非传染性疾病疫苗的新浪潮:监管挑战是什么?

IF 0.3 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY
Food and drug law journal Pub Date : 2015-01-01
Jonathan J Darrow, Aaron S Kesselheim
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引用次数: 0

摘要

疫苗是医学最伟大的成就之一,它大大减少了严重或危及生命的传染病的发病率,使人们能够活得更长、更健康。然而,随着预期寿命的延长,癌症、高血压、动脉粥样硬化和糖尿病等非传染性疾病的负担有所增加。这种疾病负担的转移加剧了对治疗或预防非传染性疾病疗法的迫切需求,目前正在加大努力开发非传染性疾病疫苗来满足这一需求。与传统疫苗一样,非传染性疾病疫苗通过调节人体免疫系统起作用,但针对的是与非传染性疾病相关的细胞、蛋白质或其他分子,而不是病原体或被病原体感染的细胞。目前正在努力开发非传染性疾病疫苗,不仅用于治疗癌症和高血压,还用于治疗成瘾、肥胖、哮喘、关节炎、牛皮癣、多发性硬化症和克罗恩病等。非传染性疾病疫苗给美国食品和药物管理局(FDA)提出了一个有趣的挑战,FDA的任务是根据有效性和安全性批准新的治疗方法。非传染性疾病疫苗是否应在与传统疫苗或生物药物相同的分析框架下进行评估?尽管借用了术语,但非传染性疾病疫苗在许多重要方面与传染病疫苗不同。由于传染病疫苗一般是给健康人接种的,通常是儿童,因此对不良事件的耐受性较低,支付意愿有限。即使是针对罕见或已被根除的疾病(如天花),在疫情爆发时,拥有传染病疫苗也很重要。传染病疫苗的效力通常很高,并且疫苗具有群体免疫和潜在根除的人群水平的益处。大量的人口福利、低支付意愿和对不良事件的低容忍度的结合解释了联邦《全国儿童疫苗伤害赔偿法》的必要性,该法案通过免除工业责任和对受伤患者的赔偿来鼓励生产和使用。这些特点和考虑因素与非传染性疾病疫苗的特点和考虑因素形成鲜明对比,提出了“疫苗”一词是否适合用于这类新药物的问题。本文探讨了新兴的一类非传染性疾病疫苗,解释了它们与传统疫苗的不同之处,并描述了这种创新型治疗方法的一些监管意义。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A New Wave of Vaccines for Non-Communicable Diseases: What Are the Regulatory Challenges?

Vaccines represent one of the greatest achievements of medicine, dramatically reducing the incidence of serious or life-threatening infectious diseases and allowing people to live longer, healthier lives. As life expectancy has increased, however, the burden of non-communicable diseases (NCDs) such as cancer, hypertension, atherosclerosis, and diabetes has increased. This shifting burden of disease has heightened the already urgent need for therapies that treat or prevent NCDs, a need that is now being met with increased efforts to develop NCD vaccines. Like traditional vaccines, NCD vaccines work by modulating the human immune system, but target cells, proteins or other molecules that are associated with the NCD in question rather than pathogens or pathogen-infected cells. Efforts are underway to develop NCD vaccines to address not only cancer and hypertension, but also addiction, obesity, asthma, arthritis, psoriasis, multiple sclerosis, and Crohn's disease, among others. NCD vaccines present an interesting challenge for the U.S. Food and Drug Administration (FDA), which is tasked with approving new treatments on the basis of efficacy and safety. Should NCD vaccines be evaluated under the same analytic frame as traditional vaccines, or that of biologic drugs? Despite the borrowed nomenclature, NCD vaccines differ in important ways from infectious disease vaccines. Because infectious disease vaccines are generally administered to healthy individuals, often children, tolerance for adverse events is low and willingness to pay is limited. It is important to have infectious disease vaccines even for rare or eradicated disease (e.g., smallpox), in the event of an outbreak. The efficacy of infectious disease vaccines is generally high, and the vaccines convey population level benefits associated with herd immunity and potential eradication. The combination of substantial population-level benefits, low willingness to pay, and low tolerance for adverse events explains the need for the federal National Childhood Vaccine Injury Compensation Act, which encourages production and uptake by providing immunity from liability to industry and compensation to injured patients. These characteristics and considerations contrast sharply with those of NCD vaccines, raising the question of whether the term "vaccine" is appropriate for this new category of drugs. The article explores the emerging class of NCD vaccines, explains how they differ from traditional vaccines, and describes some regulatory implications of this innovative type of therapeutic.

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来源期刊
Food and drug law journal
Food and drug law journal 医学-食品科技
CiteScore
0.20
自引率
50.00%
发文量
0
审稿时长
>36 weeks
期刊介绍: The Food and Drug Law Journal is a peer-reviewed quarterly devoted to the analysis of legislation, regulations, court decisions, and public policies affecting industries regulated by the U.S. Food and Drug Administration (FDA) and related agencies and authorities, including the development, manufacture, marketing, and use of drugs, medical devices, biologics, food, dietary supplements, cosmetics, veterinary, tobacco, and cannabis-derived products. Building on more than 70 years of scholarly discourse, since 2015, the Journal is published in partnership with the Georgetown University Law Center and the O’Neill Institute for National & Global Health Law. All members can access the Journal online. Each member organization and most individual memberships (except for government, student, and Emeritus members) receive one subscription to the print Journal.
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