Evidence map›Paper›PMID 25444788›Full record

ReviewVaccine2015

The complementary roles of Phase 3 trials and post-licensure surveillance in the evaluation of new vaccines.

Pier Luigi Lopalco, Frank DeStefano

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Vaccine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing 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

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

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. Observational
  9. Article
  10. Article
  11. Review
  12. Effectiveness of an Inactivated SARS-CoV-2 Vaccine in Chile.The New England journal of medicine · 2021
    Observational
  13. Article
  14. Observational
  15. The find of COVID-19 vaccine: Challenges and opportunities.Journal of infection and public health · 2021
    Review
  16. Review
  17. Article
  18. Article
  19. Article
  20. 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

2 authors.

Pier Luigi LopalcoEuropean Centre for Disease Prevention and Control (ECDC), SE-171 83 Stockholm, Sweden. Electronic address: pierluigi.lopalco@ecdc.europa.eu.
Frank DeStefanoCenters for Disease Control and Prevention, Atlanta, GA, USA.

Funding

Intramural CDC HHS CC999999
6 · The paper itself

Abstract

Vaccines have led to significant reductions in morbidity and saved countless lives from many infectious diseases and are one of the most important public health successes of the modern era. Both vaccines' effectiveness and safety are keys for the success of immunisation programmes. The role of post-licensure surveillance has become increasingly recognised by regulatory authorities in the overall vaccine development process. Safety, purity, and effectiveness of vaccines are carefully assessed before licensure, but some safety and effectiveness aspects need continuing monitoring after licensure; Post-marketing activities are a necessary complement to pre-licensure activities for monitoring vaccine quality and to inform public health programmes. In the recent past, the availability of large databases together with data-mining and cross-linkage techniques have significantly improved the potentialities of post-licensure surveillance. The scope of this review is to present challenges and opportunities offered by vaccine post-licensure surveillance. While pre-licensure activities form the foundation for the development of effective and safe vaccines, post-licensure monitoring and assessment, are necessary to assure that vaccines are effective and safe when translated in real world settings. Strong partnerships and collaboration at an international level between different stakeholders is necessary for finding and optimally allocating resources and establishing robust post-licensure processes.

Indexed as

Clinical Trials, Phase III as TopicProduct Surveillance, PostmarketingVaccinesDatabases, FactualDrug ApprovalEuropeHumansLicensureUnited StatesVaccinationVaccinesVaccine effectivenessVaccine marketing authorisationVaccine safetyVaccine trials

Identifiers

PMID25444788
PMCPMC4596394

What OpenQuestion holds

Textmetadata
LicenceTDM
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.