The Food and Drugs Administration of the Philippines has suspended clearance for Sanofi's dengue vaccine, Dengvaxia, as well as fined the French drugmaker a symbolic $2,000.
The Agency cited violations on product registration and marketing following Sanofi’s warning last month that the vaccine may cause more severe symptoms on those who had not been previously infected by dengue. Sanofi’s Dengvaxia was used in the world’s first mass immunization program against dengue fever, which was started last year. Roughly 830,000 children have been vaccinated.
The Philippines FDA had issued Sanofi a certificate of product registration in December 2015. however Sanofi failed to submit the necessary post-marketing authorization requirements after being allowed to sell its dengue vaccine. The FDA had now suspended Dengvaxia's Certificate of Product Registration (CPR) for a year, as well as ceased the vaccination program.
Read the FDA advisory
Read the Reuters coverage