MedImmune receives FDA approval for updated version of nasal flu vaccine

A more accessible version of MedImmune’s nasal flu vaccine should be available for the 2007 flu season, company officials announced Monday.

On Friday, the Food & Drug Administration granted approval of the updated version, which can be stored in the refrigerator rather than the freezer, a feature the Gaithersburg-based company hopes will boost sales of the vaccine.

The previous version of FluMist was difficult for many health care providers to carry because of the storage restrictions, said Karen Lancaster, a spokeswoman for MedImmune.

“We are confident that the approval of our refrigerated formulation for FluMist will encourage more health care providers to offer FluMist to their customers and patients,” Frank Malinoski, MedImmune’s senior vice president, medical and scientific affairs, said in a statement.

“We recognize that the frozen storage presented difficulties for some physician practices as well as for providers who administer the vaccine in places like schools, pharmacies and grocery stores, and we are confident that this improvement will enhance access to this important vaccine.”

MedImmune manufactured about 3 million doses of the vaccine, which is administered as a nasal spray rather than a shot, for the current flu season and expects to increase that number for the 2007-08 flu season, though no projections have been released.

The company also has an additional application filed with the FDA to expand the coverage of FluMist to children as young as 1 year old. Currently, the vaccine is available to people between the ages of 5 and 49. Approval is expected to come in time for the 2007-08 flu season.

MedImmune, which has three products on the market and dozens more in the pipeline, expects to close out 2006 with $1.3 billion in revenue and forecasted revenue growth of more than 15 percent in 2007.

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