FDA approves the first vaccine for dengue fever

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.


Dengue is a mosquito-borne viral disease, transmitted by female mosquitoes mainly of the species Aedes aegypti and, to a lesser extent, Ae. albopictus.Severe symptoms include dengue shock syndrome (DSS) and dengue hemorrhagic fever (DHF). These usually require hospitalization.

An estimated, 400 million people worldwide get infected by dengue each year. And until now, there were no vaccines available for the dengue fever.

The U.S Food and Drug Administration approved Dengvaxia, a first vaccine approved to prevent from 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. It 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.

Anna Abram, FDA deputy commissioner for policy, legislation, and international affairs said, “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.”

Peter Marks, M.D., director of the FDA’s Center for Biologics Evaluation and Research said, “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. 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.”

Scientists determined the vaccine effectiveness and safety in three randomized, placebo-controlled studies that involved approximately 35,000 individuals in dengue-endemic areas, including Puerto Rico, Latin America, and the Asia Pacific region. The vaccine was found to be 76% effective in preventing symptomatic, laboratory-confirmed dengue disease in individuals 9 through 16 years of age who previously had laboratory-confirmed dengue disease.

However, drug Dengvaxia is already approved in 19 countries and the European Union. But it restricted to use in individuals, who were 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 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.

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

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