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TAK-426 Zika Vaccine

Takeda's TAK-426 (PIZV) is a purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate. The absence of specific treatment makes a prophylactic Zika virus vaccine an unmet medical need, according to a recent study published by The Lancet. The vaccine was tested in a phase 1 study called PIZV or TAK-426 adjuvanted with aluminum hydroxide. TAK-426 was found well tolerated, with an acceptable safety profile, and was immunogenic in both flavivirus-naive and flavivirus-primed adults.

The peer-reviewed Journal of Infectious Diseases reported on December 9, 2022, on the two-year persistence of immune response to TAK-426 compared with that observed after natural infection. TAK-426 at 10-μg had an acceptable safety profile in FV-naive and FV-primed adults up to 24 months after dose 2. Seropositivity for neutralizing antibodies was 100% at one year and 93.8% and 76.2% at two years in FV-naive and FV-primed groups, respectively. TAK-426 responses were comparable in magnitude and kinetics with those elicited by natural Zika virus infection. These phase 1 study results support the further clinical development of TAK-426 for both FV-naive and FV-primed populations.

In February 2016, the World Health Organization (WHO) declared the Zika outbreak a Public Health Emergency of International Concern. On January 29, 2018, Takeda's Zika Vaccine candidate received U.S. FDA Fast Track Designation. On July 27, 2023, Takeda confirmed to support the expansion of our pipeline and the development of our programs, we have entered into partnerships with government organizations in Japan and the U.S. and leading global institutions.

Osaka, Japan-based Takeda is a patient-focused, values-based, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future to people worldwide. 

TAK-426 Vaccine Indication

The TAK-426 vaccine candidate prevents the Zika virus, which is caused by a virus transmitted by Aedes aegypti and Aedes albopictus mosquitoes. The Zika virus was first reported in continental South America in Brazil in May 2015. Zika virus is a flavivirus associated with congenital malformations and neurological complications. According to the World Health Organization (WHO), symptoms of Zika may include mild fever, skin rash, conjunctivitis, muscle and joint pain, malaise, or headache.

TAK-426 Vaccine Dosage

In a phase 1 study, TAK-426 was administered by intramuscular injection into the middle third of the deltoid muscle, preferably in the non-dominant arm on Days 1 (Visit 1) and 29 (Visit 4). Three different vaccine doses containing different protein concentrations (2, 5, or 10 micrograms [mcg]) will be given as a two-dose schedule to flavivirus-naive and primed healthy adults. Based on a recent study, the 10 μg TAK-426 dose was selected for further clinical development.

TAK-426 Vaccine News

December 8, 2022 - Researchers wrote: In conclusion, we confirm that PIZV has an acceptable safety profile in healthy adults aged 18–49 years, with no vaccine-related SAEs through 2 years after vaccination. Two vaccinations elicited immune responses that persisted at high titers (GMTs >100) comparable to those observed in convalescent ZIKV-infected patients up to 2 years after vaccination in FV-naive and FV-primed adults. These safety and immunogenicity profiles of the high dose (10-µg) PIZV confirm its suitability for further clinical development.

November 19, 2021 - The company presented: Measurement Of Zika Virus-Specific Antibodies Using A Microsphere-Based Competitive Immunoassay. 'Collectively, our data suggest that the assay can differentiate ZIKV-specific antibodies from antibodies to other FVs elicited by natural infection or vaccination. Availability of a ZIKV-specific antibody-based immunoassay will improve differential diagnosis, serosurveillance, and support development and implementation of ZIKV vaccines in FV endemic regions.'

May 18, 2021 - Study Interpretation: TAK-426 was well tolerated,hadh an acceptable safety profile, and was immunogenic in both flavivirus-naive and flavivirus-primed adults. Based on the safety and immunogenicity profiles of all TAK-426 doses assessed, the 10 μg TAK-426 dose was selected for further clinical development. Study Funding: Takeda Vaccines and the US Biomedical Advanced Research and Development Authority.

August 26, 2019 – A recent Zika study focused on eliminating the mosquito and sexual transmission of the Zika virus with a preventive vaccine.

January 29, 2018 - Takeda Pharmaceutical Company Limited announced that the U.S. FDA had granted Fast Track designation to TAK-426, Takeda's purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate.

September 2, 2016 - Takeda announced that BARDA, the Biomedical Advanced Research and Development Authority, has selected Takeda's Vaccine Business Unit to develop a vaccine to support the Zika response in the US and affected regions worldwide. Initial funding from BARDA, which is a division of the Office of the Assistant Secretary for Preparedness and Response within the US Department of Health and Human Services, is for $19.8 million to cover the vaccine development through Phase 1, with potential funding of up to $312 million if all options to take the vaccine through Phase 3 trials and filing of the Biologics License Application in the USA. 

TAK-426 Clinical Trials

The Journal of Infectious Diseases reported that a randomized, observer-blind, placebo-controlled, dose-selection, phase 1 trial was conducted in 18–49-year-old adults at nine centers (7 in the United States and 2 in Puerto Rico) from 13 November 2017 to 24 November 2020. The primary objectives were safety, tolerability, and immunogenicity of 3 increasing doses of TAK-426 administered as two doses 28 days apart to flavivirus (FV)–naive and FV-primed adults. Here, we report on the safety and persistence of immunity up to 2 years after primary vaccination with 10-μg TAK-426, the highest dose, and compare neutralizing antibody responses with those observed after natural infection. Results: TAK-426 at 10-μg had an acceptable safety profile in FV-naive and FV-primed adults up to 24 months after dose 2. Seropositivity for neutralizing antibodies was 100% at one year and 93.8% and 76.2% at two years in FV-naive and FV-primed groups, respectively. TAK-426 responses were comparable in magnitude and kinetics with those elicited by natural Zika virus infection.

