Post-Marketing Safety Surveillance of Autoimmune Diseases Following Bivalent Human Papillomavirus Vaccination in China

A post-marketing surveillance study of a human rabies vaccine in China (2020–2024)

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.

Safety monitoring of bivalent, quadrivalent, and 9-valent human papillomavirus vaccination in Japan: The vaccine effectiveness, networking, and universal safety (VENUS) study

Assessment of the risk of adverse events of special interest following HPV vaccination among females aged 12–26 using medical claims data linked to routine or catch-up vaccination records provided by municipalities found no statistically significant increased risk.

Real-World Effectiveness and Impact of Human Papillomavirus Vaccination in Males: A Comprehensive Review.

BACKGROUND Gender-neutral vaccination (GNV) for human papillomavirus (HPV) has increasingly been implemented worldwide. However, real-world evidence on vaccine effectiveness (VE) in males and the population-level impact of GNV remains heterogeneous. We summarized real-world VE of HPV vaccination in males and the impact of GNV. METHODS A comprehensive review was performed using Embase and PubMed from January 2007 to May 2024, for studies evaluating quadrivalent (4vHPV) or nonavalent (9vHPV) vaccines. Eligible studies assessed VE or GNV impact on HPV infections, precancerous lesions, cancer, or anogenital warts (AGW). Risk of bias was assessed using ROBINS-I and the National Institute of Health quality assessment tool. RESULTS Twenty-one geographically diverse studies were included. Most VE and VI studies demonstrated risk of bias. In males, VE reached up to 100% against oral HPV infection and 41% for penile HPV (4vHPV genotypes), with higher VE among adolescents and those vaccinated before age 23. Among men who have sex with men, VE was higher for penile HPV infection (85%), AGW (55%), and anal infection (60%). CONCLUSIONS Real-world evidence indicates that HPV vaccination substantially reduces anogenital and oral HPV infections and AGW in males. GNV programs further reduce HPV-related disease burden, reinforcing the public health significance of universal HPV vaccination programs worldwide.

Immunogenicity and safety of BNT162b2 vaccine in patients with juvenile immune mediated inflammatory disease.

BACKGROUND COVID-19 vaccines have significantly reduced mortality and are safe for healthy children; however, research in pediatric populations with juvenile immune-mediated inflammatory diseases (IMIDs) is limited. METHODS The Brazilian multicenter longitudinal SAFER-Study evaluates immunogenicity and safety of the BNT162b2/Pfizer vaccine in IMID patients. The juvenile cohort enrolled patients aged 12-17 years between August and December 2021 and compared them with adults under 40 years from the adult cohort. Safety was assessed by monitoring post-vaccination adverse events (AEs), immunogenicity was measured by IgG antibodies against the SARS-CoV-2 spike receptor-binding domain and seroconversion rates. RESULTS A total of 123 participants were included: 86 adolescents and 37 adult controls. In adolescents, local AEs were most frequent; no serious or life-threatening AEs occurred. Significant increases in IgG-S levels were observed after the two doses in both cohorts (p < 0.001). Seroconversion after the second dose reached 97% overall and 100% after the third dose. In juvenile SLE and JIA patients, vaccination did not significantly affect disease activity. CONCLUSION The BNT162b2 vaccine was safe and immunogenic in adolescents with IMIDs, including those with high immunosuppression and comorbidities, showing similar responses to adults. These findings support vaccination in this vulnerable population and contribute to evidence-based recommendations. IMPACT BNT162b2 COVID-19 vaccine demonstrated a favorable safety profile and immunogenicity in adolescents with juvenile immune-mediated inflammatory diseases (IMID), with responses comparable to those observed in adults. Real life data on this population remain limited, and further evidence regarding vaccine safety and immunogenicity is needed. This study represents the first multicenter, longitudinal registry of Brazilian adolescents with IMID receiving BNT162b2. Comprehensive data on the safety and immunogenicity of BNT162b2 in highly immunosuppressed adolescents with IMID and comorbidities are crucial to guide clinical decision-making, mitigate vaccine hesitancy, and enhance vaccination coverage within this vulnerable population.

Missed Opportunities for Human Papillomavirus Vaccine Prescription in French Military Primary Care: A KAP Survey With Scenario-Based Modeling.

Assessing the Risk of Autoimmune Diseases Following Human Papillomavirus Vaccination: A Systematic Review

Background: Human papillomavirus (HPV) vaccination is an effective strategy for preventing HPV-related cancers and infections. Concerns about a possible association between HPV vaccination and autoimmune diseases remain controversial. The aim of this systematic review was to evaluate the current evidence on the relationship between HPV vaccination and the risk of new-onset autoimmune diseases. Methods: A systematic search of PubMed and Embase was conducted in April 2026. Eligible studies assessed autoimmune outcomes following HPV vaccination in humans and included randomized controlled trials, cohort studies, case-control studies, self-controlled case series, cross-sectional studies, and pharmacovigilance analyses. Reviews, case reports, editorials, and animal studies were excluded. The review followed PRISMA 2020 guidelines. Due to methodological heterogeneity, findings were synthesized narratively. Results: Of 530 identified records, 29 studies met the inclusion criteria. Evidence from randomized trials, large cohort studies, and other observational designs involving millions of vaccinated individuals showed no consistent increase in the risk of autoimmune diseases after HPV vaccination. Most studies reported no association with Guillain–Barré syndrome, multiple sclerosis, type 1 diabetes, autoimmune thyroid diseases, inflammatory bowel disease, connective tissue disorders, or other immune-mediated conditions. Although a few studies reported significant associations, these findings were not consistently replicated. Conclusions: Current evidence does not support a consistent association between HPV vaccination and new-onset autoimmune diseases. Available data indicate a favorable safety profile, while continued surveillance remains important for detecting rare adverse events.