Sanofi's Dengue Vaccine Gets FDA Approval -- Update
02 May 2019 - 12:16PM
Dow Jones News
By Maria Armental
Sanofi SA's dengue vaccine was approved in the U.S., the first
treatment cleared by American regulators to protect against the
mosquito-borne viral infection.
The vaccine, Dengvaxia, was approved by the Food and Drug
Administration to treat people aged 9 to 16 with a
laboratory-confirmed prior infection who live in areas where the
disease occurs regularly through the year.
Dengvaxia was first approved in Mexico in 2015 and remains the
world's only approved vaccine against dengue. But safety fears have
complicated efforts to contain the growing global threat. World
Health Organization estimates put about half the world's population
at risk.
In late 2017, Sanofi said post-marketing data showed those who
haven't been infected before may have a higher risk of severe
dengue disease if they become infected after vaccination.
The Philippines, which was the first country to widely
distribute the vaccine, revoked its product-license approval this
year after a number of deaths were reported.
The virus causes a severe flu-like illness, but it can develop
into severe dengue, which is potentially deadly. It is typically
found in tropical and sub-tropical climates.
Though not common in the U.S., several U.S. territories are
prone to outbreaks, including Puerto Rico, the U.S. Virgin Islands,
American Samoa and Guam.
The disease is hard to vaccinate against because it can be
caused by four strains of the same virus. Dengvaxia targets the
four strains.
Other vaccines are being developed, including Takeda
Pharmaceutical Co.'s TAK-003, which has shown promising results in
a key trial.
Write to Maria Armental at maria.armental@wsj.com
(END) Dow Jones Newswires
May 01, 2019 22:01 ET (02:01 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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