On September 21, 2021, The Lancet reported the findings of this clinical trial. Between Nov 13, 2017, and Oct 24, 2018, 894 volunteers were screened, and 271 enrolled (125 flavivirus-naive and 146 flavivirus-primed participants). All TAK-426 doses were well tolerated with no deaths, no vaccine-related serious adverse events, and similar rates of mainly mild to moderate adverse events. Interpretation: The researchers concluded that TAK-426 was well tolerated,hadh an acceptable safety profile, and was immunogenic in both flavivirus-naive and flavivirus-primed adults. Based on these results, TAK-426 will continue to be tested in clinical settings.

QDENGA® (TAK-003) Dengue Vaccine Clinical Trials, Dosage, Indication, Side Effects

Takeda GmbH's QDENGA® (TAK-003) (Dengue Tetravalent Vaccine [Live, Attenuated]) is an approved two-dose vaccine preventing Dengue fever and/or Severe Dengue caused by any of the four serotypes of the Dengue virus. QDENGA is based on Dengue serotype 2, which provides the genetic backbone for all four Dengue virus serotypes. The active substance of QDENGA (ATC code: J07BX04) contains live attenuated Dengue viruses, which replicate locally and elicit humoral and cellular immune responses against Dengue serotypes.

Takeda's clinical development program for QDENGA consists of Phase 3, Phase 2, and Phase 1 studies. Data from children and adolescents showed that QDENGA induced immune responses against all four Dengue serotypes in both seropositive and seronegative participants. In addition, QDENGA was generally safe and well-tolerated. In a Phase 2 study published on October 17, 2024, TAK-003 elicited durable T cell responses against all four DENV serotypes, regardless of baseline serostatus, in individuals aged 4–16 years residing in dengue-endemic countries. Furthermore, TAK-003-elicited CD4+ and CD8+ T cells were multifunctional and persisted for up to 3 years post-vaccination.

On December 8, 2022, QDENGA became the first Dengue vaccine approved in Europe for use regardless of previous exposure and without the need for pre-vaccination testing. Europe's Committee for Medicinal Products for Human Use adopted a positive opinion on October 13, 2022, recommending that Takeda GmbH be granted marketing authorization for QDENGA EMEA/H/C/005155. In 2023, Brazil was the first country to integrate QDENGA into its public health system. The World Health Organization (WHO) added QDENGA® (TAK-003) to its List of Prequalified Vaccines, effective May 9, 2024. On May 3, 2024, the WHO published a paper on Dengue vaccines, including final guidance on the use of QDENGA in public vaccination programs based on the SAGE recommendation. The WHO-SAGE recommends that TAK-003 be considered for public programs in high-transmission areas for individuals aged 6-16. 

On November 3, 2025, Takeda announced data, including an exploratory analysis of a booster dose, confirming the favorable benefit-risk profile of QDENGA and that the two-dose regimen provides sustained protection against Dengue over 7 years. As of November 2025, QDENGA is authorized in the United Kingdom and 41 other countries.

Derek Wallace, President, Global Vaccine Business Unit, Takeda Pharmaceuticals, informed Vax-Before-Travel on November 6, 2025, "Dengue is spreading to areas once considered low-risk, with year-round peak seasons in many regions. These long-term data show that QDENGA's two-dose schedule provides sustained protection without a booster, simplifying vaccination efforts and improving our ability to combat Dengue globally."

Published by Nature's npj Vaccines on February 2, 2026, this review provides an overview of the rationale for some key decisions made during TAK-003 development.

Osaka-based Takeda Pharmaceutical Company Limited (TSE: 4502, NYSE: TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discovering and delivering life-transforming treatments, guided by our commitment to patients, our people, and the planet in approximately 80 countries and regions. For more information about QDENGA (TAK-003), visit www.TakedaVaccines.com. QDENGA - Trademark Details: 2019-06-04.

QDENGA (TAK-003) Vaccine Availability 2026

The WHO recommends that countries consider introducing TAK-003 into their routine immunization programs in areas with high Dengue transmission intensity, where it poses a significant public health problem. Since 2022, QDENGA has been authorized in 41 countries, and 18.6 million doses have been distributed in 11 endemic countries including Indonesia (approved Aug 2022, available April 2023), Brazil (approved Mar 2023, available June 2023, Thailand (approved May 2023, available Aug 2023), Argentina (approved Apr 2023, available Oct 2023), Malaysia (approved Feb 2024, available June 2024), Colombia (approved Sept 2023, available July 2024), Germany (approved Dec 2022, available Feb 2023), Finland (approved Dec 2022, available Feb 2023), Sweden (approved Dec 2022, available Feb 2023), Norway (approved Dec 2022, available Feb 2023), Denmark (approved Dec 2022, available Mar 2023), The Netherlands (approved Dec 2022, available Mar 2023), Luxembourg (approved Dec 2022, available March 2023), Czech Republic (approved Dec 2022, available April 2023), Austria (approved Dec 2022, available April 2023), Belgium (approved Dec 2022, available April 2023), Ireland (approved Dec 2022, available April 2023), Portugal (approved Dec 2022, available May 2023), Spain (approved Dec 2022, available May 2023), U.K. (approved Jan 2023, available 2024), Slovakia (approved Dec 2022, available Aug 2023), Italy (approved Dec 2022, available Oct 2023), Poland (approved Dec 2022, available Dec 2023), Israel (approved May 2024, available July 2024), Switzerland (approved Aug. 2024), Malasyia, Thailand, and Vietnam. As of 2025, availability in the Philippines and India was pending. On February 3, 2026, Paraguay announced the expansion of its Qdenga vaccination program.

Qdenga (TAK-003) Vaccine Efficacy

A Takeda-funded study based in Thailand concluded on June 17, 2025, that the pragmatic introduction of TAK-003 into the immunization program would prevent 44% of cases and 53% of hospitalizations, resulting in $1.346 billion in savings over 20 years.

