Evidence map›Paper›PMID 42427197›Full record

ArticleJournal of global health2026

Global disparities in regulatory approval of prophylactic vaccines, 2005-2024.

Rizhen Wang, Jing Chen, Yangmu Huang, Ming Xu

Abstract read
In one paragraph

Article in Journal of global health, 2026. 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
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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

4 authors.

Rizhen WangDepartment of Global Health, School of Public Health, Peking University, Beijing, China.
Jing ChenDepartment of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University, Beijing, China.
Yangmu HuangDepartment of Global Health, School of Public Health, Peking University, Beijing, China.
Ming XuDepartment of Global Health, School of Public Health, Peking University, Beijing, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Timely approval of prophylactic vaccines is essential to equitable access, especially in low- and middle-income countries (LMICs) disproportionately affected by vaccine-preventable diseases. In this cross-sectional analysis, we characterised the global landscape of regulatory approvals for new prophylactic vaccines over the past two decades. Methods: We retrieved data from Pharmaprojects for new prophylactic vaccines approved globally from 2005-2024. We quantified approval volume and delay - defined as the number of countries, territories, and areas (CTAs) approving each vaccine, and the time (in days) between global first approval and subsequent national approvals. We conducted an exploratory multivariable linear regression analysis to identify factors potentially associated with approval delays. Results: Of the 416 prophylactic vaccines, 67.8% received approval in only one CTA, and just 12.8% reached more than five CTAs between 2005 and 2024. By 2024, the European region had the highest total number of approvals (n = 2410), while Africa had the fewest (n = 56). Median global approval delay for prophylactic vaccines was 213 days (interquartile range (IQR) = 93.0, 768.8), ranging from 161.0 days (IQR = 84.0, 646.0) in Europe to 705.5 days (IQR = 183.3, 2220.3) in the Western Pacific region. Our multivariable models showed that a lower income level may be associated with longer delay. Other factors, such as the type of vaccine and regulatory designation, were also identified as potential correlates. Conclusions: Disparities in vaccine approval volume and timing persist across regions. Targeted policy actions are needed to strengthen regulatory systems in LMICs and reduce structural barriers to equitable vaccine access globally.

Indexed as

Drug ApprovalGlobal HealthVaccinesCross-Sectional StudiesDeveloping CountriesHumansVaccines

Identifiers

PMID42427197
PMCPMC13351647

What OpenQuestion holds

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LicenceCC BY
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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.