Evidence map›Paper›PMID 35164990›Full record

ArticleVaccine2022

Building the concept for WHO Evidence Considerations for Vaccine Policy (ECVP): Tuberculosis vaccines intended for adults and adolescents as a test case.

Sonali Kochhar, Draurio Barreira, Pauline Beattie, Marco Cavaleri, Alejandro Cravioto, Mike W Frick, Ann M Ginsberg, Ian Hudson, David C Kaslow, Sherry Kurtz and 13 more

Open access · hybridAbstract readConference Proceedings
PubMed Full text at PMC Publisher
In one paragraph

Article in Vaccine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.7field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 17 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
  8. Article
  9. Article
  10. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors at 16 institutions in 8 countries.

Sonali KochharGlobal Healthcare Consulting, New Delhi, India; Department of Global Health, University of Washington, Seattle, WA, USA. Electronic address: sonalikochhar@yahoo.co.in.
Draurio BarreiraUNITAID, Geneva, Switzerland.
Pauline BeattieEuropean & Developing Countries Clinical Trials Partnership (EDCTP), The Hague, the Netherlands.
Marco CavaleriEuropean Medicines Agency (EMA), Amsterdam, the Netherlands.
Alejandro CraviotoFaculty of Medicine of the National Autonomous University of Mexico, Mexico.
Mike W FrickTreatment Action Group, NY, USA.
Ann M GinsbergBill & Melinda Gates Foundation, Washington DC, USA.
Ian HudsonBill & Melinda Gates Foundation, London, UK.
David C KaslowPATH, Seattle, USA.
Sherry KurtzUS FDA, Silver Spring, USA.
Christian LienhardtUnité Mixte Internationale TransVIHMI (Université de Montpellier, UMI 233 IRD, U1175 INSERM), Institut de Recherche pour le Développement (IRD), Montpellier, France; Epidemiology and Population Health, Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.
Shabir A MadhiSouth African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Christopher MorganJhpiego, Baltimore, USA; School of Population and Global Health, University of Melbourne, Victoria, Australia; Burnet Institute, Melbourne, Australia.
Yalda MomeniUNICEF, Copenhagen, Denmark.
Deepali PatelGavi, the Vaccine Alliance, Geneva, Switzerland.
Helen ReesWits Reproductive Health and HIV Institute, University of Witwatersrand, Johannesburg, South Africa.
Taryn Rogalski-SalterBill & Melinda Gates Medical Research Institute, Cambridge, MA, United States.
Alexander SchmidtBill & Melinda Gates Medical Research Institute, Cambridge, MA, United States.
Boitumelo Semete-MakokotlelaSouth African Health Products Regulatory Authority (SAHPRA), Pretoria, South Africa.
Gerald VossTuBerculosis Vaccine Initiative (TBVI), Lelystad, the Netherlands.
Richard G WhiteTB Centre and Centre for the Mathematical Modelling of Infectious Diseases, London School of Hygiene and Tropical Medicine, London, UK.
Matteo ZignolWHO, Geneva, Switzerland.
Birgitte GiersingWHO, Geneva, Switzerland.
Bill & Melinda Gates Foundation · USWorld Health Organization · CHBurnet Institute · AUEuropean & Developing Countries Clinical Trials Partnership · NLEuropean Medicines Agency · NLGavi · CHInserm · FRProgram for Appropriate Technology in Health · USSouth African Medical Research Council · ZATreatment Action Group · USTuBerculosis Vaccine Initiative · NLUnitaid · CHUnited States Food and Drug Administration · USUniversidad Nacional Autónoma de México · MXUniversity of the Witwatersrand · ZAUniversity of Washington · US

Funding

Gates Foundation INV-003658World Health Organization 001
6 · The paper itself

Abstract

Currently, 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. Consequently, significant delays may result in vaccine introduction and uptake, while post-licensure data are generated to support a definitive policy decision. To 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: Evidence Considerations for Vaccine Policy (ECVP). EVCPs aim to fill a critical current gap by providing early (pre-phase 3 study design) information on the anticipated clinical trial and observational data or evidence that could support WHO and/or policy decision making for new vaccines in priority disease areas. The intent of ECVPs is to inform vaccine developers, funders, and other key stakeholders, facilitating stakeholder alignment in their strategic planning for late stage vaccine development. While ECVPs 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 Strategic Advisory Group of Experts on Immunization (SAGE) evidence to recommendation (EtR) process that is required for all vaccines seeking WHO policy recommendation. Tuberculosis (TB) vaccine candidates intended for use in the adolescent and adult target populations comprise a portfolio of priority vaccines in late-stage clinical development. As 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.

Indexed as

Tuberculosis VaccinesAdolescentHumansImmunization ProgramsPolicyVaccinationWorld Health OrganizationTuberculosis VaccinesAdolescentsAdultsClinical researchCountryDataDevelopersDonorEvidence Considerations for Vaccine PolicyFinancingImplementationPolicyPolicy makersPreferred Policy ProfileProcurementRegionalRegulatorsTuberculosisVaccineWHO

Identifiers

PMID35164990
PMCPMC8914344
OpenAlexW4211157142

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.