Evidence map›Paper›PMID 34487916›Full record

SynthesisAgeing research reviews2021

Underrepresentation of older adults in clinical trials on COVID-19 vaccines: A systematic review.

Nicola Veronese, Mirko Petrovic, Athanase Benetos, Michael Denkinger, Adalsteinn Gudmundsson, Wilma Knol, Christine Marking, George Soulis, Stefania Maggi, Antonio Cherubini and 1 more

Abstract readSystematic Review
In one paragraph

Synthesis in Ageing research reviews, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 3 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

30 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Article
  5. Article
  6. Article
  7. Observational
  8. Article
  9. SOARNet: Establishing an older adult focused practice-based research network.Journal of clinical and translational science · 2026
    Article
  10. Article
  11. Evidence paradox: Enhancing clinical trials for older adults.The journal of nutrition, health & aging · 2025
    Article
  12. Review
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  14. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors.

Nicola VeroneseDepartment of Internal Medicine and Geriatrics, University of Palermo, Palermo, Italy. Electronic address: nicola.veronese@unipa.it.
Mirko PetrovicSection of Geriatrics, Department of Internal Medicine and Paediatrics, Ghent University, Ghent, Belgium.
Athanase BenetosDepartment of Geriatrics and FHU CARTAGE-PROFILES, CHRU de Nancy and INSERM 1116, Université de Lorraine, Vandoeuvre-lès-Nancy, France.
Michael DenkingerInstitute for Geriatric Research at Agaplesion Bethesda Hospital Ulm, Ulm University and Geriatric Centre, Ulm, Germany.
Adalsteinn GudmundssonLandspitali University Hospital, Landspitali, Reykjavik, Iceland.
Wilma KnolDepartment of Geriatric Medicine, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Christine MarkingMemory Disorder Research Group, Department of Neurology, Neuroscience Centre, Copenhagen University Hospital Rigshospitalet, Denmark.
George SoulisOutpatient Geriatric Assessment Unit, Henry Dunant Hospital Center, Athens, Greece.
Stefania MaggiCNR-IN Aging Branch, Padua, Italy.
Antonio CherubiniGeriatria, Accettazione geriatrica e Centro di ricerca per l'invecchiamento, IRCCS INRCA, Ancona, Italy.
special interest group in Systematic Reviews and Meta-analyses and the task force on Pharmaceutical strategy of the European Geriatric Medicine Society (EuGMS)

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

During the COVID-19 pandemic older subjects have been disproportionately affected by the disease. Vaccination is a fundamental intervention to prevent the negative consequences of COVID-19, but it is not known if the needs and vulnerabilities of older people are adequately addressed by their inclusion in randomized clinical trials (RCTs) evaluating the efficacy of vaccines for COVID-19. Given this background, we aimed to evaluate if current and ongoing phase II-III RCTs evaluating the efficacy of COVID-19 vaccines included a representative sample of older people. A systematic literature search in PubMed and Clinicaltrials.gov was performed until May 01st, 2021. Among 474 abstracts initially retrieved, 20 RCTs (ten already published, ten ongoing) were included. In the ten studies already published, the mean age of participants was 45.2 ± 11.9 years and only 9.83% of the participants were more than 65 years, 1.66% more than 75 years and less than 1% (0.55%) more than 85 years. In the ten ongoing RCTs, many of the studies aimed at including participants older than 18 years, with one study including participants between 18 and 84 years, and two between 21 and 100 years. In conclusion, our systematic review demonstrates that in published and ongoing phase II-III randomized clinical trials evaluating the efficacy of COVID-19 vaccines only a tiny fraction of the most vulnerable group of older people was included, although they clearly were the first population that had to be vaccinated.

Indexed as

COVID-19VaccinesAgedHumansSARS-CoV-2VaccinesCOVID-19Older adultsVaccination

Identifiers

PMID34487916
PMCPMC8413602

What OpenQuestion holds

Textmetadata
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.