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Second Dengue Vaccine Seeks Authorization

March 25, 2021 • 5:22 pm CDT
(Vax Before Travel)

A second Dengue vaccine may soon become available in Europe and elsewhere. Japan-based Takeda Pharmaceutical Company Limited has applied to the European Medicines Agency to Conduct the First-Ever Parallel Assessment of a Medicinal Product for Takeda’s Dengue Vaccine Candidate known as TAK-003.

Additionally, Takada stated in a press release issued on March 25, 2021, besides the EU, it intends to submit Regulatory Filings in Argentina, Brazil, Colombia, Indonesia, Malaysia, Mexico, Singapore, Sri Lanka, Thailand, and the USA during 2021.

If approved, TAK-003 would join Dengvaxia as the only Dengue authorized vaccine.

This news is important since Dengue is the fastest spreading mosquito-borne viral disease. Dengue is mainly spread by Aedes aegypti mosquitoes and, to a lesser extent, Aedes albopictus mosquitoes. It is caused by any of four dengue virus serotypes, each of which can cause dengue fever or severe dengue.

The dengue virus can infect people of all ages and cause serious illness among children in some countries in Latin America and Asia, says the U.S. CDC.

On March 2, 2021, the CDC issued a Level 1 Travel Alert for the Americas, warning international travelers of their risks. Dengue is an ongoing risk in many parts of Central and South America, Mexico, and the Caribbean (map).

“Submission of regulatory filings for our dengue vaccine candidate, TAK-003, marks an important development for people who are living in or traveling to communities burdened by the threat of dengue,” commented Derek Wallace, VP, Dengue Global Program Leader at Takeda.

“Dengue outbreaks, which result in half a million hospitalizations globally each year, can overwhelm communities and governments because of the broad impact on the health care system. With limited options to prevent the disease, there is a pressing need for widely available dengue vaccines. Takeda is committed to working with regulatory authorities and recommending bodies to support evaluation of our submissions and achieve access for TAK-003.” 

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