Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR), U.S. Department of Health and Human Services (HHS), Washington DC, USA.
Leidos Supporting the Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR), U.S. Department of Health and Human Services (HHS), Washington DC, USA.
Expert Rev Vaccines. 2021 Mar;20(3):235-242. doi: 10.1080/14760584.2021.1886931. Epub 2021 Mar 1.
. Timely availability of effective influenza vaccine will be critical to mitigate the next influenza pandemic. The mission of Biomedical Advanced Research and Development Authority (BARDA) is to develop medical countermeasures against pandemics, including influenza and other health security threats.. Despite considerable gains in pandemic vaccine preparedness since 2009, old and new challenges threaten the pandemic influenza response capabilities of the U.S. Government: insufficient U.S.-based vaccine production, two-dose vaccination regimen, logistically complex adjuvanted formulation, and sustained surge manufacturing capacity despite no commercial market for pandemic vaccines. Although the coronavirus disease 2019 (COVID-19) pandemic has re-exposed these gaps in preparedness and response, previous investments into flexible influenza vaccine technologies proved to be critical to accelerate COVID-19 vaccine development.. BARDA addresses these challenges by implementing a pandemic influenza vaccine strategy with two key goals: 1) accelerating vaccine development and production () and 2) improving vaccine performance (). This strategy involves an end-to-end approach, including increasing manufacturing and fill-finish capacity; improving release testing speed; and funding clinical trials to improve current vaccine utilization. As demonstrated by the COVID-19 response, continued investments into this pandemic influenza vaccine strategy will further enhance the ability to respond to future emerging pandemic pathogens.
及时提供有效的流感疫苗对于减轻下一次流感大流行至关重要。生物医学高级研究与发展管理局(BARDA)的使命是开发针对大流行的医疗对策,包括流感和其他健康安全威胁。
尽管自 2009 年以来在大流行疫苗准备方面取得了相当大的进展,但旧的和新的挑战威胁着美国政府应对流感大流行的能力:美国国内疫苗生产不足、两剂疫苗接种方案、具有后勤复杂性的佐剂配方以及尽管没有大流行疫苗的商业市场,但仍需持续扩大生产能力。尽管 2019 年冠状病毒病(COVID-19)大流行再次暴露了这些准备和应对方面的差距,但先前对灵活流感疫苗技术的投资被证明对于加速 COVID-19 疫苗的开发至关重要。
BARDA 通过实施具有两个关键目标的大流行性流感疫苗战略来应对这些挑战:1)加快疫苗的开发和生产;2)提高疫苗的性能。该战略涉及端到端的方法,包括增加制造和灌装能力;提高放行测试速度;并为临床试验提供资金,以提高现有疫苗的利用率。正如 COVID-19 应对措施所表明的那样,对这一大流行性流感疫苗战略的持续投资将进一步增强应对未来新出现的大流行病原体的能力。