MedImmune announced that a date of Dec. 17 has been set for the Vaccines & Related Biological Products Advisory Committee to review its BLA for FluMist.

"Based on our dialogue with FDA, we expect a discussion at the meeting to focus around age range of children and adults for which we have adequate data of FluMist. We expect the discussion to be around the risks of elevated wheezing episodes in the subpopulation of children less than 5 years of age," MedImmune said.

This would be the second advisory committee meeting for FluMist. During a July 2001 meeting, the committee raised concerns about increased reactogenicity of the intranasal flu vaccine in asthmatics.

MedImmune received a complete response letter from FDA on July 10 that expressed concern about exacerbated rates of asthma and wheezing in FluMist patients between 18 months to 35 months of age.

One scenario to address the issue would be to exclude patients with asthma and wheezing, MedImmune has said. Another option would be to carve out the subpopulation of 18 to 35 month old patients from the proposed indication.

MedImmune previously received a complete response letter for FluMist on Aug. 31, 2001 that addressed clinical and manufacturing issues. The BLA for the intranasal vaccine was submitted in October 2000. Wyeth will market FluMist with MedImmune.

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