Sanofi Pasteur's dengue vaccine proves effective and safe; FDA identifies cGMP deviations

French drug major Sanofi (Euronext: SAN) vaccines subsidiary Sanofi Pasteur sais this morning that its tetravalent dengue vaccine candidate demonstrated proof of efficacy against dengue, a threat to almost 3 billion people, in the world’s first ever dengue efficacy trial conducted in Thailand, with excellent safety.

The vaccine generated antibody response for all four dengue virus serotypes. Evidence of protection was demonstrated against three of the four virus serotypes circulating in Thailand. Analyses are ongoing to understand the lack of protection for the fourth serotype in the particular epidemiological context of Thailand.

“Results of this first efficacy trial with Sanofi Pasteur’s dengue vaccine candidate represent a key milestone in the quest to develop a safe and efficacious human vaccine against dengue,” said Michel De Wilde, executive vice president, R&D, Sanofi Pasteur. “This is also an important development for global public health, since there is currently no specific treatment or prevention for dengue. We are fully committed to making dengue a vaccine preventable disease by bringing a safe and effective vaccine to people living in endemic regions of the world,” he added.