Dengue Vaccines Approval Timelines Company Product Date of Approval Sanofi Dengvaxia (CYD-TDV) December 2015 Takeda Pharmaceutical Company Qdenga (TAK-003) December 2022 Butantan Institute Butantan-DV (TV003-derived) November 2025 However, Dengvaxia, the first dengue vaccine to receive regulatory approval, has been discontinued commercially, while Qdenga and Butantan-DV are the approved vaccines in the market. Dengvaxia, developed by Sanofi, announced its discontinuation due ti insufficient global demand. The European Commission subsequently withdrew Dengvaxia's marketing authorization on 21 October 2025 at the request of the marketing authorization holder. The U.S. FDA continues to list Dengvaxia as an approved product for eligible individuals, but the manufacturer has discontinued production. Qdenga is Transforming the India’s Dengue Vaccines Market India reached a major milestone in July 2026 when the Central Drugs Standard Control Organisation (CDSCO) granted marketing authorization to Qdenga, making it the first dengue vaccine approved in the country. The vaccine is indicated for individuals aged 4–60 years and is administered as two 0.5 mL doses separated by three months. Qdenga targets all four dengue virus serotypes, DENV-1, DENV-2, DENV-3, and DENV-4. Clinical data reported by Qdenga demonstrate 80.2% efficacy against virologically confirmed dengue and 90.4% efficacy against dengue-related hospitalization in the pivotal clinical program cited in current reporting. The vaccine is administered as two 0.5 mL doses three months apart. How Qdenga May Influence Dengue Fever Test Results? Dengue diagnostic technologies can broadly be divided into NS1 antigen tests, RT-PCR/molecular tests, IgM antibody tests, IgG antibody tests, and Combination rapid diagnostic tests. NS1 antigen and molecular tests are primarily intended to identify evidence of the virus or viral components during active infection, whereas IgM and IgG tests identify the host immune response. This distinction becomes critical after vaccination because Qdenga intentionally stimulates the immune system to produce dengue-specific antibodies. Impact of Dengue Vaccination on Diagnostic Tests Diagnostic Method Primary Target Potential Effect of Qdenga Vaccination NS1 antigen Dengue NS1 protein Generally high specificity; vaccination itself does not normally produce an NS1-positive result RT-PCR Dengue viral RNA Can be affected shortly after vaccination because vaccine-derived RNAemia can occur NS1 + IgM/IgG rapid panels Antigen + antibodies Antibody components may be influenced by vaccination Serotype-specific molecular testing Viral genetic material Differentiation between vaccine derived and wild type virus may be technically challenging shortly after vaccination Qdenga Dengue Vaccine: Country-level Regulatory Approval Timeline Country Approval Date Regulatory Authority Indonesia August 2022 Badan Pengawas Obat dan Makanan (BPOM) European Union Countries December 2022 EU Central Marketing Authorisation United Kingdom January 2023 Medicines and Healthcare products Regulatory Agency (MHRA) Brazil March 2023 Agência Nacional de Vigilância Sanitária (ANVISA) Argentina April 2023 National Regulatory Agency of Argentina (ANMAT) Thailand May 2023 Thai FDA Colombia September 2023 INVIMA Malaysia February 2024 Malaysian regulatory authority (NPRA) Mexico March 2026 COFEPRIS India July 2026 CDSCO/DCGI Note: Globally, Qdenga has received regulatory approval in 43 countries The future of the dengue vaccine market is therefore likely to be defined by an integrated model in which vaccination, diagnostics, vector control and disease surveillance operate together. Qdenga is positioned at the center of this transition because it combines an established clinical evidence base with broad regulatory reach. On the other hand, Butantan-DV and future pipeline vaccines will increasingly compete on dosing convenience, durability, safety, serotype specific protection, manufacturing scale and cost. Share this article