Sanofi's Dengvaxia gets a boost from WHO recommendation

Dengvaxia

Sanofi’s Dengvaxia has gotten a welcome boost. Even as the first endemic nation began a large-scale vaccination campaign utilizing the dengue fever vaccine, the WHO has endorsed the shot for use in countries where the virus is more than 50% prevalent.

Based on a review of results from two Phase III studies in Latin America and Asia, a WHO panel recommended Dengvaxia vaccination “as part of a comprehensive dengue control strategy.” So far, the vaccine--which data show can prevent 66% of dengue cases and 93% of severe dengue cases--has notched regulatory approvals in Brazil, El Salvador, Mexico and the Philippines. Sanofi says it can prevent 8 in 10 dengue hospitalizations.

“These WHO SAGE recommendations further validate the scientific and medical value of Dengvaxia and send a clear message to endemic countries about the strong public health benefit to be gained by introducing the dengue vaccine in integrated disease management efforts to combat their dengue burden,” Sanofi’s R&D head Dr. Elias Zerhouni said in a statement.

But so far only the Philippines has introduced the vaccine through a national immunization drive. The endemic nation of islands became the first to do so earlier this month in a program aimed at 1 million schoolchildren, setting aside $73.5 million to cover the costs. Sanofi Pasteur’s dengue program head Guillaume Leroy told FiercePharmaAsia at the time that he expects additional regulatory approvals within “weeks or months” and more vaccination campaign announcements to come.

WHO’s endorsement could prove a key boost for a vaccine that’s still in the early stages of a high-stakes rollout. Dengue affects 390 million people worldwide each year, according to WHO figures, with 3.9 billion people in 128 countries at risk of infection. That leaves a lot of ground to cover for a shot that could see competition in the coming years from Takeda’s DENVax and a separate NIH-developed candidate undergoing a Phase III trial in Brazil. Before the Dengvaxia launch began, Sanofi said it would “flip the model” and take the vaccine to impacted regions first rather than major markets such as the U.S. and Europe.

The announcement also comes at a pivotal point for Sanofi and CEO Olivier Brandicourt, who is working to build revenues and reshape the company as competition and pricing pressure eat away at diabetes revenues. In February, the pharma eliminated 500 positions in its native France following Brandicourt’s €1.5 billion cost-cutting initiative announced in November.

Dengvaxia, analysts have predicted, could achieve $1.4 billion in sales by 2020. However, Takeda’s DENVax may be working to steal market share by that time, others have said, and the NIH-developed TV003 candidate recently showed promise in a small human challenge, protecting all patients. Those results informed the decision to take that vaccine to a 17,000-patient Phase III trial in Brazil, which has set aside $24.8 million to fund the trial, reports said, despite having approved Dengvaxia.

- here's the SAGE meeting summary
- and Sanofi's release

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