Evidence map›Paper›PMID 40179521›Full record

ArticleVaccine2025

The global regulatory landscape for combined vaccines: A comparative case study of registration strategies for diphtheria-tetanus-pertussis-containing vaccines.

Xiangchuan He, Yiwen Pu, Zeyu Li, Shitong Huan, Yue Yang

Abstract readComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Vaccine, 2025. 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. 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

5 authors.

Xiangchuan HeSchool of Pharmaceutical Sciences, Tsinghua University, Beijing 100084, China; Key Laboratory of Innovative Drug Research and Evaluation, National Medical Products Administration, Beijing 100084, China; The Scientific and Technological Achievement Transformation Center, Beijing Youan Hospital, Capital Medical University, Beijing, 100069, China.
Yiwen PuSchool of Pharmaceutical Sciences, Tsinghua University, Beijing 100084, China; Key Laboratory of Innovative Drug Research and Evaluation, National Medical Products Administration, Beijing 100084, China.
Zeyu LiSchool of Pharmaceutical Sciences, Tsinghua University, Beijing 100084, China; Key Laboratory of Innovative Drug Research and Evaluation, National Medical Products Administration, Beijing 100084, China.
Shitong HuanChina office, The Bill & Melinda Gates Foundation, Beijing, 100084, China. Electronic address: Shitong.Huan@gatesfoundation.org.
Yue YangSchool of Pharmaceutical Sciences, Tsinghua University, Beijing 100084, China; Key Laboratory of Innovative Drug Research and Evaluation, National Medical Products Administration, Beijing 100084, China. Electronic address: yanghappy@tsinghua.edu.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Diphtheria-tetanus-pertussis-containing vaccines (DTPCVs) represent the forefront of combination vaccine development globally. However, the licensing of high-valent DTPCVs varies worldwide owing to diverse regulatory requirements. Some national regulatory authorities (NRAs) have adopted flexible strategies to fast-track the approval and uptake of critical DTPCVs to address public health needs. This study examined the global regulatory status of combination vaccines, using descriptive and comparative analyses to highlight pivotal registration issues for DTPCVs. Specifically, it sheds light on the regulatory approaches of the Food and Drug Administration (FDA), European Medicines Agency (EMA), National Medical Products Administration (NMPA), and other Asian regulators through a case study of hepatitis B-containing DTPCVs. Drawing on these findings, this study advocates the initiation of regulatory convergence efforts, establishment of practical regulatory strategies, and swift approval and wider adoption of high-valent DTPCVs.

Indexed as

Diphtheria-Tetanus-Pertussis VaccineDrug ApprovalVaccines, CombinedDiphtheriaGlobal HealthHepatitis B VaccinesHumansUnited StatesUnited States Food and Drug AdministrationDiphtheria-Tetanus-Pertussis VaccineHepatitis B VaccinesVaccines, Combined

Identifiers

PMID40179521
PMCPMC12132046

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.