Sanofi’s Dengue Vaccine Gets FDA Nod But Conditions Apply; Dengvaxia Is World’s First Vaccine Against Dengue

The Food and Drug Administration (FDA) has given its approval for the use of Sanofi Pasteur’s Dengvaxia, the first vaccine against dengue fever, The Wall Street Journal reported.

The FDA approved the vaccine, Dengvaxia, subject to the condition that it can be used to treat people aged 9 to 16 with a laboratory-confirmed prior infection and living in areas where the disease is endemic (occurs regularly through the year).

In the US, the disease is particularly prevalent in Puerto Rico and a few other offshore territories and protectorates.

Dengvaxia was first approved in Mexico in 2015 and remains the world’s only approved vaccine against dengue but was subject to massive controversy when researchers found that it could worsen dengue in some people.

The Philippines is the only country in the world that has broadly used Dengvaxia, however, it revoked Sanofi’s product license and suspended the use of the vaccine after the company announced the findings of its post-marketing research.

A probe in Philippines also found ‘Causal Association’ between deaths and Sanofi Dengue Vaccine. Sanofi had however denied that its vaccine, the world’s first against dengue, had caused any deaths.