FDA OKs nasal vaccine for flu
Bernadette Tansey, Chronicle Staff Writer
Wednesday, June 18, 2003
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A nasal spray vaccine that offers the first alternative to flu shots has received Food and Drug Administration approval, a long-sought goal for the product developed in the Bay Area.
MedImmune Inc.'s FluMist, the first nasally administered vaccine in the United States and the first flu vaccine to use live virus strains, was approved by the FDA on Tuesday for healthy people between 5 and 49 years old.
MedImmune, based in Gaithersburg, Md., acquired the product in early 2002, when it bought the Mountain View firm Aviron, which was folded into a MedImmune subsidiary with research and manufacturing sites in Mountain View and Santa Clara.
FDA Commissioner Mark McClellan said FluMist will bolster overall inventories of flu vaccine. Supplies sometimes run out when manufacturers cannot produce enough doses of traditional flu shots, which are made of dead viral strains.
"This new vaccine provides another option for protection against influenza and will potentially increase the availability of the injected killed virus vaccine for those people at highest risk," McClellan said.
Influenza causes about 36,000 deaths a year in the United States, primarily among vulnerable populations, including children under 2 years old, people with other medical conditions and those 65 or older, according to the Centers for Disease Control and Prevention.
The FDA ruled out FluMist for children under 5 and patients over 50, however, following the advice of a scientific panel, which raised concerns about the live virus.
The spray is also unsuitable for people with weakened immune systems, cancer, asthma or other conditions making them susceptible to severe flu infections, the FDA said.
FluMist uses live viral strains that are modified to survive in the cool nasal passages but which die off in the warmer lung tissues. The limited viral exposure spurs the immune system to produce flu antibodies, which protect against severe illness.
MedImmune will produce up to 6 million doses for the 2003-2004 flu season at $46 per dose. Manufacturers charge about $5 for the shot, although the cost difference depends on additional distribution charges.
MedImmune has estimated FluMist sales will be up to $1 billion, but company shares lost $1.02 or 2.57 percent to close at $38.71 on Tuesday.
E-mail Bernadette Tansey at btansey@sfchronicle.com. |
