Vimkunya (Chikungunya Vaccine, Recombinant) / Emergent Biosolutions, National Institute of Allergy and Infectious Diseases, Bavarian Nordic - LARVOL DELTA

A chikungunya virus-like particle vaccine reduces chikungunya disease in cynomolgus macaques and protection is mediated by antibody transferred from vaccinated humans. (PubMed, NPJ Vaccines) - "VIMKUNYA, a CHIKV virus-like particle (CHIKV VLP) vaccine, was recently approved by regulators in the United States, European Union, and United Kingdom...Animals that received IgG doses resulting in mean reciprocal 80% neutralization titers of 35, well below the predicted protective threshold of ≥100, exhibited improved clinical outcomes compared with CHIKV-infected control animals, suggesting clinical benefits may occur at lower antibody levels. These findings demonstrate immunogenicity and protective efficacy of CHIKV VLP and relevance of neutralizing antibodies in protection, reinforcing its use in humans to protect against chikungunya disease."

Journal • Chikungunya

A multi-country study to test the efficacy, safety, and immunogenicity of a Chikungunya Virus vaccine in adolescents aged 12 to 17 and adults aged 18 and over. The study is designed so that participants receiving the vaccine (active ingredient) or placebo (inactive substance), and the researchers administrating either one, is not aware of what type of vaccine is given. (clinicaltrialsregister.eu) - P3 | N=6144 | Sponsor: Bavarian Nordic A/S

New P3 trial • Chikungunya • Infectious Disease

Travel-Related Challenges of Chikungunya Virus and Vaccination Options. (PubMed, J Epidemiol Glob Health) - "First, VLA1553, trade-named IXCHIQ, is a live-attenuated vaccine with nearly 99% seroprotection; however, it has many safety concerns, including Chikungunya-like illness (CLI), and has recently been paused for use in persons older than 60 years. Second, PXVX0317, trade-named Vimkunya, is a virus-like particle with nearly 98% seroprotection, but it does not cause CLI. Both vaccines are currently recommended for travelers visiting areas with a CDC-declared outbreak."

Journal • Review • Chikungunya • Immunology • Infectious Disease • Rheumatology

New progress in the global expansion and prevention of Chikungunya fever. (PubMed, Acta Trop) - "At the same time, vaccine development reached critical regulatory milestones in 2025: VIMKUNYA® (a virus-like particle vaccine) received regulatory approval in multiple regions, whereas IXCHIQ® (a live attenuated vaccine) faced post-marketing safety concerns leading to suspension in the United States in 2025, still licensed in some other regions, This review provides a comprehensive and up-to-date synthesis of advances in CHIKV virology, viral evolution and vector adaptation, global and China-focused epidemiology, clinical manifestations and chronic sequelae, laboratory diagnostics, therapeutic development, vaccines, and integrated prevention and control strategies. Special emphasis is placed on epidemiological trends, policy updates, and scientific developments reported during 2024-2025. Key research priorities include defining immune correlates of long-term protection, elucidating the mechanisms underlying chronic inflammatory arthritis, improving multiplex..."

Journal • Review • Chikungunya • Immunology • Inflammatory Arthritis • Musculoskeletal Pain • Rheumatology

Vaccination against chikungunya - a systematic review on the immunogenicity, tolerability, and safety of the live-attenuated vaccine (LAV) Ixchiq and the virus like particle (VLP) vaccine Vimkunya. (PubMed, Vaccine) - "In addition to mosquito protection and vector control, two vaccines with a good efficacy profile based on the surrogate marker of seroprotection are now available to prevent chikungunya. While both vaccines showed acceptable tolerability, the safety of vaccines must be continuously assessed based on further data from post-marketing surveillance of the respective populations."

Journal • Review • Chikungunya • Infectious Disease

Chikungunya virus: Current situation and future challenges. (PubMed, Biosaf Health) - "Two vaccines, IXCHIQ® (live-attenuated) and VIMKUNYATM (virus-like particle), have been licensed in Europe and the United States, and multiple candidates including inactivated, subunit, viral-vectored, and messenger ribonucleic acid (mRNA) vaccines are under development. This review summarized current knowledge on CHIKV virology, epidemiology, evolution, vaccines, and vector control, to provide insights for effective management of this re-emerging arboviral threat."

Journal • Review • Chikungunya

Vimkunya - Hope Against Chikungunya: Science, Safety, and Access. (PubMed, WMJ) - No abstract available

Journal • Chikungunya

Age-specific chikungunya outbreak response immunisation strategies in Brazil: a modelling study. (PubMed, EClinicalMedicine) - "Two chikungunya vaccines, Ixchiq and Vimkunya are licensed...If eligibility expands to younger populations, vaccinating 1-11-year age group will have relatively higher efficiency. International Vaccine Institute and Japan Agency for Medical Research and Development."

