FDA approves first quadrivalent vaccine to prevent seasonal influenza

      USA FDA has approved FluMist Quadrivalent vaccine to prevent seasonal influenza in people of age group of 2yrs to 49 yrs.It contains  strains of Influenza A and 2 strains of Influenza B.

      “Illness caused by Influenza B virus affects children, particularly young and school-aged, more than any other population,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “A vaccine containing the four virus strains most likely to spread and cause illness during the influenza season offers an additional option to aid in influenza prevention efforts.”

        Vaccination is the best method to prevent influenza. Influenza seasons are unpredictable and can be severe, even deadly. Between 1976 and 2007, estimates of seasonal influenza-associated deaths in the United States ranged from a low of about 3,000 to a high of about 49,000 people.

       The safety and effectiveness of FluMist Quadrivalent is supported by studies conducted previously for the FluMist trivalent formulation and three new clinical studies conducted in the United States involving about 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 LLC of Gaithersburg, Md.

      The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products

Source:http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm294057.htm