On October 17, 2024, the journal NPJ Vaccines published results from a study that concluded that TAK-003 was well tolerated and elicited durable T cell responses against all four Dengue virus (DENV) serotypes, irrespective of baseline serostatus, in children and adolescents aged 4–16 years living in dengue-endemic countries. TAK-003-elicited CD4+ and CD8+ T cells were multifunctional and persisted for up to 3 years post-vaccination.

An exploratory analysis published on September 11, 2024 (December 2, 2024) demonstrated a vaccine efficacy (VE) of 82.1% for the onset of protection with TAK-003 in the safety population, measured over the three months between the first and second doses. The journal Vaccine published a Short Communication on September 7, 2024, reporting that QDENGA's vaccine efficacy (VE) against disease was 82.1% up to 3 months after the first dose. On October 2, 2023, the WHO Strategic Advisory Group of Experts on Immunization (SAGE) confirmed that QDENGA demonstrated efficacy against all four serotypes of the virus in baseline seropositive children (4-16 years old) in endemic countries, as well as against serotypes 1 and 2 in baseline seronegative children. The SAGE recommended that the Vaccine be considered for introduction to children aged 6 to 16 years in settings with high Dengue disease burden and high transmission intensity. Long-term efficacy results announced on June 9, 2022, supplemented previously published TIDES clinical study data, demonstrating QDENGA met its primary endpoint of overall VE against VCD, with 80.2% efficacy at 12-month follow-up, as well as all secondary endpoints for which there were a sufficient number of Dengue cases at 18-month follow-up, including 90.4% VE against hospitalized Dengue. On May 20, 2021, an audio review of the Three-Year Efficacy of Takeda's Tetravalent Dengue Vaccine Candidate was published.

Qdenga (TAK-003) Time to Onset of Vaccine Efficacy

A study published in Vaccine on September 7, 2024, in the DEN-301 clinical trial estimated the Vaccine's efficacy onset to be approximately 2 weeks. Results from a study published in the Journal of Infectious Diseases on March 18, 2025, found that TAK-003 had a modest impact on asymptomatic Dengue infections in the first months post-vaccination, particularly among baseline seropositive participants. 

QDENGA and U.S. FDA

Takeda announced on July 11, 2023, that the Company voluntarily withdrew the U.S. Biologics License Application (BLA) for TAK-003 following discussions with the U.S. Food and Drug Administration (FDA) regarding data-collection aspects that could not be addressed within the current BLA review cycle. The plan for TAK-003 in the U.S. will be further evaluated, given the need for travelers and those living in dengue-endemic areas, such as Puerto Rico, Mexico, and Florida. On November 22, 2022, Takeda announced that the FDA had accepted and granted priority review of the Biologics License Application (BLA) for QDENGA to prevent Dengue disease caused by any Dengue virus serotype in individuals aged four years through 60 years.

QDENGA and U.S. CDC

During the U.S. Centers for Disease Control and Prevention Advisory Committee on Immunization Practices (ACIP) meeting on October 26, 2023, Dr. Gabriela Paz-Bailey (CDC/NCEZID) led a QDENGA update. Wilbur Chen, MD, presented Updates on Dengue Vaccines. On June 22, 2023, I reviewed the following presentations: ACIP Dengue Vaccines Work Group introduction,   Wilbur Chen, MD, MSc; Economic analysis and health impacts of routine vaccination with TAK-003 Dengue vaccine in San Juan, Puerto Rico; Summary of two economic models for Dengue vaccine TAK-003 use in Puerto Rico; Partial Evidence to Recommendations Framework for Dengue Vaccine TAK-003, presented by Joshua Wong, MD. On February 23, 2023, the ACIP met to discuss the following presentations: Introduction, Dr. W Chen; Takeda Dengue vaccine (TAK-003) safety and efficacy, Dr. Shibidas Biswal; Workgroup considerations, Dr. Gabriela Paz-Bailey. Previously, Laura Adams, DVM, MPH, DACVPM, led the U.S. CDC's Dengue Epidemiology vaccine overview on October 20, 2022, during the CDC/ACIP Dengue Vaccine Workgroup presentation.

QDENGA (TAK-003) Indication

Dengue is now detected in 129 countries and set a record for cases in 2024. As more travelers return to the U.S. with Dengue virus infections, the risk of local mosquito-borne transmission increases. In European Union Member States, QDENGA is indicated for the prevention of Dengue disease in individuals aged 4 years and above. It prevents Dengue, which is caused by the four Dengue serotypes. On May 15, 2024, the WHO confirmed that Qdenga is approved for use in children aged 6–16 in settings with a high Dengue burden and transmission intensity. The WHO says TAK-003 does not prevent all cases of Dengue.

QDENGA (TAK-003) Dosage

Under the approved dosing regimen, QDENGA should be administered subcutaneously in a two-dose schedule (0 and 3 months) at 0.5 mL per dose. The WHO SAGE recommends administering QDENGA in a 2-dose schedule with a 3-month interval between doses. QDENGA should be administered preferably in the upper arm in the deltoid region. QDENGA must not be injected intravascularly, intradermally, or intramuscularly. In Europe, the EMA approved after reconstitution, one dose (0.5 mL) contains Dengue virus serotype 1 (live, attenuated)*: ≥ 3.3 log10 PFU/dose Dengue virus serotype 2 (live, attenuated): ≥ 2.7 log10 PFU/dose Dengue virus serotype 3 (live, attenuated): ≥ 4.0 log10 PFU/dose Dengue virus serotype 4 (live, attenuated): ≥ 4.5 log10 PFU/dose.

On September 2, 2024, Vaccine published an analysis concluding that a single dose of TAK-003 was as effective as two doses.

QDENGA (TAK-003) Coadministraion

Co-administration with a hepatitis A vaccine has been studied without increased side effects or impaired antibody response. When co-administered with the yellow fever vaccine, a lower level of neutralizing antibodies against DENV1 was seen, the clinical significance of which is unclear. 

