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The approval was granted to Sanofi Pasteur.
The US Food and Drug Administration has the approval of Dengvaxia, the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages dengue infection and who live in endemic areas. Dengue is endemic in the U.S. territories of American Samoa, Guam, Puerto Rico and the U.S. Virgin Islands.
The safety and effectiveness of the vaccine was determined in three randomized, placebo-controlled studies involving approximately 35,000 individuals in dengue-endemic areas, including Puerto Rico, Latin America and the Asia Pacificregion. The vaccine was determined to be effective in the presence of laboratory-confirmed dengue disease in patients with laboratory-confirmed dengue disease. Dengvaxia has already been approved in 19 countries and the European Union.
The FDA granted this application Priority Review and a Tropical Disease Priority Review Voucher under a program to encourage the development of new drugs and biologics for the prevention and treatment of certain tropical diseases. The approval was granted to Sanofi Pasteur.
Dengvaxia is not approved for use in any of these viruses. Dengue is a virus that has been infected with dengue virus, and has been reported to have a dengue infection.
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