months ago following the death of four girls, who were administered this vaccine," Katoch says. He adds that it hasn't determined that PATH is at fault, "but if there are allegations, they need to be investigated, and concrete evidence has to be brought to our notice."
A number of local advocacy groups had been questioning the vaccination initiative. The Sama Resource Group for Women and Health has posted a memorandum to its website signed by 52 stakeholders that expresses concerns about Gardasil's efficacy, as well as the numerous reports of side effects. "All trials and studies to be immediately brought to a halt [until] in an open forum questions relating to safety, efficacy and cost effectiveness of the planned intervention can be justified," the groups say in the letter.
On its website, PATH says it is supporting HPV vaccine demonstration projects in India, Peru, Uganda, and Vietnam. Gardasil is marketed in India by MSD Pharmaceuticals Pvt Ltd.