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LONDON – Europe's drug regulator has been approved for the first time in the Philippines.
The European Medicines Agency said Friday it had adopted a "positive opinion" of the French pharmaceutical company Sanofi's Dengvaxia. The vaccine is the world's first against dengue, which sickens about 96 million people annually.
The mosquito-spread virus is found in tropical and sub-tropical climates across Latin and South America, Asia, Africa and elsewhere. It produces a flu-like disease that can cause joint pain, nausea, vomiting and rash. In severe cases, dengue can result in breathing problems, hemorrhaging and organ failure.
There is no specific treatment for dengue and there are no other licensed vaccines on the market.
Earlier this year, the World Health Organization said the vaccine should be dealt with "in a much safer way" and should be given to people with dengue before. The vaccine is licensed for use in 20 countries.
The U.N. health agency said there have been "significant obstacles" in using the vaccine and that it should have been developed with dengue.
Sanofi has already been diagnosed with the disease and has been sickened by dengue fever. The company said it was expected to take a 100 million-euro ($ 118 million) loss based on that news.
The Philippines was the first country to introduce a national dengue immunization program – which it halted after Sanofi's announcement last year. The government also asked for more than 3 trillion pesos ($ 59 million) from Sanofi. In February, the Philippines said the vaccine was potentially linked to the deaths of three people: all of them died of dengue despite having been immunized against it.
The country imposed a symbolic of $ 2,000 on sanofi and suspended the vaccine's approval, charging that the drugmaker broke rules on how the shot was registered and marketed.
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