Sanofi to Seek U.S. Approval for First Dengue Vaccine in Months

  • Vaccine has been cleared in 11 nations including Thailand
  • Drugmaker expects to launch vaccine in Indonesia, Costa Rica

Sanofi plans to seek U.S. approval for its dengue vaccine as early as this year after reaching the market in parts of Latin America and Asia where the mosquito-borne infection is widespread.

The French drugmaker is focusing on the most vulnerable countries before bringing the vaccine, called Dengvaxia, to more developed regions, with a goal of getting the product on the market in about 30 nations from Malaysia to Colombia, Guillaume Leroy, dengue vice president at Sanofi’s vaccines unit, said in an interview Tuesday. 

“We are showing we can provide the vaccine to the populations who need it most,” he said.

U.S. approval would provide a boost to the vaccine’s sales, which were just 1 million euros ($1.1 million) in the second quarter. Dengvaxia probably won’t meet its targets for the year due to economic and political volatility in Latin America, the Paris-based company said in July. Analysts had previously anticipated about 200 million euros in sales for 2016. The vaccine is forecast by analysts to generate about $840 million in sales in 2020 and about $1 billion in 2025.

Dengvaxia is the world’s first dengue vaccine, developed over two decades at a cost of 1.5 billion euros. Dengue has spread quickly in recent years, with an estimated 390 million infections each year. 

The vaccine has won approval in 11 countries, with authorities in Thailand, Singapore and Indonesia the latest to clear Dengvaxia. Sanofi may introduce the vaccine next in Indonesia and Costa Rica, following launches in Brazil, the Philippines, Mexico and El Salvador, he said.

“This is a very critical transition period, ” Leroy said. “It’s extremely complicated to plan very precisely what will be the speed of the decision process, the speed of the implementation and the final design of the vaccine program. That’s the reason why some adjustment has been made. But the medical and clinical value of the vaccine is getting recognized.”

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