Express infects nearly 400 million people every year! The disease is expected to usher in a new vaccine

Recently, Takeda announced that the US Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for its dengue virus vaccine TAK-003 and granted priority review status
.
TAK-003 is designed to protect people aged 6-45 years from any serotype of dengue virus infection
.

Dengue fever is an infectious disease caused by dengue virus, mainly vectored by Aedes aegypti, which spreads rapidly globally and was recognized by the World Health Organization as one of
the top 10 health threats in the world in 2019.
There are four serotypes of the dengue virus, each of which can cause symptoms
of dengue fever, such as fever.
Recovery from infection with one dengue virus serotype provides lifelong protection against that serotype and carries a higher risk of more severe symptoms
when later infected with other serotypes.
It is estimated that about 390 million people worldwide are infected with dengue virus each year, causing about 20,000 deaths
.

TAK-003 is a live attenuated vaccine designed to protect the human body from four serotypes of dengue virus
.
The vaccine was approved for the first time globally by Indonesia's National Drug and Food Administration (BPOM) in August this year and is suitable for people aged 6-45 years to avoid any serotype of dengue infection
.
In addition, the vaccine was recommended for marketing approval
by the European Commission for Medicinal Products for Human Use (CHMP) in October this year.

Image source: 123RF

The marketing application for TAK-003 is based on the results of
TIDES' pivotal Phase 3 clinical trial.
In this trial, TAK-003 met the primary endpoint that 80.
2% of symptomatic dengue infections could have been avoided at 12 months
.
TAK-003 also met the secondary endpoint of avoiding 90.
4% of dengue hospitalizations
at 18 months.
In addition, exploratory analysis with a follow-up period of up to 4.
5 years showed that the vaccine could prevent dengue infection for up to 4.
5 years (54 months) after vaccination, and avoided 84% of dengue hospitalized cases and 61% of vaccinated people from symptomatic dengue infection
among the overall vaccinated population.
These vaccinated include people
with serotypes positive and negative.

Resources:

[1] Takeda’s Biologics License Application (BLA) for Dengue Vaccine Candidate (TAK-003) Granted Priority Review by U.
S.
Food and Drug Administration.
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.
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expressed herein.
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.
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.