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First FDA-approved vaccine for the prevention of dengue disease in endemic regions
FDA News Release
May 1, 2019
The U.S. Food and Drug Administration announced today the approval of 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 U.S. territories of American Samoa, Guam, Puerto Rico and the U.S. 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. “The FDA is committed to working proactively with our partners at the U.S. 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 percent 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 U.S., the disease is regularly found in American Samoa, Puerto Rico, Guam, the U.S. 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, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “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 three randomized, placebo-controlled studies involving approximately 35,000 individuals in dengue-endemic areas, including Puerto Rico, Latin America and the Asia Pacific region. The vaccine was determined to be approximately 76 percent effective in preventing symptomatic, laboratory-confirmed dengue disease in individuals 9 through 16 years of age who previously had laboratory-confirmed Dengue disease. Dengvaxia has already been approved in 19 countries and the European Union.

The most commonly reported side effects by those who received Dengvaxia were headache, muscle pain, joint pain, fatigue, injection site pain and low-grade fever. The frequency of side effects was similar across Dengvaxia and placebo recipients and tended to decrease after each subsequent dose of the vaccine.


Dengvaxia is not approved for use in individuals not previously infected by any dengue virus serotype or for whom this information is unknown. This is because in people who have not been infected with dengue virus, Dengvaxia appears to act like 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. Therefore, health care professionals should evaluate individuals for prior dengue infection to avoid vaccinating individuals who have not been previously infected by dengue virus. This can be assessed through a medical record of a previous laboratory-confirmed dengue infection or through serological testing (tests using blood samples from the patient) prior to vaccination. 

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 twelve months later.

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. The approval was granted to Sanofi Pasteur…



Sanofi U.S. News Release
FDA approves Dengvaxia® for the prevention of dengue in individuals ages 9 through 16 living in U.S. endemic areas
[Editor’s text bolding]
BRIDGEWATER, N.J., May 1, 2019 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) approved Dengvaxia® (Dengue Tetravalent Vaccine, Live) for the prevention of dengue disease caused by serotypes 1 – 4 of the virus in individuals 9 through 16 years of age living in endemic areas of the U.S. with a laboratory-documented prior infection. Dengvaxia is the first and only vaccine approved for protection against dengue in endemic areas of the U.S…

…Dengvaxia is also approved for use in several endemic countries in Latin America and Asia where reducing the human and economic burden of dengue is a public health priority. In December 2018, the European Commission granted marketing authorization for Dengvaxia to prevent dengue in individuals living in endemic areas with a documented prior infection.

Indication for Dengvaxia® (Dengue Tetravalent Vaccine, Live)
Dengvaxia is a vaccine given to people 9 through 16 years of age to help prevent dengue infection due to dengue virus serotypes 1, 2, 3 and 4. Dengvaxia should only be given to people who have previously had a dengue infection, and live in areas where dengue is endemic.

Your child should not receive Dengvaxia if he or she has not had a previously confirmed dengue infection, or if this information is unknown. People who have not had a previous dengue infection are at increased risk for severe dengue when vaccinated with Dengvaxia and later infected with a dengue virus. Previous dengue infection can be verified by a medical record of a previous laboratory confirmed dengue infection, or by testing for dengue before vaccination.

It is unknown whether Dengvaxia is safe or protective for people living in areas where dengue is not endemic who travel to dengue endemic areas.

Important Safety Information for Dengvaxia (Dengue Tetravalent Vaccine, Live)
Dengvaxia vaccine should not be given to anyone with a history of severe allergic reaction to a previous dose of Dengvaxia or to any component of Dengvaxia.

Dengvaxia should not be given to people with a severely suppressed or compromised immune system.


Before your child can receive Dengvaxia, your child’s health care professional must determine whether your child has had a confirmed dengue infection.

Currently, no available tests have been cleared by the Food and Drug Administration (FDA) to determine a previous dengue infection. Talk with your health care professional about available tests. For the month after receiving Dengvaxia, tuberculosis skin tests may be falsely negative. If you undergo tuberculosis skin testing in the month after vaccination, tell the health care professional performing the test that you received Dengvaxia.

The most common side effects of Dengvaxia include headache, pain at the injection site, general discomfort, tiredness, and muscle aches. Other side effects can occur.

It is recommended to continue personal protection measures against mosquito bites after vaccination since vaccination with Dengvaxia may not protect all people.

Please see the full Prescribing Information for Dengvaxia (Dengue Tetravalent Vaccine, Live).