Journal • Chikungunya • Infectious Disease

Passive transfer of human sera from chikungunya virus virus-like particle vaccine (Vimkunya) recipients fully protects non-human primates from viremia. (PubMed, NPJ Vaccines) - "Data from seroepidemiology studies demonstrated that a neutralizing titer of >1:10 is protective in convalescent persons. The SNA NT80 threshold of 100 selected by US and European regulators to predict protection against CHIKV disease in humans is conservative by a factor of ~4."

Journal • Chikungunya

A chikungunya virus-like particle vaccine reduces chikungunya disease in cynomolgus macaques and protection is mediated by antibody transferred from vaccinated humans. (PubMed, Res Sq) - "VIMKUNYA, a CHIKV virus-like particle (CHIKV VLP) vaccine, was recently approved by regulators in the United States, European Union, and United Kingdom...Despite having IgG doses yielding neutralizing titers below the established predicted protective threshold of ≥ 100, animals fared better than the CHIKV-infected control animals, suggesting clinical benefits may occur at lower antibody levels. These findings demonstrate immunogenicity and protective efficacy of CHIKV VLP and relevance of neutralizing antibodies in protection, reinforcing its use in humans to protect against chikungunya disease."

Journal • Chikungunya

A storm is born: immune activation and pathogenesis in arthritogenic alphavirus infections. (PubMed, Curr Opin Virol) - "Despite recent advances, antiviral treatments remain unavailable, and to date, there is only one vaccine licensed (VIMKUNYA™ in 2025, against CHIKV), underscoring the urgent need for further research. This review explores the complex interplay between host immune responses and viral factors that lead from acute infection to chronic inflammation. Furthermore, it highlights key gaps in understanding viral persistence and immune evasion, and how to predict chronic diseases to improve therapeutic and preventive strategies against arthritogenic alphaviruses."

Journal • Review • Chikungunya • Immunology • Infectious Disease • Inflammation • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Pain • Rheumatology

Chikungunya vaccination for travelers: Practical guidance for clinical decision-making. (PubMed, J Travel Med) - "Knowledge of the profiles and key features of the live attenuated and virus-like particle vaccines will enable healthcare providers to better advise travelers who are considering chikungunya vaccination."

Journal • Chikungunya

Post-authorisation experience and reported adverse events following use of a virus-like particle chikungunya vaccine, United States and Germany, up to August 2025. (PubMed, Euro Surveill) - "A virus-like particle vaccine (CHIKV VLP, VIMKUNYA) is licensed in the United States (US), EU/EEA and the United Kingdom. Up to 31 August 2025, over 12,500 doses were administered in US and Germany; no SAEs in ≥ 65-year-olds were reported. Early post-authorisation data support its favourable safety profile in ≥ 65-year-olds."

Adverse events • Journal • Chikungunya

Acceptance of chikungunya vaccination: a rapid survey in Reunion island during an epidemic. (PubMed, Vaccine) - "During the 2025 chikungunya outbreak in Réunion Island, two vaccines-IXCHIQ (live-attenuated) and VIMKUNYA (virus-like particle)-received European Union authorization; a local campaign began in April 2025 and was temporarily adjusted for older adults after safety concerns...Comorbidities showed no significant association. Financing and implementation context, together with gender differences, were key drivers of uptake at the beginning of 2025 outbreak."

Journal • Chikungunya

A long-term (5 year) follow-up study to evaluate the safety and immune response of healthy participants 12 years of age and older who were vaccinated with a single dose of Vimkunya, and to evaluate the safety and immune response of a booster dose at 3, 4, or 5 years after the initial vaccination. (clinicaltrialsregister.eu) - P3 | N=800 | Sponsor: Bavarian Nordic A/S

New P3 trial • Chikungunya • Infectious Disease

Bavarian Nordic Announces Sale of Priority Review Voucher for USD 160 Million (GlobeNewswire) - "Bavarian Nordic was awarded the PRV in February 2025, following the approval by the U.S. Food and Drug Administration of the chikungunya vaccine, VIMKUNYA for prevention of disease caused by chikungunya virus in people 12 years of age and older. Pursuant to a license agreement assumed upon acquisition of the chikungunya vaccine in 2023, National Institutes of Health (NIH) will receive 20% of the gross proceeds from the sale of the PRV."

