The U.S. Food and Drug Administration on Wednesday gave Sanofi SA's dengue ...
CHICAGO - The U.S. Food and Drug Administration on Wednesday gave Sanofi SA’s dengue vaccine Dengvaxia a very narrow approval as the company continues to suffer from evidence that its vaccine, which took 20 years to develop, can cause severe infections in some people.
Sanofi had sought a much broader approval that would have included people aged 9 to 45, but an FDA advisory panel in March recommended the narrower age range, excluding its use in adults. The FDA stipulated that Dengvaxia is not approved for individuals who have not previously been infected by one of the four types of the virus, which is spread by mosquitoes.
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