Public Health Emergency - Leading a Nation Prepared
In the interest of attracting additional private-sector investment in the development of safe and effective Zika vaccines, the U.S. Department of Health and Human Services is making available a White Paper outlining the strategy for the endeavor.
The White Paper articulates three aims to support achievement of the long-term goal of developing a safe and effective vaccine to prevent Zika virus infection. These include: evaluating early vaccine candidates for evidence of safety and immunogenicity to establish markers of vaccine efficacy that could facilitate future trials; providing access to investigational vaccines in Zika-affected areas through appropriate regulatory mechanisms; and working with industry partners to develop safe and effective Zika vaccines towards FDA licensure as soon as possible, potentially as early as 2020.
From the perspective of vaccine manufacturers, advanced development of vaccine candidates to address emerging and re-emerging infectious disease threats is a high-risk endeavor given development costs, technical challenges, rapidly evolving disease epidemiology, and the uncertainties of market demand. We hope that the information in the White Paper will prove useful to manufacturers as they consider opportunities for clinical development and commercialization of vaccine candidates. At the same time, the Federal government will continue to work with vaccine manufacturers to mitigate commercial risks and accelerate entry of vaccine candidates into the market. This may include entering into exclusive patent licensing arrangements to advance government-developed technology, in accordance with applicable statutory and regulatory requirements.
U.S. Government Zika Vaccine Strategy: White Paper
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