JYNNEOS (live modified vaccinia virus ankara) / Bavarian Nordic - LARVOL DELTA

Mpox vaccination in Belgium: clinical guidance for implementation readiness. (PubMed, Acta Clin Belg) - "This review synthesises evidence on MVA-BN vaccine effectiveness, safety and durability to guide Belgian clinical practice...Despite antibody waning, memory responses support durable protection against hospitalisation. Post-exposure prophylaxis is ideally given within four days, though administration up to 14 days may attenuate severity."

Journal • Review • Atopic Dermatitis • Cardiovascular • Dermatitis • Dermatology • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammation

SMART: Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster RCT (clinicaltrials.gov) - P4 | N=3000 | Active, not recruiting | Sponsor: McMaster University | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease

Cross-reactive immunity against orthopoxviruses after monkeypox virus infection or smallpox vaccination. (PubMed, Int J Infect Dis) - "MPV infection and smallpox vaccination might confer OPXV cross-protection. IgA may support early mpox diagnosis, particularly in asymptomatic high-risk individuals. Complement-dependent neutralization assay may improve assessment of cross-immunity."

Journal • Infectious Disease

Bavarian Nordic A/S…announced today that the European Commission has adopted the recent Committee for Medicinal Products for Human Use (CHMP) positive opinion recommending the approval of a type II variation for IMVANEX (MVA-BN) smallpox and mpox vaccine, extending the current marketing authorization to include children 2 to less than 12 years of age. (GlobeNewswire) - "The approval is based on data from a Phase 2 clinical study (NCT06549530) involving 227 children aged 2 to <12 years and 224 adults, demonstrating non-inferior immune responses and a similar safety profile in children compared to adults following vaccination with two standard doses of MVA-BN."

CHMP • Infectious Disease

Two-year durability of MVA-BN vaccine-induced antibodies and the risk of Mpox breakthrough infections among high-risk populations: a prospective, longitudinal study. (PubMed, Clin Microbiol Infect) - "Humoral immunity following two-dose MVA-BN vaccination wanes over time, particularly among individuals without prior smallpox vaccination, whereas natural Mpox infection is associated with more durable MPXV-specific IgG responses. Breakthrough infections may occur more than two years after vaccination despite generally attenuated disease. These findings highlight the need for continued surveillance, consideration of booster vaccination strategies, and further investigation into immune correlates of protection against Mpox."

Journal • Observational data • Human Immunodeficiency Virus • Infectious Disease

Vaccine safety surveillance during an mpox outbreak, Germany, June 2022 to February 2024. (PubMed, Euro Surveill) - "The overall adverse event reporting rate adjusted for missing information on vaccine utilisation in one of 16 federal states was 98.7 adverse events per 100,000 doses.CONCLUSIONThe safety profile of the MVA-BN vaccine was in line with the summary of product characteristics. No new safety signals were identified."

Journal • Infectious Disease

The Evolving Landscape of Monkeypox: From Endemic Pathogen to Global Threat. (PubMed, Vector Borne Zoonotic Dis) - "The continued reemergence of mpox underscores the necessity for an integrated "One Health" approach to surveillance and pandemic preparedness. Future research must prioritize environmental wildlife monitoring, genomic surveillance of emerging clades, and the development of multi-epitope vaccines to effectively mitigate both zoonotic spillover and human transmission."

Journal • Review • Infectious Disease

Safety, immunogenicity, efficacy, and effectiveness of mpox vaccines in pregnant persons, children, and adolescents: a protocol for a living systematic review and meta-analysis. (PubMed, Syst Rev) - "This LSR will synthesize evidence on mpox vaccines across populations, with particular focus on pregnant persons, children, and adolescents. As mpox continues to pose a global threat, particularly in endemic and low-resource settings, timely and rigorous assessment of vaccine performance is essential to guide equitable immunization policies and maternal-child health strategies."

