Evidence map›Paper›PMID 37027085›Full record

ReviewAging clinical and experimental research2023

Exclusion of older adults and immunocompromised individuals in influenza, pneumococcal and COVID-19 vaccine trials before and after the COVID-19 pandemic.

Katrine Bukan, Toby Pearce-Slade, Mads Eiberg, Marco Tinelli, Dafna Yahav, Jose Tuells, Olivier Epaulard, Jon G Holler, Casper Roed, Christian Søborg and 2 more

Open access · hybridAbstract readReview
In one paragraph

Review in Aging clinical and experimental research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
4.9field-weighted citation impact, top 4% 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

9 citing papers in PubMed, 23 citations in OpenAlex.

  1. Article
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  9. A targeted approach to vaccine hesitancy.Oxford open immunology · 2023
    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

12 authors at 6 institutions in 6 countries.

Katrine Bukan *Department of Pulmonary Medicine and Infectious Diseases, Copenhagen University Hospital - North Zealand, Hillerød, Denmark.
Toby Pearce-Slade *Department of Pulmonary Medicine and Infectious Diseases, Copenhagen University Hospital - North Zealand, Hillerød, Denmark.
Mads EibergDepartment of Pulmonary Medicine and Infectious Diseases, Copenhagen University Hospital - North Zealand, Hillerød, Denmark.
Marco TinelliEuropean Society of Clinical Microbiology and Infectious Diseases (ESCMID) Study Group for Infections in the Elderly (ESGIE), Basel, Switzerland.
Dafna YahavEuropean Society of Clinical Microbiology and Infectious Diseases (ESCMID) Study Group for Infections in the Elderly (ESGIE), Basel, Switzerland.
Jose TuellsEuropean Society of Clinical Microbiology and Infectious Diseases (ESCMID) Vaccine Study Group (EVASG), Basel, Switzerland.
Olivier EpaulardEuropean Society of Clinical Microbiology and Infectious Diseases (ESCMID) Vaccine Study Group (EVASG), Basel, Switzerland.
Jon G HollerDepartment of Pulmonary Medicine and Infectious Diseases, Copenhagen University Hospital - North Zealand, Hillerød, Denmark.
Casper RoedDepartment of Pulmonary Medicine and Infectious Diseases, Copenhagen University Hospital - North Zealand, Hillerød, Denmark.
Christian SøborgDepartment of Pulmonary Medicine and Infectious Diseases, Copenhagen University Hospital - North Zealand, Hillerød, Denmark.
Jens-Ulrik Stæhr JensenDepartment of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Zitta Barrella HarboeDepartment of Pulmonary Medicine and Infectious Diseases, Copenhagen University Hospital - North Zealand, Hillerød, Denmark. zitta.barrella.harboe@regionh.dk.ORCID http://orcid.org/0000-0001-5552-0095
Copenhagen University Hospital · DKUniversity of Copenhagen · DKCentre Hospitalier Universitaire de Grenoble · FRIRCCS Istituto Auxologico Italiano · ITSheba Medical Center · ILUniversity of Alicante · ES

Funding

Danmarks Frie Forskningsfond 0134-00257BKræftens Bekæmpelse KBVU-MS R320-A18526Kræftens Bekæmpelse R327-A19137Lundbeckfonden R349-2020-835
6 · The paper itself

Abstract

backgroundOlder adults and immunocompromised individulas are often excluded from vaccine trials.

aimWe hypothesised that during the coronavirus disease 2019 (COVID-19) pandemic, the proportion of trials excluding these patients decreased.

methodsUsing the US Food and Drug Administration and and European Medicines Agency search engines, we identified all vaccines approved against pneumococcal disease, influenza (quadrivalent vaccines), and COVID-19 from 2011 to 2021. Study protocols were screened for direct and indirect age exclusion criteria and exclusion of immunocompromised individuals. In addition, we reviewed the studies with no explicit exclusion criteria and investigated the actual inclusion of those individuals.

resultsWe identified 2024 trial records; 1702 were excluded (e.g., use of other vaccine or risk group); and 322 studies were eligible for our review. Among the pneumococcal and influenza vaccine trials (n = 193), 81 (42%) had an explicit direct age exclusion, and 150 (78%) had an indirect age-related exclusion. In total, 163 trials (84%) trials were likely to exclude older adults. Among the COVID-19 vaccine trials (n = 129), 33 (26%) had direct age exclusion and 82 (64%) had indirect age exclusion; in total, 85 (66%) trials were likely to exclude older adults. Therefore was a 18% decrease in the proportion of trials with age-related exclusion between 2011 and 2021 (only influenza and pneumococcal vaccine trials) and 2020-2021 (only COVID-19 vaccine trials) (p = 0.014). In a sub-analysis assessing observational and randomised trials, the decrease was 25% and 9%, respectively. Immunocompromised individuals were included in 87 (45%) of the pneumococcal and influenza vaccine trials compared with 54 (42%) of the COVID-19 vaccine trials (p = 0.058).

conclusionsDuring the COVID-19 pandemic, we found a decrease in the exclusion of older adults from vaccine trials but no significant change in the inclusion of immunocompromised individulas.

Indexed as

COVID-19Influenza, HumanInfluenza VaccinesAgedCOVID-19 VaccinesHumansPandemicsPneumococcal VaccinesCOVID-19 VaccinesInfluenza VaccinesPneumococcal VaccinesCOVID-19 vaccineExclusionImmunocompromisedInfluenza vaccineOlder adultsPneumococcal vaccineVaccine trials

Identifiers

PMID37027085
PMCPMC10080508
OpenAlexW4362692866

What OpenQuestion holds

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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.