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加速麻疹和风疹微阵列贴片的开发以消除麻疹和风疹:最新进展,尚存挑战。

Accelerating the Development of Measles and Rubella Microarray Patches to Eliminate Measles and Rubella: Recent Progress, Remaining Challenges.

机构信息

Immunization, Vaccines and Biologicals, World Health Organization, Geneva, Switzerland.

Independent, La Rippe, Switzerland.

出版信息

Front Public Health. 2022 Mar 2;10:809675. doi: 10.3389/fpubh.2022.809675. eCollection 2022.

Abstract

Measles and rubella microarray patches (MR-MAPs) are critical in achieving measles and rubella eradication, a goal highly unlikely to meet with current vaccines presentations. With low commercial incentive to MAP developers, limited and uncertain funding, the need for investment in a novel manufacturing facility, and remaining questions about the source of antigen, product demand, and regulatory pathway, MR-MAPs are unlikely to be prequalified by WHO and ready for use before 2033. This article describes the current progress of MR-MAPs, highlights challenges and opportunities pertinent to MR-MAPs manufacturing, regulatory approval, creating demand, and timelines to licensure. It also describes activities that are being undertaken by multiple partners to incentivise investment in and accelerate the development of MR-MAPs.

摘要

麻疹和风疹微阵列贴片(MR-MAPs)对于实现麻疹和风疹的消除至关重要,而目前的疫苗接种情况几乎不可能实现这一目标。由于 MAP 开发人员的商业激励因素较低、资金有限且不确定、需要投资于新型制造设施,以及关于抗原来源、产品需求和监管途径的问题仍然存在,因此 MR-MAPs 不太可能获得世卫组织的预认证,并且在 2033 年之前无法准备好使用。本文描述了 MR-MAPs 的当前进展,重点介绍了与 MR-MAPs 制造、监管批准、创造需求和许可时间表相关的挑战和机遇。它还描述了多个合作伙伴正在开展的活动,以激励对 MR-MAPs 的投资并加速其开发。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b2d0/8924450/9d902ff93cf0/fpubh-10-809675-g0001.jpg

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