The drug application was granted the FDAâ€™s Priority Review designation, as well as 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.
Officials with the FDA has approved Dengue Tetravalent Vaccine, Live (Dengvaxia, Sanofi Pasteur), the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages 9 through 16 years who have laboratory-confirmed previous dengue infection and who live in endemic areas.
The drug application was granted the FDA’s Priority Review designation, as well as 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.
Dengue is endemic in the United States territories of American Samoa, Guam, Puerto Rico and the US Virgin Islands.
“Dengue disease is the most common mosquito-borne viral disease in the world and global incidence has increased in recent decades,” said Anna Abram, FDA deputy commissioner for policy, legislation, and international affairs, in a prepared statement. “The FDA is committed to working proactively with our partners at the US Centers for Disease Control and Prevention, as well as international partners, including the World Health Organization, to combat public health threats, including through facilitating the development and availability of medical products to address emerging infectious diseases. 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."
The CDC estimates more than one-third of the world’s population is living in areas at risk for infection by dengue virus which causes dengue fever, a leading cause of illness among people living in the tropics and subtropics.
The first infection with dengue virus typically results in either no symptoms or a mild illness that can be mistaken for the flu or another viral infection. A subsequent infection can lead to severe dengue, including dengue hemorrhagic fever (DHF), a more severe form of the disease that can be fatal. Symptoms may include stomach pain, persistent vomiting, bleeding, confusion and difficulty breathing. Approximately 95% of all severe/hospitalized cases of dengue are associated with second dengue virus infection.
Because there are no specific drugs approved for the treatment of dengue disease, care is limited to the management of symptoms.
Each year, an estimated 400 million dengue virus infections occur globally according to the CDC. Of these, approximately 500,000 cases develop into DHF, which contributes to about 20,000 deaths, primarily among children. Although dengue cases are rare in the continental US, the disease is regularly found in US territories, as well as Latin America, Southeast Asia and the Pacific islands.
“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 a prepared statement. “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 safety and effectiveness of the vaccine was determined in 3 randomized, placebo-controlled studies involving approximately 35,000 individuals in dengue-endemic areas. The vaccine was determined to be approximately 76% effective in preventing symptomatic, laboratory-confirmed dengue disease in individuals 9 through 16 years of age who previously had laboratory-confirmed dengue disease. This vaccine has already been approved in 19 countries and the European Union.
The most commonly reported adverse effects by those who received the dengue vaccine were headache, muscle pain, joint pain, fatigue, injection site pain and low-grade fever.
Dengvaxia is a live, attenuated vaccine that is administered as 3 separate injections, with the initial dose followed by 2 additional shots given 6 and 12 months later.
The dengue vaccine is not approved for use in individuals not previously infected by any dengue virus serotype or for whom this information is unknown.
First FDA-approved vaccine for the prevention of dengue disease in endemic regions [news release]. Silver Spring, MD; May 1, 2019: FDA website. https://www.fda.gov/news-events/press-announcements/first-fda-approved-vaccine-prevention-dengue-disease-endemic-regions. Accessed May 1, 2019.