Large Molecule / Drug Approvals

Sanofi gets FDA nod for controversial dengue vax, with restrictions

May 02, 2019

The U.S. FDA has granted a restricted approval for Sanofi's dengue vaccine, Dengvaxi, despite the global controversies surrounding the drug.

The FDA says the drug may only be given to people aged 9 through 16 who have laboratory-confirmation of a previous dengue infection and live in areas where the disease is prevalent (Puerto Rico, the U.S. Virgin Islands, Guam or American Samoa).

Sanofi was looking for a broader approval that would have included people aged 9 to 45, but an FDA advisory panel in March recommended excluding its use in adults.

In late 2017, Sanofi conceded that Dengvaxia could increase the risk of severe dengue in children who had never been exposed to the virus, triggering two congressional inquiries and a criminal investigation in the Philippines, where 800,000 school-age children had already been vaccinated. Then in March, the Philippine Department of Justice announced plans to indict employees from Sanofi and former and current Philippine health officials over 10 deaths it said were linked to the vaccine.

The FDA stipulated that Dengvaxia is not approved for individuals who have not previously been infected by one of the four types of the virus because the vaccine "appears to act like a first dengue infection – without actually infecting the person with wild-type dengue virus – such that a subsequent infection can result in severe dengue disease."

Read the FDA release