FDA Approves First FluMist Quadrivalent for Influenza Vaccination

The U.S. Food and Drug Administration has approved the FluMist Quadrivalent, a vaccine to prevent seasonal influenza in people ages 2 through 49.

FluMist Quadrivalent is the first influenza vaccine to contain four strains of the influenza virus, two influenza A strains and two influenza B strains. Like the already approved FluMist trivalent, the quadrivalent vaccine contains weakened forms of the virus strains and is administered as a spray into the nose.

 



The safety and effectiveness of FluMist Quadrivalent is supported by studies conducted previously for the FluMist trivalent formulation and three new clinical studies involving approximately 4,000 children and adults. The studies demonstrated that the immune responses were similar between FluMist Quadrivalent and FluMist.

Adverse reactions reported were similar among those receiving FluMist Quadrivalent and FluMist. The most commonly reported adverse reactions were runny or stuffy nose in both children and adults and headache and sore throat in adults. FluMist Quadrivalent is manufactured by MedImmune in Gaithersburg, Md.

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