Mexico will be the first country in the world to have a vaccine available for dengue fever when it begins shipping early next year following approval today by Mexican authorities.
But the new vaccine, developed by the French pharmaceutical firm Sanofi, has produced the best results among people with previous exposure to the virus.
Guillaume Leroy, leader of the dengue team at Sanofi Pasteur, the company’s vaccines division, said the vaccine acted best as an immunity booster for such people.
Dengue fever is a mosquito-borne disease seen by the World Health Organization as a threat to about half the world’s population. Some 400 million people are believed to be infected annually.
Called Dengvaxia, the vaccine has only been approved in Mexico for patients aged nine to 45 who live in areas where the disease is endemic, barring its use for younger children — considered to be more at risk — and tourists.
Leroy added that additional data will be needed before considering whether the vaccine may be of use to travelers.
“Mexico is one of the countries where we started our clinical trials, which has been associated with the program from the very beginning and whose regulatory authority is certified by the World Health Organization,” said Sanofi Pasteur executive vice-president of vaccines, Olivier Charmeil.
Mexican regulators cleared the use of the vaccine based on the results of a clinical testing program that included over 40,000 people of different ages from 15 countries.
During the trials, the vaccine reduced the risk of hospitalization by 80% and lowered the possibility of developing the most severe, hemorrhagic form of the disease by 93%.
Deliveries to Mexico from a plant near Lyon, France, will start early next year, said Charmeil and Leroy.
Charmeil said the drug’s pricing would be determined with the Mexican government over the next few weeks. He told the Wall Street Journal that the price would reflect the “value” of the vaccine in terms of the savings that it could bring about elsewhere. He said the total annual cost of treating dengue was around $9 billion globally, and that prevention strategies such as mosquito nets cost a further $6 billion to $9 billion.
Dengvaxia is shaping up to be a “blockbuster” product for the company, said Charmeil, who added that the vaccine is the “innovation of the decade” and is expected to generate over US $1 billion per year in sales.
Other drugmakers including Japan’s Takeda and the United States’ Merck are also working on dengue vaccines but are believed to be several years behind.
In Mexico, 7,136 cases of dengue were reported between January 1 and July 28 5,728 of which were classic and 1,408 hemorrhagic, with 11 deaths.