Evidence map›Paper›PMID 39650698›Full record

ArticleJournal of immunological sciences2018

The Role of The African Vaccine Regulatory Forum (AVAREF) in The Accelerated Clinical Evaluation of Ebola Vaccine Candidates During the Large West Africa Epidemic.

Bartholomew Dicky Akanmori, David Mukanga, Ahmed Bellah, Tieble Traore, Michael Ward, Richard Mihigo

Abstract read
In one paragraph

Article in Journal of immunological sciences, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

11 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Review
  11. Review
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

6 authors.

Bartholomew Dicky AkanmoriImmunization and Vaccines Development, Family and Reproductive Health Cluster, WHO Regional Office for Africa.
David MukangaRegulatory Systems Strengthening, Essential Medicines and Health Products, WHO Headquarters.
Ahmed BellahRegulatory Systems Strengthening, Essential Medicines and Health Products, WHO Headquarters.
Tieble TraoreImmunization and Vaccines Development, Family and Reproductive Health Cluster, WHO Regional Office for Africa.
Michael WardRegulatory Systems Strengthening, Essential Medicines and Health Products, WHO Headquarters.
Richard MihigoImmunization and Vaccines Development, Family and Reproductive Health Cluster, WHO Regional Office for Africa.

Funding

World Health Organization 001
6 · The paper itself

Abstract

In emergency situations, clinical trials of new vaccines and therapies in resource-constrained settings place an additional burden on the limited resources of low and middle-income countries. The clinical trials of vaccines against Ebola Virus Disease (EVD) in Africa presented challenges on how to ensure there was enough capacity for ethics and regulatory reviews and oversight while still allowing for accelerating the clinical evaluations. Using the African Vaccine Regulatory Forum (AVAREF) platform WHO supported African countries to provide ethics and regulatory reviews and oversight, ensuring that these trials were completed in unprecedented shorter timelines than normal, that is, months instead of years. Pathways were defined, external expertise provided and appropriate review models implemented in the countries which hosted these critical studies. This paper discusses the work around the clinical trials, the models of reviews and timelines for clinical trials and highlights the important lessons revealed. More investments are required to monitor safety during clinical trials, strengthen systems for licensure of new products and implement robust post-marketing surveillance, among other components for effective clinical trials before the next pandemic surfaces.

Indexed as

African Vaccine Regulatory ForumClinical EvaluationEbolaRoleVaccine

Identifiers

PMID39650698
PMCPMC7617095

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.