New Dengue Vaccine Approved in Europe
Vaccine from Japanese drugmaker Takeda will provide an alternative to a Sanofi vaccine that has been dogged by safety issues
European health regulators cleared a new dengue vaccine from Takeda Pharmaceutical Co., a decision that could pave the way for its use around the world against the devastating mosquito-borne virus.
The European Commission approved the two-dose shot in people ages 4 years and older, Takeda said Thursday.
The approval of the vaccine, called Qdenga, is likely to speed its review in many countries outside Europe, such as Mexico, Argentina and Thailand, where dengue is endemic. Indonesia approved the Takeda shot’s use last summer in people 6 to 45 years.
The new vaccine would provide an alternative to the other licensed vaccine, Dengvaxia from Sanofi SA, which has been dogged by safety issues.
Countries outside Europe must approve the vaccine themselves. Some participated in the commission’s review, however, and will likely accelerate their own processes to make the shot available, said Gary Dubin, president of Takeda’s global vaccine business unit.
“We know dengue has a very significant impact on all these people and all these countries so we think it’s a very significant milestone,” Takeda Chief Executive Christophe Weber said in an interview.
Qdenga could generate peak annual sales of at least $700 million, Tokyo-based Takeda said.
Approximately four billion people in tropical regions of the world are at risk of infection with the virus, which is carried by an aggressive mosquito that teems in populated areas.
An estimated 390 million people a year are infected with dengue, about 100 million actually become ill, and 40,000 die of severe disease, according to the World Health Organization and U.S. Centers for Disease Control and Prevention.
Most dengue cases don’t produce symptoms or are mild, but some people can develop flulike illness such as a high fever and muscle pain and in rare instances die.
Sanofi said in 2017 that Dengvaxia could in some cases worsen, rather than prevent, symptoms of dengue. Children who were immunized in the Philippines fell ill, with some hospitalizations and deaths.
Since Sanofi disclosed the safety issues, public health experts and governments around the world have been looking forward to the potential availability of a new vaccine.
The WHO recommends against giving Dengvaxia to people who haven’t been previously infected with dengue.
A Sanofi spokesman said that U.S. and European authorization of its vaccine in endemic areas supports the “public health value of the vaccine in dengue prevention.” He said some countries rely on Dengvaxia to protect against dengue and that the company is committed to helping prevent the disease and will work to make Dengvaxia available where it is registered.
Qdenga doesn’t require people to be tested for previous dengue infection, unlike Sanofi’s vaccine, Takeda executives said.
“The fact that our vaccine can be used regardless of prior exposure is a massive difference” between the Takeda and Sanofi vaccines, Mr. Weber said.
Researchers studied Qdenga in a large Phase 3 trial of more than 20,000 healthy children ages 4 to 16 years.
The researchers found the vaccine reduced the risk of dengue illnesses in children by about 80% some 12 months after they got the second dose, Takeda reported in the New England Journal of Medicine in 2019.
Researchers continued to monitor study subjects for a total of 4½ years. The researchers found the vaccine was about 84% effective against hospitalized dengue and 61% against symptomatic dengue, according to data Takeda presented at a medical conference earlier this year.
Researchers said they haven’t found any major safety concerns during the testing.
Takeda has also filed for regulatory approval in the U.S.