U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted this week on on the safety and effectiveness of Sanofi Pasteur’s Dengvaxia® (Dengue Tetravalent Vaccine Live Attenuated).
In people 9 to less than 17 years of age, the Committee voted favorably on effectiveness (13 to one) and safety (10 to four). In people 9 through 45, the Committee voted six to seven (with one abstention) on effectiveness and seven to seven on safety.
Dengvaxia has been approved in about a dozen countries to date to include Mexico, The Philippines, Brazil, El Salvador, Costa Rica, Paraguay, Guatemala, Peru, Indonesia, Thailand and Singapore.
However in the Philippines, a number of adverse events or reactions and Sanofi’s “brazen defiance of FDA’s directives and its continued failure to comply” prompted the Philippines FDA to permanently revoke the Certificates of Product Registration (CPR).
The FDA is expected to make its decision by May 1, 2019.
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