Vaccine Efficacy and Disease Burden Evaluation

A special issue of Vaccines (ISSN 2076-393X). This special issue belongs to the section "Epidemiology and Vaccination".

Deadline for manuscript submissions: 31 August 2026 | Viewed by 4164

Special Issue Editor


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Guest Editor
Beijing Center for Disease Prevention and Control, School of Public Health, Capital Medical University, Beijing, China
Interests: early warning and evaluation of the prevention and control strategy for infectious diseases

Special Issue Information

Dear Colleagues,

Vaccines represent one of the most significant public health interventions for the prevention of infectious diseases. However, their success relies on rigorous evaluations of vaccine efficacy and effectiveness (VE), as well as accurate assessments of disease burden.VE varies by population, context, and pathogen mutations, while disease burden—encompassing incidence, mortality, and economic and societal impacts—guides vaccine prioritization and resource allocation.

We are pleased to invite you to contribute to this Special Issue, entitled “Vaccine Efficacy and Disease Burden Evaluation”. This Special Issue aims to collate high-quality research that advances methodologies and provides insights into VE evaluation and disease burden estimation.

For this Special Issue, original research articles and reviews are welcome to be submitted. Topics of interest include, but are not limited to, the following: research on vaccine efficacy, effectiveness, and safety across populations; studies on immunity persistence and correlates of protection; quantification of disease burden for vaccine-preventable diseases; impact assessments of vaccination programs; and methodological innovations.

We look forward to receiving your contributions.

Dr. Xiaoli Wang
Guest Editor

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Keywords

  • vaccine efficacy
  • vaccine effectiveness
  • disease burden
  • vaccination programs
  • immunogenicity

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Published Papers (4 papers)

