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Keyword: fluad

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  • FDA Approves First Seasonal Influenza Vaccine Containing an Adjuvant

    11/25/2015 8:37:16 AM PST · by catnipman · 66 replies
    Infection Control Today ^ | 11/25/2015 | staff
    The Food and Drug Administration (FDA) announces that it has approved Fluad, the first seasonal influenza vaccine containing an adjuvant. Fluad, which is manufactured using an egg-based process, is formulated with the adjuvant MF59, an oil-in-water emulsion of squalene oil. The study showed that Fluad induced antibody levels that were comparable to the levels induced by Agriflu [i.e., no better.] Fluad was approved using the accelerated approval regulatory pathway, which allows the FDA to approve products for serious or life-threatening diseases based on evidence that the product has an effect on an outcome that is reasonably likely to predict clinical...