MANILA (BLOOMBERG) - Sanofi's controversial dengue fever vaccine was dealt another blow as the Philippines permanently banned the treatment that created 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 the country's regulator, according to a statement on Tuesday. In December 2017, the organisation suspended the vaccine for a year due to similar reasons.
"Its brazen defiance of FDA's directives and its continued failure to comply leaves us no other recourse," said Ms Nela Charade G. Puno, director general of the Philippines' FDA, in the statement.
Sanofi did not immediately respond to requests for comment. The company said in the past that the Philippines suspension was not related to the product profile of the vaccine.
The drugmaker has faced setbacks with its Dengvaxia shot, which it spent over two decades and €1.5 billion (S$2.3 billion) developing.
In 2017, a company analysis found that people who had never suffered from dengue before getting the treatment had a greater risk of developing severe disease if they were later infected. Sanofi cut the value of its stockpiles, and analysts slashed their sales estimates.
The 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 United States Food and Drug Administration. However, the drug has hit hurdles in getting into other countries, with local media reporting Malaysia is reviewing the vaccine.
The issue has been sensitive in the Philippines, as the government administered the vaccine as part of its free immunisation drive. Complications allegedly related to the vaccine have led to a wariness of all immunisations. President Rodrigo Duterte appealed this month for citizens to overcome their fears and have children inoculated against an outbreak of measles.
Dengue, a mosquito-borne virus also known as break-bone fever, affects roughly 400 million people around the world each year. Sanofi's Dengvaxia is the world's first and only vaccine on the market for the disease.
While Sanofi is working on a diagnostic tool to help salvage Dengvaxia, rival drugmakers are striving to avoid similar setbacks. Takeda Pharmaceutical Co continues to push ahead with its experimental dengue vaccine. Last month, the Japanese drugmaker announced that the treatment hit its main goal in a late-stage study.