Prabhu Malavika, Eckert Linda O
Department of Obstetrics & Gynecology, University of Washington, 1959 NE Pacific Street, Seattle, WA 98195, USA.
Department of Obstetrics & Gynecology, University of Washington, 1959 NE Pacific Street, Seattle, WA 98195, USA; Institute of Vaccine Research, World Health Organization, Avenue Appia 20, Geneva 27 1211, Switzerland.
Papillomavirus Res. 2016 Dec;2:185-189. doi: 10.1016/j.pvr.2016.10.002. Epub 2016 Oct 26.
The World Health Organization (WHO) serves as a key organization to bring together experts along the continuum of vaccine development and regulatory approval, among its other functions. Using the revision of WHO's guidelines on prophylactic human papillomavirus (HPV) vaccine as an example, we describe the process by which (1) a need to revise the guidelines was identified; (2) a group of stakeholders with complementary expertise and key questions were identified; (3) a scientific review was conducted; (4) consensus on revisions was achieved; (5) guidelines were updated, reviewed widely, and approved. This multi-year process resulted in the consensus that regulatory agencies could consider additional endpoints, such as persistent HPV infection or immune equivalence, depending on the design of the HPV vaccine trials. Updating the guidelines will now accelerate vaccine development, reduce costs of clinical trials, and lead to faster regulatory approval.
世界卫生组织（WHO）在其诸多职能中，是一个将疫苗研发和监管审批各环节的专家汇聚在一起的关键组织。以WHO预防性人乳头瘤病毒（HPV）疫苗指南的修订为例，我们描述了以下过程：（1）确定修订指南的必要性；（2）确定一组具备互补专业知识和关键问题的利益相关者；（3）进行科学审查；（4）就修订达成共识；（5）更新指南，广泛审查并批准。这一历经数年的过程达成了如下共识：监管机构可根据HPV疫苗试验的设计，考虑额外的终点指标，如持续性HPV感染或免疫等效性。现在更新指南将加速疫苗研发，降低临床试验成本，并实现更快的监管批准。
