Sanofi-Pasteur, the vaccines arm of French drugmaker Sanofi-Aventis, announced this morning that it has begun Phase III clinical testing of its dengue fever vaccine in Australia.
According to the firm, its jab is the “world’s most clinically advanced dengue vaccine candidate”, being the first to reach Phase III after successfully wrapping up Phase I and II studies in adults and children in the US, Asia and Latin America.
Now, marking the final stage of development for the vaccine, which targets all four virus serotypes causing disease, the Phase III trial launched in Australia is part of a global programme aiming to secure approval of a novel vaccine for the prevention of dengue disease in children and adults.
As yet there is no specific treatment on the market for dengue fever, a mosquito-borne disease, which, the firm noted, is a potential threat to almost half of the world’s population and remains a public health priority throughout Latin America and Asia.
Around 220 million people are infected with the disease every year, of which two million will develop dengue hemorrhagic fever, a leading cause of hospitalisation and thus significant drain on medical resources in affected areas, highlighting the urgent medical need for an effective vaccine.
Sanofi is working hard to get the world’s first dengue vaccine to market, and says the Phase III trial will be the first to use its jab produced with industrial scale processes to show that it achieves the consistency criteria required for regulatory approval.
“We are now entering the final laps of a long run that Sanofi Pasteur started almost 20 years ago,” said Wayne Pisano, president and chief executive of the company, and, if successful, the firm is committed to introducing the vaccine in countries where dengue is of highest public health priority, he stressed.