QDENGA® Dengue Vaccine Now Available in Australia

Dengue vaccine now available for Australian travellers

October 1, 2026

More than 94 per cent of dengue cases reported in Australia in the 12 months to 30 March 2025 were acquired overseas.²
QDENGA® (dengue tetravalent vaccine [live, attenuated]) is now available in Australia for the prevention of dengue disease in individuals from four years of age.¹

SYDNEY, AUSTRALIA, 1 October 2026: Australians heading overseas are being reminded to seek travel-health advice early and discuss dengue prevention with a healthcare professional.

A total of 2,641 dengue cases were reported to Australia’s National Notifiable Diseases Surveillance System in the 12 months to 30 March 2025, with more than 94 per cent acquired overseas.²

Dengue is a mosquito-borne viral infection. While many infections are asymptomatic or cause mild illness, some people develop symptoms including high fever, severe headache, pain behind the eyes, muscle and joint pain, nausea, vomiting and rash. In some cases, dengue can progress to severe disease and require hospitalisation.³

Dengue occurs across many destinations regularly visited by Australians, including Indonesia, Thailand, Vietnam, India, the Philippines, Malaysia, Singapore and Fiji.⁴

Travellers do not need to be visiting remote or rural areas to be at risk. The mosquitoes that transmit dengue can be found in cities and popular tourist areas, meaning travellers may be exposed while staying at resorts, sightseeing or visiting family and friends.

For Australian traveller Ella Stiebel, dengue was not something she had given much thought to before a family trip to Bali.

Ella had sought travel-health advice before leaving Australia and received a number of recommended vaccinations. While she recalls dengue being discussed, it wasn't a risk that particularly stayed with her.

During the trip, Ella began feeling dizzy, weak and unable to eat. At first, she assumed the combination of heat, humidity and physical activity had caused heat exhaustion. But her symptoms continued to worsen.

“I was feeling really unwell. I was dizzy, I couldn't look at my phone because the light hurt my eyes, I wasn't hungry and I had this unbearable headache,” Ella said.

“I spent seven days in a hotel room.”

“I lost three kilos in about a week. Those whole seven days, I did not experience Bali. I was stuck in the hotel room, unable to move due to the illness.”

Ella's father also became ill during the family trip. By the night before she was due to fly home to Australia, Ella said the severity of her headache had left her worried about whether she could manage the flight.

She remained unwell for approximately another week after returning to Australia and was unable to work or attend university.

The experience has changed the way Ella thinks about preparing for international travel.

“I thought I was pretty well-prepared. We'd been to a travel clinic and had organised the vaccinations we needed, but dengue just wasn't something that was really front of mind for me,” she said.

“Now I think much more about the health risks before I travel, rather than assuming it won't happen to me.”

“Ella’s experience highlights a travel-health risk that Australians frequently underestimate, particularly when travelling to familiar holiday destinations,” said Dr Deb Mills, Medical Director of Dr Deb The Travel Doctor.

“When planning an overseas trip, travellers tend to think about flights, accommodation, activities, passport etc. Planning for healthy travel sometimes never gets onto that to-do list,” Dr Mills said.

“The important thing is to think about your health before you are sweating in a foreign hospital. All travellers need to get advice about the health risks at their destination – ideally well before departure.”

Avoiding mosquito bites remains an important part of dengue prevention, and eligible travellers now have an additional dengue prevention measure to discuss with their healthcare professional.

“Travel health shouldn't be something you leave until the week before you fly,” Dr Mills said.

“If you have an overseas trip coming up, particularly to somewhere dengue is present, talk to a travel doctor or GP early about your destination, your individual circumstances and the prevention measures that may be appropriate for you.”

QDENGA® (dengue tetravalent vaccine [live, attenuated]) is available in Australia for the prevention of dengue disease in individuals from four years of age.¹

Vaccination does not replace measures to prevent mosquito bites. Travellers should continue to take appropriate precautions to reduce their exposure to mosquitoes.

About Dengue

Dengue is a viral infection transmitted to humans through the bite of infected mosquitoes. It can be caused by any of four dengue virus serotypes.

While a majority of primary dengue infections are asymptomatic or cause mild illness, some people develop high fever, severe headache, pain behind the eyes, muscle and joint pain, nausea, vomiting, swollen glands or rash. A small proportion of infections can progress to severe dengue, which may require hospital care.³

Dengue is found in tropical and subtropical climates worldwide, predominantly in urban and semi-urban areas.