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Research

14 pages, 255 KB  
Article
Safety of Sabin-Strain Inactivated Poliovirus Vaccine Administered Alone or Concomitantly with Other Vaccines: A Population-Based Post-Marketing Surveillance Study
by Lin Chang, Yuxi Liu, Yuan Ren, Jing Li, Xing Fang and Yurong Li
Vaccines 2026, 14(3), 241; https://doi.org/10.3390/vaccines14030241 - 6 Mar 2026
Viewed by 801
Abstract
Background/Objectives: Sabin-strain inactivated poliovirus vaccine has been increasingly incorporated into routine immunization programs as part of the global strategy to eradicate poliomyelitis. As childhood immunization schedules become more complex, concerns persist regarding the safety of concomitant vaccination. Although randomized controlled trials and [...] Read more.
Background/Objectives: Sabin-strain inactivated poliovirus vaccine has been increasingly incorporated into routine immunization programs as part of the global strategy to eradicate poliomyelitis. As childhood immunization schedules become more complex, concerns persist regarding the safety of concomitant vaccination. Although randomized controlled trials and regional surveillance studies have demonstrated acceptable safety profiles, additional population-based real-world evidence remains valuable for evaluating the safety of sIPV administered concomitantly with other vaccines under routine programmatic conditions. Methods: A retrospective observational study was conducted using vaccination records and adverse events following immunization surveillance data collected in Liaoning Province, China, between 1 January 2022 and 30 June 2025. All reported adverse events following immunization following Sabin-strain inactivated poliovirus vaccine administration were extracted from the Chinese National AEFI Surveillance System. The reporting rates were calculated per 100,000 administered doses. Multivariable Poisson regression models with robust variance estimation were used to estimate adjusted rate ratios and 95% confidence intervals comparing standalone and concomitant sIPV administration, adjusting for sex, age in months, dose number, and city. Interaction analyses between vaccination mode and dose number were additionally performed. Results: A total of 205,576 sIPV doses were administered, including 144,724 doses administered alone and 60,852 doses administered concomitantly with other vaccines. Fifty-six adverse events following immunization were reported, corresponding to an overall reporting rate of 27.24 per 100,000 doses. Most reported adverse events following immunization were general reactions (91.07%), and all occurred within seven days after vaccination. The reporting rates for sIPV administered alone and concomitantly were 26.26 and 29.58 per 100,000 doses, respectively, with no significant difference between groups (p = 0.7869). After adjustment, concomitant sIPV administration was not associated with an increased risk of adverse events following immunization compared with standalone administration (adjusted rate ratios = 1.13, 95% confidence intervals: 0.59–2.16). No significant interaction between vaccination mode and dose number was identified. Conclusions: Sabin-strain inactivated poliovirus vaccine demonstrated a favorable safety profile when administered either alone or concomitantly with other vaccines. These findings support the continued use of flexible and synchronized vaccination strategies involving Sabin-strain inactivated poliovirus vaccine in routine immunization programs. Full article
(This article belongs to the Special Issue Vaccine Efficacy and Disease Burden Evaluation)
14 pages, 248 KB  
Article
Safety of an SV-1 Cell Line-Based Varicella Vaccine Before and After Integration into the Expanded Program on Immunization: A Real-World Study in Jiangsu Province, China
by Jing Yu, Yurong Li, Zhiguo Wang, Xiang Sun, Guodong Kang, Borong Xu, Yuanyuan Zhu, Xun Li, Xiaozhe Song, Yonghong Sun, Dongsheng Liu, Yuan Ren, Xueyan Sha and Ran Hu
Vaccines 2026, 14(3), 200; https://doi.org/10.3390/vaccines14030200 - 24 Feb 2026
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Abstract
Background/Objectives: Varicella is a highly contagious childhood disease that may cause severe complications in susceptible populations. The SV-1 cell line-based varicella vaccine (VarV [SV-1]) has been increasingly used in routine immunization; however, safety and reporting patterns during the transition from partial use [...] Read more.
Background/Objectives: Varicella is a highly contagious childhood disease that may cause severe complications in susceptible populations. The SV-1 cell line-based varicella vaccine (VarV [SV-1]) has been increasingly used in routine immunization; however, safety and reporting patterns during the transition from partial use to full Expanded Program on Immunization (EPI) implementation remain poorly characterized. This study aimed to evaluate the safety profile and reporting dynamics of VarV (SV-1) before and after its incorporation into the Expanded Program on Immunization in Jiangsu Province, China. Methods: A retrospective observational study was conducted using data from the Jiangsu Provincial Immunization Integrated Service Management Information System and the Chinese National Adverse Event Following Immunization (AEFI) Information System (CNAEFIS), including all reported AEFI following VarV (SV-1) vaccination among children under 6 years of age during 2021–2023. Temporal trends, distribution characteristics, and factors associated with AEFI reporting were assessed using descriptive analyses, negative binomial (NB) regression models, and interrupted time series (ITS) analysis. Results: A total of 1,208,500 doses of VarV (SV-1) were administered, and 634 AEFI cases were reported, corresponding to an overall reporting rate of 52.46 per 100,000 doses. Most reported events were mild, self-limiting common reactions, predominantly pyrexia and injection-site reactions. No serious adverse events were identified. Although no immediate level change was observed at EPI implementation, a significant increasing post-EPI trend was detected, consistent with enhanced surveillance sensitivity rather than a change in intrinsic vaccine safety. Abnormal reactions were rare and resolved without sequelae. Conclusions: AEFI reporting rates following VarV (SV-1) vaccination in Jiangsu Province were within expected ranges, predominantly mild and reversible. Findings support the favorable safety profile of the VarV (SV-1) in routine childhood immunization programs and provide real-world evidence to support continued implementation of the two-dose varicella vaccination strategy within the EPI. Full article
