U.S. FDA Approves Sanofi Pasteur’s Dengue Vaccine With Major Restrictions On Use

Reuters: Sanofi wins U.S. approval to sell dengue vaccine but with major restrictions
“The U.S. Food and Drug Administration on Wednesday gave Sanofi SA’s dengue vaccine Dengvaxia a very narrow approval as the company continues to suffer from evidence that its vaccine, which took 20 years to develop, can cause severe infections in some people…” (Steenhuysen, 5/1).

STAT: FDA approves the first vaccine for dengue fever, but with major restrictions
“…The agency ruled that Dengvaxia, manufactured by Sanofi Pasteur, can only be used in individuals aged 9 to 16 living in parts of the United States where the dengue virus is endemic — in other words, where it circulates on an ongoing basis. Dengue is found only in Puerto Rico and a few other U.S. offshore territories and protectorates. Furthermore, the vaccine can only be given to children and teens who have had one previous laboratory-confirmed case of dengue…” (Branswell, 5/1).

Wall Street Journal: Sanofi’s Dengue Vaccine Gets FDA Approval
“…Dengvaxia was first approved in Mexico in 2015 and remains the world’s only approved vaccine against dengue. But safety fears have complicated efforts to contain the growing global threat. World Health Organization estimates put about half the world’s population at risk. … The Philippines, which was the first country to widely distribute the vaccine, revoked its product-license approval this year after a number of deaths were reported…” (Armental, 5/1).