Indonesia’s National Agency for Drug and Food Control (BPOM) approved Takeda’s dengue vaccine candidate in August 2022. The vaccine, QDENGA (TAK-003), was approved for use in patients from 6 to 45 years old. It is the only vaccine for dengue that is approved in Indonesia “regardless of previous dengue exposure” and without a pre-vaccination test. This contrasts with Sanofi’s Dengvaxia. Dengvaxia can only be used in seropositive children between 9 and 16. This regulation was implemented after it became apparent that the vaccine might cause more serious illness in seronegative recipients.
Dengue is a mosquito-borne viral disease that is prevalent in over 125 countries. Recently, Indonesia has experienced a significant proportion of the disease burden across the world. It reported over 63,000 cases and nearly 600 deaths in the first half of 2022.
QDENGA is based on a live-attenuated dengue serotype 2 virus, which Takeda suggests provides the “genetic ‘backbone’ for all four dengue virus serotypes”. It was assessed across a “robust clinical development programme including more than 28,000 participants. Takeda’s “pivotal” Tetravalent Immunisation against Dengue Efficacy Study (TIDES) trial met its goal of vaccine efficacy with 80.2% after 12 months. It was “generally well tolerated” and no significant safety risks were identified.
Gary Dubin, president of Takeda’s Vaccine Business Unit, stated that dengue can “affect anyone”.
“Developing this innovating dengue vaccine has been an exciting challenge, and its approval in Indonesia is an important achievement”.
He reflected that Takeda is “proud” but will keep up the work to make the vaccine available globally.
Dr Anggraini Alam, Sp.A(K), is a paediatric infectious disease consultant. He has witnessed the “burden” in the communities he serves and suggests that there is an ongoing fear” of both “physical” and “financial” consequences.
“Vaccination will offer health care providers in Indonesia a welcomed advancement in dengue prevention, along with vector control, allowing us to reduce the burden of dengue and protect the broader population”.
Takeda has filed for approval of TAK-003 in the EU and other markets. It is likely that it will submit to the FDA in a few months. This is the first of Takeda’s vaccines to be marketed outside Japan. Looking forward, Takeda’s global vaccine business is “applying innovation to tackle some of the world’ most challenging infectious diseases”.
To hear more about generating protection against diseases such as dengue, come to the World Vaccine Congress in Europe, 2022.