Innovative Dengue Vaccine Gains Another Approval

The defense against a mosquito-borne viral disease that has spread to over 125 countries and is one of the World Health Organization's top threats to global health expanded today in Brazil.

An innovative Dengue vaccine that does not require pre-vaccination testing was approved by the National Health Surveillance Agency (ANVISA) to prevent dengue in Brazil caused by any of the four virus serotypes.

Takeda's QDENGA® is the only dengue vaccine approved for use in individuals regardless of previous exposure to dengue and without the need for pre-vaccination testing.

The approval of QDENGA is based on results across nineteen Phase 1, 2, and 3 clinical trials with more than 28,000 children and adults.

"Brazil has a high prevalence of dengue, and the country needs effective and safe vaccine options to help manage the significant burden dengue places on its health care systems and its communities," said José Manuel Caamaño, president of Takeda in Brazil, in a press release on March 13, 2023.

"Based on our clinical trial results, we are hopeful that QDENGA could have a positive impact on the incidence of symptomatic dengue in Brazil, including dengue cases that require hospitalization."

"Bringing QDENGA to countries around the world remains a top priority for Takeda, and this approval is a step toward our purpose to deliver better health for people and a brighter future for the world."

QDENGA has already been authorized in Indonesia, Europe, and the U.K., but not the U.S.

The U.S. Food and Drug Administration (FDA) is currently reviewing QDENGA's (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003) information.

The FDA approved Sanofi Pasteur's Dengvaxia® vaccine in 2019, but with testing requirements.

QDENGA is based on a live-attenuated dengue serotype 2 virus, which provides the genetic "backbone" for all four dengue virus serotypes.

In Brazil, QDENGA is indicated for preventing dengue disease caused by any dengue virus serotype in individuals from 4 to 60 years of age and should be administered subcutaneously as a 0.5 mL dose at a two-dose (0 and 3 months) schedule under the approved dosing regimen.

This mosquito-borne viral disease poses a significant global public health threat to half the world's population, causing dengue outbreaks in numerous countries in 2023.

Additionally, severe dengue has become a leading cause of hospitalization and death among children and adults in some of the countries within the region.

In 2022 Brazil saw more than 1.4 million cases of dengue and more than 1,000 deaths, a 162.5% increase in cases compared to 2021.

In the U.S., Florida, and Puerto Rico have reported both travel-related and locally acquired dengue cases in 2022 and 2023.