Correspondence
Addressing questions about the HPV vaccine project in India A recent News item by Dinesh Sharma1 inaccurately reports conclusions from the investigation by the Indian Parliament’s Standing Committee on Health of a human papillomavirus (HPV) vaccine delivery project in India, and perpetuates errors made in the actual investigation’s report. We wish to correct these issues. Programme for Appropriate Technology in Health (PATH), the Indian Council of Medical Research (ICMR), and the state governments of Andhra Pradesh and Gujarat worked on this HPV vaccine project,1 from 2009 to 2010, to explore suitable strategies for vaccine delivery, and to help to provide information for national health authorities about whether it would be feasible or appropriate to introduce the HPV vaccine in the future to protect girls against HPV, the main cause of cervical cancer.2 The work in India was part of a four-country project— national immunisation programmes in Peru, Uganda, and Vietnam did a similar demonstration project for vaccine delivery.2 Across the
four project countries, the study generated important evidence for feasible ways to give HPV vaccines,2 and this evidence contributed to GAVI Alliance’s decision to subsidise HPV vaccines for the world’s poorest countries. HPV vaccines were licensed in India by the Drug Controller General of India in 2008, before their use in this project. The parliamentary report itself ignores the extensive evidence about the safety3 and efficacy4 of HPV vaccines, and falsely suggests that deaths were causally linked to the vaccines. WHO has reviewed HPV vaccine safety and confirmed that there have been no deaths attributable to these vaccines.3 State investigations of the deaths of seven girls and the enquiry committee report of Nov 9, 2010, both concluded that there was no evidence that any deaths were caused by the vaccines.5 Contrary to Sharma’s article, the ICMR, India’s most senior medical research authority, reviewed and approved the project protocol, and at their request, PATH ensured the study protocol was reviewed and approved by the Drug Controller General of India, India’s National Health Ministry Steering Committee, the state governments of Andhra
www.thelancet.com/oncology Vol 14 November 2013
Pradesh and Gujarat, two Indian ethics committees, and one international ethics committee. PATH followed all guidance provided by the ICMR and a national project advisory group, which included representatives from India’s National Technical Advisory Group on Immunisation, and other esteemed scientists. DSL and JDS are employees of Programme for Appropriate Technology in Health (PATH), an international non-profit organisation.
*D Scott LaMontagne, Jacqueline D Sherris [email protected] HPV Vaccine Project (DSL), and Public Health Impact (JDS), Programme for Appropriate Technology in Health, Seattle, WA 98121, USA. 1
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Sharma DC. Rights violation found in HPV vaccine studies in India. Lancet Oncol 2013; 14: e443. LaMontagne DS, Barge S, Le NT, et al. Human papillomavirus vaccine delivery strategies that achieved high coverage in low- and middle-income countries. Bull World Health Organ 2011; 89: 821–30B. WHO. Global Advisory Committee on Vaccine Safety, 12–13 June 2013. Wkly Epidemiol Rec 2013; 88: 301–12. Schiller JT, Castellsagué X, Garland SM. A review of clinical trials of human papillomavirus prophylactic vaccines. Vaccine 2012; 30: F123–38. Interim Report of the Committee appointed by the Govt. of India, no V.25011/160/2010-HR, 15th April, 2010, to enquire into “Alleged irregularities in the conduct of studies using Human Papilloma Virus (HPV) vaccine” by PATH in India, November 9th, 2010.
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Addressing questions about the HPV vaccine project in India A recent News item by Dinesh Sharma1 inaccurately reports conclusions from the investigation by the Indian Parliament’s Standing Committee on Health of a human papillomavirus (HPV) vaccine delivery project in India, and perpetuates errors made in the actual investigation’s report. We wish to correct these issues. Programme for Appropriate Technology in Health (PATH), the Indian Council of Medical Research (ICMR), and the state governments of Andhra Pradesh and Gujarat worked on this HPV vaccine project,1 from 2009 to 2010, to explore suitable strategies for vaccine delivery, and to help to provide information for national health authorities about whether it would be feasible or appropriate to introduce the HPV vaccine in the future to protect girls against HPV, the main cause of cervical cancer.2 The work in India was part of a four-country project— national immunisation programmes in Peru, Uganda, and Vietnam did a similar demonstration project for vaccine delivery.2 Across the
four project countries, the study generated important evidence for feasible ways to give HPV vaccines,2 and this evidence contributed to GAVI Alliance’s decision to subsidise HPV vaccines for the world’s poorest countries. HPV vaccines were licensed in India by the Drug Controller General of India in 2008, before their use in this project. The parliamentary report itself ignores the extensive evidence about the safety3 and efficacy4 of HPV vaccines, and falsely suggests that deaths were causally linked to the vaccines. WHO has reviewed HPV vaccine safety and confirmed that there have been no deaths attributable to these vaccines.3 State investigations of the deaths of seven girls and the enquiry committee report of Nov 9, 2010, both concluded that there was no evidence that any deaths were caused by the vaccines.5 Contrary to Sharma’s article, the ICMR, India’s most senior medical research authority, reviewed and approved the project protocol, and at their request, PATH ensured the study protocol was reviewed and approved by the Drug Controller General of India, India’s National Health Ministry Steering Committee, the state governments of Andhra
www.thelancet.com/oncology Vol 14 November 2013
Pradesh and Gujarat, two Indian ethics committees, and one international ethics committee. PATH followed all guidance provided by the ICMR and a national project advisory group, which included representatives from India’s National Technical Advisory Group on Immunisation, and other esteemed scientists. DSL and JDS are employees of Programme for Appropriate Technology in Health (PATH), an international non-profit organisation.
*D Scott LaMontagne, Jacqueline D Sherris [email protected] HPV Vaccine Project (DSL), and Public Health Impact (JDS), Programme for Appropriate Technology in Health, Seattle, WA 98121, USA. 1
2
3
4
5
Sharma DC. Rights violation found in HPV vaccine studies in India. Lancet Oncol 2013; 14: e443. LaMontagne DS, Barge S, Le NT, et al. Human papillomavirus vaccine delivery strategies that achieved high coverage in low- and middle-income countries. Bull World Health Organ 2011; 89: 821–30B. WHO. Global Advisory Committee on Vaccine Safety, 12–13 June 2013. Wkly Epidemiol Rec 2013; 88: 301–12. Schiller JT, Castellsagué X, Garland SM. A review of clinical trials of human papillomavirus prophylactic vaccines. Vaccine 2012; 30: F123–38. Interim Report of the Committee appointed by the Govt. of India, no V.25011/160/2010-HR, 15th April, 2010, to enquire into “Alleged irregularities in the conduct of studies using Human Papilloma Virus (HPV) vaccine” by PATH in India, November 9th, 2010.
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