TOKYO: Sanofi’s controversial dengue vaccine was dealt another blow as the Philippines permanently banned the treatment, which set off a health scare in the country.
The country’s Food and Drug Administration said the French drugmaker failed to submit post-approval documents required by regulators, according to a statement on Tuesday.
The vaccine wasn’t on sale in the Philippines, having already been suspended there for a year.
Sanofi appealed the decision and said the regulator wasn’t questioning “the safety and efficacy of Dengvaxia.”
The vaccine brings in little revenue, and many analysts started discounting its contribution to Sanofi’s bottom line after researchers found it posed a risk to people who had never suffered from dengue – putting them at risk of a more severe infection if they got the shot.
Sanofi shares were little changed in Paris, trading at 74.56 euros.
Takeda Pharmaceutical is making progress on a rival injection for dengue, the mosquito-borne virus that affects roughly 400 million people around the world each year.
The Sanofi vaccine has been approved for use in several countries in Latin America and Asia.
It received European Commission approval in December and is under priority review with the US Food and Drug Administration.
However, the drug has hit hurdles in getting into other countries, with local media reporting Malaysia is reviewing the vaccine.
In the Philippines, the shot was administered as part of free vaccination drive and complications allegedly related to the product kindled resistance to getting any immunisations.
President Rodrigo Duterte this month asked citizens to overcome their fears and have children inoculated against an outbreak of measles.
Sanofi’s “brazen defiance of FDA’s directives and its continued failure to comply leaves us no other recourse,” Nela Charade G. Puno, director general of the Philippines’ FDA, said in the statement.