People travelling to destinations where dengue is present should take steps to avoid mosquito bites, including using appropriate insect repellent, wearing protective clothing and staying in accommodation with suitable mosquito protection.

About QDENGA®

QDENGA® is available in Australia for the prevention of dengue disease in individuals from four years of age.¹

Its clinical efficacy was assessed in DEN-301, a pivotal Phase 3 double-blind, randomised, placebo-controlled study involving 20,099 children aged 4–16 years across five countries in Latin America and three countries in Asia.¹

During the study's primary endpoint period, QDENGA demonstrated overall vaccine efficacy of 80.2% against virologically confirmed dengue and 95.4% against hospitalisation due to virologically confirmed dengue, measured from 30 days to 12 months after the second dose.¹

Anyone considering vaccination should speak with a healthcare professional about their individual circumstances.

For more information about QDENGA, refer to the Consumer Medicine Information (CMI) at: https://rss.medsinfo.com.au/tk/cmi.cfm?product=tkcqdeng.

The ATAGI statement on the Clinical use of the Dengue vaccine Qdenga for Australians is available at https://www.health.gov.au/resources/publications/atagi-statement-on-the-clinical-use-of-dengue-vaccine-in-older-adults-in-australia?language=en.

Side effects: All medicines can have side effects. The most common side effects with QDENGA include injection-site pain, headache, muscle aches, injection-site redness, feeling unwell, weakness, and fever. These reactions are usually mild to moderate, occur within two days of vaccination, and last 1–3 days. They are generally less frequent after the second dose.

Contraindications: QDENGA is contraindicated in individuals with hypersensitivity to its active substances, excipients, or a previous dose; congenital or acquired immune deficiency, including immunosuppressive treatment; symptomatic HIV infection or asymptomatic HIV infection with impaired immune function; pregnancy; or breastfeeding.

Precautions: Vaccination should be postponed during an acute severe febrile illness. Appropriate medical treatment should be readily available for rare anaphylactic reactions. Protection may not develop against all dengue serotypes and may decline over time, so mosquito-bite prevention should continue. Avoid pregnancy for at least one month after vaccination. The safety and efficacy of QDENGA have not been established in people with renal or hepatic impairment or those over 60 years of age.

Interactions: QDENGA should not be given during immunosuppressive treatment. Following treatment with immunoglobulins or blood products, wait at least 6 weeks, preferably 3 months, before vaccination. QDENGA may be administered with hepatitis A, yellow fever, or human papillomavirus vaccines, using separate injection sites where applicable.¹ Please refer to the Consumer Medicine Information for more information.

PBS/NIP Information: QDENGA is not listed on the Pharmaceutical Benefits Scheme (PBS) or the National Immunisation Program (NIP).

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. Patients can help by reporting any side effects to their doctor, or directly at https://www.tga.gov.au/reporting-problems. Healthcare professionals are asked to report any suspected adverse events at https://www.tga.gov.au/reporting-problems.

Disclosure: Dr Deb Mills has served on an advisory board for which compensation was received. In relation to this Takeda media announcement, no compensation was provided to Dr Mills, and the opinions expressed are her own. Dr Mills has been briefed by Takeda on the approved use of this product.

Patient stories contained within this media release are not representative of all patients’ experience with dengue.

About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit Takeda.com.

Media Contacts

Takeda Media Relations
[email protected]

Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

Medical Information

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.

References

Therapeutic Goods Administration. Australian Product Information: QDENGA® dengue tetravalent vaccine (live, attenuated). Approved 2 June 2026.
Australian Centre for Disease Control. National Notifiable Diseases Surveillance System (NNDSS) Fortnightly Report: 17 March to 30 March 2025.
World Health Organization. Dengue and severe dengue. Updated 21 August 2025.
Centers for Disease Control and Prevention. Areas with Risk of Dengue. Available at: http://cdc.gov/dengue/areas-with-risk/index.html

C-APROM/AU/QDE/0022. Date of preparation: September 2026.

