Jul 2026· Frontiers in Public Health· Vol 14· 0 citations· 33 references
Medicine
TL;DR
Yisheng Jun’an® rabies vaccine exhibits a favorable safety profile with mild-to-moderate reactions, support its use in post-exposure prophylaxis, supporting its use in post-exposure prophylaxis.
Abstract
Background and objective To evaluate the safety profile of Yisheng Jun’an® freeze-dried human rabies vaccine (Vero cell) through post-marketing surveillance in China (2020–2024), focusing on adverse reaction patterns and influencing factors. Methods A retrospective observational study analyzed 2,419 adverse events from the national Direct Adverse Event Reporting System (DAERS) and manufacturer-collected data. Adverse reactions were categorized by type, severity, and subgroup (age, gender, dose number, etc.) using the Medical Dictionary for Regulatory Activities (MedDRA) for standardized coding. Analysis of incidence rates with 95% confidence intervals, use of the chi-square test to assess associations, and cross-subgroup comparisons were conducted to elucidate the safety profile of the vaccine. Results In total, 2,419 AEs were reported, yielding an overall incidence of 7.406 per 100,000 doses (95% CI 7.11–7.71). Systemic reactions comprised 83.38% and local reactions 16.62%. Seventeen serious adverse events (0.70%) occurred; no deaths were reported and all recovered. The most common categories were general disorders/administration-site conditions (83.38%) and immune system disorders (5.70%). AEs were most frequent after the first dose (85.49%) and declined markedly with subsequent doses. Systemic reactions were more common in children (0–10 years: 37.99%). Conclusion Yisheng Jun’an® rabies vaccine exhibits a favorable safety profile with mild-to-moderate reactions, supporting its use in post-exposure prophylaxis.
Background/Objectives: The potential of vaccines to trigger autoimmune diseases (ADs) has been extensively investigated and remains a routine focus of vaccine-safety research. This post-marketing, real-world study compared the risk of ADs between females who received bivalent human papillomavirus (HPV) vaccine (Cecolin) and unvaccinated females. Methods: Eligible females aged 9–45 years registered in the Xiamen Health and Medical Big Data Center from September 2020 to December 2023 (post-Cecolin period) were enrolled. Cecolin recipients constituted the exposed cohort, and a matched unexposed cohort was generated in a 1:4 ratio based on age and calendar year. Case validation was conducted to determine optimal identification algorithms. Incidence rates (IRs) were calculated and incidence rate ratios (IRRs) with 95% confidence intervals (CIs) were derived from zero-inflated Poisson regression. Results: Overall incidence of ADs was 70.63 per 100,000 person-years (95% CI: 67.59–73.77) in the post-Cecolin period. Compared with matched unexposed cohorts, vaccinated females showed a significantly lower AD risk in both contemporaneously matched (IRR = 0.23, 95% CI: 0.08–0.65; p = 0.006) and historically matched (IRR = 0.21, 95% CI: 0.07–0.66; p = 0.008) analyses. Conclusions: Consistent with prior evidence, this study provides real-world evidence further confirming that Cecolin vaccination does not increase the risk of ADs. It adds the first large-scale post-marketing safety evidence for this Chinese domestic bivalent HPV vaccine, filling a critical evidence gap. These results may inform vaccination policy and guide post-licensure safety monitoring in China and other countries that have introduced this vaccine.
ABSTRACT Safety data on human papillomavirus (HPV) vaccination in the Japanese population remain limited owing to the lack of healthcare databases available for vaccine safety assessment. In this study, we assessed the risk of adverse events of special interest (AESIs) following HPV vaccination among females aged 12–26 y using medical claims data linked to routine or catch-up vaccination records provided by municipalities. We conducted a population-based cohort study and self-controlled case series (SCCS) from April 2015 to March 2023 for bivalent/quadrivalent vaccines and from April 2023 to March 2024 for the 9-valent vaccine. All females eligible for the vaccination program were included in the cohort study, whereas only those who experienced AESIs were included in the SCCS. The observation period was classified according to vaccination status as unvaccinated and post-vaccination risk periods following the first, second, and third doses. Adjusted rate ratios with 95% confidence intervals were estimated for the cohort and SCCS. In the bivalent/quadrivalent vaccines analysis cohort (25131 females), 1763, 1492, and 975 received the first, second, and third doses, respectively. In the 9-valent vaccine analysis cohort (38970 females), 3931, 2389, and 934 received the first, second, and third doses, respectively. Rates of 54 AESIs were calculated during unvaccinated periods. AESIs with feasible quantitative analyses for either the bivalent/quadrivalent or 9-valent vaccines included migraine, hypotension, asthma, polycystic ovary syndrome, postural orthostatic tachycardia syndrome, hypothyroidism, hyperthyroidism, and epilepsy. No statistically significant increased risk following HPV vaccination was observed for these AESIs. Larger datasets are needed to assess rarer AESIs.
