WuXi Vaccines Receives Brazil's ANVISA GMP Certification [Accessibility Statement] Skip NavigationSUZHOU, China, Feb. 11, 2026 /PRNewswire/ -- WuXi Vaccines, a wholly-owned subsidiary of WuXi Biologics, dedicated to vaccine Contract Development and Manufacturing Organization (CDMO), announced today that it has received Good Manufacturing Practices (GMP) certification for its fill and finish facility (DP17) in Suzhou from Brazil's Agência Nacional de Vigilância Sanitária (ANVISA). The facility is providing i ...

Core Insights - Valneva SE and Instituto Butantan have initiated a Pilot Vaccination Strategy (PVS) in Brazil for Valneva's chikungunya vaccine, IXCHIQ®, aimed at generating real-world evidence on its effectiveness and safety [1][2] Group 1: Pilot Vaccination Strategy - The PVS will be implemented in ten Brazilian municipalities selected based on epidemiological and operational criteria, targeting adults aged 18 to 59 years with a goal of achieving 20% to 40% vaccine coverage [2] - Valneva will donate up to 500,000 doses of IXCHIQ® to the Brazilian Ministry of Health for the program [2] - IXCHIQ® received marketing approval in Brazil in April 2025, marking the first approval of a chikungunya vaccine in an endemic country [2] Group 2: Public Health Context - Brazil has reported over one million chikungunya cases from January 2019 to July 2024, including 263,502 cases in 2024, resulting in 246 deaths [3] - The World Health Organization has called for urgent action to prevent a potential major chikungunya epidemic globally [3] Group 3: Collaboration and Support - Valneva and Instituto Butantan signed an agreement in January 2021 for the technology transfer of the chikungunya vaccine, which will be developed and commercialized in Latin America [4] - This collaboration is supported by the Coalition for Epidemic Preparedness Innovations (CEPI) and the European Union [4]

Core Insights - Valneva SE has received marketing authorization from Brazil's ANVISA for its single-dose chikungunya vaccine IXCHIQ®, marking the first approval of a chikungunya vaccine in an endemic country [1][2] - The vaccine is part of Valneva's strategy to enhance access in low- and middle-income countries (LMICs), supported by CEPI and the EU [1][6] - The approval allows for large-scale clinical trials in Brazil, including Phase 4 trials to gather additional data on vaccine effectiveness [3] Company Developments - IXCHIQ® is already approved in the EU for individuals aged 12 and older and in the U.S., Canada, and the U.K. for those aged 18 and older [2] - Valneva is collaborating with Instituto Butantan for local manufacturing and distribution of the vaccine in Brazil, with potential approval for another vaccine candidate, VLA1555, expected in mid-2025 [4] - The company aims to ensure rapid access to its vaccines in Brazil and other regional markets, addressing a significant public health need as Brazil reported over 1 million chikungunya cases since 2019 [5][6] Clinical Trials and Research - Valneva is conducting a Phase 2 trial in children aged 1 to 11 years in the Dominican Republic and Honduras, with positive results reported in January 2025 [7] - A pivotal Phase 3 study in children is expected to begin in Q4 2025, with plans to evaluate the vaccine in pregnant women in outbreak-affected countries [8] Public Health Context - Chikungunya virus, transmitted by Aedes mosquitoes, has caused significant outbreaks globally, with over 720,000 cases reported in the Americas from January to July 2023 [5][10] - The World Health Organization has identified chikungunya as a major public health issue, with the disease's economic impact expected to grow due to climate change [10]

Core Viewpoint - Valneva SE is responding to a chikungunya outbreak in La Réunion by providing 40,000 doses of its vaccine IXCHIQ, with a focus on vaccinating vulnerable populations, particularly adults aged 65 and over with co-morbidities [1][2][4]. Group 1: Company Actions and Vaccine Details - Valneva will supply 40,000 doses of IXCHIQ starting in early April, with the option to provide more doses as needed [1]. - IXCHIQ is the world's first licensed chikungunya vaccine, approved for individuals aged 18 and older in the U.S., Europe, Canada, and the UK, with a recent positive opinion from the EMA for a label extension to individuals aged 12 and older [3][5]. - The company is focused on expanding access to IXCHIQ, including a partnership with CEPI that received a $41.3 million grant to enhance vaccine access in Low- and Middle-Income Countries (LMICs) [5][6]. Group 2: Public Health Context and Response - Chikungunya cases in La Réunion have surged, with 8,600 cases reported and nearly 3,000 new cases in the week of March 3 to 9, 2025, prompting local authorities to implement a Level 4 emergency crisis management plan [2]. - The Haute Autorité de Santé recommended prioritizing vaccination for adults aged 65 and over, especially those with co-morbidities, followed by adults aged 18 and over with co-morbidities [4]. - The CDC has issued a travel alert due to the outbreak, highlighting the potential for transmission to mainland France and other territories [2]. Group 3: Broader Implications and Partnerships - Valneva has signed an exclusive license agreement with the Serum Institute of India to supply IXCHIQ in Asia, ensuring affordable access to public health markets in LMICs [6][7]. - The company previously established a partnership with Instituto Butantan in Brazil for the development and marketing of a local chikungunya vaccine for Latin American countries [7]. - The World Health Organization has identified chikungunya as a significant public health issue, with the disease affecting over 110 countries and the economic impact expected to grow due to climate change [9].