Evidence map›Paper›PMID 41644572›Full record

ReviewNPJ vaccines2026

Quantitative benefit-risk analysis for prophylactic vaccines in the context of FDAs benefit-risk framework.

Hong Yang, Osman N Yogurtcu, Ujwani Nukala, Patrick R Funk, Hector S Izurieta, Richard A Forshee

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in NPJ vaccines, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Review
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

6 authors.

Hong YangOffice of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, US FDA, Silver Spring, MD, USA. hong.yang@fda.hhs.gov.
Osman N YogurtcuOffice of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, US FDA, Silver Spring, MD, USA.
Ujwani NukalaOffice of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, US FDA, Silver Spring, MD, USA.
Patrick R FunkOffice of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, US FDA, Silver Spring, MD, USA.
Hector S IzurietaOffice of Vaccines Research and Review, Center for Biologics Evaluation and Research, US FDA, Silver Spring, MD, USA.
Richard A ForsheeOffice of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, US FDA, Silver Spring, MD, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Benefit-risk assessment (BRA) plays a vital role in the development and approval of drugs and biologics, including vaccines. The U.S. Food and Drug Administration recently published the final guidance "Benefit-Risk Assessment for New Drugs and Biological Products", which presents a structured framework for evaluating the benefit-risk (BR) of drugs and biological products and encourages the use of quantitative BR analysis (qBRA) to support complex decision-making. Unique challenges arise when assessing the BR of prophylactic vaccines, including the extrapolation of clinical trial data to real-world outcomes. To address these challenges, qBRA has been used to assist in some cases of decision-making related to vaccines. This article explores key steps and considerations for the qBRA of vaccines within the FDA BR framework. We explore the processes of "Framing the Research Question and Scope," "Identifying Key Benefit and Risk Endpoints," "Selecting the Quantitative Approach and Characterization of Uncertainties," "Gathering Data and Establishing qBRA Model Assumptions," and "Interpreting and Communicating the BRA Results," highlighting major considerations for each step. By carefully considering these processes and their challenges, we aim to help develop qBRAs that effectively inform decisions, ensuring that the benefits of authorized and licensed vaccines outweigh their risks.

Identifiers

PMID41644572
PMCPMC13083997

What OpenQuestion holds

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LicenceCC BY
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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.