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Carolina Schmalzried

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Aug 3, 2024, 5:44:17 PM8/3/24
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Dengue is a mosquito-borne viral disease that poses a significant global public health threat, with prevalence in over 125 countries.2 In recent years, Indonesia has experienced almost half of the dengue disease burden within Southeast Asia and continues to suffer from one of the highest burdens of dengue in the world.2,3 In the first half of 2022 alone, Indonesia reported over 63,000 dengue cases and nearly 600 deaths spread across 455 cities in 34 provinces.5

Takeda is proud to make QDENGA available to health care providers and their eligible patients in Indonesia and to work with BPOM and local health experts to make the vaccine accessible in the coming months. QDENGA is currently undergoing regulatory review for the prevention of dengue in children and adults in the European Union (EU) and in dengue-endemic countries outside the EU through the EU-M4all (previously Article 58) procedure. It is not approved for use in other countries.

In Indonesia, QDENGA is indicated for the prevention of dengue disease caused by any dengue virus serotype in individuals six years to 45 years of age and should be administered subcutaneously as a 0.5 mL dose at a two-dose (0 and 3 months) schedule pursuant to approved dosing regimen.1 The use of QDENGA should be in accordance with official recommendations.

Contraindications: Hypersensitivity to the active substances or excipients listed, or to previous QDENGA dose. Individuals with congenital or acquired immune deficiency, including immunosuppressive therapies such as chemotherapy or high doses of systemic corticosteroids (eg, 20 mg/day or 2 mg/kg body weight/day of prednisone for 2 weeks or more) within 4 weeks prior to vaccination. Individuals with symptomatic HIV infection or asymptomatic HIV infection with impaired immune function. Pregnant and breast-feeding women.

The drug information contained herein is intended to disclose corporate information. Nothing contained in this document should be considered a solicitation, promotion, or indication for any prescription drug, including those currently under development.

EU-M4all (or EU-Medicines for all) is a procedure designed to facilitate patient access to essential medicines or vaccines intended to prevent or treat diseases of major public health interest. Through the EU-M4all procedure (previously known as the Article 58 procedure), the EMA, in cooperation with the World Health Organization (WHO), can provide scientific opinion on medicines and vaccines for public health priority diseases that are intended for markets outside of the EU.

The double-blind, randomized, placebo-controlled Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial is evaluating the safety and efficacy of two doses of TAK-003 in the prevention of laboratory-confirmed symptomatic dengue fever of any severity and due to any of the four dengue virus serotypes in children and adolescents.8 Study participants were randomized 2:1 to receive two doses of TAK-003 0.5 mL or placebo on Months 0 and 3, administered subcutaneously.8 The study is comprised of five parts. Part 1 and the primary endpoint analysis evaluated vaccine efficacy (VE) and safety through 12 months after the second dose.8 Part 2 continued for an additional six months to complete the assessment of the secondary endpoints of VE by serotype, baseline serostatus and disease severity, including VE against hospitalized dengue.8 Part 3 evaluated VE and long-term safety by following participants for an additional two and a half to three years, as per World Health Organization (WHO) recommendations.11 Part 4 will evaluate efficacy and safety for 13 months following booster vaccination, and Part 5 will evaluate long-term efficacy and safety for one year after completion of Part 4.11

The trial is taking place at sites in dengue-endemic areas in Latin America (Brazil, Colombia, Panama, the Dominican Republic and Nicaragua) and Asia (Philippines, Thailand and Sri Lanka) where there are unmet needs in dengue prevention and where severe dengue is a leading cause of serious illness and death among children.11 Baseline blood samples were collected from all individuals participating in the trial to allow for evaluation of safety and efficacy based on serostatus. Takeda and an independent Data Monitoring Committee of experts are actively monitoring safety on an ongoing basis.

Dengue is pandemic prone, and outbreaks are observed in tropical and sub-tropical areas and have recently caused outbreaks in parts of the continental United States and Europe.14,15 Approximately half of the world now lives under the threat of dengue, which is estimated to cause 390 million infections and around 20,000 deaths globally each year.14,16 The dengue virus can infect people of all ages and is a leading cause of serious illness among children in some countries in Latin America and Asia.14

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

The Indonesia Population (Live) counter shows a continuously updated estimate of the current population of Indonesia delivered by Worldometer's RTS algorithm, which processes data collected from the United Nations Population Division.

