Brazil's National Health Surveillance Agency (Anvisa) has made a groundbreaking decision by approving the first-ever vaccine against chikungunya, a viral disease transmitted by the Aedes aegypti mosquito. This significant development, announced on April 15, 2025, comes as a collaborative effort between the Butantan Institute, based in Brazil, and the French-Austrian pharmaceutical company Valneva.
The vaccine, known as IXCHIQ®, has shown promising results in clinical trials conducted in the United States. These trials, which involved 4,000 volunteers aged between 18 and 65, demonstrated an impressive 98.9% immunogenicity rate, with neutralizing antibodies persisting for at least six months, as published in a study in The Lancet in June 2023. With this approval, the vaccine is now authorized for administration to individuals over the age of 18 in Brazil.
Esper Kallás, the Director of the Butantan Institute, explained that the Ministry of Health plans to prioritize vaccination for residents in endemic regions, which are areas that have reported the highest incidence of chikungunya cases. Currently, Brazil is experiencing a significant chikungunya outbreak, with 267,000 probable cases and over 200 deaths reported in 2024 alone. Globally, there have been approximately 620,000 cases.
As the world’s first licensed chikungunya vaccine, IXCHIQ® has already received approval from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Kallás emphasized the importance of this vaccine, particularly given the chronic joint pain that can result from chikungunya infections, a symptom that sets it apart from other mosquito-borne diseases such as dengue and Zika.
Meanwhile, Valneva is set to showcase its new vaccine at the upcoming 25th World Vaccine Congress, scheduled to take place from April 21-24, 2025, at the Walter E. Washington Convention Center in Washington, D.C. Valneva’s Chief Executive Officer, Thomas Lingelbach, will lead a team of senior managers at the event, highlighting the company’s commitment to addressing public health challenges.
During the congress, Valneva will present IXCHIQ® and participate in various discussions, including an interactive work group session hosted by Dr. Hanneke Schuitemaker, Valneva's Chief Science Officer. This session will focus on “Prophylactic Enteric Disease Vaccines and Antimicrobial Resistance.” Additionally, Valneva is a finalist for two awards at the Vaccine Industry Excellence Awards, specifically for the Best Biotech Award and the Best Prophylactic Vaccine Award for its Lyme disease vaccine candidate, VLA15, which is currently in Phase 3 trials in partnership with Pfizer.
On April 23, 2025, Susanne Eder-Lingelbach, Vice President of Clinical Development at Valneva, will present key data supporting the licensure of the chikungunya vaccine and plans to confirm its effectiveness. The following day, Valneva's Chief Medical Officer, Dr. Juan Carlos Jaramillo, will participate in a panel discussion titled “The Urgent Need for Vaccines Against Mosquito-Borne Diseases.” This panel will also feature experts from various organizations, including the Coalition for Epidemic Preparedness Innovations and the Walter Reed Army Institute of Research.
The chikungunya virus (CHIKV) has become a significant public health concern since its re-emergence in 2004, leading to large-scale outbreaks across over 110 countries in Asia, Africa, Europe, and the Americas. The World Health Organization (WHO) has classified chikungunya as a major public health problem, especially as climate change is expected to expand the geographical range of the mosquito vectors responsible for its transmission.
Valneva has positioned itself as a leader in the vaccine industry, focusing on the development, manufacture, and commercialization of prophylactic vaccines for infectious diseases. The company’s strategic approach aims to address unmet medical needs, and it has successfully advanced multiple vaccines from research and development to regulatory approvals. In addition to IXCHIQ®, Valneva markets three proprietary travel vaccines and is developing a pipeline that includes candidates for Lyme disease and the Zika virus.
As Valneva prepares for its presentation at the World Vaccine Congress, the significance of IXCHIQ® cannot be overstated. With a growing number of chikungunya cases worldwide and the potential for further outbreaks, this vaccine represents a crucial advancement in public health efforts to combat mosquito-borne diseases.
In summary, the approval of IXCHIQ® by Anvisa marks a pivotal moment in the fight against chikungunya, offering hope to millions affected by this debilitating disease. With the vaccine's integration into Brazil's public health system pending a decision from the National Commission for the Incorporation of Technologies (Conitec), the next steps will be critical in determining how effectively this vaccine can be deployed, particularly in the most affected regions.
