BRIDGEWATER,
N.J., May 1, 2019 /PRNewswire/
-- The U.S. Food and Drug Administration (FDA)
approved Dengvaxia® (Dengue Tetravalent Vaccine,
Live) for the prevention of dengue disease caused by serotypes 1 –
4 of the virus in individuals 9 through 16 years of age living in
endemic areas of the U.S. with a laboratory-documented prior
infection. Dengvaxia is the first and only vaccine approved
for protection against dengue in endemic areas of the U.S.
"Dengue is
endemic and prone to outbreaks in several U.S. territories,
including Puerto Rico, the
U.S. Virgin Islands and
American Samoa. Despite this
public health threat, there is no treatment and there has been no
previously approved vaccine available in these areas," said
David Greenberg, MD, Regional
Medical Head North America, Sanofi Pasteur. "Today's FDA
approval of Dengvaxia allows us to bring a critical medical
prevention tool to at-risk populations, helping combat and prevent
dengue among children living in U.S. dengue endemic areas."
Dengvaxia is also approved for use in several
endemic countries in Latin America
and Asia where reducing the human
and economic burden of dengue is a public health priority. In
December 2018, the European
Commission granted marketing authorization for Dengvaxia to prevent
dengue in individuals living in endemic areas with a documented
prior infection.
Indication for Dengvaxia® (Dengue
Tetravalent Vaccine, Live)
Dengvaxia is a vaccine given to
people 9 through 16 years of age to help prevent dengue infection
due to dengue virus serotypes 1, 2, 3 and 4. Dengvaxia should only
be given to people who have previously had a dengue infection, and
live in areas where dengue is endemic.
Your child should not receive Dengvaxia if he or
she has not had a previously confirmed dengue infection, or if this
information is unknown. People who have not had a previous dengue
infection are at increased risk for severe dengue when vaccinated
with Dengvaxia and later infected with a dengue virus. Previous
dengue infection can be verified by a medical record of a previous
laboratory confirmed dengue infection, or by testing for dengue
before vaccination.
It is unknown whether Dengvaxia is safe or
protective for people living in areas where dengue is not endemic
who travel to dengue endemic areas.
Important Safety Information for Dengvaxia
(Dengue Tetravalent Vaccine, Live)
Dengvaxia vaccine should
not be given to anyone with a history of severe allergic reaction
to a previous dose of Dengvaxia or to any component of
Dengvaxia.
Dengvaxia should not be given to people with a
severely suppressed or compromised immune system.
Before your child can receive Dengvaxia, your
child's health care professional must determine whether your child
has had a confirmed dengue infection.
Currently, no available tests have been cleared
by the Food and Drug Administration (FDA) to determine a previous
dengue infection. Talk with your health care professional about
available tests. For the month after receiving Dengvaxia,
tuberculosis skin tests may be falsely negative. If you undergo
tuberculosis skin testing in the month after vaccination, tell the
health care professional performing the test that you received
Dengvaxia.
The most common side effects of Dengvaxia include
headache, pain at the injection site, general discomfort,
tiredness, and muscle aches. Other side effects can
occur.
It is recommended to continue personal protection
measures against mosquito bites after vaccination since vaccination
with Dengvaxia may not protect all people.
Please see the full Prescribing Information
for Dengvaxia (Dengue Tetravalent Vaccine, Live).
About Sanofi
Sanofi is dedicated to supporting people through their health
challenges. We are a global biopharmaceutical company focused on
human health. We prevent illness with vaccines, provide innovative
treatments to fight pain and ease suffering. We stand by the few
who suffer from rare diseases and the millions with long-term
chronic conditions.
With more than 100,000 people in 100 countries,
Sanofi is transforming scientific innovation into healthcare
solutions around the globe.
Sanofi, Empowering Life
Media
Relations Contact Nicolas Kressmann Tel.: +1 732-532-5318
Nicolas.Kressmann@Sanofi.com
|
Investor Relations Contact George Grofik
Tel.: +33 (0)1 53 77 45 45
ir@sanofi.com
|
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Source: Sanofi (EURONEXT: SAN) (NASDAQ: SNY)
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