PARIS (Reuters) – Sanofi said on Monday that a late-stage clinical study showed that its dengue vaccine candidate met its main goal and was highly effective against severe cases of the disease.
The French drugmaker’s Sanofi Pasteur division intends to file for registration for the vaccine in several endemic countries next year, it said in a statement.
“Subject to regulatory approval, the world’s first dengue vaccine could be available in the second half of 2015,” Sanofi said.
The Phase III study involved 31,000 participants across 10 endemic countries in Asia and Latin America, Sanofi said. Every year, an estimated 500,000 people are hospitalized due to severe dengue, according to the drugmaker.
Sanofi has invested more than $1.7 billion in the past 20 years in developing the vaccine, which is several years ahead of potential competitors. The firm has built a dedicated factory near Lyon in southern France with capacity to produce 100 million doses a year.
(Reporting by James Regan; Editing by John Irish)