FDA Approves First Vaccine for Dengue Disease

On May 1, 2019, FDA announced the approval of Sanofi Pasteur’s Dengvaxia, 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 who have laboratory-confirmed previous dengue infection and who live in endemic areas. Dengue is endemic in the US territories of American Samoa, Guam, Puerto Rico, and the US Virgin Islands.

Dengvaxia is a live, attenuated vaccine that is administered as three separate injections, with the initial dose followed by two additional shots given six and 12 months later. The vaccine has been approved in 19 countries and the European Union in December 2018.

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. 

According to the CDC, an estimated 400 million dengue virus infections occur globally each year. 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 United States, the disease is regularly found in American Samoa, Puerto Rico, Guam, and the US Virgin Islands 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 FDA’s Center for Biologics Evaluation and Research, in an agency press release. “As the second infection with dengue is often much more severe than the first, FDA’s approval of this vaccine will help protect people previously infected with dengue virus from subsequent development of dengue disease.”

“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 an agency press release. “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."

Source: FDA