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MANILA (BLOOMBERG) – Sanofi's controversial dengue vaccine has suffered another blow, while the Philippines has banned the treatment that has caused a health alert in the country.
The country's Food and Drug Administration said the French drug maker had failed to submit the post-approval documents required by the country's supervisory authority, according to a statement released Tuesday. In December 2017, the organization suspended the vaccine for one year for similar reasons.
"Her bravery against FDA guidelines and her continued non-compliance leaves us no other recourse," said Nela Charade G. Puno, FDA chief executive in the Philippines, in the statement.
Sanofi did not immediately respond to requests for comment. The company said in the past that the suspension in the Philippines was not related to the product profile of the vaccine.
The drug maker suffered setbacks with its Dengvaxia shot, which it has spent more than two decades and 1.5 billion euros ($ 2.3 billion) in development.
In 2017, an badysis of the company revealed that people who had never suffered from dengue before treatment were more likely to contract a serious illness if they were subsequently infected. Sanofi reduced the value of its inventory and badysts reduced their sales estimates.
The vaccine has been approved for use in several countries in Latin America and Asia. It received approval from the European Commission in December and is currently the subject of a priority review by the US Food and Drug Administration. However, the drug encountered barriers to entering other countries, with local media reporting that Malaysia was reviewing the vaccine.
The issue was sensitive in the Philippines, with the government administering the vaccine as part of its free vaccination campaign. Complications allegedly related to the vaccine led to mistrust of all vaccinations. President Rodrigo Duterte this month called on citizens to overcome their fears and to vaccinate their children against a measles epidemic.
Dengue, a mosquito-borne virus, also known as bone fever, affects approximately 400 million people worldwide each year. Sanofi's Dengvaxia is the first and only vaccine in the world on the disease market.
While Sanofi is working on a diagnostic tool to help save dengvax, rival drug makers are trying to avoid similar failures. Takeda Pharmaceutical Co. continues to advance its experimental dengue vaccine. Last month, the Japanese drug manufacturer announced that the treatment was achieving its primary goal in an advanced phase study.
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