Dengue Vaccine Access Expanded

Dengue fever outbreaks continue to confront numerous countries in 2023. To extend access to dengue vaccines, the U.S. Food and Drug Administration (FDA) recently approved a supplement Biologics License Application (sBLA) for Dengue Tetravalent Vaccine, Live (Dengvaxia®).

On June 30, 2023, the FDA issued to Michael F. Stirr, Sanofi Pasteur, Inc. BL 125682/40, to include safety and efficacy data that support the use of Dengvaxia in individuals 6 through 16 years of age, with laboratory-confirmed previous dengue infection and living in endemic areas.

This FDA expansion is important as no specific medication to treat dengue infection exists.

As of July 3, 2023, the FDA's review of this supplement was associated with the following National Clinical Trial numbers: NCT01373281, NCT01374516, NCT00842530, and NCT01983553.

The three-dose Dengvaxia's (CYD-TDV) original BLA was approved by the FDA on May 1, 2019. It was first licensed in Mexico in 2015 for use in individuals 9-45 years of age and is now licensed in over 20 countries. 

Dengvaxia is the only dengue vaccine recommended for routine use by the U.S. CDC's Advisory Committee on Immunization Practices.

Before being vaccinated with Dengvaxia, the CDC's vaccine committee says healthcare providers that if a patient has dengue symptoms or lives in or has recently traveled to an area with a risk of dengue and has not previously been infected, they are at increased risk for Severe Dengue disease when vaccinated and subsequently infected with the dengue virus. 

Dengue is caused by infection with any of the four dengue viruses.

According to the CDC, these viruses are transmitted in tropical and subtropical regions by infected  Aedes mosquito species.

During the summer of 2023, locally-acquired dengue cases have been reported in Florida, Texas, Puerto Rico, and Costa Rica.