FDA Approves The First vaccine, Dengvaxia, For The Prevention Of Dengue.

First FDA-approved vaccine for the prevention of dengue disease in endemic regions

 
Dengue is a disease caused by the bite of a mosquito infected with any one of four specific Dengue viruses. It causes high fever, severe headache, pain behind the eye, joint pain, and muscle pain. The mosquitos that carry this disease are mainly in tropical areas so travelers may arrive in the United States with dengue fever. Although most cases occurring in the United States are associated with travel to areas where dengue is endemic, there have been occasional outbreaks of local dengue virus transmission, particularly in southern states.

Dengue fever symptoms include sudden onset of a fever that may last from 2 to 7 days with intense headache, joint and muscle pain, and a rash. Mild bleeding of the nose or gums may occur. The hemorrhagic form of dengue fever is more severe and symptoms may include loss of appetite, persistent vomiting, high fever, headache, difficulty breathing, and abdominal pain. This may lead to shock and circulatory failure.Dengue fever may occur from 3 to 14 days after being bitten by an infected mosquito, but usually within 4 to 7 days.
"Dengue is endemic and prone to outbreaks in several U.S. territories, including Puerto Rico, the U.S. Virgin Islands and American Samoa. Despite this public health threat, there is no treatment and there has been no previously approved vaccine available in these areas," said David Greenberg, MD, Regional Medical Head North America, Sanofi Pasteur. "Today's FDA approval of Dengvaxia allows us to bring a critical medical prevention tool to at-risk populations, helping combat and prevent dengue among children living in U.S. dengue endemic areas."

"Dengue disease is the most common mosquito-borne viral disease in the world and global incidence has increased in recent decades, 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." said Anna Abram, FDA deputy commissioner for policy, legislation, and international affairs. "

SILVER SPRING, Md., May 1, 2019 /PRNewswire/ -- 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 Pacificregion. 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.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Megan McSeveney, megan.mcseveney@fda.hhs.gov, 240-402-4514 
Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration