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Sanofi wins US approval to sell dengue vaccine but with major restrictions
THE US 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.
The FDA says the drug may only be given to people aged nine to 16 who have laboratory-confirmation of a previous dengue infection and live in areas where the disease is prevalent, such as Puerto Rico, the US Virgin Islands and American Samoa.
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. REUTERS