QDENGA Co-Administration With HPV9 Vaccine

According to a recent phase 3 clinical study published in the journal Vaccines (Volume 62, August 30, 2025, 127558), dengue-endemic countries, such as the Kingdom of Thailand, have already initiated national Human Papillomavirus (HPV) school-based vaccination programs. Researchers wrote on July 30, 2025, 'Due to the overlapping age range targeted by many vaccines, including 9vHPV (Merck GARDASIL 9®) and TAK-003 (Takeda's QDENGA®), integration of Dengue vaccination into existing vaccination programs could be a beneficial approach to increase vaccine coverage and reduce operational costs.'

QDENGA (TAK-003) Side Effects

A Phase 4 study published by ScienceDirect (Volume 42, Issue 26) on October 4, 2024, identified anaphylaxis as a safety signal for TAK-003 vaccines in adolescents. Most cases of anaphylaxis occurred 15 minutes after vaccination. In response, Brazil's Ministry of Health published recommendations to intensify efforts to ensure safe vaccination, including training for healthcare professionals and post-vaccination observation.

The ongoing Phase 3 study of TAK-003 showed that the rates of serious adverse events were 2.9% in the TAK-003 group and 3.5% in the placebo group during the long-term follow-up (i.e., the second half of the three-year follow-up period). Still, none of the cases were related to the study drug. The European Medicines Agency states that there is no clear evidence of an increased risk of severe Dengue disease in individuals who have been previously infected with the disease.

QDENGA (TAK-003) Adverse Reactions

The most frequently reported adverse reactions post TAK-003 vaccination in subjects 4 to 60 years of age were injection site pain (50%), headache (35%), myalgia (31%), injection site erythema (27%), malaise (24%), asthenia (20%), and fever (11%). Very common (≥1/10 of subjects): upper respiratory tract infection, decreased appetite, irritability, headache, drowsiness, myalgia, injection site pain, injection site erythema, malaise, asthenia, and fever.

In February 2025, a study reported that Vaccine-related reactions were frequently reported, predominantly after the first dose in dengue-naïve participants.

QDENGA (TAK-003) Contraindications

Contraindications include hypersensitivity to the listed active substances or excipients, as well as a history of hypersensitivity to QDENGA. Individuals with congenital or acquired immune deficiency, including immunosuppressive therapies such as chemotherapy or high doses of systemic corticosteroids (e.g., 20 mg/day or 2 mg/kg body weight/day of prednisone for two weeks or more) within four weeks before vaccination. Individuals with symptomatic HIV infection or asymptomatic HIV infection, with impaired immune function, and pregnant and breastfeeding women.

QDENGA (TAK-003) Vaccination of Pregnant Women

A post-hoc analysis published on March 18, 2025, found no evidence of increased adverse pregnancy outcomes following unintentional TAK-003 vaccination within the exposure window, compared with placebo.

QDENGA Format

Qdenga is available as a powder and as an injection solution. 

QDENGA (TAK-003) Vaccination Breakthrough Case

The immune response to Dengue infection is complex and multifaceted, and the infection can progress to severe disease with limited clinical signs. This study, published in October 2024, examined a case involving a child who developed Dengue symptoms after receiving the Qdenga vaccination. Despite initial negative diagnostic results, molecular analysis confirmed DENV4 infection.

QDENGA (TAK-003) Price

Takeda indicated in a March 16, 2023, presentation that the price of QDENGA in Indonesia would be USD 40 per dose, with an ex-factory price of USD 26. For the travel market segment, vaccine pricing will be similar to that of other innovative travel vaccines in their respective countries. For example, the retail price in Germany would be USD 115 per dose. In Brazil, reports indicate QDENGA's price is about $171.

Qdenga (TAK-003) Vaccine Revenues

QDENGA Q4 FY2024 (April 2024-March 2025) Revenue was JPY 35.6B (+259%), QDENGA's FY2024 H1 Revenue was JPY 19.9B (+863% growth); FY2024 Q1 Revenue was JPY 9.5B (+1,099% growth). 

QDENGA Vaccine Production

Biological E. Limited is committed to manufacturing up to 50 million QDENGA vaccine doses annually, accelerating Takeda's ability to deliver 100 million doses annually by 2030. 

QDENGA Vaccine News

November 3, 2025 - "QDENGA is the most comprehensively studiedDenguee vaccine, with more than 60,000 participants globally in the clinical program, and these long-term data highlight the durability of its safety and efficacy profile, across diverse populations worldwide," said Derek Wallace, M.D., president of the Global Vaccine Business Unit at Takeda.

August 25, 2025 - A study reported: We find some evidence of a risk of vaccine-induced disease enhancement in seronegative vaccine recipients for Dengue serotypes 3 and 4, especially for children under 6 years of age. Because of this, the benefits of vaccination in lower-transmission settings are less specific, and more data on the long-term efficacy of Qdenga against serotypes 3 and 4 are needed.

June 9, 2025 - Thailand's Public Health Minister Somsak Thepsuthin unveiled a new national strategy during the 2025 ASEAN Dengue Day event, which includes deploying QDENGA vaccinations in 2025.

February 18, 2025 - The Philippine Medical Association requested access to new-generation Dengue vaccines.

September 7, 2024: The journal Vaccine published a Short communication titled "Early onset of protection of the TAK-003 Dengue vaccine: Data from the DEN-301 clinical trial." The Estimated time to the onset of Qdenga vaccine efficacy was approximately two weeks.

May 10, 2024 - The World Health Organization prequalified Takeda's QDENGA vaccine. "The prequalification of TAK-003 is an important step in the expansion of global access to Dengue vaccines, as it is now eligible for procurement by UN agencies, including UNICEF and PAHO," said Dr Rogerio Gaspar, WHO Director for Regulation and Prequalification.

May 9, 2024 - Takeda announced financial results for fiscal year 2023 (period ended March 31, 2024).

