INTERNATIONAL REGULATORY APPROACH FOR IXCHIQ®, VACCINE FOR THE PREVENTION OF CHIKUNGUNYA
Resumen
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Referencias
Agência Nacional de Vigilância Sanitária - Anvisa. (2025). IXCHIQ (vacina chikungunya): novo registro. Obtenido de Ministério da Saúde: https://www.gov.br/anvisa/pt-br/assuntos/medicamentos/novos-medicamentos-e-indicacoes/ixchiqvacina-chikungunya-novo-registro
Auerswald, H. (2018). Broad and long-lasting immune protection against various Chikungunya genotypes demonstrated by participants in a cross sectional study in a Cambodian rural community. Obtenido de National Library of Medicine: https://pmc.ncbi.nlm.nih.gov/articles/PMC5837154/
European Centre for Disease Prevention and Control. (2025). Chikungunya virus disease worldwide overview. Obtenido de European Centre for Disease Prevention and Control: https://www.ecdc.europa.eu/en/chikungunya-monthly
European Medicines Agency. (2024). Ixchiq, vacuna contra el chikungunya. Obtenido de European Medicines Agency: https://www.ema.europa.eu/en/medicines/human/EPAR/ixchiq
European Medicines Agency. (2025). PRIME: priority medicines. Obtenido de European Medicines Agency: https://www.ema.europa.eu/en/humanregulatory-overview/research-development/prime-priority-medicines
Health Canada. (2014). Guidance Document - Submission and Information Requirements for Extraordinary Use New Drugs (EUNDs).Obtenido de Health Canada: https://www.canada.ca/en/health-canada/services/drugshealth-products/biologics-radiopharmaceuticalsgenetic-therapies/applications-submissions/guidance-documents/submission-informationrequirements-extraordinary-drugs-eunds.html
Health Canada. (2017). Priority Review of Drug Submissions (Therapeutic Products). Obtenido de Health Canada: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fact-sheets/priority-review-drugsubmissions-therapeutic-products.html
Kang, H., Lim, A., Clark, A., Colón González, F. J., Clapham, H. E., Carrera, J.-P., et al. (2025). Age-specific chikungunya outbreak response immunisation strategies in Brazil: A modelling study. eClinicalMedicine, 90, 103690. https://doi.org/10.1016/j.eclinm.2025.103690
Kling, K., Falman, A., Branke, L., Ramharter, M., Rothe, C., Schönfeld, C., & Grünewald, T. (2026). 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. Vaccine, 75, 128251. https://doi.org/10.1016/j.vaccine.2026.128251
Ly, H. (2024). Ixchiq (Vla1553): The first FDA approved vaccine to prevent disease caused by Chikungunya virus infection. Virulence, 15(1), 2301573. https://doi.org/10.1080/21505594.2023.2301573
Ministerio de Salud de El Salvador. (2026). Casos sospechosos de chikungunya 2026. Obtenido de Boletín Epidemiológico 2026: https://boletin.salud.gob.sv/superset/dashboard/2/?standalone=2
Organización Mundial de la Salud. (2020). COVID-19 Fases de desarrollo de una vacuna. Obtenido de Organización Mundial de la Salud: https://www.paho.org/es/documentos/covid-19fases-desarrollo-vacuna
Organización Mundial de la Salud. (2025). ¿Cómo se desarrollan las vacunas? Obtenido de Organización Mundial de la Salud: https://www.who.int/es/news-room/feature-stories/detail/how-are-vaccines-developed
U.S. Food and Drug Administration. (2025). Accelerated Approval Program. Obtenido de U.S. Food and Drug Administration: https://www.fda.gov/drugs/nda-andbla-approvals/accelerated-approvalprogram#:~:text=La%20FDA%20implement%C3%B3%20su%20Programa,a%20su%20retirada%20del%20mercado
World Health Organization. (2025). Chikungunya virus disease- Global situation. Obtenido de World Health Organization: https://www.who.int/emergencies/disease-outbreak-news/item/2025DON581#:~:text=In%20Thailand%2C%20a%20total%20of,January%20and%2014%20September%202025
