Valneva and Instituto Butantan Announce Initiation of a Pilot Vaccination Campaign in Brazil with Single-Shot Chikungunya Vaccine IXCHIQ®
Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company and Instituto Butantan, one of the world’s largest biomedical research centers, today announced the initiation of a Pilot Vaccination Strategy (PVS) in Brazil using Valneva’s single-shot chikungunya vaccine, IXCHIQ®. The pilot vaccination program will serve as the basis for post-marketing commitment studies evaluating the effectiveness and safety of IXCHIQ® in a real-world setting and generating real-world evidence in a large population.
The PVS, agreed between the Brazilian Ministry of Health (MoH) and Instituto Butantan, will be implemented in ten Brazilian municipalities strategically selected based on epidemiological and operational criteria in support of the PVS. In line with the current IXCHIQ® label in Brazil, adults aged 18 to 59 years will be invited to participate, with the objective of achieving 20% to 40% vaccine coverage within the target population. Valneva, through its partner Instituto Butantan, will donate up to 500,000 doses of IXCHIQ® to the Brazilian MoH, for use in the program. IXCHIQ® was granted marketing approval in Brazil in individuals 18 years of age and older by the Brazilian Health Regulatory Agency (ANVISA) in April 20251, marking the world’s first approval of a chikungunya vaccine in an endemic country.
Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, “Contributing to this large-scale pilot vaccination strategy underscores our continued commitment to supporting global preparedness against the growing threat of chikungunya. With IXCHIQ® already available in several markets, generating robust real-world data in regions with active CHIKV transmission remains critical. This program is expected to provide additional evidence of the vaccine’s performance and further reinforce its public health value.”
Esper Kallas M.D., Ph.D., Director, Instituto Butantan, outlined the path towards the PVS, stating: "This program stems from a deeply rigorous scientific collaboration between Valneva, Instituto Butantan, and leading arbovirus experts. Through continuous engagement with the Ministry of Health, regional health secretaries, and ANVISA, I am confident that we have built a program that is both robust and regulatory-compliant. These combined efforts are expected to enable timely access to vaccination and reduce the significant public health burden posed by this arboviral disease."
The World Health Organization has called for urgent action to prevent a potential major chikungunya epidemic from sweeping the globe2. So far, Brazil has reported the highest number of chikungunya cases worldwide, with over one million cases between January 2019 and July 2024, including 263,502 cases in 2024 alone, which resulted in 246 deaths.
Valneva and Instituto Butantan signed an agreement in January 20215 for the technology transfer of Valneva’s chikungunya vaccine to Instituto Butantan, which will develop, manufacture and commercialize the vaccine in Latin America. This collaboration falls within the framework of the funding agreement between Valneva and the Coalition for Epidemic Preparedness Innovations (CEPI), with support from the European Union.
Contact
Laetitia Bachelot-Fontaine
VP Global Communications & European Investor Relations
M +33 (0)6 4516 7099
laetitia.bachelot-fontaine@valneva.com
Joshua Drumm, Ph.D.
VP Global Investor Relations
M +001 917 815 4520
joshua.drumm@valneva.com