Real-World Evidence for Comprehensive Assessment of Vaccines

Dear Colleagues,

Vaccines are among the most successful and cost-effective public health interventions, yet their evaluation has traditionally centered on a narrow set of metrics—primarily safety, immunogenicity, and direct disease prevention. Recent scholarship increasingly recognizes that the full value of vaccination extends far beyond these immediate health gains, encompassing broader health spillovers, economic productivity, social welfare, and even cognitive benefits such as reduced dementia risk. The World Health Organization has formalized this expanded perspective through the Full Value of Vaccine Assessment (FVVA) framework, which synthesizes evidence on public health need, supply–demand dynamics, market considerations, and multidimensional health, financial, and economic impacts. Real-world evidence (RWE)—derived from electronic health records, immunization registries, administrative claims databases, disease surveillance systems, and pragmatic clinical studies—has emerged as an indispensable complement to RCT data, offering unique insights into vaccine effectiveness, rare adverse events, long-term protection, and broader population-level outcomes .

This Special Issue, titled “Real-World Evidence for Comprehensive Assessment of Vaccines,” is dedicated to advancing the generation, analysis, and translation of real-world evidence to support comprehensive assessment of vaccines across the entire life course. We invite contributions that address the spectrum of RWE applications in vaccinology—from robust observational study designs and statistical methodologies to the integration of RWE into regulatory, policy, and clinical decision-making frameworks.

Our aim is to curate a collection of at least 10 high-quality articles that will serve as a definitive resource on the current state, methodological innovations, and future directions of vaccine RWE, potentially forming a book-length compendium that bridges clinical research, epidemiology, data science, and health policy.

We are pleased to invite you to submit your original research and review articles to our upcoming Special Issue. We seek to foster interdisciplinary dialogue between clinical investigators, epidemiologists, biostatisticians, health economists, and public health practitioners to strengthen the evidence base for vaccine decision-making.

This Special Issue aims to advance the generation, analysis, and translation of real-world evidence to support comprehensive assessment of vaccines across diverse populations and real-world settings. The subject directly relates to the journal's scope by addressing vaccine effectiveness and safety post-licensure, pharmacoepidemiological methodologies, population-level health outcomes, and the integration of evidence into clinical and public health decision-making—all of which are core to the journal's mission of advancing knowledge in vaccine science, infectious disease prevention, and immunization policy. 

Topics of interest include, but are not limited to, the following:

(1) Advanced observational study designs for vaccine effectiveness estimation, including target trial emulation, quasi-experimental approaches, and active comparator designs.

(2) Real-world effectiveness studies across diverse populations, including the elderly, immunocompromised individuals, pregnant women, children, and specific ethnic/racial groups. Clinical trials and real-world effectiveness studies of new and established vaccines.

(3) Strategies to address vaccine hesitancy, acceptance, and confidence across diverse populations.

(4) The impact of vaccination on public health outcomes, including but not limited to disease burden, pandemic preparedness and antimicrobial resistance, etc.

(5) Development of intelligent query systems and retrieval-augmented generation (RAG) frameworks for vaccine information access and decision support.

We look forward to receiving your contributions.

Dr. Da Feng
Dr. Jie Chang
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 250 words) can be sent to the Editorial Office for assessment.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-anonymized peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Vaccines is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2700 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

• vaccination
• vaccine effectiveness
• public health
• real-world evidence (RWE)
• full value of vaccine assessment (FVVA)
• health policy
• diverse population