October 3, 2023 – Takeda announced that the WHO Strategic Advisory Group of Experts on Immunization issued recommendations for the use of QDENGA.

July 11, 2023 - "Our clinical program was designed to account for the complex global nature of Dengue, and data from our 4.5-year trial has built confidence in TAK-003's ability to help provide long-term protection against Dengue, with a positive benefit and risk profile regardless of baseline serostatus," said Gary Dubin, M.D., president of Takeda's Vaccines Business Unit.

June 22, 2023 - The U.S. CDC's Advisory Committee on Immunization Practices reviewed various Dengue vaccine presentations.

May 23, 2023 - Filomeno Fortes, Director of Portugal's Institute of Hygiene and Tropical Medicine, confirmed the authorization of the Qdenga vaccine.

May 11, 2023 - Takeda announced its collaboration with Brazil's National Health Surveillance Agency. In March 2023, QDENGA received the first approval in Latin America.

March 13, 2023 - José Manuel Caamaño, president of Takeda in Brazil, stated in a press release, "We are proud to make our vaccine available to the Brazilian government and health care providers with the hope that it may become an important tool to help combat Dengue as part of an integrated Dengue management program along with vector control."

February 6, 2023 - Takeda UK Ltd. announced that the U.K.'s Medicines and Healthcare products Regulatory Agency had granted marketing authorization for Qdenga. 

October 20, 2022: The U.S. CDC vaccine committee presented Dengue Epidemiology: Globally and in the U.S., including ACIP Dengue vaccine recommendations.

October 14, 2022 - The EMA's human medicines committee recommended granting marketing authorization for the QDENGA Dengue Tetravalent Vaccine (Live, Attenuated) to prevent Dengue virus serotypes 1, 2, 3, and 4 in individuals aged four years and above.

August 22, 2022: Gary Dubin, president of Takeda's Vaccine Business Unit, announced, "We're proud to introduce QDENGA as a new Dengue prevention tool to the people of Indonesia. We will continue to work with additional regulatory agencies to make QDENGA available globally."

March 17, 2020 - The Lancet published the 'Safety and immunogenicity of a tetravalent Dengue vaccine in children aged 2–17.

November 6, 2019: Takeda's Dengue Vaccine Candidate Demonstrates Protection in Children Aged Four to 16, Regardless of Previous Dengue Exposure. 

November 5, 2019 – Takeda Pharmaceutical Company announced plans for a new manufacturing plant in Singen, Germany, for TAK-003. 

January 29, 2019 - Takeda announced that TAK-003, which is in a pivotal Phase 3 trial, met the primary efficacy endpoint.

September 7, 2016 - Takeda Initiated the Global Phase 3 Clinical Trial (TIDES) of the Dengue Vaccine Candidate (TAK-003).

QDENGA TAK-003 Clinical Trials

The approval of QDENGA is based on results from 19 Phase 1, 2, and 3 trials involving more than 28,000 children and adults, including 4.5 years of follow-up data from the global, pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial. The study was designed in collaboration with the World Health Organization (WHO) for a second-generation Dengue vaccine. A study published in the journal Vaccine on August 22, 2023, reported an efficacy of approximately 80.2% (95% CI, 73.3–85.3) against any serotype in the primary analysis. QDENGA's effectiveness declined over time, with 62% (95% CI, 56.6–66.7) efficacy at 3 years and 61.2% (95% CI, 56.0–65.8) at 4.5 years.

As of June 9, 2022, through four and a half years, TAK-003 demonstrated 84.1% vaccine efficacy (VE) (95% CI: 77.8, 88.6) against hospitalized Dengue, with 85.9% VE (78.7, 90.7) in seropositive individuals and 79.3% VE (63.5, 88.2) in seronegative individuals. TAK-003 also demonstrated an overall vaccine efficacy (VE) of 61.2% (95% CI: 56.0-65.8) against virologically confirmed Dengue (VCD), with 64.2% VE (58.4-69.2) in seropositive individuals and 53.5% VE (41.6-62.9) in seronegative individuals. Observations of VE varied by serotype and remained consistent with previously reported results. TAK-003 was generally well tolerated, and no critical safety risks were identified. No evidence of disease enhancement was observed during the 54-month exploratory follow-up analysis.

PREVNAR 20® Vaccine Clinical Trials, Dosage, News, Side Effects, Usage

Pfizer Inc.'s PREVNAR 20® (20vPnC, APEXXNAR, PF-06482077) is a 20-valent pneumococcal conjugate vaccine that protects adults from a substantial invasive pneumococcal disease and pneumonia burden. PREVNAR 20 includes the 13 serotypes contained in Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) plus seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F). PREVNAR 20 also contains capsular polysaccharide conjugates for seven other serotypes that cause pneumococcal disease and have been associated with high case-fatality rates, antibiotic resistance, and/or meningitis. The 20 serotypes in 20vPnC are responsible for most currently circulating pneumococcal diseases globally.

On June 8, 2021, Pfizer confirmed the U.S. FDA Approved PREVNAR 20 for preventing invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae serotypes in the vaccine in adults. The FDA previously granted Pfizer's 20vPnC Fast Track Designation in May 2017 and Breakthrough Therapy Designation in August 2020 for the pediatric indication of IPD. In addition, the European Medicines Agency (EMA) issued its Approval for the brand name Apexxnar on February 15, 2022. On April 27, 2023, the FDA approved PREVNAR 20 for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae serotypes contained in the vaccine in infants and children six weeks through 17 years of age and for the prevention of otitis media in infants six weeks through five years of age caused by the original seven serotypes contained in PREVNAR®.

On June 22, 2023, the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) unanimously voted to recommend PREVNAR 20 for routine use to help protect infants and children from IPD caused by the 20 Streptococcus pneumoniae serotypes covered by the vaccine and for the prevention of otitis media in infants six weeks through five years of age caused by the original seven serotypes contained in PREVNAR.

