And this first dengue vaccine is now approved and made available in the Philippines making history as the first place in the world where this much awaited vaccine was launched.
On December 22, 2015 the Philippines granted marketing approval to Sanofi Pasteur for its tetravalent dengue vaccine, the first registered in Asia contributing to fight against this life- threatening disease.
Highly-endemic areas like Mexico was granted the first license of the vaccine last December 8, 2015 followed by the Philippines a few days after. Brazil was the third while El Salvador and Paraguay got their licenses just this month of February.
The Dengue Tetravalent Vaccine is a live attenuated vaccine containing dengue serotypes 1 to 4. It is given through the subcutaneous route as a 3- dose series every 6 months from the first dose. The recommended age indication is from 9 to 45 years, based on studies showing optimal safety and efficacy within these age groups.
For the last 5 years, there has been consistent data showing approximately 64% of dengue cases in the pre-adolescence, adolescence and adult age groups. There was still no sustained long term benefit found for those less than 9 years of age. Further studies will soon provide additional clinical information over time on the benefit-risk in this younger age group.
The Philippine launching, which was held last Tuesday, February 23 at Marriott Hotel in Pasay City was attended by a great number of medical professionals in the public and private sectors nationwide.
Renowned speakers like Dr. Salvacion R. Gatchalian, MD, FPPS, FPIDSP, FPSMID (Associate Professor at the UP College of Medicine and Immediate PastÂ President of the Pediatric Infectious Disease Society of the Philippines) talked on Dengue Epidemiology and Burden while Dr. Ma. Rosario Z. Capeding, MD, FPPS, FPIDSP, FPSMID, Head of the Department of Microbiology Research Institute for Tropical Medicine and Principal Investigator of the research opened the Scientific Session.
The other speakers were Dr. Lyndon L. Lee Suy, MD, MPH, DOHÂ Director 3 of Disease Prevention and Control Bureau who shared on Dengue Public Health Impact. Dr. Alain Bouckenooghe, MD, MPH, DTM&H, Associate Vice President and Regional Head of Clinical Research and Development – Sanofi Pasteur Asia, explained the clinical development of the dengue vaccine.
According to Dr. Bouckenooghe, results from the phase 3 efficacy studies of the vaccine across ten endemic countries including more than 40,000 children and adolescents in Asia and in Latin America and the Carribean, as well as 23 additional studiesÂ were considered as basis for this approval.
The approval covers an indication for the prevention of symptomatic dengue of any serotype and any severity in people of ages 9-45 years living in endemic areas.
According to the studies, the vaccine can reduce severe dengue by 93% or 9 out of 10.
The launch had threeÂ significant “firsts”.
One, the country was the first in the world to launch the vaccine.
Two, the Philippines is the first grantee in Asia.
And three, the country is the first to implement the vaccine in a National Immunization Program (NIP), though in selected areas only, namely Regions 3, 4A and the NCR.
These regions have the most number of dengue cases in the last few years. They will be giving their first doses of the vaccineÂ on April, May and June this year to Grade 4 students in public schools not less than 9 years old and the succeeding doses 6 months after.
With this breakthrough in preventive medicine, it is with great hope that the burden of this fatal disease will be averted considering that the annual global cost of dengue is $8 billion, according to the World Health Organization (WHO).Â (cvda)