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Pharmaceuticals / Regulatory Affairs

Filipino FDA Pulls Sanofi’s Dengue Vaccine After Safety Reports

Dec. 11, 2017
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The Philippines’ Food and Drug Administration pulled Sanofi’s dengue fever vaccine from the market until it complies with the agency’s directives.

The regulator told Sanofi to conduct an information dissemination campaign through advisories, dear doctor letters and patient forums. The move comes a week after Sanofi disclosed clinical studies finding the vaccine posed risks for patients with no prior infection.

More than 700,000 youths were given the vaccine under the country’s mass immunization program. The Filipino government has confirmed that about 10 percent, or 70,000, are at risk for more severe forms of the fever in the two years following vaccination.

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