* More than 94 per cent of dengue cases reported in Australia in the 12 months to 30 March 2025 were acquired overseas.2 * QDENGA® (dengue tetravalent vaccine [live, attenuated]) is now available in Australia for the prevention of dengue disease in individuals from four years of age.1 **SYDNEY, AUSTRALIA, 1 October 2026:** Australians heading overseas are being reminded to seek travel-health advice early and discuss dengue prevention with a healthcare professional. A total of 2,641 dengue cases were reported to Australia’s National Notifiable Diseases Surveillance System in the 12 months to 30 March 2025, with more than 94 per cent acquired overseas.2 Dengue is a mosquito-borne viral infection. While many infections are asymptomatic or cause mild illness, some people develop symptoms including high fever, severe headache, pain behind the eyes, muscle and joint pain, nausea, vomiting and rash. In some cases, dengue can progress to severe disease and require hospitalisation.3 Dengue occurs across many destinations regularly visited by Australians, including Indonesia, Thailand, Vietnam, India, the Philippines, Malaysia, Singapore and Fiji.4 Travellers do not need to be visiting remote or rural areas to be at risk. The mosquitoes that transmit dengue can be found in cities and popular tourist areas, meaning travellers may be exposed while staying at resorts, sightseeing or visiting family and friends. For Australian traveller **Ella Stiebel**, dengue was not something she had given much thought to before a family trip to Bali. Ella had sought travel-health advice before leaving Australia and received a number of recommended vaccinations. While she recalls dengue being discussed, it wasn't a risk that particularly stayed with her. During the trip, Ella began feeling dizzy, weak and unable to eat. At first, she assumed the combination of heat, humidity and physical activity had caused heat exhaustion. But her symptoms continued to worsen. “I was feeling really unwell. I was dizzy, I couldn't look at my phone because the light hurt my eyes, I wasn't hungry and I had this unbearable headache,” Ella said. “I spent seven days in a hotel room.” “I lost three kilos in about a week. Those whole seven days, I did not experience Bali. I was stuck in the hotel room, unable to move due to the illness.” Ella's father also became ill during the family trip. By the night before she was due to fly home to Australia, Ella said the severity of her headache had left her worried about whether she could manage the flight. She remained unwell for approximately another week after returning to Australia and was unable to work or attend university. The experience has changed the way Ella thinks about preparing for international travel. “I thought I was pretty well-prepared. We'd been to a travel clinic and had organised the vaccinations we needed, but dengue just wasn't something that was really front of mind for me,” she said. “Now I think much more about the health risks before I travel, rather than assuming it won't happen to me.” “Ella’s experience highlights a travel-health risk that Australians frequently underestimate, particularly when travelling to familiar holiday destinations,” said **Dr Deb Mills, Medical Director of Dr Deb The Travel Doctor**. “When planning an overseas trip, travellers tend to think about flights, accommodation, activities, passport etc. Planning for healthy travel sometimes never gets onto that to-do list,” Dr Mills said. “The important thing is to think about your health before you are sweating in a foreign hospital. All travellers need to get advice about the health risks at their destination – ideally well before departure.” Avoiding mosquito bites remains an important part of dengue prevention, and eligible travellers now have an additional dengue prevention measure to discuss with their healthcare professional. “Travel health shouldn't be something you leave until the week before you fly,” Dr Mills said. “If you have an overseas trip coming up, particularly to somewhere dengue is present, talk to a travel doctor or GP early about your destination, your individual circumstances and the prevention measures that may be appropriate for you.” QDENGA® (dengue tetravalent vaccine [live, attenuated]) is available in Australia for the prevention of dengue disease in individuals from four years of age.1 Vaccination does not replace measures to prevent mosquito bites. Travellers should continue to take appropriate precautions to reduce their exposure to mosquitoes. ## About Dengue Dengue is a viral infection transmitted to humans through the bite of infected mosquitoes. It can be caused by any of four dengue virus serotypes. While a majority of primary dengue infections are asymptomatic or cause mild illness, some people develop high fever, severe headache, pain behind the eyes, muscle and joint pain, nausea, vomiting, swollen glands or rash. A small proportion of infections can progress to severe dengue, which may require hospital care.3 Dengue is found in tropical and subtropical climates worldwide, predominantly in urban and semi-urban areas. People travelling to