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Dengue vaccine use in PHL on hold pending WHO guidelines

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The Philippines has become the first country in Asia to license the world’s first vaccine for dengue prevention. But it may take some time before the vaccine will actually be used widely.

The country’s Food and Drug Administration approved on 23 December a tetravalent vaccine called Dengvaxia to fight the four separate strains of dengue that have defied preventive control for so long.

Developed by Sanofi Pasteur, the vaccine division of French pharmaceutical giant Sanofi, Dengvaxia has been authorised for sale in the local market starting in January 2016. But the Philippines’ Department of Health will have to wait for the WHO vaccine prequalification guidelines and recommendations before funding can be provided for large-scale procurement.

Dengvaxia is the first anti-dengue vaccine granted regulatory approval in Asia. Two weeks earlier, Mexico gave its nod, the first country to do so. The vaccine is being reviewed by 20 other countries in Asia and Latin America.

The WHO considers dengue as the fastest-growing mosquito-borne disease worldwide, with cases rising 30 times in the last half century. That puts over half of the world’s population potentially at risk, 67 million in Asia alone. The jet age and the migration to cities have spurred dengue endemicity from only nine to more than 100 countries.

Dengvaxia is welcome news to the Philippines where dengue cases increased by 9.2 per cent from January 1 to August 8 compared to the same period last year. By October, dengue cases already neared the 100,000 mark.

The vaccine has the potential to have “a significant impact” on public health in view of the high disease burden in endemic countries, says Maria Rosario Capeding of the Philippines' Research Institute for Tropical Medicine.

The institute has been a major partner in the vaccine’s development, involved in all three phases of its clinical development. All phases were done in metropolitan Manila and Cebu and rural areas. Other countries participated only in the third phase of testing on patients for efficacy, effectiveness, and safety.

“Approval of the first dengue vaccine in Asia, which bears 70 per cent of global disease burden, is a major milestone in dengue prevention and public health,” says Olivier Charmeil, president and chief executive officer of Sanofi Pasteur.

By 2018 or 2019, Sanofi is expected to earn over US$1 billion each year from selling Dengvaxia. It cost Sanofi 1.5 billion euros (US$1.6 billion) over 20 years to research and develop the vaccine. The bill covers 25 clinical studies involving 40,000 volunteers across 15 countries.  —

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