The first vaccine licensed for dengue, DENGVAXIA, manufactured by Sanofi Pasteur, was approved for use in December 2015 in the Philippines by the Philippines FDA. In the spring of 2016, health officials launched a $67 million dollar school-based dengue vaccination program for children nine years of age and older.
Dengue, which cause a mild infection in about 25 percent of individuals with no prior exposure to the virus, can be severe and fatal when a person becomes infected a second time by a different strain of the virus. Despite concerns expressed by scientists on the potential risk that vaccination could act like the first infection and cause enhanced disease when a person comes into contact with dengue, the World Health Organization (WHO) approved DENGVAXIA in 2016 for use in children nine and older.
In November 2017, after Sanofi Pasteur confirmed that DENGVAXIA could cause severe dengue disease in vaccinated children with no past history of dengue, DENGVAXIA vaccine campaigns in the Philippines were immediately halted. Health officials reported that by September 2018, 130 vaccinated children had died, with 19 confirmed to be linked to enhanced disease.
In 2019, the Department of Justice (DOJ) in the Philippines announced that it found probable cause to charge ten Philippine health officials and officials from its Research Institute for Tropical Medicine and the country’s Food and Drug Administration along with six individuals from Sanofi Pasteur, the maker of DENGVAXIA, for recklessness in association with the deaths of ten children who received the vaccine.
In December 2023, a Philippine regional court ordered cases related to the deaths of children vaccinated with DENGVAXIA be consolidated and refiled. The 35 cases allege that “reckless imprudence” by former Health Secretary Janette Garin along and 17 other Department of Health officials and physicians resulted in the death of the vaccinated children. The cases have been filed as criminal cases against these officials, who have since failed to end criminal proceedings against them.
Despite the known risks associated with DENGVAXIA, the U.S. Food and Drug Administration (FDA) approved use of the vaccine on May 1, 2019 in children nine through 16 years of age with laboratory confirmed past history of dengue illness and living in dengue endemic regions. Sanofi Pasteur had initially requested approval of the vaccine for persons aged nine through 45, however, the FDA’s Vaccine and Related Biologics Products Advisory Committee (VRBPAC) determined that the clinical evidence did not show that the vaccine was effective in preventing disease in adults who lived in dengue-endemic U.S. territories and Freely Associated States.
VRBPAC voted 13 to 1 in favor of the vaccine’s efficacy in children nine through 16 years, but only voted 10 to 4 in favor of the vaccine’s safety for use in this population.
In 2021, the U.S. Centers for Disease Control and Prevention recommended use of DENGVAXIA dengue vaccine for children nine through 16 years in 2021 with laboratory confirmed past history of dengue illness living in dengue endemic regions.
The CDC reported reviewing all available dengue IgG tests available in the U.S. and determined that two tests were satisfactory for sensitivity, but no single test met the specificity requirement of 98 percent. Sensitivity in testing is the ability of a test to accurately confirm the presence of the disease, while specificity is the ability of a test to accurately determine that a disease is not present.
As a result, the CDC determined that a two-test algorithm using both the EUROIMMUN Anti-Dengue Virus NS1 Type 1-4 ELISA (IgG) and the CTK BIOTECH OnSite Dengue IgG Rapid Test were needed to be used prior to DENGVAXIA vaccination. The use of this two-test algorithm reportedly met the requirement for both sensitivity (greater than or equal to 75 percent) and specificity (greater than or equal to 98 percent). As of February 2024, neither test recommended for use by the CDC has been cleared by the FDA.
In June 2023, the FDA approved use of DENGVAXIA in children aged six through 16 years of age with laboratory confirmed past history of dengue disease living in dengue endemic areas. No additional clinical trials were completed for this expanded age approval. Instead, the FDA approved use of the vaccine in children as young as six was based on a post-hoc analysis of data from previous clinical trials conducted by the manufacturer.
A second dengue vaccine manufactured by Takeda pharmaceuticals is approved for use in Brazil, Argentina, the United Kingdom, the European Union, Thailand, and Indonesia; however, company officials voluntarily withdrew its application for approval to the US FDA in July 2023 and stated that the decision was due to FDA requests for additional data not captured in clinical trial data.
IMPORTANT NOTE: NVIC encourages you to become fully informed about Dengue and the Dengue vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.