destinations where dengue is present should take steps to avoid mosquito bites, including using appropriate insect repellent, wearing protective clothing and staying in accommodation with suitable mosquito protection. ## About QDENGA® QDENGA® is available in Australia for the prevention of dengue disease in individuals from four years of age.1 Its clinical efficacy was assessed in DEN-301, a pivotal Phase 3 double-blind, randomised, placebo-controlled study involving 20,099 children aged 4–16 years across five countries in Latin America and three countries in Asia.1 During the study's primary endpoint period, QDENGA demonstrated overall vaccine efficacy of 80.2% against virologically confirmed dengue and 95.4% against hospitalisation due to virologically confirmed dengue, measured from 30 days to 12 months after the second dose.1 Anyone considering vaccination should speak with a healthcare professional about their individual circumstances. For more information about QDENGA, refer to the Consumer Medicine Information (CMI) at: [https://rss.medsinfo.com.au/tk/cmi.cfm?product=tkcqdeng](https://rss.medsinfo.com.au/tk/cmi.cfm?product=tkcqdeng). The **ATAGI statement on the Clinical use of the Dengue vaccine Qdenga for Australians** is available at [https://www.health.gov.au/resources/publications/atagi-statement-on-the-clinical-use-of-dengue-vaccine-in-older-adults-in-australia?language=en](https://www.health.gov.au/resources/publications/atagi-statement-on-the-clinical-use-of-dengue-vaccine-in-older-adults-in-australia?language=en). **Side effects:** All medicines can have side effects. The most common side effects with QDENGA include injection-site pain, headache, muscle aches, injection-site redness, feeling unwell, weakness, and fever. These reactions are usually mild to moderate, occur within two days of vaccination, and last 1–3 days. They are generally less frequent after the second dose. **Contraindications:** QDENGA is contraindicated in individuals with hypersensitivity to its active substances, excipients, or a previous dose; congenital or acquired immune deficiency, including immunosuppressive treatment; symptomatic HIV infection or asymptomatic HIV infection with impaired immune function; pregnancy; or breastfeeding. **Precautions:** Vaccination should be postponed during an acute severe febrile illness. Appropriate medical treatment should be readily available for rare anaphylactic reactions. Protection may not develop against all dengue serotypes and may decline over time, so mosquito-bite prevention should continue. Avoid pregnancy for at least one month after vaccination. The safety and efficacy of QDENGA have not been established in people with renal or hepatic impairment or those over 60 years of age. **Interactions:** QDENGA should not be given during immunosuppressive treatment. Following treatment with immunoglobulins or blood products, wait at least 6 weeks, preferably 3 months, before vaccination. QDENGA may be administered with hepatitis A, yellow fever, or human papillomavirus vaccines, using separate injection sites where applicable.1 Please refer to the Consumer Medicine Information for more information. **PBS/NIP Information:** QDENGA is not listed on the Pharmaceutical Benefits Scheme (PBS) or the National Immunisation Program (NIP). ▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. Patients can help by reporting any side effects to their doctor, or directly at [https://www.tga.gov.au/reporting-problems](https://www.tga.gov.au/reporting-problems). Healthcare professionals are asked to report any suspected adverse events at [https://www.tga.gov.au/reporting-problems](https://www.tga.gov.au/reporting-problems). **Disclosure:** Dr Deb Mills has served on an advisory board for which compensation was received. In relation to this Takeda media announcement, no compensation was provided to Dr Mills, and the opinions expressed are her own. Dr Mills has been briefed by Takeda on the approved use of this product. Patient stories contained within this media release are not representative of all patients’ experience with dengue. ## About Takeda Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit [Takeda.com](http://www.takeda.com/). ## Media Contacts Takeda Media Relations [[email protected]](mailto:[email protected]) ## Important Notice For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws. The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies. ## Medical Information 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. ## References 1. Therapeutic Goods Administration. Australian Product Information: QDENGA® dengue tetravalent vaccine (live, attenuated). Approved 2 June 2026. 2. Australian Centre for Disease Control. National Notifiable Diseases Surveillance System (NNDSS) Fortnightly Report: 17 March to 30 March 2025. 3. World Health Organization. Dengue and severe dengue. Updated 21 August 2025. 4. Centers for Disease Control and Prevention. Areas with Risk of Dengue. Available at: [http://cdc.gov/dengue/areas-with-risk/index.html](http://cdc.gov/dengue/areas-with-risk/index.html) C-APROM/AU/QDE/0022. Date of preparation: September 2026.