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|Title: ||Data and product needs for influenza immunization programs in low- and middle-income countries: Rationale and main conclusions of the WHO preferred product characteristics for next-generation influenza vaccines|
|Authors: ||Neuzil, Kathleen|
Hoz, Fernando de la
Karron, Ruth A.
Madhi, Shabir A.
Spiro, David J.
Ortiz, Justin R.
|Citation: ||Neuzil, K.M. et al. (2017). Data and product needs for influenza immunization programs in low- and middle-income countries: Rationale and main conclusions of the WHO preferred product characteristics for next-generation vaccines. Vaccine. DOI: http://dx.doi.org/10.1016/j.vaccine.2017.08.088|
|Abstract: ||In 2017, WHO convened a working group of global experts to develop the Preferred Product Characteristics (PPC) for Next-Generation Influenza Vaccines. PPCs are intended to encourage innovation in vaccine development. They describe WHO preferences for parameters of vaccines, in particular their indications, target groups, implementation strategies, and clinical data needed for assessment of safety and efficacy. PPCs are shaped by the global unmet public health need in a priority disease area for which WHO encourages vaccine development. These preferences reflect WHO’s mandate to promote the development of vaccines with high public health impact and suitability in Low- and Middle-Income Countries (LMIC). The target audience is all entities intending to develop or to achieve widespread adoption of a specific influenza vaccine product in these settings. The working group determined that existing influenza vaccines are not well suited for LMIC use. While many developed country manufactures and research funders prioritize influenza vaccine products for use in adults and the elderly, most LMICs do not have sufficiently strong health systems to deliver vaccines to these groups. Policy makers from LMICs are expected to place higher value on vaccines indicated for prevention of severe illness, however the clinical development of influenza vaccines focuses on demonstrating prevention of any influenza illness. Many influenza vaccine products do not meet WHO standards for programmatic suitability of vaccines, which introduces challenges when vaccines are used in low-resource settings. And finally, current vaccines do not integrate well with routine immunization programs in LMICs, given age of vaccine licensure, arbitrary expiration dates timed for temperate country markets, and the need for year-round immunization in countries with prolonged influenza seasonality. While all interested parties should refer to the full PPC document for details, in this article we highlight data needs for new influenza vaccines to better demonstrate the value proposition in LMICs.|
|Subject Keywords: ||preferred product characteristics|
low- and middle-income countries
World Health Organization
|Sponsors: ||Centers for Disease Control and Prevention (CDC); World Health Organization Initiative for Vaccine Research (U50 CK000431)|
|Description: ||World Health Organization report from the WHO Preferred Product Characteristics for Next-Generation Influenza Vaccines Advisory Group|
|Appears in Collections:||Institute for Global Health|
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