A dengue fever vaccine developed by the French pharmaceutical giant Sanofi has been approved for use by Mexico, the first approval in the world for any vaccine for the disease, which afflicts tens of millions of people around the world and is becoming an increasing threat.
Sanofi said in a news release Wednesday that the vaccine, which it is calling Dengvaxia, was approved by Mexico’s Federal Commission for the Protection against Sanitary Risk for prevention of dengue in people 9 to 45 years old living in endemic areas.
“Today, with this first marketing authorization of Dengvaxia, we have achieved our goal of making dengue the next vaccine-preventable disease,” Olivier Brandicourt, chief executive of Sanofi, said in a statement. “This is a historic milestone for our company, for the global public health community and, most importantly, for half the world’s population who lives at risk of dengue.”
Also known as breakbone fever, the disease can cause high temperature and intense joint and muscle pain. In severe cases, it causes hemorrhagic fever, which is marked by bleeding and shock and can be fatal.
A viral disease that is transmitted by mosquitoes, the number of cases has been increasing and the disease has been spreading out of its traditional home in developing countries in the tropics. There is now an outbreak in Hawaii, and there was one last year in Tokyo, the first one in Japan in nearly 70 years. The Florida Keys had some cases in 2009 for the first time in decades.
In clinical trials, the vaccine reduced the risk of developing dengue by about 60 percent. Some experts have said this is less effective than desired, raising questions about how widely the vaccine would be used. And in one trial the vaccine seemed less effective in young children, who are most susceptible to the disease.
But Sanofi itself and some other experts said that that level of effectiveness would be welcomed, given that there is now no treatment for dengue. In one trial involving children 9 to 16 in Latin America and the Caribbean, the vaccine reduced the risk of hospitalization from dengue by 80 percent.
An estimated 50 million to 100 million people a year are sickened by dengue, though that might be an underestimate. One study said about 400 million people are infected each year, with about 100 million of them feeling sick to some degree.
Sanofi has been suffering from declining sales in its big diabetes drug business, the result of new competition and heavier discounting by manufacturers. Dengvaxia might help, but that would depend on it being approved by other countries in addition to Mexico. It also depends on how much Sanofi can charge for the vaccine. Many vaccines for developing countries are sold at low prices.
Sanofi said it had begun manufacturing Dengvaxia and that it would eventually be able to produce 100 million doses annually.