Indonesia To Launch Takeda’s QDENGA Dengue Vaccine Jab in 2023

QDENGA, a live-attenuated, dengue tetravalent vaccine, formerly known as TAK-003 was approved by Indonesia’s Badan Pengawas Obat dan Makanan (BPOM) for the prevention of dengue caused by any serotype (DENV-1, DENV-2, DENV-3, DENV-4) in individuals aged 6 – 46 years. This is the first approval for QDENGA globally (1). Its use in Indonesia will roll out in 2023 (2).

It is for use in individuals regardless of dengue history and omits the need for pre-vaccination testing. Pre-vaccination screening to vaccinate only those with a history of past infection, was a requirement in DENGVAXIA, a dengue vaccine developed by Sanofi Pasteur which caused an increased risk of severe disease in dengue-naïve recipients. Ongoing Phase 3 TIDES (Tetravalent Immunization against Dengue Efficacy Studies) enrolled approximately 20,000 individuals demographically situated in dengue-endemic areas within Asia and Latin America. 

Clinical Efficacy & Safety (4)

The primary endpoint was overall vaccine efficacy (VE) against virologically confirmed dengue (VCD) which was met in TIDES with 80.2% efficacy at a 12-month follow-up. The VE was 95.4% for preventing hospitalisations due to VCD fever and up to 3 years post-second dose, VE in preventing VCD was shown in all 4 serotypes in baseline dengue seropositive subjects (3). After 3 years from the second dose, the VE is as follows: 

1. VCD

1. Hospitalised VCD

Although VE against VCD and hospitalised VCD varied by country due to differing predominant serotypes (all 4 in Asia, only DENV-1 and DENV-2 in Latin America), VE against hospitalised VCD was higher than for VCD in all countries. Cumulative VE was relatively lower in the youngest age group (4-5 years) but there was no observable trend across age groups. Efficacy continued to decrease over the years post-vaccine but remained robust in hospitalised VCD. A study is ongoing on booster shots administered 4 years after the second dose.

5 deaths and 2.9% serious adverse events were reported in recipients of TAK-003, none of which were related to the vaccine. No cases of antibody-dependent enhancement (ADE), a condition in which vaccination induces antibodies causing more severe subsequent infection, have been reported in TIDES.

Dosing Recommendation (1)

Administration of QDENGA is via subcutaneous injection of 0.5 mL dose at 2-dose schedule (0 and 3 months). The upper arm of the deltoid region is recommended. Intravenous, intramuscular, or intradermal injections are contraindicated. 

References:

1. https://www.takeda.com/newsroom/newsreleases/2022/takedas-qdenga-dengue-tetravalent-vaccine-live-attenuated-approved-in-indonesia-for-use-regardless-of-prior-dengue-exposure/ 
2. https://www.nature.com/articles/d41586-022-03546-2 
3. http1s://www.nejm.org/doi/10.1056/NEJMoa1903869 
4. https://academic.oup.com/cid/article/75/1/107/6381105?login=false