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6/18/2003

FluMist Licensed for Upcoming Flu Season

Kate Traynor

The Food and Drug Administration (FDA) yesterday approved the licensing of FluMist, an intranasal live vaccine indicated for the prevention of disease caused by influenza A and B viruses.

FluMist is both the first intranasal vaccine and the first live influenza vaccine licensed by FDA. The product is manufactured by MedImmune Vaccines Inc. and marketed by MedImmune and Wyeth Vaccines. A MedImmune press release stated that the vaccine will be available in late summer to early fall of this year for use during the 2003–2004 flu season.

According to the product's labeling (PDF), FluMist is indicated for use in healthy children and adolescents ages 5–17 years and adults ages 18–49 years. Children and adults outside of these age ranges should be administered an injectable influenza vaccine instead of FluMist, if vaccination is indicated.

Common adverse events in clinical trial participants who received the vaccine included fever, nasal congestion, rhinitis, and sinusitis.

The intranasal vaccine is contraindicated in children and adolescents who are receiving aspirin therapy, because influenza infection and aspirin use are associated with an increased risk for Reye syndrome. FluMist is also contraindicated in people with a history of Guillain Barre syndrome; in people with an immune deficiency; and in people receiving immunosuppressive therapy.

The labeling warns that FluMist should not be administered to people with asthma or another reactive airways disease. Use of the vaccine should be avoided in patients with an underlying condition that can lead to severe disease after influenza infection, such as diabetes or cardiovascular or pulmonary disorders.

According to the product's labeling, FluMist should not be administered concurrently with other vaccines or used within 48 hours after the administration of antiviral therapy that is active against influenza A or B viruses. In general, antiviral agents should not be administered within two weeks after administering the vaccine.

FluMist is supplied frozen and packaged in units of 10 prefilled single-use sprayers for intranasal administration. Instructions for thawing and administering the product are included in the labeling.