FluMist
From Wikipedia, the free encyclopedia
FluMist is the product name of a nasal spray vaccine against the flu virus manufactured by MedImmune, Inc. that was introduced in 2003. [1] It was the first and (as of 2006) the only live attenuated vaccine for influenza (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) 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 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.
FluMist is more expensive than the injectable vaccine, and 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 company reports distributing 1.6 million doses in 2005.[5] 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]
Noninferiority tests against injected (killed virus) vaccinations have showed the vaccine more effective at preventing influenza in childrenaged 6 to 17 [7] [8] but a 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 is expected to be on the market in fall of 2007.
[edit] References
- ^ FDA approval letter
- ^ CDC Q&A about nasal-spray flu vaccine
- ^ Appleby, Julie. "Nasal FluMist overcomes obstacles to reach public" USA Today. 7 January 2004.
- ^ Rosenwald, Michael. "Sales Falling Short, Survey Finds; Md. Company Increased Vaccine Production at U.S. Government's Request" The Washington Post. 6 January, 2005.
- ^ "Finance; MedImmune reports revenues of $1.2 billion" Drug Week. 3 March 2006. (subscription required)
- ^ Rosenwald, Miachel S. "Sales of MedImmune's Flu Vaccine Drop Sharply" Washington Post. 3 February 2006.
- ^ FluMist More Effective Than Injections For Small Children And Babies. Medical News Today. 01 May 2006.
- ^ 'FluMist MedImmune clinical data (phase III) (influenza).' R&D Focus Drug News 30 January 2006.
- ^ Study: Flu Shots Better Than FluMist. cbsnews.com. 13 Dec 2006.
- ^ "MedImmune begins shipping live intranasal flu vaccine for 2006-2007 after U.S. FDA release". Drug Week. 26 Aug 2006. (press release)
