THE WORLD’S first vaccine against dengue virus will be approved for use in the country by the end of the year, making the Philippines the second country to make it available in the market next to Mexico, according to the Department of Health (DOH).
Health Secretary Janette Garin disclosed that the Food and Drug Administration (FDA) was on the last phase of deliberations in approving the use of Dengvaxia, which was developed by French pharmaceutical company Sanofi.
“We had a meeting with FDA and they are wrapping up the review. After the approval, this means it will now be available for the private sector,” said Garin in a recent interview. “We are looking to issue the FDA approval before the end of the year,” she said.
Garin had expected the Philippines to be the first country to give the green light to the sale and use of the dengue vaccine.
But on Dec. 9, Mexico granted marketing authorization to the vaccine, which will curb the spread of the disease caused by all four dengue virus stereotypes in children and adults residing in endemic areas.
Dengue is endemic in the Philippines, where about 100,000 people get infected yearly and hundreds die due to the virus.
From January to October this year alone, the DOH has recorded 108,263 dengue cases nationwide, with 31.8 percent aged 5 to 14 years old. More than 300 deaths have also been reported during this period.
But with the vaccine, the DOH is hoping to significantly bring down the number of infections and deaths.
Garin said the FDA is in the process of completing the guidelines in relation to giving Sanofi the license to market the dengue vaccine.
“We are reviewing many literatures and the FDA is also looking at the effect of the vaccine on not only one but four strains of the virus,” said the health chief.
Once the FDA has issued its approval for the market and use of the Dengvaxia in the country, the DOH will need to seek World Health Organization pre-qualification of the vaccine and its guidelines and recommendations to proceed with procurement, she said.
Garin said the DOH is seriously considering making the dengue vaccine a Philippine Health Insurance Corp. benefit, making it available to members at “a very discounted price.”
Officials of the French drug-maker paid a courtesy call on President Aquino while he was in Paris for the 21st Conference of Parties for the United Nations Framework Convention on Climate Change early this month.
Garin was present during the meeting, along with Finance Secretary Cesar Purisima, Trade Secretary Gregory Domingo and Transportation Secretary Joseph Emilio Abaya.
During the meeting, Sanofi expressed its gratitude to the Philippines for its major contribution for the development of the vaccine for 20 years, said Garin.
“The Philippines was among the countries where the three phases of the clinical trials were conducted so our country is very vital to the success of the vaccine,” she said, noting that officials of Sanofi also commended the Research Institute for Tropical Medicine.