Sanofi Receives Narrow FDA Approval for Dengue Vaccine

The U.S. Food and Drug Administration (FDA) has given Sanofi SA’s dengue vaccine Dengvaxia a narrow approval since the vaccine can cause severe infections in some people.

According to FDA, Sanofi can sell the drug only to people age 9 years through 16 years who have laboratory confirmation of a previous dengue infection and live in areas where the disease is prevalent such as Puerto Rico, the U.S. Virgin Islands and American Samoa. It is not approved for individuals who have not previously been infected by one of the four types of the virus, which is spread by mosquitoes. Sanofi had sought broader approval of the vaccine to include people age 9 years through 45 years, but FDA excluded its use in adults after Sanofi disclosed Dengvaxia could increase the risk of severe dengue in children who had never been exposed to the virus, which triggered a government investigation in the Philippines where 800,000 school-aged children had already been vaccinated.

“Today’s FDA approval of Dengvaxia allows us to bring a critical medical prevention tool to at-risk populations, helping combat and prevent dengue, particularly among children, in U.S. dengue endemic areas,” said David Greenberg, MD, Sanofi’s regional medical head for North America.

In December, Dengvaxia won European approval for people age 9 years to 45 years living in endemic areas who have a documented prior infection. The World Health Organization said last spring that Dengvaxia should only be used on individuals with proven prior dengue exposure.