World’s first vaccine for the dengue hemorrhagic fever, the fastest growing mosquito-borne disease, was approved by the Mexican authorities on Wednesday.
According to World Health Organization, the disease affects as many as 400 million people each year.
The Federal Medical Safety Agency said that the vaccine has been tested on over 29,000 patients around the world.
Mexico has not disclosed the name of the firm, but the French drug maker Sanofi Pasteur announced it will produce the vaccine, which will be named Dengvaxia.
The vaccine is for all four dengue virus serotypes and is aimed for people aged between nine to 45.
It will be used in areas where the disease is endemic.
Guillaume Leroy, who leads the dengue team at Sanofi Pasteur, said that the vaccine acted best as an immune booster for patients who have been exposed to the disease earlier.
Dengue hemorrhagic fever, the most extreme form of the disease, which can cause internal bleeding, shock, organ failure and death, is usually seen in people who have suffered from another form of the disease in the past.
Dr In-Kyu Yoon, director of the international Dengue Vaccine Initiative, said that the drug "may potentially have a significant public health impact," but noted "we still don't know how much Sanofi will charge."
"It probably will work best in those regions and countries that have the highest rate."
"Mexico is one of the countries where we started our clinical trials, which has been associated with the programme from the very beginning and whose regulatory authority is certified by the WHO," said Olivier Charmeil, Sanofi's executive vice president for vaccines.
Sanofi said in its statement that the drug "prevented nine out of 10 cases of severe dengue and eight out 10 hospitalisations due to dengue."
Whether the Mexican government will pay for the vaccine has not yet been decided, as it is mostly needed in poor, low-lying states.
Mexico's National Vaccination Council will meet to decide on the matter, the head of the health regulatory agency, Mikel Arriola, told AFP.
Mexican health authorities estimate the vaccine could prevent 8,000 hospitalisations and 104 deaths per year.
Mosquitoes transmit the dengue virus. Its symptoms include high fevers and severe muscle and joint pain. There's no specific treatment for dengue.
Mexico has been involved in Sanofi’s research for the vaccine since 2006.
Other drug makers including US firm Merck, Japan's Takeda and Britain's Glaxo Smith Kline are also working on dengue vaccines but are several years behind.
The vaccines may bring in over 1 billion dollars in sales each year to the company.