Pfizer announced on March 13, 2024, that the European Commission (EC) had granted marketing authorization for the company to market the vaccine in the European Union under the brand name PREVENAR 20®. This EC authorization is valid in all 27 EU member states, including Iceland, Lichtenstein, and Norway. It follows the recent positive opinion of the European Medicines Agency's Committee for Medicinal Products for Human Use.

For more information, please visit New York-based pfizer.com. (NYSE: PFE). On January 30, 2024, Pfizer announced Prevnar 13 & 20 revenues were down 7% operationally, driven primarily by the pediatric indication in emerging markets due to lower demand and unfavorable timing of customer orders.

PREVNAR 20 Indication

The U.S. CDC recommends pneumococcal vaccination for children and adults 65 or older. In addition, older children and other adults should also get pneumococcal vaccines in certain situations. Globally, pneumococcal pneumonia is estimated to cause about 500,000 deaths and 30 million episodes annually in adults 70 and older. The CDC says the 20 serotypes included in 20vPnC are responsible for the most currently circulating pneumococcal disease in the U.S. and globally. In addition, the seven new serotypes included in 20vPnC cause IPD and are associated with high case-fatality rates, antibiotic resistance, and/or meningitis.

PREVNAR 20 Dosage

The 20vPnC (PF-06482077) vaccine is administered as an intramuscular injection.

PREVNAR 20 News

January 15, 2025 - The Pan American Health Organization, the Government of Argentina, Pfizer, and the pharmaceutical company Sinergium Biotech have announced a joint effort to facilitate local production and regional access to the 20-valent pneumococcal conjugate vaccine (PCV20).

March 13, 2024 - Alexandre de Germay, Chief International Commercial Officer, Executive Vice President, Pfizer. PREVENAR 20 builds on Pfizer's decades-long commitment to developing vaccines to help prevent potentially life-threatening infections, and we are proud to now provide the broadest serotype coverage of any pneumococcal conjugate vaccine for children in Europe."

January 26, 2024 - Pfizer Inc. announced that the EMA's CHMP adopted a positive opinion, recommending the granting of a marketing authorization for its 20-valent pneumococcal conjugate vaccine candidate for active immunization to prevent invasive disease, pneumonia, and acute otitis media-caused by Streptococcus pneumoniae in infants, children, and adolescents from 6 weeks to less than 18 years of age.

June 22, 2023 - "We are thrilled with today's ACIP decision as it recognizes the increased level of protection that PREVNAR 20 will provide to millions of infants and children against pneumococcal disease," said  Luis Jodar, Ph.D., Chief Medical Affairs Officer, Vaccines/Antivirals and Evidence Generation, Pfizer. This decision represents a significant step in improving public health. It allows pediatricians and other clinicians to offer the broadest serotype pneumococcal conjugate vaccine available to help protect infants and their families from life-threatening infections caused by the 20 serotypes covered by the vaccine".

April 27, 2023 - The U.S. FDA approved PREVNAR 20® for Infants and Children.

July 21, 2022 -  Pfizer Canada ULC announced that the PREVNAR 20 vaccine is now available in Canada. 

Prevnar 20 (Apexxnar) Pneumococcal Vaccine Clinical Trials

Pfizer continues to test Prevnar 20 in various clinical trials.

In 2020, Pfizer initiated the Phase 3 clinical trial program for the pediatric indication of 20vPnC. Four core Phase 3 pediatric studies will help expand the data on the safety, tolerability, and immunogenicity of 20vPnC. These studies collectively enrolled approximately 4,700 infants and 800 toddlers and children of all ages, including:

A Phase 3 study describing the tolerability and safety and comparing the immunogenicity of 20vPnC to Prevnar 13® in infants vaccinated at 2, 4, 6, and 12-15 months of age in the U.S. (NCT04382326)

A Phase 3 study described the tolerability and safety of 20vPnC, with Prevnar 13® serving as the control in infants vaccinated at 2, 4, 6, and 12-15 months of age in multiple countries. (NCT04379713)

A Phase 3 study describing the tolerability and safety and comparing the immunogenicity of 20vPnC to Prevnar 13® in infant vaccination at approximately 2, 4, and 11-12 months of age in Europe and Australia (NCT04546425)

A Phase 3 study in children 15 months through <18 years of age receiving a single dose of 20vPnC in the U.S. (NCT04642079).

Flucelvax® Influenza Vaccine Clinical Trials, Efficacy, Indication, Side Effects

CSL Seqirus Flucelvax® is a cell culture-based influenza vaccine that protects people against various virus strains, as recommended by the World Health Organization (WHO). Flucelvax is the first and only trivalent cell-based influenza vaccine indicated for use in individuals six months and older who do not have the B/Yamagata influenza virus strain. Approved by the U.S. Food and Drug Administration (FDA) in 2012 and 2016, Flucelvax is indicated (STN: BL 125408, BL 125408/586) for everyone six months and older eligible to receive an influenza vaccine for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and types B contained in the vaccine.

Flucelvax is the first FDA-approved flu vaccine to use cells instead of chicken eggs. It represents the first significant advance in flu vaccine manufacturing technology since flu vaccine production began in the 1930s. This modern manufacturing process enables the flu shot to be antibiotic-free, helps protect against the four identified flu strains for the 2020-2021 season, and is well-tolerated. Moreover, cell-based flu vaccine production does not use flu viruses grown in eggs and is not dependent on the availability of eggs. Additionally, cell-based flu vaccines that utilize cell-based candidate vaccine viruses (CVVs) can provide better protection than traditional, egg-based flu vaccines.

The U.S. Centers for Disease Control and Prevention (CDC) confirmed in 2023 that viruses used to make cell-based vaccines may be more similar to circulating "wild" flu viruses than those used to make egg-based vaccines. Cell-based influenza vaccine technology may offer advantages over the standard influenza manufacturing process, including greater scalability and faster production during an influenza pandemic. On June 21, 2023, the Advisory Committee on Immunization Practices (ACIP) presented considerations and proposed recommendations for the 2023-2024 flu season in the U.S. On February 22, 2023, the CDC's ACIP agenda highlighted preliminary data on the effectiveness of cell-based influenza vaccines (i.e., Flucelvax) during the 2022-23 flu season.