Clinical • Journal • Retrospective data • Infectious Disease

Who got vaccinated for mpox? A cross-sectional survey on behavioral correlates of vaccine uptake among men who have sex with men attending an STI/HIV reference center in Rome, Italy. (PubMed, BMC Infect Dis) - "Among MSM participants in our survey, mpox vaccination uptake was reported by only about one quarter of the individuals. Uptake was independently and positively associated with both chemsex and HIV-PrEP use, with HIV-PrEP showing the strongest association. Overall uptake remains suboptimal, highlighting persistent gaps in mpox vaccination coverage among individuals at higher risk. This underscores the need to reinforce integrated combination-prevention pathways in HIV/STI services, also in the context of HIV PrEP continuum."

Journal • Erectile Dysfunction • Human Immunodeficiency Virus • Infectious Disease

Mpox Disease Severity Reduced in Intradermally MVA-BN Vaccinated Compared to Unvaccinated Patients in Sweden: A Retrospective 2024-2025 Observational Case-series. (PubMed, Open Forum Infect Dis) - "Dose-sparing intradermal MVA-BN vaccination is associated with sustained reduction in mpox severity for up to 3 years. Continued vaccination of high-risk populations is supported, while prospective studies are needed to clarify long-term protection and optimize vaccination strategies."

Journal • Retrospective data • Human Immunodeficiency Virus • Infectious Disease • Pain

Neutralising antibody responses to MPXV clades Ia, Ib, and IIb after infection or vaccination: a multicountry observational study. (PubMed, Lancet Infect Dis) - "Humoral immunity elicited by historical or contemporary smallpox vaccination was associated with little neutralising activity across MPXV clades. Of note, previous MPXV clade IIb infection induced cross-reactive antibody binding but low-magnitude neutralising activity against clade Ib. Although additional immune mechanisms could contribute to protection, these findings highlight important constraints in antibody-mediated cross-clade immunity and emphasise the need for vaccines and antibody-based countermeasures that address antigenic divergence among orthopoxviruses."

Journal • Observational data • Allergy • Immunology • Infectious Disease

Tracking the Trail of Monkeypox: From Origins to Outbreak Control. (PubMed, Cell Biochem Funct) - "Furthermore, it examines current challenges in disease detection and control and identifies opportunities to strengthen surveillance, prevention, and treatment strategies. Overall, this article aims to serve as a consolidated resource on MPXV, highlighting its epidemiology, clinical significance, and implications for global public health preparedness."

Journal • Review • Infectious Disease

Summary of the National Advisory Committee on Immunization (NACI) rapid response: Updated guidance on the use of Imvamune® for the prevention of mpox. (PubMed, Can Commun Dis Rep) - "NACI now recommends that in addition to previously identified groups at high risk of mpox, certain travellers to areas with ongoing community transmission of mpox virus clade I should receive Imvamune. Healthcare workers travelling internationally to support mpox outbreaks should also receive Imvamune, and domestic healthcare workers with a high risk of frequent exposure may consider vaccination with Imvamune on an individual basis."

Journal

Rethinking mpox: epidemiology, clinical variants, diagnosis, and response. (PubMed, Osong Public Health Res Perspect) - "It also assesses diagnostic approaches, including molecular and point-of-care techniques, and evaluates the efficacy and limitations of current and emerging vaccines, such as JYNNEOS and ACAM2000. Future priorities include improving global surveillance, refining case definitions, expanding diagnostic access, and ensuring equitable vaccine distribution. Understanding the expanding clinical and epidemiological profile of mpox is essential for timely diagnosis, containment, and preparedness against future outbreaks."

Journal • Infectious Disease

Vaccination to prevent Mpox Infection (MPOX-VAX Study) (clinicaltrialsregister.eu) - P4 | N=218 | Active, not recruiting | Sponsor: University College Dublin | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease

A comparison of two- and three-dose MVA-BN mpox vaccination series on anti-monkeypox virus immunity. (PubMed, NPJ Vaccines) - "Furthermore, we found that boosting with a third dose of MVA-BN increases IgG avidity against certain MPXV antigens, as part of a booster-specific seroprofile. These findings provide critical insights into optimizing immune responses through MVA-BN boosters, presenting a potential approach to addressing the limited MPXV-specific immunity observed following the primary series."

