Sanofi Pasteur wishes to clarify and correct recent misleading comments on the dengue vaccine’s safety and the process of obtaining its license in the Philippines (“Health sec yields to Congress blackmail,” Letters, 12/10/16).
The dengue vaccine is a product of two decades of scientific innovation and collaboration of some 25 clinical studies in 15 countries throughout Asia and Latin America, involving more than 40,000 people. The vaccine has been documented to be effective at protecting two-thirds of individuals (66 percent) aged nine years and older against dengue over the 25-month follow-up phase of the efficacy studies. This clinical evidence on the dengue vaccine was published in the New England Journal of Medicine in July 2015; it was also reported that the vaccine provides even greater protection against severe dengue (93 percent) and can prevent 80 percent of hospitalizations due to dengue in the study population 9 years and older over the 25-month follow-up period. As you may be aware, hospitalization and severe disease due to dengue lead to the bulk of the human and economic burden of this disease in dengue-endemic countries like the Philippines.
Based on the published scientific and medical evidence on this vaccine, we want to assure the public that the dengue vaccine is safe and effective.
We also want to reiterate that Sanofi Pasteur always observes all local and international laws and regulations when seeking approval of its vaccines. Our company registers vaccines with governments all over the world and we have a highly regulated compliance process we follow.
The initial dossier containing the scientific, clinical and test data was submitted to the Food and Drug Administration in January 2015. The decision was not taken until December 2015 after study and consideration by officials. While the Philippines was the first country in Asia to license the vaccine and second in the world (after Mexico), it has now been approved for use in 13 countries—Mexico, Philippines, Brazil, El Salvador, Costa Rica, Paraguay, Guatemala, Peru, Bolivia, Indonesia, Thailand, Singapore and Cambodia.
Moreover, the World Health Organization published a position paper in July recommending the use of the vaccine as an integral part of comprehensive dengue prevention measure in areas where the disease is highly endemic following a two-year review of the documentation on the vaccine.
We regret any controversy which diverts attention away from the principal purpose of the vaccine and our program with the Philippine government—to save lives and reduce the social, medical and financial impact of this disease on the people of the Philippines. The approved dengue vaccine, which is endorsed for use in public immunization programs in highly endemic settings like the Philippines by the WHO, is being administered today in three regions of the Philippines and the program will be expanded to a fourth region as Department of Health officials announced in Congress. It is imperative that these schoolchildren who are receiving the vaccine and their families be reassured about the safety of the vaccine by balanced coverage of this topic in the media and responsible, evidence-based statements by members of the Philippine medical community.
RUBY DIZON, medical director, Sanofi Pasteur Philippines