Sanofi's First Vaccine to Prevent Dengue Fever Gets Brazilian Government's Approval

The dengue vaccine, Dengvaxia, manufactured by the French pharmaceutical giant Sanofi has received approval from regulators in three countries.

The world’s first-ever dengue fever vaccine has been authorized in Brazil. The French manufacturer says the vaccine has the potential to save hundreds of lives.

The tropical disease, a flu-like illness carried by mosquitoes, killed 839 people this year in Brazil and infected more than 1.5 million.

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The experimental drug allowed 80.8% of children aged nine and older to avoid hospitalization. For younger children, the vaccine efficacy was 56.1%.

‘Dengue is now endemic in more than 100 countries due to globalization, urbanization, climate change and air travel that helps it to move into more temperate zones.’

The sprawling South American country's decision to allow the new vaccine, called Dengvaxia, is a coup for French pharmaceutical giant Sanofi, which has now gotten the green light from regulators in three countries.

Mexico became the first country to allow the vaccine on December 9, and the Philippines followed suit last week.

Sanofi has requested regulatory approval in 20 countries across Asia and Latin America.

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The Philippines became the first Asian country to approve the sale of the world's first-ever dengue vaccine, dengvaxia, manufactured by Sanofi.

The vaccine is a potential "blockbuster" drug for the company, which estimates it could generate more than $1 billion a year in revenue.

The Brazilian government said regulators must still set a price per dose, a process that takes about three months on average.

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Dengavaxia, the first dengue fever vaccine produced by Sanofi has been approved for use in Mexico. Dengue fever is caused by dengue virus.

A separate review would have to be carried out for the vaccine to be incorporated in the national vaccination plan, a health ministry official told AFP.

Scientists have long been stumped by dengue, which has four separate strains.

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The Butantan Institute in Sao Paulo has received approval from the National Technical Commission for Biosecurity to begin the third phase clinical studies.

Clinical tests -- carried out on 40,000 people from 15 countries -- have found Dengvaxia can immunize two-thirds of people aged nine years and older, rising to 93 percent for the more severe form of the disease, dengue hemorrhagic fever.

Dengue infects as many as 400 million people per year, and the deadliest form kills 22,000 per year, says the World Health Organization.

It was once considered a disease of the tropics, endemic in only nine countries.

But globalization, urbanization, climate change and air travel are helping it to move into more temperate zones. It is now endemic in more than 100 countries.

The WHO says cases have risen 30-fold over the last 50 years, with more than half the world's population potentially at risk.

The 20 countries where Sanofi Pasteur hopes for regulatory approval have a total population of two billion people -- 200 million of them in Brazil.

Source-AFP