• 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

      Neuzil, Kathleen; Bresee, Joseph; Hoz, Fernando de la; Johansen, Kari; Karron, Ruth A.; Krishnan, Anand; Madhi, Shabir A.; Mangtani, Punam; Spiro, David J.; Ortiz, Justin R. (2017-08)
      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.
    • Global influenza seasonality to inform country-level vaccine programs: An analysis of WHO FluNet influenza surveillance data between 2011 and 2016

      Newman, Laura (Laura P.), 1983-; Bhat, Niranjan; Fleming, Jessica Ann; Neuzil, Kathleen (PLOS One, 2018-02-21)
      By analyzing publicly available surveillance data from 2011±2016, we produced countryspecific estimates of seasonal influenza activity for 118 countries in the six World Health Organization regions. Overall, the average country influenza activity period was 4.7 months. Our analysis characterized 100 countries (85%) with one influenza peak season, 13 (11%) with two influenza peak seasons, and five (4%) with year-round influenza activity. Surveillance data were limited for many countries. These data provide national estimates of influenza activity, which may guide planning for influenza vaccination implementation, program timing and duration, and policy development.