The worldwide dengue vaccine panorama has entered a brand new section, with three dengue vaccine merchandise having obtained regulatory approval globally up to now: Dengvaxia (CYD-TDV), Qdenga (TAK-003), and Butantan-DV (TV003-derived).
Dengue Vaccines Approval Timelines
| Firm | Product | Date of Approval |
|---|---|---|
|
Sanofi
|
Dengvaxia (CYD-TDV)
|
December 2015
|
|
Takeda Pharmaceutical Firm
|
Qdenga (TAK-003)
|
December 2022
|
|
Butantan Institute
|
Butantan-DV (TV003-derived)
|
November 2025
|
Nevertheless, Dengvaxia, the primary dengue vaccine to obtain regulatory approval, has been discontinued commercially, whereas Qdenga and Butantan-DV are the authorized vaccines out there. Dengvaxia, developed by Sanofi, introduced its discontinuation due ti inadequate world demand. The European Fee subsequently withdrew Dengvaxia’s advertising authorization on 21 October 2025 on the request of the advertising authorization holder. The U.S. FDA continues to checklist Dengvaxia as an authorized product for eligible people, however the producer has discontinued manufacturing.
Qdenga is Reworking the India’s Dengue Vaccines Market
India reached a serious milestone in July 2026 when the Central Medicine Customary Management Organisation (CDSCO) granted advertising authorization to Qdenga, making it the primary dengue vaccine authorized within the nation. The vaccine is indicated for people aged 4–60 years and is run as two 0.5 mL doses separated by three months. Qdenga targets all 4 dengue virus serotypes, DENV-1, DENV-2, DENV-3, and DENV-4.
Medical knowledge reported by Qdenga reveal 80.2% efficacy towards virologically confirmed dengue and 90.4% efficacy towards dengue-related hospitalization within the pivotal medical program cited in present reporting. The vaccine is run as two 0.5 mL doses three months aside.
How Qdenga Might Affect Dengue Fever Check Outcomes?
Dengue diagnostic applied sciences can broadly be divided into NS1 antigen assessments, RT-PCR/molecular assessments, IgM antibody assessments, IgG antibody assessments, and Mixture speedy diagnostic assessments.
NS1 antigen and molecular assessments are primarily supposed to determine proof of the virus or viral elements throughout energetic an infection, whereas IgM and IgG assessments determine the host immune response. This distinction turns into important after vaccination as a result of Qdenga deliberately stimulates the immune system to provide dengue-specific antibodies.
Affect of Dengue Vaccination on Diagnostic Assessments
| Diagnostic Methodology | Main Goal | Potential Impact of Qdenga Vaccination |
|---|---|---|
|
NS1 antigen
|
Dengue NS1 protein
|
Usually excessive specificity; vaccination itself doesn’t usually produce an NS1-positive end result
|
|
RT-PCR
|
Dengue viral RNA
|
Could be affected shortly after vaccination as a result of vaccine-derived RNAemia can happen
|
|
NS1 + IgM/IgG speedy panels
|
Antigen + antibodies
|
Antibody elements could also be influenced by vaccination
|
|
Serotype-specific molecular testing
|
Viral genetic materials
|
Differentiation between vaccine derived and wild kind virus could also be technically difficult shortly after vaccination
|
Qdenga Dengue Vaccine: Nation-level Regulatory Approval Timeline
| Nation | Approval Date | Regulatory Authority |
|---|---|---|
|
Indonesia
|
August 2022
|
Badan Pengawas Obat dan Makanan (BPOM)
|
|
European Union International locations
|
December 2022
|
EU Central Advertising and marketing Authorisation
|
|
United Kingdom
|
January 2023
|
Medicines and Healthcare merchandise Regulatory Company (MHRA)
|
|
Brazil
|
March 2023
|
Agência Nacional de Vigilância Sanitária (ANVISA)
|
|
Argentina
|
April 2023
|
Nationwide Regulatory Company of Argentina (ANMAT)
|
|
Thailand
|
Might 2023
|
Thai FDA
|
|
Colombia
|
September 2023
|
INVIMA
|
|
Malaysia
|
February 2024
|
Malaysian regulatory authority (NPRA)
|
|
Mexico
|
March 2026
|
COFEPRIS
|
|
India
|
July 2026
|
CDSCO/DCGI
|
Word: Globally, Qdenga has obtained regulatory approval in 43 international locations
The way forward for the dengue vaccine market is subsequently prone to be outlined by an built-in mannequin through which vaccination, diagnostics, vector management and illness surveillance function collectively. Qdenga is positioned on the heart of this transition as a result of it combines a longtime medical proof base with broad regulatory attain. Alternatively, Butantan-DV and future pipeline vaccines will more and more compete on dosing comfort, sturdiness, security, serotype particular safety, manufacturing scale and price.
Begin Your Journey to Higher Enterprise
