FDA Approves Dengue Virus Vaccine for Pediatric Patients

The US Food and Drug Administration (FDA) has approved the first vaccine indicated for the prevention of dengue disease caused by all virus serotypes, in people aged 9-16 years old.

Dengvaxia, from Sanofi Pasteur, will be capable of aiding at-risk pediatric patients facing the endemic in US territories including Samoa, Guam, Puerto Rico, and the US Virgin Islands.

The virus can present itself in serotypes 1, 2, 3, and 4, and is prevalent in areas near approximately one-third of the world’s population, according to the US Centers for Disease Control Prevention (CDC). Dengue fever is the leading cause of illness among people living in tropical and subtropical region, and commonly presents with either no symptoms or a misleading, mild illness in first-time patients.

Subsequent infection symptoms may include stomach pain, persistent vomiting, bleeding, confusion and difficulty breathing. Approximately 95% of all severe or hospitalized cases of dengue fever are associated with second virus infection.

An estimated 400 million annual dengue virus infections occur globally, according to the CDC. Of those, about 500,000 cases develop into dengue hemorrhagic fever (DHF). The condition contributes to about 20,000 annual deaths, primarily in pediatric patients.

“While there is no cure for dengue disease, today’s approval is an important step toward helping to reduce the impact of this virus in endemic regions of the United States,” Anna Abram, FDA deputy commissioner for policy, legislation, and international affairs, said in a statement.

The vaccine’s efficacy and safety was determined by data from 3 randomized, placebo-controlled trials involving approximately 35,000 participants in dengue-endemic areas including Puerto Rico, Latin America, and the Asia Pacific region. Investigators reported the vaccine had an approximate 76% efficacy in preventing symptomatic, laboratory-confirmed dengue disease among patients aged 9-16 years old who previously had laboratory-confirmed dengue disease.

Commonly reported adverse events with vaccine including headache, muscle plain, joint pain, fatigue, injection site pain, and low-grade fever. Dengvaxia is not approved for individuals not previously infected by any dengue virus serotype.

Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, explained that an infection by 1 type of dengue virus typically provides immunity against that speficic serotype.

“But a subsequent infection by any of the other 3 serotypes of the virus increases the risk of developing severe dengue disease, which may lead to hospitalization or even death,” Marks said. “As the second infection with dengue is often much more severe than the first, the FDA’s approval of this vaccine will help protect people previously infected with dengue virus from subsequent development of dengue disease.”

Dengvaxia was approved under the Priority Review and Tropical Disease Priority Review Voucher programs—the latter of which encourages the development of new drugs and biologics for the prevention and treatment of tropical diseases.