@article{fdi:010084539,
  title = {{B}uilding the concept for {WHO} {E}vidence {C}onsiderations for {V}accine {P}olicy ({ECVP}) : tuberculosis vaccines intended for adults and adolescents as a test case},
  author = {{K}ochhar, {S}. and {B}arreira, {D}. and {B}eattie, {P}. and {C}avaleri, {M}. and {C}ravioto, {A}. and {F}rick, {M}. {W}. and {G}insberg, {A}. {M}. and {H}udson, {I}. and {K}aslow, {D}. {C}. and {K}urtz, {S}. and {L}ienhardt, {C}hristian and {M}adhi, {S}. {A}. and {M}organ, {C}. and {M}omeni, {Y}. and {P}atel, {D}. and {R}ees, {H}. and {R}ogalski-{S}alter, {T}. and {S}chmidt, {A}. and {S}emete-{M}akokotlela, {B}. and {V}oss, {G}. and {W}hite, {R}. {G}. and {Z}ignol, {M}. and {G}iersing, {B}.},
  editor = {},
  language = {{ENG}},
  abstract = {{C}urrently, no formal mechanisms or systematic approaches exist to inform developers of new vaccines of the evidence anticipated to facilitate global policy recommendations, before a vaccine candidate approaches regulatory approval at the end of pre-licensure efficacy studies. {C}onsequently, significant delays may result in vaccine introduction and uptake, while post-licensure data are generated to support a definitive policy decision. {T}o address the uncertainties of the evidence-to-recommendation data needs and to mitigate the risk of delays between vaccine recommendation and use, {WHO} is evaluating the need for and value of a new strategic alignment tool: {E}vidence {C}onsiderations for {V}accine {P}olicy ({ECVP}). {EVCP}s aim to fill a critical current gap by providing early (pre-phase 3 study design) information on the antic-ipated clinical trial and observational data or evidence that could support {WHO} and/or policy decision making for new vaccines in priority disease areas. {T}he intent of {ECVP}s is to inform vaccine developers, funders, and other key stakeholders, facilitating stakeholder alignment in their strategic planning for late stage vaccine development. {W}hile {ECVP}s are envisaged as a tool to support dialogue on evidence needs between regulators and policy makers at the national, regional and global level, development of an {ECVP} will not preclude or supersede the independent {WHO}s {S}trategic {A}dvisory {G}roup of {E}xperts on {I}mmunization ({SAGE}) evidence to recommendation ({E}t{R}) process that is required for all vaccines seeking {WHO} policy recommendation. {T}uberculosis ({TB}) vaccine candidates intended for use in the adolescent and adult target populations comprise a portfolio of priority vaccines in late-stage clinical development. {A}s such, {TB} vaccines intended for use in this target population provide a test case to further develop the {ECVP} concept, and develop the first {WHO} {ECVP} considerations guidance. {C}rown {C}opyright ({C}) 2021 {P}ublished by {E}lsevier {L}td.},
  keywords = {{WHO} ; {V}accine ; {P}referred {P}olicy {P}rofile ; {E}vidence {C}onsiderations for ; {V}accine {P}olicy ; {D}ata ; {P}olicy ; {R}egulators ; {P}olicy makers ; {C}linical research ; {I}mplementation ; {T}uberculosis ; {A}dolescents ; {A}dults ; {D}evelopers ; {C}ountry ; {R}egional ; {D}onor ; {P}rocurement ; {F}inancing ; {MONDE}},
  booktitle = {},
  journal = {{V}accine},
  volume = {40},
  numero = {12},
  pages = {1681--1690},
  ISSN = {0264-410{X}},
  year = {2022},
  DOI = {10.1016/j.vaccine.2021.10.062},
  URL = {https://www.documentation.ird.fr/hor/fdi:010084539},
}