title: United States of America Department of Health and Human Services support for advancing influenza vaccine manufacturing in the developing world.
abstract: 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.
authors.affiliation: US Department of Health and Human Services, Biomedical Advanced Research and Development Authority, Washington, DC, USA. Michael.Perdue@hhs.gov
authors.forename: Michael L
authors.initials: ML
authors.lastname: Perdue
authors.forename: Rick A
authors.initials: RA
authors.lastname: Bright
mesh_terms: D002986:Clinical Trials as Topic; D003906:Developing Countries; D004345:Drug Industry / Q000191:economics* / Q000458:organization & administration*; D006801:Humans; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000276:immunology / Q000600:supply & distribution*; D007251:Influenza, Human / Q000453:epidemiology* / Q000517:prevention & control*; D013678:Technology, Pharmaceutical / Q000191:economics* / Q000458:organization & administration*; D014481:United States; D014483:United States Dept. of Health and Human Services; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000276:immunology / Q000600:supply & distribution; D014944:World Health Organization
chemical_list: D007252:Influenza Vaccines; D014613:Vaccines, Attenuated