BRASIILIA • Brazil has become the first South American nation to authorise the world's first dengue vaccine, which its French manufacturer says has the potential to save hundreds of lives in the country.
The tropical disease, a flu-like illness carried by mosquitoes, killed 839 people this year in Brazil and infected more than 1.5 million.
Sprawling Brazil's decision on Monday to allow the new vaccine, called Dengvaxia, is a coup for French pharmaceutical giant Sanofi Pasteur, which has now received the green light from regulators in three countries.
Mexico became the first country to allow the vaccine on Dec 9, and the Philippines followed suit last week. Sanofi has requested regulatory approval in 20 countries across Asia and Latin America.
The vaccine is a potential "blockbuster" drug for the company, which estimates that it could generate more than US$1 billion (S$1.4 billion) a year in revenue.
- • Dengue infects as many as 400 million people every year, and the deadliest form kills 22,000 per year.
- • The number of cases in the world has risen 30-fold over the last 50 years, making it the world's fastest-growing mosquito-borne disease.
• It was once considered a disease of the tropics, endemic in only nine countries. But due to globalisation, urbanisation, climate change and air travel, it is now endemic in more than 100 countries.
The Brazilian government said regulators must still set a price per dose, a process that takes about three months on average.
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 Agence France-Presse.
Scientists have long been stumped by dengue, which has four separate strains.
Clinical tests - carried out on 40,000 people from 15 countries - have found Dengvaxia can immunise two-thirds of people aged nine years and older, rising to 93 per cent for the more severe form of the disease, dengue haemorrhagic fever.
Dengue can trigger a crippling fever along with headache, nausea, vomiting, muscle and joint pain, and skin rashes similar to measles.
Dengue infects as many as 400 million people per year, and the deadliest form kills 22,000 per year, says the World Health Organisation (WHO). The disease results in bleeding and blood plasma leakage. It can be fatal, in particular among children.
It was once considered a disease of the tropics, endemic in only nine countries. But globalisation, urbanisation, 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, making it the world's fastest-growing mosquito-borne disease and leaving more than half of the world's population potentially at risk. Around 2.5 per cent of the people hospitalised due to dengue fever every year die, the WHO adds.
The 20 countries where Sanofi Pasteur hopes for regulatory approval have a total population of two billion people, 200 million of them in Brazil.