Journal • Infectious Disease

High-throughput multiplex immunoassay for the detection of mpox and MVA-BN vaccination up to 2 years after exposure in Belgium: a retrospective diagnostic accuracy study. (PubMed, Lancet Microbe) - "The assay shows high sensitivity and specificity for detecting previous mpox infection in unvaccinated individuals, with reliable performance up to 2 years after infection. Strong concordance with neutralising antibody titres supports the assay's potential for monitoring long-term infection and vaccine-induced immunity. However, previous vaccination status should be considered when interpreting results."

Journal • Retrospective data • Infectious Disease

JYNNEOS Smallpox Vaccine in Adult Healthcare Personnel at Risk for Mpox in the Democratic Republic of the Congo (clinicaltrials.gov) - P3 | N=1600 | Completed | Sponsor: Centers for Disease Control and Prevention | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease

Both Smallpox and Mpox Vaccine Reduce Mpox Disease Severity and Symptoms. (PubMed, Open Forum Infect Dis) - "Both incomplete and complete vaccine courses including smallpox vaccination during childhood appear to reduce Mpox disease severity and symptoms. In settings of limited vaccine resources, unvaccinated risk groups should be prioritized."

Journal • Human Immunodeficiency Virus • Infectious Disease • Pain • CD4

Comparability Trial of the MVA-BN Vaccine Manufactured in Different Production Cells (clinicaltrials.gov) - P2 | N=970 | Active, not recruiting | Sponsor: Bavarian Nordic | Recruiting ➔ Active, not recruiting | N=744 ➔ 970

Enrollment change • Enrollment closed • Infectious Disease

Study to Assess the Safety and Immunogenicity of TPOXX® When Administered Orally for 28 Days With JYNNEOS (clinicaltrials.gov) - P2 | N=100 | Active, not recruiting | Sponsor: SIGA Technologies | Trial completion date: Jan 2026 ➔ Jan 2027 | Trial primary completion date: Jan 2026 ➔ Jan 2027

Trial completion date • Trial primary completion date

Mpox and the one health approach. (PubMed, Dialogues Health) - "Vaccine effectiveness of JYNNEOS varies by population and dosing regimen, while randomized trials (PALM007, STOMP) have not demonstrated statistically significant clinical benefit of tecovirimat on primary endpoints. Environmental surveillance and genomic sequencing remain critical to tracking transmission dynamics. Even amid sustained human-to-human transmission, integrated One Health strategies-linking human, animal, and environmental surveillance are essential for outbreak containment, equitable vaccine deployment, and long-term prevention."

Journal • Review • Pediatrics

Safety of MVA-BN vaccine in health-care personnel in DR Congo: a prospective cohort study. (PubMed, Lancet Infect Dis) - P3 | "This study adds to the growing body of literature on the safety of MVA-BN in different populations. Although limited by incomplete grading of specific adverse events, low numbers of pregnant participants, and differences in health-care access and infrastructure, the data from this cohort in DR Congo do show good safety outcomes for up to 2 years with both liquid and lyophilised vaccine formulations. Because MVA-BN vaccination campaigns are crucial to clade I and clade II mpox outbreak responses, the data from this study supporting safety of MVA-BN in this population are key to build vaccine confidence."

Journal

Immunogenicity and safety of MVA-BN vaccine administered 5 years after a two-dose primary series in DR Congo: a prospective cohort study. (PubMed, Lancet Infect Dis) - "These data show that primary MVA-BN vaccination induces sustained immunological memory up to 5 years after vaccination and that a booster dose strongly enhances circulating antibody levels and durability. Future studies should clarify the role of circulating antibody concentrations as a correlate of protection from monkeypox virus infection."

Journal • Infectious Disease

Maternal and Pediatric Use of Vaccines for Mpox: A Living Systematic Review and Meta-analysis of Safety and Effectiveness. (PubMed, Drug Saf) - "Vaccinia-based vaccines appear generally safe in pregnancy and children. However, evidence on the safety and effectiveness of third-generation mpox vaccines is still scarce. High-quality prospective studies and strengthened pharmacovigilance are urgently needed to inform policy and clinical decision making."

Journal • Retrospective data • Review • Infectious Disease • Pediatrics