vaccines
The fight against dengue, a mosquito-borne disease that affects millions of people around the world each year, has taken a significant step forward with the development of specific vaccines.
Currently, there are several vaccination options available against the disease. On this page we try to provide detailed information on how these medical innovations are changing the landscape of prevention of this disease. From the latest scientific advances to recommendations for use and vaccination schedules, our goal is to offer a complete guide that illustrates the importance of vaccination as a key tool in the fight against dengue.
Dengue vaccination should be viewed as part of an integrated strategy to control the disease, including vector control, appropriate case management, community education and community participation.
QDENGA® (TAK-003)
Is a new tetravalent vaccine based on live attenuated viruses against dengue that has been developed by the pharmaceutical company Takeda.
Mechanism of action
It is designed to protect against any of the 4 serotypes.
It is a live attenuated virus vaccine based on serotype 2. A structure that provides the genetic “backbone” for the four serotypes of the virus.
Administration Mode
It should be administered subcutaneously in a dose of 0.5 ml on a two-dose schedule (0 and 3 months) in accordance with the approved dosing regimen.
December 2022
Vaccine approved by the EU. The EU approval has been supported by results from 19 phase 1, 2 and 3 trials with more than 28,000 children and adults, including four and a half years of follow-up data from TIDES. The vaccine met its primary endpoint of overall efficacy by preventing 80.2% of symptomatic dengue cases 12 months after vaccination. Additionally, it met its key secondary endpoint by preventing 90.4% of hospitalizations 18 months after vaccination. Efficacy varied by serotype (DENV1–4).
The use of a pre-vaccination screening strategy to limit vaccination to HIV-positive individuals in settings with high dengue transmission is not recommended, as this would substantially reduce the public health impact of vaccination and increase programmatic costs.
Indications
WHO recommends the use of TAK-003 in children aged 6 to 16 years in settings with high intensity of dengue transmission. Within this age range, vaccination should ideally be initiated 1 to 2 years before the peak age-specific incidence of dengue-related hospital admissions, although programmatic alignment with the administration of dengue is also an important consideration. other health and vaccination interventions in schools.
Other important data
Contraindications
A history of anaphylaxis to any component of the vaccine is a contraindication to vaccination. If anaphylaxis occurs after any dose, a subsequent dose of the vaccine should not be administered.
Co-administration
1 comprimido a la semana
Presentación: medicación extranjera, no dispensación en farmacias en EspañaAvailable evidence supports coadministration of TAK-003 with yellow fever and hepatitis A vaccines. Studies are underway to evaluate coadministration with HPV vaccines. From coadministration studies of other vaccines, TAK-003 can be coadministered with other inactivated, subunit, or mRNA vaccines, except for live vaccines, for which more data are required. When administered concomitantly, the vaccines should be injected into separate sites, preferably in different extremities. Continuous monitoring of pharmacovigilance is recommended.
Precautions
A history of anaphylaxis from any other vaccine or injectable therapy (i.e., intramuscular, intravenous, or subcutaneous vaccines or therapies) is not a contraindication to vaccination; however, for such individuals, a risk assessment should be performed by a healthcare professional.
It remains uncertain whether there is an increased risk of anaphylaxis with the use of TAK-003, and advice should be provided regarding the potential risk which should be balanced against the benefits of vaccination. These people should be observed for 30 minutes after vaccination in healthcare settings where anaphylaxis can be treated immediately.
As a small number of anaphylactic reactions have also been reported in vaccinees without a history of anaphylaxis, WHO recommends that TAK-003 vaccine be administered only in settings where anaphylaxis can be treated. Until more data is available, all vaccinees should be observed for at least 15 minutes after vaccination.
Booster dose
Some decline in vaccine effectiveness was observed over the five-year trial period. There is currently no data on the use of booster doses. Additional studies are being conducted to determine the use of a booster dose and its optimal timing. Consequently, a booster dose is not recommended.
TRAVELERS
People living in non-endemic countries and who have previously been infected with any of the 4 dengue virus serotypes after traveling to dengue-endemic countries, may benefit from the TAK-003 vaccine to prevent a second dengue infection (and , therefore potentially more serious) when they travel. again to an endemic country.
Frequent travelers, long-term travelers, migrants and long-term expatriates are more likely to have had a previous dengue infection (and are therefore more likely to be seropositive) compared to those who travel for the first time or for a short duration.
The benefits of TAK-003 vaccination are lower for travelers who have never experienced dengue infection (and are therefore seronegative) compared to seropositive travelers.
Travelers should be informed that the vaccine may not confer protection against DENV3 and DENV4 if they are seronegative, and that there is a potential risk of severe dengue if seronegative individuals are exposed to DENV3 and DENV4. Travelers also need to be informed that dengue transmission is heterogeneous within countries and that circulating serotypes may vary during different periods. The greatest benefit with the least risk occurs during an ongoing epidemic due to DENV2 or DENV1 at the destination.
Although pre-vaccination screening is not required to determine HIV status, when available its use could be considered to inform risk-benefit assessment.
Protection begins 14 days after the first dose and has been demonstrated between the first and second doses; therefore, the first dose can be administered up to 14 days before traveling to a country where dengue is endemic. To guarantee the durability of the protection, a second dose is necessary after a minimum interval of 3 months. Until more data on efficacy and safety profiles are available, WHO recommends a lower age limit of 6 years and an upper age limit of 60 years for travelers.