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FDA releases CAIV-T documents

May 15, 2007 1:48 AM UTC

FDA will ask the Vaccines and Related Biological Products Advisory Committee on Wednesday whether the benefit/risk profile of CAIV-T intranasal influenza vaccine from MedImmune (MEDI) warrants approval in children 12-23 months of age. Data from the MICP 111 study in children 6-59 months of age showed that 12 (0.3%) of the CAIV-T group were hospitalized due to wheezing, 10 of whom were 6-23 months of age, versus eight (0.2%) of the control group, four of whom were 6-23 months. Documents released on Monday say "the clinical relevance of the imbalance in respiratory adverse events identified in MICP 111" should be discussed, and that "risks associated with CAIV-T use must be weighed against the increased hospitalization rates in children less than 24 months of age due to influenza." ...