The Food and Drug Administration (FDA) has approved Dengvaxia (dengue tetravalent vaccine, live; Sanofi) for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4.
Dengvaxia is approved for use in patients 9-16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas. “Infection by one type of dengue virus usually provides immunity against that specific serotype, but a subsequent infection by any of the other 3 serotypes of the virus increases the risk of developing severe dengue disease, which may lead to hospitalization or even death,” said Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research. “As the second infection with dengue is often much more severe than the first, the FDA’s approval of this vaccine will help protect people previously infected with dengue virus from subsequent development of dengue disease.”
The approval was based on data from 2 placebo-controlled studies involving over 35,000 patients in dengue-endemic areas. Patients were randomized 2:1 to receive either Dengvaxia or saline placebo and were monitored for symptomatic virologically-confirmed dengue (VCD) starting at Day 0; vaccine efficacy was assessed beginning 28 days after the third vaccination for 12 months.
Results showed that among patients 9-16 years of age who previously had laboratory-confirmed dengue disease, the vaccine was approximately 76% effective in preventing symptomatic, VCD disease. The most frequently reported adverse reactions in those who received the vaccine were headache, injection site pain, malaise, asthenia, and myalgia.
Dengvaxia is not approved for use in patients not previously infected by any dengue virus serotype or for whom this information is unknown. Administration to those not previously infected by dengue virus is associated with an increased risk of severe dengue disease when the vaccinated individual is subsequently infected with any dengue virus serotype. As there is no FDA-approved test to determine previous dengue infection, infection status should be evaluated either through medical records or through serotesting prior to vaccination.
“Dengue is endemic and prone to outbreaks in several US territories, including Puerto Rico, the US Virgin Islands and American Samoa,” 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 US dengue endemic areas.” The safety and effectiveness of the vaccine have not been established in individuals living in dengue non-endemic areas who travel to dengue endemic areas.
Dengvaxia is supplied as a lyophilized powder to be reconstituted with the supplied diluent. The live, attenuated vaccine is administered as 3 separate subcutaneous injections given 6 months apart (at month 0, 6, and 12).
For more information visit FDA.gov.