Commercial • Chikungunya

A multi-country study to test the safety and effectiveness of a chikungunya virus vaccine in children aged 2 to 11. The study is designed so that neither the participants nor the researchers know who is getting the vaccine and who is getting a placebo (an inactive substance). (clinicaltrialsregister.eu) - P3 | N=720 | Sponsor: Bavarian Nordic A/S

New P3 trial • Chikungunya • Infectious Disease

Vimkunya vaccine approved to prevent disease caused by the chikungunya virus in people 12 years of age and older (GOV.UK) - "The Medicines and Healthcare products Regulatory Agency (MHRA) has today (1 May 2025) approved a vaccine (Vimkunya) used to prevent disease caused by the chikungunya virus in people 12 years of age and older...This vaccine has been approved through the International Recognition Procedure (IRP). The IRP allows the MHRA to take into account the expertise and decision-making of trusted regulatory partners for the benefit of UK patients....As with any medicine, the MHRA will keep the safety and effectiveness of this vaccine under close review."

MHRA approval • Chikungunya

Long-term Follow-up Study to Evaluate Safety and Immunogenicity of PXVX0317 Single or Booster Vaccination (clinicaltrials.gov) - P3 | N=800 | Active, not recruiting | Sponsor: Bavarian Nordic | Recruiting ➔ Active, not recruiting

Enrollment closed • Chikungunya • Infectious Disease

Chikungunya virus virus-like particle vaccine safety and immunogenicity in adolescents and adults in the USA: a phase 3, randomised, double-blind, placebo-controlled trial. (PubMed, Lancet) - P3 | "Vimkunya induces a rapid and robust immune response. These findings support the potential for this vaccine to protect individuals aged 12-64 years from disease caused by chikungunya virus."

Journal • P3 data • Chikungunya • Fatigue • Musculoskeletal Pain • Pain

Chikungunya virus virus-like particle vaccine safety and immunogenicity in adults older than 65 years: a phase 3, randomised, double-blind, placebo-controlled trial. (PubMed, Lancet) - P3 | "We provide robust data from adults aged 65 years and older showing that Vimkunya is well tolerated and can provide a high rate of protection within 2 weeks postvaccination and during 6 months of follow-up."

Journal • P3 data • Chikungunya

Bavarian Nordic Announces Acceptance of Marketing Authorization Application for Chikungunya Vaccine in the UK for Persons Aged 12 and Older (GlobeNewswire) - "Bavarian Nordic...announced today that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has validated the marketing authorization application and accepted to start the review of the Company’s single-dose chikungunya vaccine, CHIKV VLP vaccine, for active immunization for the prevention of disease caused by chikungunya virus in individuals 12 years and older."

MHRA filing • Chikungunya

Bavarian Nordic Receives Marketing Authorization in Europe for Chikungunya Vaccine for Persons Aged 12 and Older (GlobeNewswire) - "Bavarian Nordic A/S...today announced that the European Commission has granted marketing authorization in Europe for VIMKUNYA for active immunization for the prevention of disease caused by chikungunya virus in individuals 12 years and older....The approval, valid in all EU member states, as well as in Iceland, Liechtenstein, and Norway....Bavarian Nordic also recently submitted a Marketing Authorization Application (MAA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA) with potential approval of the chikungunya vaccine in the UK in the first half of 2025....Bavarian Nordic will launch VIMKUNYA in key European markets in the first half of 2025....The marketing authorization was granted...based on results from two phase 3 clinical trials which enrolled more than 3,500 healthy individuals 12 years of age and older."

EMA approval • Launch Europe • MHRA filing • Chikungunya

Bavarian Nordic Receives U.S. FDA Approval of Chikungunya Vaccine for Persons Aged 12 and Older (GlobeNewswire) - "Bavarian Nordic...announced today that the U.S. Food and Drug Administration (FDA) has approved VIMKUNYA (Chikungunya Vaccine, Recombinant) for injection, the first virus-like particle (VLP) single-dose chikungunya vaccine in the U.S. for persons 12 years of age and older....The FDA approved VIMKUNYA under Priority Review, based on results from two phase 3 clinical trials which enrolled more than 3,500 healthy individuals 12 years of age and older....Bavarian Nordic aims to provide commercial availability of VIMKUNYA in the U.S. in the first half 2025."

FDA approval • Launch US • Chikungunya • Infectious Disease

Bavarian Nordic Receives Positive CHMP Opinion for Chikungunya Vaccine for Persons Aged 12 and Older (GlobeNewswire) - "First chikungunya vaccine recommended by the CHMP for persons as young as 12 years old.The virus-like particle (VLP) single-dose chikungunya vaccine is expected to launch in key European markets in the first half of 2025, pending final marketing authorization...After accelerated assessment, the CHMP’s recommendation is primarily based on results from two phase 3 clinical trials...The European Commission...will review the CHMP recommendation and is expected to make a final decision in the coming months...Bavarian Nordic will now also submit a Marketing Authorization Application (MAA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA) under the International Recognition Procedure (IRP), with potential approval of the chikungunya vaccine in the UK in the first half of 2025.The vaccine is also currently under priority review with the U.S. Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) action date set for February 14, 2025."

CHMP • EMA approval • Launch Europe • MHRA approval • MHRA filing • PDUFA • Chikungunya