Refrigerated version of intranasal flu vaccine approved

This step will likely increase the formulation's availability next season. Meanwhile, companies are taking orders for supplies of both intranasal and injectable versions.

By Victoria Stagg Elliott — Posted Jan. 29, 2007

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The Food and Drug Administration gave the nod Jan. 8 to a refrigerated version of FluMist, the intranasal influenza vaccine, according to a statement issued by MedImmune Inc., which manufactures the product.

This approval is considered a significant step toward increasing FluMist's availability. First approved in 2003, the formulation came with a requirement that it be kept frozen. As a result, it could only be administered in a limited number of settings and only ever accounted for a small fraction of the tens of millions of vaccines which are used annually.

"We recognize that the frozen storage presented difficulties for some physician practices. ... We are confident that this improvement will enhance access to this important vaccine," said Frank M. Malinoski, MD, PhD, MedImmune's senior vice president for medical and scientific affairs.

In addition, FluMist is only approved for those ages 5 to 49. The company intends to pursue a go-ahead for use in children as young as 12 months who do not have a history of wheezing or asthma. If such a change is made, the number of doses for the upcoming season will be increased.

This step is the latest development in efforts to increase flu vaccine supplies, which physicians have viewed as unstable in recent years.

Looking forward, several distributors have started taking orders for vaccine to be used during the 2007-08 season. ASD Healthcare, FFF Enterprises and Henry Schein Inc. started accepting pre-bookings the first week of January. Sanofi Pasteur, which shipped 50 million doses this past season, is also building a new vaccine production facility in Swiftwater, Pa., that will double its capacity. It is expected to be operational in time to make vaccines for next flu season.

Medical societies and public health agencies are also continuing their work to improve the system. The National Influenza Vaccine Summit, an initiative co-sponsored by the American Medical Association and the Centers for Disease Control and Prevention, has been working to better communication among stakeholders and will hold its annual meeting in March.

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External links

National Influenza Vaccine Summit, co-sponsored by the American Medical Association and the Centers for Disease Control and Prevention (link)

Prevent Influenza Now! (link)

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