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12:00 AM
 | 
Jul 27, 2009
 |  BioCentury  |  Regulation

FluMist ramps up fast

If pandemic H1N1 influenza hits the U.S. hard this fall, the nation's first line of defense could be a live attenuated influenza vaccine based on FluMist manufactured by the MedImmune Inc. subsidiary of AstraZeneca plc.

MedImmune, FDA and HHS are working on plans that could allow the company to supply 42 million doses of pandemic H1N1 vaccine in September, at least a month and possibly two months before comparable quantities of inactivated vaccine are available in the U.S., EVP of operations Ben Machielse told BioCentury. By year end, 179 million doses of the intranasal vaccine could be available.

Data reported at an FDA advisory committee meeting last week indicate that MedImmune has been far more successful in producing a swine influenza (H1N1) vaccine than manufacturers of traditional inactivated viruses.

In addition, MedImmune's vaccine is likely to provide a higher level of protection with a single dose, Raburn Mallory, the company's director of clinical development, infectious disease and vaccines, told the Vaccines and Related Biological Products Advisory Committee.

FDA officials and advisory committee members said they expect little protection from a single dose of an inactivated pandemic H1N1 influenza vaccine. Most of the protection will come only after a second...

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