US Department of Health and Human Services, Biomedical Advanced Research and Development Authority, Washington, DC, USA.
Vaccine. 2011 Jul 1;29 Suppl 1:A48-50. doi: 10.1016/j.vaccine.2011.02.080.
Since 2005, the Government of the United States of America has provided more than US$ 50 million to advance influenza vaccine development in low-resourced countries. This programme has provided a unique opportunity for the US Government to develop a comprehensive view of, and to understand better the challenges and future needs for influenza vaccines in the developing world. The funding for this programme has been primarily through a cooperative agreement with the World Health Organization (WHO) to support directly its capacity-building grants to government-owned or -supported vaccine manufacturers in developing countries. A second cooperative agreement with the Program for Appropriate Technologies in Health (PATH) was initiated to accelerate the completion of a current Good Manufacturing Practice cGMP production facility, along with supporting facilities to obtain a reliable source of eggs, and to conduct clinical trials of influenza vaccine manufactured in Vietnam. This mechanism of utilizing cooperative agreements to support capacity-building for vaccine development in low-resourced settings has been novel and unique and has yielded fruitful returns on minimal investment. The information derived from this programme helps to clarify not only the development challenges for influenza vaccines and how the United States may assist in meeting those challenges, but also other vaccine development issues common to manufacturers in developing countries. While building the initial capacity to produce influenza vaccines can be a straightforward exercise, the sustainability of the enterprise and expansion of subsequent markets will be the key to future usefulness. There is hope for expansion of the global influenza vaccine market. Ongoing burden of disease studies are elucidating the impact of influenza infections, particularly in children, and more countries will take note and respond accordingly, since respiratory diseases are now the number one killer of children under five years of age. In addition to achievements described in this issue of Vaccine, the programme has been successful from the US perspective because the working relationships established between the US Department of Health and Human Services' (HHS) Assistant Secretary for Preparedness and Response Biomedical Advanced Research and Development Authority (BARDA) and its partners have assisted in advancing influenza vaccine development at many different levels. A few examples of BARDA's support include: establishment of egg-based influenza vaccine production from "scratch", enhancement of live attenuated influenza vaccine (LAIV) production techniques and infrastructure, completion of fill/finish operations for imported bulk vaccine, and training in advanced bio-manufacturing techniques. These HHS-supported programmes have been well-received internationally, and we and our partners hope the successes will stimulate even more interest within the international community in maximizing global production levels for influenza vaccines.
自 2005 年以来，美利坚合众国政府已提供超过 5000 万美元，以促进资源匮乏国家的流感疫苗开发。该计划为美国政府提供了一个独特的机会，使美国政府能够全面了解并更好地理解发展中国家流感疫苗的挑战和未来需求。该计划的资金主要通过与世界卫生组织（WHO）的合作协议提供，该协议直接支持其向发展中国家政府拥有或支持的疫苗制造商提供能力建设赠款。与适宜卫生技术规划（PATH）的第二项合作协议已经启动，目的是加快当前良好生产规范（cGMP）生产设施的完成，以及获得可靠的鸡蛋来源和进行在越南制造的流感疫苗临床试验的支持设施。这种利用合作协议支持资源匮乏环境下疫苗开发能力建设的机制是新颖独特的，并且在最小投资的情况下产生了丰硕的回报。该计划提供的信息不仅有助于阐明流感疫苗的开发挑战以及美国如何协助应对这些挑战，而且还阐明了发展中国家制造商面临的其他疫苗开发问题。虽然建立生产流感疫苗的初始能力可能是一项简单的工作，但企业的可持续性和后续市场的扩展将是未来有用性的关键。扩大全球流感疫苗市场是有希望的。正在进行的疾病负担研究正在阐明流感感染的影响，特别是在儿童中，更多的国家将注意到这一点并做出相应的回应，因为呼吸道疾病现在是五岁以下儿童的头号杀手。除了本文所述的成就外，该计划从美国的角度来看是成功的，因为美国卫生与公众服务部（HHS）准备和应对助理部长生物医学高级研究与发展局（BARDA）与其合作伙伴之间建立的工作关系在许多不同层面上都有助于推进流感疫苗的开发。BARDA 支持的一些例子包括：从头开始建立基于鸡蛋的流感疫苗生产、增强减毒活流感疫苗（LAIV）生产技术和基础设施、完成进口散装疫苗的灌装/完成操作，以及培训先进的生物制造技术。这些 HHS 支持的计划在国际上受到好评，我们和我们的合作伙伴希望这些成功将激发国际社会对最大程度地提高流感疫苗全球产量的更大兴趣。
