It’s been a perplexing puzzle in the flu vaccine world — what’s going on with FluMist?
The Advisory Committee on Immunization Practices said last June that the live-attenuated vaccine, made by MedImmune (a division of AstraZeneca) should not be used this flu season because some US studies from three recent years suggested it offered poor or no protection in children aged 2 to 17.
The ACIP meets next week in Atlanta and discussion of the FluMist problem is again on the agenda. No vote is scheduled. Still, the company said Friday it is working to win back a green light for use from the committee.
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The easy answer would be rapidly mutating viral strains, or maybe Americans put too much other stuff up their noses. The problem has also probably led to some corporate agita as well. Reminds me when I worked for Lorex Pharmaceuticals, a JV between GD Searle and Synthelabo (now Sanofi). We were phase 3 of an international development program for what would have been the first non benzodiazepine anxiolytic. As the US monitor I was responsible for reviewed the lab results as they came across the printer. There was an unmistakable trend, with about 15% of the study subjects having significantly elevated liver enzymes along with pretty weak efficacy. When we informed our French JV partners who originally developed the drug they said “how come our drugs don’t work in America”. Ironically our next joint project was development of Ambien, which turned out to be, and still is a very popular drug. Development of the anxiolytic was eventually stopped due to the liver function problem.