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US FDA takes new dengue vaccine by Japanese firm Takeda for priority review

Takeda has carried out phase 3 trials of the vaccine candidate and found it to be 80.2% effective in preventing symptomatic dengue cases after a year of vaccination.

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New Delhi: A new dengue vaccine candidate is being evaluated by the US Food and Drug Administration (FDA) for the prevention of the viral disease caused by any serotype.

The vaccine candidate, TAK-003, developed by Japanese pharmaceutical Takeda, was granted priority review of the Biologics License Application (BLA). The vaccine may potentially prevent dengue disease in individuals between 4 and 60 years of age.

Dengue is a mosquito-borne virus that is endemic in more than 125 countries. Over the last two decades, the incidence of dengue has increased globally and is a leading cause of fever among American travellers returning from Latin America, the Caribbean and Southeast Asia.

TAK-003 is based on a live-attenuated serotype 2 dengue virus – which is a weakened version of the live virus. The particular strain was chosen for the vaccine because it provides a genetic “backbone” for all four variants of dengue viruses.

“If approved, we believe TAK-003 has the potential to become an important dengue prevention option for healthcare providers, and we continue to be encouraged by our discussions with the FDA,” Gary Dubin, president of the Global Vaccine Business Unit at Takeda said in a statement.

“This year, of the 888 dengue infections in the US, 96 per cent were a result of travel to dengue endemic areas. Of the 316 dengue infections in US endemic territories, 97 per cent were locally transmitted,” the statement further said.

In India, dengue is an endemic disease, with more than 1,93,245 cases reported last year. This year, 1,10,473 cases have been reported as of 31 October.

Takeda has already carried out phase 3 trials for the safety and efficacy data of the vaccine candidate. In the trials, the vaccine was found to be 80.2 per cent effective in preventing symptomatic dengue cases a year after vaccination. The trials also showed a 90.4 per cent efficacy in preventing hospitalisations at 18 months.

The team found that the vaccine further demonstrated protection against dengue fever, 4.5 years after vaccination.

At present, vaccine candidate TAK-003 has been approved only by Indonesia. Takeda said it will also process regulatory filings in other dengue-endemic and non-endemic countries too.

Phase 2 trials of the vaccine in children and adolescents had shown that TAK-003 induced immune responses against all four dengue serotypes which lasted through 48 months after vaccination.

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