KUALA LUMPUR, May 3 — The United States’ Food and Drug Administration (FDA) has approved a controversial vaccine against dengue fever, but with various restrictions.
Stat reported that Dengvaxia, produced by Sanofi Pasteur, can only be used in those aged nine to 16 in parts of the US where the dengue virus is endemic. Dengue is reportedly found only in Puerto Rico and some other US offshore territories and protectorates.
The vaccine — which has been banned in the Philippines after it was linked to several deaths — will only be allowed to be given to children and teenagers who have had a previous case of dengue confirmed by laboratory tests.
“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 US dengue-endemic areas,” Dr David Greenberg, Sanofi’s regional medical head for North America, was quoted saying.
Sanofi’s post-marketing research reportedly showed that Dengvaxia increased the risk of severe infection in children who were not previously infected with dengue, even though the vaccine protected people who have been infected with the virus at least once.
Philippine prosecutors have reportedly charged Sanofi, six of its employees, and former and current Philippine health officials over the deaths of over 30 children that they blamed on the use of Dengvaxia.
The vaccine was reportedly given to over 800,000 schoolchildren in the Philippines before Sanofi acknowledged that it could cause “severe disease” among those who had not previously been infected with dengue fever.