PATH provided an update on its joint HPV vaccine project in India. PATH said that over the past few months, a post-licensure observational study involving administration of HPV vaccine in India, conducted as part of PATH’s global HPV Vaccines: Evidence for Impact project, “has been the focus of allegations from various groups. Recently these have been covered in the press, mainly in India. As a precaution, the Government of India has decided to suspend all project HPV vaccination and to conduct an inquiry to respond to voiced concerns.” PATH said that the project is being implemented by the immunization departments of India’s Andhra Pradesh and Gujarat states and “was carried out only after receiving all required approvals in India and the United States. PATH is cooperating fully with the government inquiry to assist in allaying voiced concerns.” To date, 23,500 girls have been fully vaccinated by the Ministries of Health and Family Welfare in Andhra Pradesh and Gujarat utilizing HPV vaccines licensed for sale in India and donated by Merck and GlaxoSmithKline.
Dr. Christopher Elias, president and CEO of PATH, said, “The mission of PATH worldwide, and in India, is to improve the health of people by advancing technologies, strengthening systems, and encouraging healthy behaviors. The HPV Vaccines: Evidence for Impact project was designed to address all three of these areas. The post-licensure observational study is generating data about vaccine coverage, feasibility, acceptability, and implementation costs associated with different HPV vaccine delivery strategies. The project also assesses cervical precancer screening and treatment strategies. It was designed, in cooperation with government agencies, to assist India’s public health system in identifying the most effective and affordable strategies to help prevent cervical cancer, a disease that kills an estimated 143,000 Indian women every year.
“For approval of the post-licensure observational study, PATH and its Indian collaborators worked with two ethical review committees in India and one in the United States to design study protocols and informed consent materials. PATH is confident that these procedural safeguards informed and guided all aspects of study implementation and conduct.”
vaccines and global health :: ethics and policy 