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Rachel V Thomas

QDENGA: India’s First Approved Dengue Vaccine May Hit Shelves In 2027; How Effective Is It?

India’s first approved <span>dengue vaccine</span>, <span>QDENGA</span>, could be available in the private market by the first half of 2027, Dr Reddy’s Laboratories said. The company is partnering with Japan’s <span>Takeda</span> to promote and distribute the vaccine in India.

“Subject to the completion of applicable processes with local authorities, the vaccine is anticipated to become available in the first half of 2027,” the companies said.

<h2>QDENGA Vaccine: Why The Launch Matters</h2>

<strong>Also read: </strong><a href="https://www.healthandme.com/health-news/delhi-dengue-cases-rise-in-september-is-weather-fueling-the-surge-article-156168632" data-type="tilCustomLink">Delhi Dengue Cases Rise In September: Is Weather Fueling The Surge?</a>

India’s dengue burden has risen 11-fold over the past two decades. Rapid urbanization, climate change and mosquito breeding have contributed to the growing public health challenge.

A nationwide ICMR dengue surveillance study found that all four dengue virus serotypes — DENV-1 to DENV-4 — are circulating across multiple regions. About one in 14 patients had concurrent infections with multiple serotypes.

<h2>QDENGA Approved In India: Who Can Take It?</h2>

QDENGA received market authorization from the Drug Controller General of India (DCGI) in July to prevent dengue in people aged 4 to 60 years.

According to Takeda, it can be given regardless of previous dengue infection and does not require pre-vaccination testing.

Since 2022, QDENGA has been approved in 43 countries across Asia, Latin America and Europe. It is also part of Brazil’s National Immunization Program and public immunization programs in Argentina, Colombia and Indonesia.

<strong>READ: </strong><a href="https://www.healthandme.com/health-wellness/dengue-is-spreading-beyond-monsoons-and-into-new-regions-across-india-says-expert-article-154332385" data-type="tilCustomLink">Dengue Is Spreading Beyond Monsoons And Into New Regions Across India, Says Expert</a>

QDENGA is designed to protect against all four dengue virus serotypes, regardless of previous dengue exposure.

The DCGI approval is supported by Takeda’s clinical program, which included 19 Phase 1, 2 and 3 trials involving more than 28,000 participants.

The pivotal Phase III TIDES trial included more than 20,000 participants across eight countries. Key findings included:

<ul><li>80.2% efficacy against virologically confirmed dengue one year after the second dose.</li><li>90.4% efficacy against dengue-related hospitalization at 18 months.</li><li>84.1% protection against dengue-related hospitalization after 4.5 years.</li><li>Data showed protection across all four serotypes for up to seven years.</li></ul>

An Indian Phase III trial involving people aged 4 to 60 years also found the vaccine safe, well tolerated and immunogenic.

From U-WIN Success To India's Dengue Vaccine, Immunization Expert Shares Roadmap

QDENGA (TAK-003) is a live-attenuated <span>tetravalent dengue vaccine</span> targeting all four dengue virus serotypes.

It is given as two 0.5 mL subcutaneous doses, three months apart. The vaccine uses a DENV-2 backbone with structural proteins from DENV-1, DENV-3 and DENV-4.

The WHO recommends QDENGA for use in dengue-endemic settings without pre-vaccination screening. It is also WHO-prequalified for procurement through agencies including UNICEF and PAHO.

Dr Reddy’s will handle promotion and distribution in the private market, while Takeda will retain rights to promote and distribute QDENGA in India’s public market.

In February 2024, Takeda partnered with Hyderabad-based vaccine maker Biological E to expand QDENGA production.

Biological E plans to manufacture 50 million doses annually, supporting Takeda’s goal of producing 100 million doses globally each year by the end of the decade.

The company’s production will focus heavily on multi-dose vials for public health sectors and National Immunization Programs in dengue-endemic countries globally.

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India’s first approved dengue vaccine, QDENGA, could be available in the private market by the first half of 2027, Dr Reddy’s Laboratories said. The company is partnering with Japan’s Takeda to promote and distribute the vaccine in India.“Subject to the completion of applicable processes with local authorities, the vaccine is anticipated to become available in the first half of 2027,” the companies said.QDENGA Vaccine: Why The Launch MattersAlso read: Delhi Dengue Cases Rise In September: Is Weather Fueling The Surge?India’s dengue burden has risen 11-fold over the past two decades. Rapid urbanization, climate change and mosquito breeding have contributed to the growing public health challenge.A nationwide ICMR dengue surveillance study found that all four dengue virus serotypes — DENV-1 to DENV-4 — are circulating across multiple regions. About one in 14 patients had concurrent infections with multiple serotypes.QDENGA Approved In India: Who Can Take It?QDENGA received market authorization from the Drug Controller General of India (DCGI) in July to prevent dengue in people aged 4 to 60 years.According to Takeda, it can be given regardless of previous dengue infection and does not require pre-vaccination testing.Since 2022, QDENGA has been approved in 43 countries across Asia, Latin America and Europe. It is also part of Brazil’s National Immunization Program and public immunization programs in Argentina, Colombia and Indonesia.How Effective Is QDENGA?READ: Dengue Is Spreading Beyond Monsoons And Into New Regions Across India, Says ExpertQDENGA is designed to protect against all four dengue virus serotypes, regardless of previous dengue exposure.The DCGI approval is supported by Takeda’s clinical program, which included 19 Phase 1, 2 and 3 trials involving more than 28,000 participants.The pivotal Phase III TIDES trial included more than 20,000 participants across eight countries. Key findings included:80.2% efficacy against virologically confirmed dengue one year after the second dose.90.4% efficacy against dengue-related hospitalization at 18 months.84.1% protection against dengue-related hospitalization after 4.5 years.Data showed protection across all four serotypes for up to seven years.An Indian Phase III trial involving people aged 4 to 60 years also found the vaccine safe, well tolerated and immunogenic.What Is QDENGA?   QDENGA (TAK-003) is a live-attenuated tetravalent dengue vaccine targeting all four dengue virus serotypes.It is given as two 0.5 mL subcutaneous doses, three months apart. The vaccine uses a DENV-2 backbone with structural proteins from DENV-1, DENV-3 and DENV-4.The WHO recommends QDENGA for use in dengue-endemic settings without pre-vaccination screening. It is also WHO-prequalified for procurement through agencies including UNICEF and PAHO.QDENGA Manufacturing In IndiaDr Reddy’s will handle promotion and distribution in the private market, while Takeda will retain rights to promote and distribute QDENGA in India’s public market.In February 2024, Takeda partnered with Hyderabad-based vaccine maker Biological E to expand QDENGA production.Biological E plans to manufacture 50 million doses annually, supporting Takeda’s goal of producing 100 million doses globally each year by the end of the decade.The company’s production will focus heavily on multi-dose vials for public health sectors and National Immunization Programs in dengue-endemic countries globally.

india’s first approved dengue vaccine qdenga may hit shelves in 2027: how effective is it?

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