Despite complications due to turmoil in Latin America, Sanofi’s Dengvaxia launch presses on, with talks to implement the vaccine on a large scale in a number of countries “going very positively,” according to a company dengue expert.
Dr. Cesar Mascareñas, Sanofi Pasteur’s director of global medical affairs for dengue, told FiercePharma that a campaign utilizing the vaccine in Mexico is likely to be announced following a recent recommendation by a national vaccination council. Other nations in Latin America and Asia are talking over strategies that would utilize three-dose vaccine through public campaigns, he said.
Since its launch, Dengvaxia has been tripped up by turmoil in Latin America, and it turned in just €1 million in second-quarter sales. At the time, execs stated the all-too-obvious fact that Dengvaxia would miss the company’s €200 million sales estimate for the year.
Large-scale public campaigns are seen as a key to the launch, but so far, only the Philippines and Brazil’s Paraná state have announced such programs.
Meanwhile, Sanofi Pasteur is focusing on expanding geographically. It has submitted Dengvaxia for licensure in 25 countries, and more approvals are expected this month in Asia and Latin America, Mascareñas said. According to a recent press release, 9 countries have approved the shot.
Hot on Sanofi’s tail is Takeda Pharmaceuticals, which entered Phase III with TAK-003 last week. Analysts have estimated dengue vaccines could be a $1 billion market or more per year, but given Dengvaxia's slow start and dengue's prevalence pattern, which is mostly in developing countries, it’s unclear whether the market would be big enough for both the Sanofi and Takeda vaccines, plus another candidate that’s in Phase III testing in Brazil.
Last week, a study in Science said that if used in areas of low dengue prevalence, Dengvaxia could potentially make infections worse. That didn’t change any of Sanofi’s expectations or strategies, Mascareñas said, because it was only a “mathematical model” and not “evidence-based.” Plus, he said, it was one of 8 models considered by the WHO in making its recommendation that the vaccine be used in countries where the virus is more than 50% prevalent.
"It’s not new information for the experts," he said. "It has been taken into account by the experts at the WHO."
Rather than first launching in the U.S. and Europe, Sanofi early on said it was “flipping the model” for its Dengvaxia launch, favoring wide access in endemic, middle-income nations. The company spent $1.5 billion and 20 years developing the shot.
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