Evidence map›Paper›PMID 39887891›Full record

SynthesisPharmacoepidemiology and drug safety2025

Quantitative Benefit-Risk Assessment of Vaccination Against COVID-19: A Systematic Review.

E Claire Newbern, Lea Wildisen, Rita Verstraeten, Corinne Willame, Kevin Haynes, Bennett Levitan, Nicolas Praet

Abstract readSystematic Review
In one paragraph

Synthesis in Pharmacoepidemiology and drug safety, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

E Claire NewbernJohnson & Johnson Innovative Medicine, Global Epidemiology, Horsham, Pennsylvania, USA.ORCID 0000-0002-8486-6471
Lea WildisenJohnson & Johnson Innovative Medicine, Basel, Switzerland.ORCID 0000-0003-2097-8674
Rita VerstraetenJohnson & Johnson Innovative Medicine, Beerse, Belgium.
Corinne WillameJohnson & Johnson Innovative Medicine, Beerse, Belgium.
Kevin HaynesJohnson & Johnson Innovative Medicine, Global Epidemiology, Horsham, Pennsylvania, USA.
Bennett LevitanJohnson & Johnson Innovative Medicine, Titusville, New Jersey, USA.
Nicolas PraetJohnson & Johnson Innovative Medicine, Beerse, Belgium.ORCID 0009-0006-7271-4186

Funding

Janssen Pharmaceuticals
6 · The paper itself

Abstract

purposeWith the introduction of COVID-19 vaccines, there has been a proliferation of quantitative benefit-risk assessments (qBRAs). Prior work on other types of vaccines has found that published qBRAs have not always clearly reported methods and/or results needed to assist in the application of the qBRA findings. The aim was to systematically identify, review, and critically assess published COVID-19 vaccine qBRA. The ultimate goal is to support the future development of robust qBRA for existing, new, and updated vaccines.

methodsWe systematically reviewed COVID-19 vaccine qBRAs identified from multiple sources through April 17, 2023, including literature databases, selected Health Authority websites, and a grey literature search. We critically assessed whether key features typical of qBRA were presented in these reports.

resultsWe identified 37 COVID-19 vaccine qBRAs from screening 2220 publications and 18 other sources. The qBRAs were conducted on two mRNA and two adenoviral vector COVID-19 vaccines. Only one qBRA represented low- and middle-income countries. Although many qBRAs used simple calculations (n = 25), more complex models were presented in 15 reports. Simple approaches were able to employ stratification by age and/or sex to highlight safety issues affecting specific demographic groups and scenarios to account for changes in viral transmission and vaccine effectiveness over time. Details regarding data sources and analytic methods were missing or limited in some reports.

conclusionsThis comprehensive description and critical assessment of COVID-19 vaccine qBRAs together with available guidance can be used to support the development of robust and transparent future vaccine qBRAs.

Indexed as

COVID-19COVID-19 VaccinesVaccinationHumansRisk AssessmentSARS-CoV-2COVID-19 VaccinesCOVID‐19quantitative benefit–risk assessmentvaccination

Identifiers

PMID39887891
PMCPMC11779546

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.