(This article belongs to the Special Issue Vaccine Efficacy and Disease Burden Evaluation)
10 pages, 368 KB  
Article
Rotavirus Vaccine Coverage and Surveillance of Adverse Events Following Immunization in a Birth Cohort of Children (2017–2023) in Suzhou, China
by Jinling Gao, Kunpeng Zhu, Lin Luan, Benfeng Zheng, Juan Xu, Yiheng Zhu, Xianquan Fan, Haitao Wang and Na Liu
Vaccines 2026, 14(2), 139; https://doi.org/10.3390/vaccines14020139 - 29 Jan 2026
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Abstract
Objectives: To analyze the changes in the proportion of the rotavirus vaccine among children born in the 2017–2023 cohort and to assess the current status of rotavirus vaccination coverage in Suzhou, China. To monitor adverse events following immunization (AEFIs) so as to [...] Read more.
Objectives: To analyze the changes in the proportion of the rotavirus vaccine among children born in the 2017–2023 cohort and to assess the current status of rotavirus vaccination coverage in Suzhou, China. To monitor adverse events following immunization (AEFIs) so as to provide data for scientific guidance regarding the rotavirus vaccine. Methods: The basic information of children born between 1 January 2017 and 31 December 2023 in Suzhou and information regarding rotavirus vaccination were collected through the child module of Jiangsu Province Vaccination Integrated Service Management Information System. Information on AEFI case reports was collected from the AEFI monitoring system of the China Information System for Disease Control and Prevention. Descriptive epidemiological methods were used to analyze the rotavirus vaccine characteristics and AEFI classification, and the Mann–Whitney U test was used for comparative analysis. Results: The proportion of children born in the 2017–2023 cohort who received the first dose of the rotavirus vaccine was 14.65%. The reassortant rotavirus vaccine, live, oral, pentavalent (RV5) proportion gradually increased, and the vaccine proportion of children in the 2023 birth cohort reached the highest. The peak age for rotavirus vaccination was between 2 and 8 months. A total of 49,507 children (99.88%) received the first dose of RV5 at the age of 6–12 weeks in this birth cohort, and there was a statistically significant difference in the median duration of the first dose of RV5 among children of different age groups (p < 0.001). A total of 89 cases of AEFIs were reported, and the reported incidence of AEFIs was 3.47/10,000 doses. Among them, 86 cases of general reactions were reported, with a reported incidence of 3.35/10,000 doses, and three cases of abnormal reactions were reported, with a reported incidence of 0.12/10,000 doses. Conclusions: The rotavirus vaccine proportion of children born in Suzhou from 2017 to 2023 was not high. The incidence of AEFI reports from the rotavirus vaccine is relatively low, indicating a favorable safety profile. Efforts should prioritize strengthening health education on rotavirus gastroenteritis to enhance public confidence in vaccination, thereby ensuring the effective prevention and control of rotavirus gastroenteritis. Full article
(This article belongs to the Special Issue Vaccine Efficacy and Disease Burden Evaluation)
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16 pages, 3126 KB  
Article
Cost-Effectiveness Analysis of a Bivalent Vaccine for Hand, Foot, and Mouth Disease: A Simulation-Based Study in Beijing, China
by Mengyao Li, Ying Shen, Yonghong Liu, Hui Yao, Zhuowei Luo, Da Huo, Xiang Xu, Wenhui Zhu, Shuaibing Dong, Lei Jia, Renqing Li, Bingyi Yang and Xiaoli Wang
Vaccines 2026, 14(1), 91; https://doi.org/10.3390/vaccines14010091 - 17 Jan 2026
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Abstract
Background: Hand, foot, and mouth disease (HFMD) remains a major public-health concern in China. While the monovalent EV-A71 vaccine has effectively reduced EV-A71–associated cases, it offers no protection against CV-A16. The introduction of a bivalent EV-A71/CV-A16 vaccine may offer broader protection, but its [...] Read more.
Background: Hand, foot, and mouth disease (HFMD) remains a major public-health concern in China. While the monovalent EV-A71 vaccine has effectively reduced EV-A71–associated cases, it offers no protection against CV-A16. The introduction of a bivalent EV-A71/CV-A16 vaccine may offer broader protection, but its economic viability under different immunization strategies remains uncertain. Methods: We developed a dynamic transmission model integrated with cost-effectiveness analysis to assess the epidemiological and economic impact of a hypothetical bivalent EV-A71/CV-A16 vaccine in China. Based on the immunization program policy, seven vaccination strategies, vaccine effectiveness (VE) levels ranging from 50–95% against EV-A71/CV-A16, and coverage levels from 0–95% were evaluated. The threshold vaccine price (TVP) was derived based on incremental cost-effectiveness ratio (ICER) calculations. Cost-effectiveness was assessed using willingness-to-pay (WTP) thresholds defined as 1–3 times the gross domestic product (GDP) per capita. Results: The mean cost of two doses of the monovalent EV-A71 vaccine was USD133.0 (95% CI: 126.9–139.1). Strategy 2, which targeted individuals unvaccinated with the monovalent EV-A71 vaccine, demonstrated the most favorable cost-effectiveness. At 45% coverage and 85% vaccine effectiveness, the estimated threshold price per dose was USD 107.7 (95% CI: 103.4–112.0), with threshold vaccine prices increasing as coverage declined. When vaccination coverage exceeded 80%, the threshold vaccine price decreased substantially, falling below USD 45.9 (95% CI: 43.5–48.3) per dose. Conclusions: Large-scale inclusion in the national immunization program may not be economically justified at current cost levels. Targeted voluntary vaccination of unvaccinated, susceptible populations represents a more cost-effective and practical strategy during the early stage of vaccine introduction. Full article
(This article belongs to the Special Issue Vaccine Efficacy and Disease Burden Evaluation)
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