FDA Approves Dengvaxia Vaccine

The US Food and Drug Administration (FDA) has announced the approval of the vaccine Dengvaxia for the prevention of dengue disease in children aged 9 to 16 years with a laboratory-confirmed case of previous dengue infection. Eligible individuals must live in an endemic region of the US, which include American Samoa, Guam, Puerto Rico and the US Virgin Islands.

Dengvaxia, produced by Sanofi Pasteur, is a live, attenuated vaccine, with an initial dose administered followed by 2 additional shots given 6 and 12 months later.

Dengvaxia is not approved for use in individuals who have not previously been infected by any serotype of dengue or for those without serological proof of illness. The reason behind this is, according to the FDA's statement is that Dengvaxia "appears to act as a first dengue infection, without actually infecting the person with wild-type dengue virus — such that a subsequent infection can result in severe dengue disease."

An individual's first infection with dengue virus usually does not result in symptoms or is a mild illness that may be mistaken for influenza. A second infection, however, can lead to severe dengue, including dengue hemorrhagic fever, which can be fatal. Symptoms include stomach pain, vomiting, bleeding, confusion and difficulty breathing. There are no drugs approved for the treatment of dengue. Each year, an estimated 400 million dengue virus infections occur globally according to the US Centers for Disease Control and Prevention. Of these, approximately 500,000 cases develop into dengue hemorrhagic fever, which contributes to about 20,000 deaths, primarily among children.

“Infection by one type of dengue virus usually provides immunity against that specific serotype, but a subsequent infection by any of the other three serotypes of the virus increases the risk of developing severe dengue disease, which may lead to hospitalization or even death,” said Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research in the FDA's announcement. “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.”

The FDA's approval was based upon the results of 3 randomized, placebo-controlled studies, which evaluated the safety and efficacy of the vaccine in 35,000 individuals in dengue-endemic areas, including Puerto Rico, Latin America and the Asia Pacific region. These studies report that the vaccine was 76% effective in preventing symptomatic, laboratory-confirmed dengue disease in the indicated population, of children between 9-16 years who previously had laboratory-confirmed dengue disease.

The most commonly reported side effects in these studies were headache, muscle pain, joint pain, fatigue, injection site pain and low-grade fever.

Dengvaxia has already been approved in 19 countries and the European Union.

The FDA granted this application Priority Review and a Tropical Disease Priority Review Voucher under a program intended to encourage development of new drugs and biologics for the prevention and treatment of certain tropical diseases, such as dengue.