Sanofi Gets Limited FDA Approval For New Dengue Vaccine

The United States Food and Drug Administration approved, this week, the very first dengue fever vaccine. This is the first of its kind-type of protection against one of the most common diseases which, of course, affects mostly people in third world countries.  Unfortunately, though, testing of the vaccine also revealed that it has the potential to increase risk of severe infection in some patients. 

Essentially, the US FDA ruled that this drug manufactured by Sanofi Pasteur, Dengvaxia, can only be administered on patients between the ages of 9 and 16 who live in regions of the United States where the dengue virus has become endemic.  Of course, dengue is only consistently found in Puerto Rico and a few other offshore US territories and protectorates.  

In addition to this, the vaccine can only be administered to children and teens who have at least one existing laboratory-confirmed dengue case. While this puts a restriction on the vaccine and shrinks its market in the US, Sanofi said it is still pleased by the decision from the FDA.

For one, Sanofi regional medical head for North America Dr. David Greenberg comments, “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.”

With that, then, Sanofi Pasteur is now collaborating with a diagnostics maker to develop, together, a new point-of-care, rapid diagnostic test that is specifically designed to identify prior dengue infections among patients. 

Furthermore, a Sanofi spokesman goes on to say, “The FDA requested additional data in people 17 through 45 years of age, particularly in countries where the dengue burden is lower, to supplement our bridging data. We are open to evaluating additional opportunities to expand Dengvaxia’s indication as new clinical and epidemiological data becomes available.”

This will be crucial, then, as Dengvaxia could face competition from a prospective treatment from Takeda.  Their TAK-003 shot is still considered experimental but the Japanese pharmaceuticals company has cleared it through a very large phase 3 trial for children and teenagers (regardless of any previous infection).