Evidence map›Paper›PMID 39772096›Full record

ArticleVaccines2024

Platform Technology in Global Vaccine Regulation: Development, Applications, and Regulatory Strategies with Insights from China.

Xiaojing Li, Su Jin, Shuyang Guo, Dan Yang, Wenbo Sai, Xiao Qiu, Xin Zhao, Lan Wang, Tao Wang, Min Li

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Vaccines, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. 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

10 authors.

Xiaojing LiCenter for Drug Evaluation, National Medical Products Administration, Zone 2, No. 22 Guangde Street, Beijing Economic and Technological Development Zone, Beijing 100076, China.
Su JinCenter for Drug Evaluation, National Medical Products Administration, Zone 2, No. 22 Guangde Street, Beijing Economic and Technological Development Zone, Beijing 100076, China.
Shuyang GuoCenter for Drug Evaluation, National Medical Products Administration, Zone 2, No. 22 Guangde Street, Beijing Economic and Technological Development Zone, Beijing 100076, China.
Dan YangCenter for Drug Evaluation, National Medical Products Administration, Zone 2, No. 22 Guangde Street, Beijing Economic and Technological Development Zone, Beijing 100076, China.
Wenbo SaiCenter for Drug Evaluation, National Medical Products Administration, Zone 2, No. 22 Guangde Street, Beijing Economic and Technological Development Zone, Beijing 100076, China.
Xiao QiuCenter for Drug Evaluation, National Medical Products Administration, Zone 2, No. 22 Guangde Street, Beijing Economic and Technological Development Zone, Beijing 100076, China.
Xin ZhaoCenter for Drug Evaluation, National Medical Products Administration, Zone 2, No. 22 Guangde Street, Beijing Economic and Technological Development Zone, Beijing 100076, China.
Lan WangState Key Laboratory of Drug Regulatory Science, National Institutes for Food and Drug Control, Beijing 102629, China.
Tao WangCenter for Drug Evaluation, National Medical Products Administration, Zone 2, No. 22 Guangde Street, Beijing Economic and Technological Development Zone, Beijing 100076, China.
Min LiCenter for Drug Evaluation, National Medical Products Administration, Zone 2, No. 22 Guangde Street, Beijing Economic and Technological Development Zone, Beijing 100076, China.

Funding

State Key Laboratory of Drug Regulatory Science Foundation grant 2024SKLDRS0224
6 · The paper itself

Abstract

The concept of "platform technology" gained prominence after the Ebola outbreak and since then has become essential to international vaccine (prophylactic vaccines against infectious disease) regulatory frameworks. Its significance was further amplified during the COVID-19 pandemic, where platform technology enabled the rapid development and approval of vaccines, optimizing regulatory processes, and enhancing global public health responses. As a transformative tool, platform technology streamlines product development, allowing for the reduction in the number of clinical trials or exemption from certain clinical trials and facilitating cross-referencing in regulatory submissions. Despite significant efforts to establish standardized regulatory procedures, challenges remain, particularly in achieving a unified definition and application of platform technology across regions. This paper explores the evolution, applications, and regulatory strategies of platform technology, with a focus on China's experience in this field. China's approach, encompassing risk assessment, and the expedited approval of emergency vaccines, offers valuable insights into global regulatory coordination. By analyzing China's regulatory contributions and international practices, this paper highlights the potential of platform technology to address future pandemics, including "Pathogen X", and underscores the importance of harmonizing global regulatory efforts to strengthen public health preparedness and response.

Indexed as

emergency vaccine approvalplatform technologypublic healthregulatory strategiesvaccine regulation

Identifiers

PMID39772096
PMCPMC11728622

What OpenQuestion holds

Textmetadata
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.