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FDA panel backs expanded label for CAIV-T

May 17, 2007 1:16 AM UTC

MedImmune (MEDI) said on Wednesday that FDA's Vaccines and Related Biological Products Advisory Committee voted in favor of expanding the label of CAIV-T intranasal influenza vaccine to include children 12-59 months of age without history of wheeze. The committee voted unanimously that MEDI demonstrated the efficacy of the refrigerator-stable formulation of FluMist in the proposed population and 9-6 that the benefits exceed the risks.

The committee voted 14-1 that CAIV-T demonstrated efficacy in children 6-23 months of age; however, the panel voted 12-3 that the benefits do not outweigh the risks in children 6-23 months regardless of wheezing history. In briefing documents posted ahead of the meeting, FDA cited data from the MICP 111 study in children 6-59 months of age that 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 (See BioCentury Extra, Monday, May 14, 2007). ...