In the know: Dengvaxia

Developed by the French pharmaceutical firm Sanofi Pasteur, Dengvaxia is the first dengue vaccine to be licensed in the world.   It was first licensed in Mexico in December 2015, but only for people aged 9 to 45 who are living in dengue-endemic areas in the country.

The vaccine is given as a three-dose series via subcutaneous injection in the upper arm, with the second and third doses administered at six months’ intervals after the first dose.

The dengue vaccine, which protects against four dengue virus serotypes, underwent 25 clinical studies in countries across Southeast Asia and Latin America. The key efficacy results of the studies showed a 65.6-percent reduction in symptomatic dengue, an 80.8-percent reduction in hospitalization and a 93.2-percent reduction in severe dengue.

The World Health Organization however recommends that countries should consider introducing the dengue vaccine only in geographic settings (national or subnational), where epidemiological data indicate a high burden of disease.

In December 2015, Dengvaxia was licensed and approved for use in the Philippines by the Food and Drug Administration (FDA), making it the first country where the vaccine is commercially available.

In April 2016, the Department of Health provided free vaccines to selected Grade 4 public school pupils in Metro Manila, Central Luzon and Calabarzon as part of their school-based immunization program. The three regions were reported to have the highest number of dengue cases in the country.

The government has allotted a total of P3.5 billion for the immunization program which will include monitoring the beneficiaries in the next five years for possible side effects.

In December 2016, the FDA directed Sanofi to cease and desist from disseminating advertisements for Dengvaxia in any form of mass or social media. Sanofi was also asked to stop activities promoting and marketing the vaccine.

The FDA said the ads violated Administrative Order No. 65 s. 1989,  prohibiting advertisement in any form of prescription or ethical drugs.

—Sources: DOH, WHO, Inquirer Archives