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Global Dengue Vaccines Disease Analysis Report 2021-2022: Approvals of TV003/TV005 and Domestic Vaccines will Lead to Considerable Competition -


The "Disease Analysis: Dengue Vaccines" report has been added to's offering.

The dengue vaccines market is expected to expand rapidly following the anticipated launch of TAK-003 in 2021/22.

The pipeline remains active with two late-phase live-attenuated vaccines (LAVs), Takeda's TAK-003 and Merck & Co's TV003/TV005, in development in dengue-endemic regions. TV003/TV005 was initially developed by the US National Institute of Allergy and Infectious Diseases (NIAID) and has been licensed to the Butantan Institute in Brazil, where it is in Phase III trials; Merck & Co in the US, Canada, China, Europe, and Japan; and various other developers in India, the Middle East, and Asia-Pacific markets, with the goal of ensuring market access by facilitating cheaper domestic production in key dengue-endemic regions.

As the first-to-market vaccine with strong efficacy against severe dengue (67-80% reduction in hospitalization rates), Dengvaxia was anticipated to generate blockbuster sales; however, the vaccine has been a commercial failure with sales as low as $4m in 2017. This is primarily due to post-marketing safety issues, with a disproportionate efficacy to DENV-4 hypothesized to be the reason for an increased risk of hospitalization in seronegative individuals (placebo 1.87% vs 3.06% treated).

Following revisions to WHO guidelines in 2018, Dengvaxia's use was restricted to seropositive individuals, which substantially reduced its target population. Given that most dengue-endemic regions consist of low-income countries, they are unlikely to implement the necessary serostatus screening programs that would allow identification of individuals eligible to receive Dengvaxia. With two pipeline candidates demonstrating efficacy regardless of serostatus and improved dosing schedules, Dengvaxia is under threat of obsolescence.

TAK-003, a second-generation LAV, is the most promising pipeline candidate and is expected to supersede Dengvaxia. Given TAK-003's clean safety profile, better dosing schedule, and strong efficacy in both seronegative and seropositive individuals, the publisher expects that it will rapidly capture market-leader status.

Phase III data indicate that TAK-003 has a major competitive advantage of being efficacious regardless of serostatus, which makes it a much more attractive candidate for national immunization programs, since parallel serostatus screening programs are not required. Importantly, this also places TAK-003 in a position to establish a monopoly in the lucrative traveler market, given that Dengvaxia's inconvenient dosing schedule and lack of efficacy in seronegative individuals effectively preclude its use in this setting.

Additional advantages include the vaccine's favorable two-dose schedule (0 and 3 months), which will likely have a higher compliance rate than Dengvaxia's three-dose regimen (0, 6, 12 months), and the wider target age range (4-16 years), which will address the unmet need of providing an immunization strategy for younger children.

Having reported strong Phase II immunogenicity data with a balanced tetravalent immunogenic response as well as providing protection in a human challenge study, Merck & Co's TV003/TV005 is another threat to Dengvaxia. TV003/TV005 remains behind TAK-003 in development, with a Phase III trial in Brazil assessing the vaccine's safety and efficacy expected to be completed in H2 2021. If the vaccine demonstrates the expected protection against all four serotypes in both seropositive and seronegative individuals, it will be in a strong position to compete with TAK-003.

Notably, a strong response against DENV-3 would be highly desirable for TV003, since TAK-003 showed lesser efficacy against this serotype in its pivotal TIDES study. An additional advantage of the vaccine will be its single-dose schedule, which is superior to TAK-003's two-dose (0 and 3 months) and Dengvaxia's three-dose (0, 6, 12 months) schedules. A single-dose vaccine will also be particularly attractive as a travel vaccine, since this is more convenient and can be administered at short notice.

GlaxoSmithKline, the Walter Reed Army Institute of Research (WRAIR), and the Oswaldo Cruz Foundation have evaluated a tetravalent purified formalin-inactivated virus vaccine, DPIV, though as GlaxoSmithKline does not list any dengue vaccines in its pipeline, it is unclear whether the company intends to further develop the vaccine. So far, the vaccine has demonstrated promising results in two Phase I trials, with tetravalent neutralizing antibody responses in all vaccinated individuals.

An inactivated vaccine has potential advantages over LAVs as it can be administered safely to immunocompromised individuals and is also less likely to run into the issue of serotype interference, whereby one strain replicates more efficiently, leading to an imbalanced immune response to one serotype and lesser responses to remaining serotypes. To date, the publisher has not identified any additional planned or ongoing studies for DPIV.

In addition to favorable efficacy and safety profiles, tiered pricing strategies will also play a major role in the success of vaccines. With many dengue-endemic markets being unable to afford expensive public immunization programs at premium prices typically accepted by more developed US/EU markets, lower prices that reflect lesser ability to pay will be needed to improve access in low-income countries. Lower profitability in public sector immunization programs will be offset by higher profitability in private and traveler markets, where premium prices can be achieved.

Future competition from cheaper domestically produced versions of TV003/TV005 in Brazil and certain Asia-Pacific countries could also lock out branded vaccines from the public sectors of these markets. Exportation to other dengue-endemic markets could also pose a serious strategic threat to Takeda's TAK-003.

The overall likelihood of approval of a Phase I antiviral asset is 12.9%, and the average probability a product advances from Phase III is 68.5%. Antiviral products, on average, take 8.4 years from Phase I to approval, compared to 9.0 years in the overall infectious disease space.

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