On July 10, 2025, CSL Seqirus announced that the Company had commenced shipping its differentiated portfolio of influenza vaccines for the 2025/26 U.S. season. 

In the United Kingdom and European Union, Flucelvax is marketed as FLUCELVAX® TETRA.

CSL Seqirus reported on February 12, 2024, a half-year revenue of $ 1.804 billion, which was up 2% over the same period last year. In the U.S., CSL Seqirus operates a state-of-the-art cell-based manufacturing facility in Holly Springs, NC, purpose-built in partnership with the Biomedical Advanced Research and Development Authority (BARDA) to increase cell-based vaccine manufacturing capacity and combat pandemic influenza threats. On August 15, 2023, the Company announced that significant progress had been made on constructing the new cell-culture influenza vaccine facility in Melbourne, which is expected to be operational by 2026. Seqirus is part of CSL Limited (ASX: CSL), headquartered in Melbourne, Australia. The CSL Group employs over 20,000 people in more than 60 countries.

Flucelvax Vaccine Effectiveness 

Additionally, data presented by the Marshfield Clinic Research Institute on February 22, 2023, demonstrated that cell-based influenza vaccines, such as FluecelVax, provided 71% effectiveness in children between 6 months and 18 years old and 54% effectiveness among adults aged 18 years and older.

Flucelvax Vaccine Indication

A six-month or longer age indication for FLUCELVAX is approved in the U.S., Argentina, Canada, Taiwan, Australia & New Zealand to prevent disease caused by influenza A and type B viruses in the vaccine. For additional information on Seqirus influenza vaccines for the upcoming flu season, as well as resources about vaccination campaigns and CDC guidance, visit flu360.com.

Flucelvax Vaccine Pediatric 

A study funded by Seqirus CLS and published on October 15, 2023, concluded that using a QIVc is effective in pediatric patients, with evidence of incremental benefits over using a QIVe in preventing hospitalizations and influenza-related medical encounters in nearly all published studies. The use of QIVc in pediatric populations is cost-effective when incorporated into a broader scheme that spans multiple age groups. The lack of potential for mismatch due to egg adaptation, combined with manufacturing benefits, means that cell-based influenza vaccines can play an essential role in population-level protection against Influenza.

Flucelvax Vaccine Pregnancy

On October 25, 2023, Gregg C. Sylvester, MD, MPH, Seqirus, presented at the ACIP Meeting - Pregnancy Outcomes with ccIIV4 (Flucelvax); Post Marketing Study. The independent expert committee found no evidence of a safety concern. These data support the use of ccIIV4 for immunization against Influenza in pregnant women and the fetus/infant population. Additionally, Nicky Klein, MD, PhD, Director of the Kaiser Permanente Vaccine Study Center, presented the safety of the quadrivalent recombinant influenza vaccine in pregnant women and their infants. In summary, within a large population of influenza-vaccinated pregnant women, no differences were observed in pregnancy, birth, and neonatal/infant outcomes when comparing RIV4 with SD-IIV4. No safety concerns were identified after RIV4 use in pregnancy.

CSL Seqirus presented original safety data at the Infectious Diseases Society for Obstetrics and Gynecology annual meeting from a new prospective observational cohort study evaluating pregnancy outcomes and fetal events of interest following vaccination with the Company's cell-based Flucelvax QIVc. The study found no unexpected adverse pregnancy outcomes in pregnant women in the U.S. who were vaccinated with QIVc.

On July 30, 2021, Seqirus announced a 'prospective observational cohort study that evaluated pregnancy outcomes and events of interest in the fetus or infant following vaccination with QIVc during any trimester. "Pregnant people (women) and people (women) who have recently given birth can be particularly vulnerable to infectious diseases like influenza," commented Christopher Robinson, M.D., MSCR, Charleston Maternal-Fetal Medicine and study author, in a press release. "These data provide further reassurance on the safe use of seasonal influenza vaccines in pregnant people (women)."

Flucelvax Vaccine Price

CSL Seqirus provides a coding and billing guide for healthcare providers. 

Flucelvax Vs. Egg-Based Vaccines

On December 19, 2023, the Original Research should have presented real-world evidence (RWE) evaluating clinical outcomes among seniors aged 65 years or older, indicating a superior clinical benefit of all adjuvanted trivalent vaccines over standard egg-derived quadrivalent inactivated influenza vaccines. In a meta-analysis of RWE from cohort design studies, the pooled estimate for the relative vaccine effectiveness of V3 compared with IIV4e for the prevention of influenza-related medical encounters was 13.7% (95% confidence interval: 3.1%–24.2%).

Flucelvax Vaccine Dosage

Flucelvax is a preservative- and latex-free vaccine for intramuscular injection only. It is available as a 0.5ml intramuscular vaccine per dose.

Flucelvax Vaccine Side Effects

CSL Seqirus published a FluCelVax vaccine side effect disclosure in 2016, followed by Australia, and the EMA updated Flucelvax Tetra in 2020. The most common (≥10%) local and systemic reactions in adults 18-64 years of age were injection site pain (45.4%), headache (18.7%), fatigue (17.8%), and myalgia (15.4%), injection site erythema (13.4%), and induration (11.6%), according to the U.S. FDA.

Flucelvax Vaccine News

July 10, 2025 - Stefan Merlo, Vice President of Commercial Operations, North America, CSL Seqirus, stated, "In light of this, we are fully committed to supporting our partners in their efforts to protect the health of their communities by offering a differentiated portfolio of flu vaccines with options designed to provide higher levels of protection compared to traditional vaccines, helping address factors that commonly impact vaccine effectiveness."

