FDA approves1st vaccine vs dengue

MANILA, Philippines - The Food and Drug Administration (FDA) has granted marketing approval to Dengvaxia, making it the first vaccine for the prevention of dengue to be licensed in Asia, pharmaceutical firm Sanofi Pasteur said yesterday.

Olivier Charmeil, Sanofi Pasteur president and chief executive officer, noted in a statement that Dengvaxia is a tetravalent dengue vaccine that can prevent the disease caused by all four dengue types in individuals from nine to 45 years old living in endemic areas.

“Approval of the first dengue vaccine in Asia, which bears 70 percent of global disease burden, is a major milestone in dengue prevention and public health,” Charmeil claimed.

He said the “approval of Dengvaxia in the Philippines, following closely the first approval in Mexico, is further evidence of Sanofi Pasteur’s long-standing commitment to introduce this innovative new vaccine first in countries where dengue is a major public health threat.”

Sanofi Pasteur is the vaccine division of Sanofi. It claims that the dengue fever burden in Asia continues to be the highest globally, with an estimated 67 million people stricken annually.

As an urban disease, dengue attacks populations of Asia in the form of unpredictable outbreaks capable of paralyzing health care systems, negatively impacting social and economic activity.

The Sanofi statement also said that Asian endemic countries spend an estimated $6.5 billion per year in both direct medical and indirect costs.

According to Philippine Foundation for Vaccination president May Book Montellano, the “prevention of dengue is an urgent and growing medical priority in the Philippines.”

“Vaccination is widely accepted as one of the most cost-effective ways to reduce the spread of infectious diseases like dengue,” she said.

Montellano added that the vaccine approval in the Philippines would be “a critical addition to the ongoing public education and vector control efforts currently directed towards dengue prevention in our country.”

In an earlier interview, Health Secretary Janette Garin said the Philippines has a crucial role in the clinical trials for the vaccine, as she maintained that all three phases of the clinical development of the vaccines were done in the Philippines, while the other countries participated only in Phase 3.

“The Philippines is really very vital to the success of the vaccine’s development. Sanofi wants to team up with the Filipino teams again in their future researches,” she added.

The Philippine study was done at the Research Institute for Tropical Medicine, the country’s leading referral center for infectious diseases.