After 20 Years of Research

The first vaccine against dengue fever won clearance in Mexico, an initial step toward preventing a mosquito-borne infection that puts half of the world’s population at risk.

Sanofi expects more approvals in “upcoming weeks” for the product, called Dengvaxia, in Latin America and Asia, Olivier Charmeil, who heads the Paris-based company’s vaccines unit, said in a telephone interview. The injection can thwart all four types of the virus, which has appeared in Portugal, France, Florida and Japan recently and increased the risk of “explosive outbreaks,” according to the World Health Organization

Dengvaxia, developed over the past 20 years at a cost of 1.5 billion euros ($1.65 billion), including manufacturing investments, awaits approval in at least 19 other countries. Mexico’s regulator endorsed it for people between the ages of 9 and 45 living in areas where the disease is endemic.

Dengvaxia’s sales may reach $1.4 billion by 2020, according to analyst estimates compiled by Bloomberg. Sanofi said Dengvaxia “will be priced at a fair, affordable, equitable and sustainable price.” Some countries may distribute it for free, said Guillaume Leroy, vice president of the dengue vaccine team at Sanofi. The shot isn’t recommended for children under 9 years old because clinical studies suggest it protects them less well.

“We are making dengue a preventable disease, which makes us incredibly proud,” Charmeil said in the interview.

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Mexico approves dengue vaccine

The Government of Mexico has approved the use of the first-ever vaccine for dengue fever.

Mexico’s Federal Commission for the Protection against Sanitary Risks (COFEPRIS) approved the vaccine, Dengvaxia for use in people from 9 to 45, living in areas where dengue is endemic.

Sanofi, the French drug company which manufactures Dengvaxia, will have the vaccine available for private purchase in Mexico as early as 2016, and has also applied for around 20 marketing approvals from countries in Latin America and Asia.

The company announced that it will have two million doses available in 2017, and the capacity to make 100 million doses a year, should the need arise.

“With this first marketing authorization of Dengvaxia, we have achieved our goal of making dengue the next vaccine-preventable disease,” said Olivier Brandicourt, MD, Chief Executive Officer, Sanofi.

Dengvaxia, a live virus vaccine, works against all four subtypes of dengue. The vaccine is comprised of an attenuated yellow fever virus genetically engineered to produce proteins from the dengue virus and stimulate the body’s immune system to make antibodies to those proteins.

In its clinical trials, Dengvaxia, reduced the risk of developing dengue by about 60 percent. While some experts have contested that it has less than the desired effect, many agree that with no existing treatment for dengue fever, 60 percent is sufficient.

The trials showed that the vaccine tends to be least effective in children younger than 9, particularly those younger than 6, and may even increase their risk of having more severe onsets of dengue later in life, according to a longer term follow-up from the clinical trials.

Conservative estimates from pharmaceutical companies are that between 50-100 million people contract dengue every year.

The Reporter