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MedImmune Resolves FDA Observations Regarding Manufacturing Process for FluMist(R)
Date:9/7/2007

iciency. The safety and efficacy of FluMist have not been established in pregnant women or for patients with chronic underlying medical conditions, including asthma or reactive airways disease; the vaccine should not be administered to these patients.

In randomized, placebo-controlled clinical trials of FluMist in its refrigerated and frozen formulations, the most common solicited adverse events in the indicated population (n=11,604) included runny nose/nasal congestion, sore throat, cough, irritability, headache, chills, vomiting, muscle aches, decreased appetite, abdominal pain, and decreased activity/feeling of tiredness/weakness.

On January 5, 2007, the FDA approved MedImmune's sBLA for a refrigerated version of FluMist, which is being manufactured for the 2007-2008 influenza season. Prior seasons' versions required frozen storage. Due to the seasonal nature of influenza vaccine, full prescribing information for the refrigerated version does not yet contain complete details on vaccine strains to be included for this season's vaccine. However, preliminary prescribing information can be found at http://www.fda.gov/cber/label/inflmed010507LB.pdf.

About MedImmune

MedImmune strives to provide better medicines to patients, new medical options for physicians and rewarding careers to employees. Dedicated to advancing science and medicine to help people live better lives, the company is focused on the areas of infectious diseases, cancer and inflammatory diseases. With approximately 3,000 employees worldwide and headquarters in Maryland, MedImmune is wholly owned by AstraZeneca plc (LSE: AZN.L, NYSE: AZN). For more information, visit MedImmune's website at http://www.medimmune.com.


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