C. Ishiguro, Hiroya Morita, W. Mimura et al.· Human Vaccines & Immunothera...· 0 citations
ABSTRACT Based on the Chinese National Adverse Events Following Immunization Surveillance Information System (CNAEFIS), a descriptive epidemiological analysis was conducted on Adverse Events Following Immunization (AEFI) of National Immunization Program (NIP) vaccines in Shenyang from 2009 to 2024, to understand the distribution characteristics and reporting status of AEFI using passive surveillance data in the region. Reaction types were classified according to national unified surveillance standards. Descriptive epidemiological analysis was carried out from temporal, regional, demographic and vaccine-specific distributions, and AEFI reporting rate was calculated. From 2009 to 2024, a total of 3,420 cases of AEFI associated with NIP vaccines were reported, with an annual average reporting rate of 15.8 per 100,000 doses. Among these, the reporting rate of common vaccine reactions was 14.87 per 100,000, and that of rare vaccine reactions was 0.54 per 100,000. Differences in reporting rates between districts were statistically significant (χ2 = 618.9, p < .05). Most reported events were common reactions, and rare reactions were infrequently reported. There were obvious regional disparities in AEFI surveillance performance. Surveillance training and management should be further strengthened in low-reporting districts to reduce regional gaps and improve overall reporting performance.
Nina Jia, Wei-Wen Zhong, Dongmei Gao et al.· Human Vaccines & Immunothera...· 0 citations
REGISTRATION
Per Pfizer's policies on studies of Pfizer products, this study was posted on clinicaltrials.gov prior to analyses (NCT06923137).
OBJECTIVE
To assess COVID-19 burden of disease, KP.2-adapted BNT162b2 COVID-19 vaccine uptake (2024-2025 formula), and vaccine effectiveness for children less than 5, 5-11, and 12-17 years of age.
STUDY DESIGN
This retrospective cohort study used linked claims and vaccine registry data from California and Louisiana from August 22, 2024, to March 31, 2025. Inclusion criteria limited the sample to children without documented immunocompromised status and with complete demographic data. Vaccination status was treated as a time-varying exposure. The primary outcome was the composite of medically attended COVID-19 encounters in the emergency department (ED), urgent care (UC), or inpatient setting derived from administrative claims data. Analyses included incidence rates and, when possible, adjusted hazard ratios using Cox models.
RESULTS
Among 2.6 million children aged less than 18 years who met inclusion criteria, approximately 2% received a single dose of the KP.2-adapted BNT162b2 COVID-19 vaccine. Median follow-up was 7.4 months. Vaccinated children were more likely to reside in California, have commercial insurance, and prior COVID-19 or influenza vaccination. Across age groups, the prevalence of underlying medical conditions was higher in children with medically attended COVID-19 (ED, UC, or inpatient setting). Vaccination was associated with significantly lower rates of medically-attended COVID-19 across all age strata, with an associated 43% vaccine effectiveness pooled across all children aged less than 18 years (95% CI: 10-64).
CONCLUSION
KP.2-adapted BNT162b2 COVID-19 vaccine provided significant protection against emergency department, urgent care, and inpatient encounters for COVID-19 in children.
K. Andersen, Tara Ahi, Maria D. McColgan et al.· Jornal de Pediatria· 0 citations
INTRODUCTION
Enterovirus 71 (EV-A71) is a principal cause of hand, foot, and mouth disease (HFMD), potentially leading to severe neurological complications in children. Inactivated EV-A71 vaccines have been introduced. This study compares the immunogenicity, safety, and efficacy of EV-A71 vaccines versus placebo in pediatric populations.
RESEARCH DESIGN AND METHODS
Following a PROSPERO-registered protocol, RCTs involving EV-A71 in children were identified via PubMed, Scopus, Cochrane, and ClinicalTrials.gov. Two independent reviewers performed screening, extraction, and RoB assessments (RoB 2.0).
RESULTS
Five phase III RCTs involving 36,659 children were included. EV-A71 vaccination significantly increased seropositivity across follow-up periods, including early (RR 5.8), medium-term (RR 3.09), and long-term (RR 2.95) response. Seroconversion was significantly higher in the vaccinated group (pooled RR 13.04, 95% CI 2.80-60.61; p < 0.001). Geometric mean titers, analyzed using the ratio of means approach, were significantly higher in the vaccinated group during early and medium-term follow-up. Vaccine efficacy against EV-A71-associated HFMD exceeded 98% (pooled RR 0.02, 95% CI 0.01-0.09; p = 0.0028; I2 = 50%). Solicited local and systemic adverse events were mild and comparable between groups.
CONCLUSION
Inactivated EV-A71 vaccines robust immunogenicity, high clinical efficacy, and an acceptable safety profile in children. Future studies should explore long-term protection, booster schedules, and multivalent formulations against non-EV-A71 serotypes.
Muhammad Gilang Dwi Putra, Rodman Tarigan Girsang, Rais Amaral Haq et al.· Expert Review of Vaccines· 0 citations
Objectives
To describe the distribution and characteristics of adverse events following immunization (AEFI) using a large US pharmacovigilance database.
Methods
A retrospective descriptive analysis of Individual Case Safety Reports (ICSRs) from the FDA AEMS database (January 2017-March 2026) was conducted. Reports were analyzed by vaccine type, adverse event terms, demographics, reporting year, and reporter category.
Results
A total of 2 169 603 ICSRs were identified, with 44.0% classified as serious. COVID-19 vaccines accounted for 78.4% of reports, reflecting mass vaccination campaigns. The most frequently reported events were headache (12.8%), pyrexia (11.8%), and fatigue (11.1%), predominantly non-serious and consistent with known reactogenicity profiles. Reporting peaked in 2021 (48.8%). Females accounted for 60.6% of reports. Non-COVID vaccines contributed substantially fewer reports.
Conclusions
Most vaccine-associated adverse events were mild and expected. Findings support a favorable benefit-risk profile and highlight the importance of continuous pharmacovigilance systems for vaccine safety monitoring.
E. Castellana, MR Chiappetta· Hospital Pharmacy· 0 citations