Evidence map›Paper›PMID 26379011›Full record

ReviewHuman vaccines & immunotherapeutics2016

Pandemrix™ and narcolepsy: A critical appraisal of the observational studies.

Thomas Verstraeten, Catherine Cohet, Gaël Dos Santos, Germano Lc Ferreira, Kaatje Bollaerts, Vincent Bauchau, Vivek Shinde

Abstract readReview
In one paragraph

Review in Human vaccines & immunotherapeutics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
–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

20 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Article
  5. Review
  6. Vaccine safety - is the SARS-CoV-2 vaccine any different?Human vaccines & immunotherapeutics · 2021
    Review
  7. Influenza in Children.Cold Spring Harbor perspectives in medicine · 2021
    Review
  8. Article
  9. Review
  10. Article
  11. Review
  12. Article
  13. Review
  14. Article
  15. Narcolepsy Associated with Pandemrix Vaccine.Current neurology and neuroscience reports · 2018
    Review
  16. Article
  17. Article
  18. Review
  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

7 authors.

Thomas Verstraetena P95 Pharmacovigilance and Epidemiology Services ; Leuven , Belgium.
Catherine Cohetb GSK Vaccines ; Wavre , Belgium.
Gaël Dos Santosc Business & Decision Life Sciences (contractor for GSK Vaccines) ; Brussels , Belgium.
Germano Lc Ferreiraa P95 Pharmacovigilance and Epidemiology Services ; Leuven , Belgium.
Kaatje Bollaertsa P95 Pharmacovigilance and Epidemiology Services ; Leuven , Belgium.
Vincent Bauchaub GSK Vaccines ; Wavre , Belgium.
Vivek Shinded GSK Vaccines ; King of Prussia , PA USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A link between Pandemrix™ (AS03-adjuvanted H1N1 pandemic influenza vaccine, GSK Vaccines, Belgium) and narcolepsy was first suspected in 2010 in Sweden and Finland following a number of reports in children and adolescents. Initial scepticism about the reported association faded as additional countries reported similar findings, leading several regulatory authorities to restrict the use of Pandemrix™. The authors acknowledge that currently available data suggest an increased risk of narcolepsy following vaccination with Pandemrix™; however, from an epidemiologist's perspective, significant methodological limitations of the studies have not been fully addressed and raise questions about the reported risk estimates. We review the most important biases and confounders that potentially occurred in 12 European studies of the observed association between Pandemrix™ and narcolepsy, and call for further analyses and debate.

Indexed as

Epidemiologic MethodsEuropeHumansInfluenza VaccinesNarcolepsyInfluenza Vaccinespandemrixepidemiological bias, H1N1, influenza, narcolepsy, vaccine

Identifiers

PMID26379011
PMCPMC4962758

What OpenQuestion holds

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Registered trials

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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.