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.
“We are making dengue a preventable disease, which makes us incredibly proud,” Charmeil said.
Meanwhile, the number of cases in Hawaii’s outbreak rose again Wednesday. Six more cases were reported, bringing the number of infected to 145, with 128 of them island residents and 17 visitors. Thirty-two cases are children, and 113 are adults.
Other companies are developing alternative approaches to frustrate the virus while a handful of vaccine candidates remain under evaluation in clinical trial.
Recently, Honolulu-based Hawaii Biotech Inc. was awarded funding by the U.S. Army for the first phase of developing a dengue vaccine. The research contract is aimed at developing a more protective and faster-working vaccine for military personnel than other vaccine candidates that are currently in clinical trials. There are three phases, with the clinical trials being the last, before a company can seek regulatory approval.
One of those candidates in clinical trials is Takeda Pharmaceuticals, which has been working on a live attenuated dengue vaccine for the four serotypes of dengue since about 2012.
They viewed news of the potential breakthrough in Mexico as positive.
“Any progress on potential protection against dengue is a step in the right direction,” said Elissa Johnsen, head of Product and Pipeline Communications for Takeda Pharmaceuticals. “We believe that immunization is one of the most effective ways to save lives. As 40 percent of the world’s population lives under the threat of dengue, an effective vaccine may prove to be an important tool in controlling dengue in both endemic and non-endemic countries around the world.”
But it’s not just in Hawaii: Outbreaks are on the rise globally.
Unlike malaria, another disease spread by mosquitoes, dengue affects wealthier urban populations in middle-income countries in Latin America and Asia in addition to poorer African nations. A water shortage in Sao Paulo prompted residents to store drinking supplies in pots and tanks, creating breeding grounds for mosquitoes and a dengue epidemic involving thousands of cases this year.
Dengvaxia, developed over the past 20 years at a cost of $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.
Charmeil said that the company would file for approval in Europe in 2016, and in the U.S. in 2017.
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.
Dengue infection causes flu-like illness that can develop into potentially fatal complications. Warning signs include bleeding gums, vomiting, rapid breathing and severe abdominal pain. One recent estimate indicates about 390 million dengue infections per year, according to the WHO. It kills less than 1 percent of those infected.
On Hawaii Island, five to seven new cases have been added daily on a fairly consistent basis over the past couple of weeks, although on Tuesday, no new cases were reported.
Researchers with the Centers for Disease Control and Prevention are currently trapping mosquitoes and trying to gain a better understanding of where the infectious insects are concentrated. New cases continue to occur in the hotspot from Keauhou to south of Hookena and have begun to crop up in South Hilo and Puna.
“It’s not clear whether the vaccine will do anything for the Big Island’s ongoing battle against the fever. The vaccine would have to be approved by the Food and Drug Administration before it could be used here,” CDC spokeswoman Candice Hoffmann said.
The state Department of Health has also ruled out 477 potential cases since the outbreak was discovered in late October.
“Takeda also is committed to developing a life-saving dengue vaccine for people around the world,” Johnsen added. “We believe an optimal vaccine would provide protection against all four types of the virus for both children and adults, those living in endemic areas and travelers, as well as those who have and have not had previous exposure to dengue infection.”
West Hawaii Today staff Chelsea Jensen and Bret Yager contributed to this report.
