A safe and effective dengue vaccine given to children in Puerto Rico is being discontinued due to low global demand.
The AAP Puerto Rico Chapter and the Centers for Disease Control and Prevention (CDC) say they remain committed to vaccinating children with Dengvaxia from Sanofi while the vaccine remains available for the next two years. Puerto Rico recently declared dengue to be a public health emergency and so far this year there have been 664 cases with 394 hospitalizations.
“Amid the challenges of climate change, the burden of dengue fever is escalating, particularly impacting children aged 9-16 who face a heightened risk of severe infection,” said Gredia Huerta-Montanez, M.D., FAAP, immediate past president of the AAP Puerto Rico Chapter and a member of the AAP Council on Environmental Health and Climate Change Executive Committee. “Vaccination, alongside measures to prevent mosquito bites and control breeding sites, could play a crucial role in preventing this illness.”
Dengvaxia, which can protect against four types of dengue, has been available in some countries since 2015. In 2021, the CDC’s Advisory Committee on Immunization Practices (ACIP) recommended its use in the U.S. for children ages 9-16 years who live in endemic areas and have laboratory confirmation of a previous dengue infection. In the U.S., it is only used in Puerto Rico.
A Sanofi spokesperson stressed the decision to discontinue the vaccine “is not driven by quality, safety or efficacy concerns.” The vaccine will be discontinued in September 2025. The final doses will expire in September 2026.
“There are limited Dengvaxia programs in place due to the complexity of implementation,” the Sanofi spokesperson said.
The vaccine is given in a series of three doses six months apart and has an efficacy of 82% for symptomatic dengue infection. However, administration is complicated because giving the vaccine to children who have never had dengue puts them at increased risk of severe dengue infection. Therefore, children need to be screened before vaccination using tests with high levels of sensitivity and specificity to confirm previous infections.
Sanofi said it has made efforts to support this screening process but “uptake has remained low.”
Dr. Huerta-Montanez said she was shocked to hear of the discontinuation. Since the vaccine has been available for such a short time in Puerto Rico, its distribution has been largely limited to federally qualified health centers. Officials were preparing for a wider rollout.
“After this long-awaited vaccine that took so many resources, energy, time and work to develop and we didn’t even have the chance to see how it would impact Puerto Rico,” Dr. Huerta-Montanez said.
She lamented the lack of access to vaccines and medicines in places that need them most but can’t afford them.
“This situation underscores the economic dimension of vaccine production and distribution, often neglecting economically disadvantaged areas,” she said.
The AAP Puerto Rico Chapter, national AAP, CDC and Puerto Rico Department of Health will continue to work together to vaccinate children.
“Dengvaxia is safe and effective when administered as recommended,” said LCDR Joshua Wong, M.D., medical officer at the CDC’s Dengue Branch. “ … Testing before vaccination remains available in Puerto Rico. CDC will continue supporting the implementation and use of this vaccine as recommended by ACIP.”
While Dengvaxia is the only dengue vaccine approved for use in the U.S., several others are approved in other countries or in development, according to the CDC. The National Institutes of Health developed TV003 and licensed it to several manufacturers. Recently published data from phase 3 trials of an analogous vaccine in Brazil showed about 80% overall efficacy.
A dengue vaccine from Takeda is licensed in several countries and recommended by the World Health Organization. The company had started the process of seeking U.S. approval but withdrew its application last year.
Dengue is the world’s most common arboviral disease with up to 400 million infections annually. In the U.S., it is most seen in territories and freely associated states. However, cases also have been seen in several states in the continental U.S. Dr. Huerta-Montanez said she expects that to continue due to climate change.
“Data suggest climate change is increasing the burden of … diseases transmitted by mosquitoes, so it won’t be long before you start seeing locally transmitted cases of dengue with increased frequency in the states, in places that used to be cooler, more temperate,” she said.
The most common symptoms of dengue include fever accompanied by nausea, vomiting, rash, myalgias, arthralgias, retroorbital pain, headache and/or leukopenia. About 5% of infections result in severe disease.
Health officials in Puerto Rico recommend people protect themselves by removing accumulated water from their homes and outdoor areas, using insect repellent that contains DEET or picaridin, wearing long-sleeved clothing outdoors, using mosquito nets for sleeping and installing wire mesh screens on doors and windows.
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