Sanofi today announced the positive results of a 20,000 strong phase III trial of their pioneering dengue vaccine
This final study from Sanofi Pasteur, Sanofi’s vaccine arm, has demonstrated a 60.8 reduction in cases of dengue fever amongst it’s 20,875 strong population of 9-16 year olds in Latin America. This was accompanied by a 80% reduction in hospitalisations caused by the fever.
Over 40% of the world’s population is currently at risk of dengue. With the WHO estimating the number of cases each year between 50 and 100 million, and with half a million sever hospitalisations each year, the human and economic costs of dengue are huge. A vaccine able to reduce cases by 60%, or even 40% as in earlier trials, will dramatically impact the economies and quality of life for populations, both rich and poor, across the globe.
These positive results will no doubt come as a relief to Sanofi after the disappointing results of their last Phase III trial that showed a reduction in cases of just 40%. But with a much larger patient population in the Latin American study (20,000 compared to 10,000 in the Asia study), the results are comforting and should prove more reliable in the long run. The trial also covered 5 different countries covering a much wider range of demographics, providing researchers with a better understanding of the effects of the vaccine.
We’re talking about different regions, different seasons, different demographics, and it’s very important for a vaccine to perform consistently, so these results are extremely pleasing”Nicholas Jackson, Head of dengue Research and Development, Sanofi Pasteur – Source Reuters
This latest phase III trial demonstrated the vaccine to be 42.3 % efficient in tackling stereotype 2 of the four stereotypes, up 7.3% on the Asia trial. The participating countries were Brazil, Colombia, Mexico, Honduras, and Puerto Rico.
A more detailed analysis of the results is due to be presented at the American Society of Tropical Medicine and Hygiene’s annual meeting this November.
Sanofi aims to get the vaccine through marketing approval in the next year, pushing the vaccine as a three dose regimen, which is thought could bring in an extra $1 billion on top of Sanofi Pasteur’s current ~$3.7 billion a year. Sanofi is already producing the vaccine in bulk at it’s new dedicated production facility in Neuville-sur-Saone, France. The plant went live back in July, and aims to sell the first doses in the latter half of 2015.
See the press release here