According to the package insert for DENGVAXIA, the most commonly reported adverse reactions following vaccination included headache, injection site pain, generalized discomfort (malaise), lack of energy, and muscle pain. Additional reported adverse reactions included abdominal pain, vomiting, shortness of breath, generalized redness of the skin (erythema), hives, asthma crisis, and vertigo.
The safety of DENGVAXIA vaccine was evaluated in 12 clinical trials that studied the vaccine in children aged six through 16 years, with 22,924 receiving at least one vaccine dose, and 10,668 receiving a placebo (reported as a 0.9 percent sodium chloride solution). In the 12 clinical trials, there were four serious non-fatal adverse events that were considered to be related to DENGVAXIA. Adverse events within 24 hours of the first dose of vaccine included a convulsion and an asthma attack, and disseminated encephalomyelitis reported as occurring seven days following the first dose of the vaccine. Additionally, an adverse event of hives within 24 hours of the second dose was also reported.
From dose one through 72 months, 53 deaths (0.2 percent) occurred among children who received DENGVAXIA, and 34 deaths (0.3 percent) among those who received the placebo, representing an increase in death of about 56 percent in vaccinated children. However, according to clinical trial investigators and the FDA, none of the deaths were linked to vaccination.
DENGVAXIA vaccine has been linked to severe dengue infection, dengue associated hospitalization, and death in individuals whose dengue infection status before vaccination was not known, and who developed dengue after vaccination.
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. According to the DOJ, Philippine health officials disregarded regulations and purchased nearly $68 million worth of the vaccine even though clinical trials had not yet been completed.
Over 700,000 students in the Philippines were administered DENGVAXIA vaccine in 2016. In late 2017, Sanofi Pasteur announced that DENGVAXIA could cause severe dengue infection in vaccinated people without a prior history of dengue infection who subsequently contracted the infection.
In December 2023, a Philippine regional court ordered that 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.
Using the MedAlerts search engine, as of December 27, 2024, there have been 551 reports of dengue vaccine reactions, including 187 hospitalizations, and 269 deaths, which translates to nearly 50 percent of the adverse events reported resulted in death. Additionally, nearly all of the reported adverse reactions and deaths associated with the dengue vaccine were in children receiving the vaccine without laboratory confirmation of a previous dengue infection and who subsequently developed a second infection, seemingly justifying concerns relating to the potential for the vaccine to trigger severe disease.
Outstanding Safety Concerns
It is not known whether DENGVAXIA dengue vaccine, a live virus vector vaccine, is capable of recombination. Recombination occurs when two related genomic variants of a virus infect the same cell and cause a new and potentially virulent virus. For example, the oral polio vaccine (OPV), a traditional live attenuated vaccine, has recombined with related human enteroviruses to cause new circulating vaccine-derived polioviruses (cVDPV). While this process is known to occur between traditional live attenuated vaccines and wild-type viruses, it is not yet known whether this can also occur with the use of novel live virus vector vaccine technologies.
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.
