Bill & Melinda Gates Foundation, New Delhi, Delhi, India.
Ministry of Health & Family Welfare, Government of India, New Delhi, India.
Am J Trop Med Hyg. 2022 Mar 15;106(5_Suppl):48-55. doi: 10.4269/ajtmh.21-1168. Print 2022 May 11.
We used the introduction of the Japanese encephalitis (JE) vaccine in India as an example to understand more fully the process of introducing any new clinical product in India. We discuss the key decision-making points as well as the many activities involved in introducing a new clinical product in India's public health program. We write from our experience in supporting the government of India to introduce new products successfully-namely, vaccines-to India's health system. In India, the process begins with identifying the public health problem (e.g., an outbreak of JE), deciding to take action, prioritizing where action is needed, securing a supply and price of the intervention (the vaccine; in this case, the live, attenuated SA 14-14-2 vaccine), and determining how to ensure effective rollout of the intervention (the vaccination program). Reflecting on the experience of the JE vaccination program helped to inform the introduction of the triple-drug therapy of ivermectin, diethylcarbamazine, and albendazole in India as a new treatment protocol for lymphatic filariasis.
我们以印度引入乙型脑炎(JE)疫苗为例,深入了解在印度引入任何新的临床产品的过程。我们讨论了关键决策点以及在印度公共卫生计划中引入新的临床产品所涉及的许多活动。我们根据在支持印度政府成功引入新产品——即疫苗——进入印度卫生系统的经验进行撰写。在印度,这一过程始于确定公共卫生问题(例如 JE 的爆发),决定采取行动,确定需要采取行动的优先事项,确保干预措施(疫苗;在这种情况下,是减毒活疫苗 SA 14-14-2)的供应和价格,并确定如何确保干预措施的有效推出(疫苗接种计划)。对 JE 疫苗接种计划的经验进行反思有助于为在印度引入伊维菌素、乙胺嗪和阿苯达唑的三药疗法提供信息,作为治疗淋巴丝虫病的新治疗方案。