Anti-dengue drug approved
THE FOOD and Drug Administration (FDA) has finally approved the much-awaited vaccine against the deadly dengue virus, making the Philippines the first in Asia to make a vital step in the prevention of the disease.
French pharmaceutical company Sanofi secured its first regulatory approval in Mexico a fortnight ago and is currently being reviewed by around 20 countries in Asia and Latin America.
In a statement Wednesday, Sanofi said the FDA gave the green light to use Dengvaxia in the Philippines not long after being approved in Mexico, where dengue is also endemic.
Scientists have long been stumped by dengue, which has four separate strains, forcing researchers to find a drug able to fight all of them at once.
It can trigger a crippling fever, along with muscle and joint pain. There is no known cure, and children are at particular risk.
Sanofi said the vaccine was developed for the prevention of the mosquito-borne disease caused by all four dengue strains in people aged 9 to 45 living in endemic areas in the country.
It was also found to reduce the risk of hospitalization by 80 percent.
“The approval of the first dengue vaccine in Asia, which bears 70 percent of the global disease burden, is a major milestone in dengue prevention and public health,” Sanofi president and chief executive officer Olivier Charmeil said Wednesday.
Several million doses of the vaccine are ready to ship, and Sanofi expects annual production to reach 100 million doses by 2017.
Sanofi’s research and development work took 20 years, costing more than 1.5 billion euros ($1.6 billion).
But the vaccine could bring the company more than $1 billion annually starting in 2018 or 2019, analysts said.
Dengue is the fastest growing mosquito-borne disease in the world, causing nearly 400 million infections annually, according to the World Health Organization (WHO).
The WHO said cases have risen 30-fold over the last 50 years, with more than half the world’s population potentially at risk.
Asia has the highest dengue fever burden globally, with roughly 67 million people getting infected every year.
The Philippines alone records an average of 100,000 dengue virus infections every year, resulting to hundreds of deaths.
The deadliest form of the disease kills 22,000 people a year, the WHO said.
From January to October this year, the Department of Health (DOH) has recorded 108,263 dengue cases nationwide and more than 300 deaths.
“Prevention of dengue is an urgent and growing medical priority in the Philippines,” said Dr. May Book-Montellano, president of the Philippine Foundation for Vaccination. “Vaccination is widely accepted as one of the most cost-effective ways to reduce the spread of infectious diseases like dengue.”
Montellano said the approval of the world’s first dengue vaccine in the Philippines will be a “critical addition” to the continuous public education and vector control efforts on dengue prevention in the country.
Sanofi said it was introducing the dengue vaccine first in Asia and Latin America, where the virus is a major public health priority, to reduce the burden globally and help achieve the WHO’s goal of reducing dengue mortality by 50 percent and morbidity by 25 percent by 2020 in endemic countries.
Disease of the tropics
Dengue was once considered a disease of the tropics, endemic in only nine countries. But globalization, urbanization, climate change and jet travel are helping it to move into more temperate zones.
It is now endemic in more than 100 countries.
It also said the vaccine was the culmination of 20 years of scientific innovation and collaboration and 25 clinical studies in 15 countries around the world, where over 40,000 volunteers participated in the clinical study program.
Health Secretary Janette Garin said the Philippines participated in all three phases of the clinical development of Dengvaxia. The clinical studies were conducted in Cebu and several areas in Metro Manila, among selected locations.
In an earlier interview, Garin said the government has to wait for the WHO prequalification of the vaccine and its guidelines and recommendations before it can proceed with the procurement.
“It has to go through the procurement process. We also have to provide funding for that,” she said.
Garin also said the DOH is seriously studying the possibility of making the dengue vaccine a Philippine Health Insurance Corp. benefit, making it available to enrolled members at a “very discounted price.”
Garin Wednesday said the vaccine will be available in the market by next month in private clinics and hospitals.
Other pharmaceutical companies are developing dengue vaccines, including US firm Merck, Japan’s Takeda and Britain’s GlaxoSmithKline, but Sanofi is ahead of the competition. With a report from AFP
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