July 9, 2024 - CSL Seqirus announced that it has commenced shipping its differentiated portfolio of influenza vaccines.

July 1, 2024 - The U.S. FDA wrote: We hereby approve the draft content of labeling, including the Package Insert submitted on March 28, 2024, and the draft carton and container labels submitted on the same date, as well as under Amendment 2, dated June 3, 2024.

February 8, 2024 - "Influenza continues to cause a significant public health burden, and the agility to rapidly adapt vaccines to match the circulating strains remains paramount. We are proud to say that we have responded swiftly to meet the FDA's directive and are committed to working with health authorities to support this transition ahead of the 2024/25 flu season," said Gregg Sylvester, Chief Health Officer and Head of Medical Affairs, CSL Seqirus.

October 11, 2023 - CSL Seqirus announced new data from three studies supporting the clinical, public health, and economic value of cell-based and adjuvanted seasonal influenza vaccines. The data highlights the effectiveness and value of influenza vaccination in the U.S. across all relevant age groups, risk profiles, and influenza seasons with different levels of influenza burden.

August 15, 2023 - CSL Seqirus reported that FLUCELVAX® sales recently increased by 30%.

July 17, 2023 - CSL Seqirus announced it has begun to ship 55 million cell-based, adjuvanted, and egg-based influenza vaccines across the U.S.

September 26, 2022 - Seqirus published data that "show the benefits of adjuvanted and cell-based influenza vaccine technology advances, like aTIV and QIVc, in reducing influenza-related outcomes compared to high-dose or standard vaccines in the real-world setting," said Dr. Gregg Sylvester, Chief Health Officer

July 11, 2022 - CSL Seqirus announced the shipping of its influenza vaccines for the 2022/23 flu season. 

June 6, 2022 - Seqirus announced the completion of an expansion to its manufacturing facility in Holly Springs, N.C., which supports the formulation and fill-finish of cell-based influenza vaccines in pre-filled syringes for global communities. The U.S. FDA-approved manufacturing facility and pre-filled syringe line will allow Seqirus to increase its capacity to supply the U.S. market with FLUCELVAX® QUADRIVALENT vaccines.

June 2, 2022 - Seqirus announced its manufacturing facility in Holly Springs, North Carolina. It has successfully met all the criteria required to establish domestic manufacturing capability for cell-based seasonal and pandemic influenza vaccines, as outlined by the Biomedical Advanced Research and Development Authority (BARDA). Additionally, the joint investment enables Seqirus to sustain the production of differentiated seasonal cell-based influenza vaccines.

October 19, 2021 - Seqirus presented new real-world evidence (RWE) at the International Society for Influenza and Other Respiratory Virus Diseases (ISIRV) global meeting. Most notably, Seqirus' cell-based quadrivalent seasonal influenza vaccine (QIVc) was more effective than standard, egg-based quadrivalent influenza vaccines (QIVe) in reducing influenza-related medical encounters (IRME) in children (aged ≥4 to ≤17) and adults (aged ≥18) during the 2019/20 U.S. influenza season.

October 15, 2021 - New Jersey-based Seqirus announced that the U.S. FDA had approved FLUCELVAX® QUADRIVALENT for an expanded age indication for children as young as six months old.

August 19, 2021 - Seqirus announced plans to accelerate the development of its next-generation messenger RNA (mRNA) vaccine technology, self-amplifying messenger RNA (sa-mRNA), by establishing a dedicated sa-mRNA program. Seqirus is developing several sa-mRNA-based influenza vaccine candidates, with pre-clinical results demonstrating promise compared to more traditional influenza vaccine technologies. The Company targets clinical trials for seasonal and pandemic influenza vaccine candidates in the second half of 2022.

July 30, 2021 - The Flucelvax Quadrivalent Vaccine (QIVc) was safe for pregnant women. "These data provide additional safety information regarding unexpected pregnancy complications and/or fetal outcomes to healthcare providers considering vaccination to protect their pregnant patients from the flu," said Josephine van Boxmeer, lead Clinical Scientist for the study at Seqirus and an author. "We are committed to helping to protect as many people as possible against influenza, including those who are pregnant."

May 3, 2021 - Seqirus-US presented new Phase 3 clinical data demonstrating that the Company's cell-based quadrivalent seasonal influenza vaccine (QIVc) was as safe and immunogenic as a standard quadrivalent seasonal influenza vaccine (QIV) in children six months through <4 years of age during the U.S. 2019/20 influenza season.

March 18, 2021 - Seqirus announced that Health Canada had approved FLUCELVAX® QUADRIVALENT.

March 4, 2021 - Seqirus announced that the U.S. Food and Drug Administration had approved FLUCELVAX® QUADRIVALENT (Influenza Vaccine), the Company's cell-based quadrivalent influenza vaccine (QIVc), for an expanded age indication for people two years of age and older.

December 9, 2020 - Seqirus presented new real-world evidence at the European Scientific Working Group on Influenza 2020 showing the clinical benefits of a cell-based, quadrivalent seasonal influenza vaccine (QIVc) in preventing influenza-related medical encounters compared to an egg-based quadrivalent influenza vaccine (QIVe) during the 2018 - 2019 influenza season.

October 29, 2020 - Seqirus presented absolute efficacy data on the Company's cell-based quadrivalent influenza vaccine (QIVc) from a randomized controlled trial, which met its primary endpoint in children and adolescents between ≥2 <18 years of age over three influenza seasons.

July 30, 2020 - Seqirus announced it has begun shipping its portfolio of seasonal influenza vaccines to customers in the U.S. for the 2020/21 influenza season. Seqirus is one of the world's largest influenza vaccine companies, well-positioned to supply up to 60 million doses to the U.S. market, depending on demand.

Flucelvax Clinical Trials

Seqirus continues to evaluate the Efficacy, Safety, and Immunogenicity of QIVc in clinical trials.