Population: Overall total population (both sexes and all ages) in the country as of July 1 of the year indicated, as estimated by the United Nations, Department of Economic and Social Affairs, Population Division. World Population Prospects: The 2022 Revision. For forecasted years, the U.N. medium-fertility variant is used.

Migrants (net): The average annual number of immigrants minus the number of emigrants over the preceding five year period (running from July 1 to June 30 of the initial and final years), or subsequent five year period (for 2016 data). A negative number means that there are more emigrants than immigrants.

Median Age: age that divides the population into two numerically equal groups: half of the people are older than the median age indicated and half are younger. This parameter provides an indication of age distribution.

Fertility Rate: (Total Fertility Rate, or TFR), it is expressed as children per woman. It is calculated as the average number of children an average woman will have during her reproductive period (15 to 49 years old) based on the current fertility rates of every age group in the country, and assuming she is not subject to mortality.

Global Rank: Position held by Indonesia in the list of all countries worldwide ranked by population (from the highest population to the lowest population) as of July 1 of the year indicated.

That final figure of 1.04% may not seem like a lot but on a population of over 250 million, it leads to some significant increases. As the Jakarta Post reported in 2013, Indonesia's population has doubled within just 40 years from 119 million in 1971 to almost 240 million in 2010, based on figures from the Central Statistics Agency. In another 40 years, the country's population is expected to climb much higher.

According to the Jakarta Post author, the high Muslim population in Indonesia is leading to a very high birth rate, which cannot be sustained. The article points out that Jakarta, Indonesia's largest city, is in a naturally flood-prone area, and the depth and extent of floods only increases as the population density increases.

Indonesia is made up of more than 17,000 islands with over 1.9 million square miles of land,. About 56.7% of Indonesia's population lives on Java, the most populous island. The population density of Indonesia is currently at 140.08 individuals per square kilometer.

According to the 2010 official population data, Indonesia has 11 cities with a population over 1 million, although estimates from 2014 show that there are now 14 cities that have populations that exceed 1 million. The 10 largest cities in Indonesia, with populations as of 2014, are:

Jakarta isn't just the most populous city in Indonesia; it's also the most populous in Southeast Asia and the 14th most populated city on earth. The official metropolitan area, known as Jabodetabek, is the third largest in the world, and the metropolis's suburbs extend even further. The entire area has a population of over 30 million, which makes it one of the largest conurbations on earth. It's also one of the fastest-growing cities on earth, growing faster than Beijing and Bangkok, with a population density in the city proper of 15,342 people per square kilometer (39,740/square mile).

In addition to this diverse population, Indonesia is also the world's most populous Muslim-majority country, as just over 87% of Indonesians declared Muslim on the 2010 census. 9.87% are Christian, 1.69% are Hindu, 0.72% are Buddhist and 0.56% practice other faiths. The Indonesian constitution grants religious freedom although the government only officially recognizes Islam, Protestantism, Roman Catholicism, Buddhism, Hinduism, and Confucianism.

There are more than 700 languages spoken in Indonesia. Bahasa Indonesia, a form of Malay, is the official language and is used mostly in education, media, commerce, and administration. Most people in Indonesia actually tend to speak other languages as their primary language, however.

The median age of the population in Indonesia is approximately 30.2 years of age, 42.4% of the population between 25 and 54 years of age. The 0-14 age group is currently just over 25%, strengthening the number of youths that will come into the workforce as the current workers move past working age.

In terms of accessibility to clean water and sanitation facilities, approximately 87.4% have improved access to clean drinking water while 12.6% still struggle. Only 60.8% have improved access to sanitation while 39.2% still have unimproved accessibility to sanitation services. However, Indonesia maintains a fairly high literacy rate of 95.4% among the entire population with males having a slight advantage of roughly 4% over females.

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