FluMist

FluMist is the product name of a nasal spray flu vaccine manufactured by MedImmune, Inc. that was introduced in 2003. ^[1] It was the first and (as of 2007) the only live attenuated vaccine for influenza available outside of Russia, and is also called Live Attenuated Influenza Vaccine(LAIV). ^[2]

FluMist was originally developed by Hunein "John" Maassab, Professor of Epidemiology at the University of Michigan School of Public Health in Ann Arbor, Michigan and later by Aviron under the sponsorship of NIH in the mid-1990s. MedImmune, Inc. purchased Aviron in 2002, and the FDA approved FluMist in June of 2003.^[3] FluMist was first made available in September 2003.

The Food and Drug Administration (FDA) initially approved the new vaccine only for healthy people ages 5 to 49, unlike the injectable vaccines, which are approved for people over 6 months of age, because of initial concerns over side effects. Healthy people are the group least likely to suffer serious complications from catching the flu, and have traditionally been discouraged from taking flu shots, particularly early in the season, in years when flu vaccine may be in short supply. In 2006, FluMist received FDA approval for use in healthy children two years old and onward.

FluMist was initially priced higher than the injectable vaccines, but sold only 500,000 of the 4 million doses it produced its first year on the market, despite a comparative shortage of flu vaccine in fall 2004.^[4] The price was sharply lowered the next year, and the company reports distributing 1.6 million doses in 2005.^[5] Because of the price drop, despite selling almost three times as many doses in 2005, the company reported $21 million in FluMist sales, compared to $48 million the previous year.^[6] Further cuts in pricing had to await FDA approval of a refrigerator-cooled FluMist formulation, as the initial formulation required freezer storage and thawing on demand before administration. The refrigerated formulation was approved for the 2007-2008 flu season, so that the original price differential is now largely or completely a historical note.

Tests against injected (killed virus) vaccinations have shown that FluMist is more effective than needle shots in preventing influenza in children aged 6 to 17 ^{[7] [8]} but one smaller study in adults showed significantly lower effectiveness in adults. ^[9] MedImmune has developed a new version of the vaccine, called CAIV-T, which does not require storage in a freezer. The FDA approved CAIV-T for the same age group (ages 5-49) in August 2006 following completion of phase 3 clinical trials. ^[10] CAIV-T has been approved by the FDA and will be the version offered on the market in beginning in fall of 2007.

In June 2006, the National Institutes of Health (NIH) began enrolling participants in a Phase 1 H5N1 study of an intranasal influenza vaccine candidate based on MedImmune's live, attenuated vaccine technology.^[11]

References

1. ^ FDA approval letter
2. ^ CDC Q&A about nasal-spray flu vaccine
3. ^ Appleby, Julie. "Nasal FluMist overcomes obstacles to reach public" USA Today. 7 January 2004.
4. ^ Rosenwald, Michael. "Sales Falling Short, Survey Finds; Md. Company Increased Vaccine Production at U.S. Government's Request" The Washington Post. 6 January, 2005.
5. ^ "Finance; MedImmune reports revenues of $1.2 billion" Drug Week. 3 March 2006. (subscription required)
6. ^ Rosenwald, Miachel S. "Sales of MedImmune's Flu Vaccine Drop Sharply" Washington Post. 3 February 2006.
7. ^ FluMist More Effective Than Injections For Small Children And Babies. Medical News Today. 01 May 2006.
8. ^ 'FluMist MedImmune clinical data (phase III) (influenza).' R&D Focus Drug News 30 January 2006.
9. ^ Study: Flu Shots Better Than FluMist. cbsnews.com. 13 Dec 2006.
10. ^ "MedImmune begins shipping live intranasal flu vaccine for 2006-2007 after U.S. FDA release". Drug Week. 26 Aug 2006. (press release)
11. ^ MedImmune Press release MedImmune and National Institutes of Health Begin Clinical Testing of a Live, Attenuated Intranasal Vaccine Against an H5N1 Avian Influenza Virus published June 15, 2006

External links

• FluMist Website
• FluMist information on University of Michigan, School of Public Health website
• [www.who.int/entity/vaccine_research/diseases/influenza/Roudenko.pdf Live Attenuated Vaccine in Russia] presentation on Russian live influenza vaccines since 1961
• Using Live, Attenuated Influenza Vaccine for Prevention and Control of Influenza Supplemental Recommendations of the Advisory Committee on Immunization Practices (ACIP) MMWR 52 RR13 (2003)

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