FDA approves Dengvaxia® for the prevention of dengue in individuals ages 9 through 16 living in U.S. endemic areas

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.

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