FDA approves first four-strain flu vaccine

Thursday, 1 March 2012

AstraZeneca today announced that MedImmune, its biologics arm, has received approval from the US Food and Drug Administration (FDA) for FluMist® Quadrivalent (Influenza Vaccine Live, Intranasal) in the prevention of influenza. This marks the first four-strain influenza vaccine approved by the FDA.

All other licensed seasonal influenza vaccines currently available in the US are trivalent, containing three strains (two strains of type A influenza (A/H1N1 and A/H3N2) and one B lineage strain). FluMist Quadrivalent contains four strains (two type A strains and two type B lineages) to help provide broad protection against circulating influenza A and B.

“MedImmune and AstraZeneca are pleased to be able to take the next steps in making this product available to the public. We believe that the inclusion of an additional B strain in an annual influenza vaccine could provide a direct health benefit to individual vaccine recipients in the event that the correct B lineage either is not selected for inclusion in a trivalent vaccine, or if both lineages co-circulate,” said Bahija Jallal, MedImmune’s Executive Vice President of Research and Development.

NOTES TO EDITORS

About FluMist® Quadrivalent (Influenza Vaccine Live, Intranasal)

FluMist Quadrivalent is a vaccine that is sprayed into the nose to help protect against influenza. It can be used in children, adolescents, and adults ages 2 through 49. FluMist Quadrivalent is similar to MedImmune’s trivalent Influenza Vaccine Live, Intranasal (FluMist), except FluMist Quadrivalent provides protection against an additional influenza strain. FluMist Quadrivalent may not prevent influenza in everyone who gets vaccinated.

The most common side effects are runny or stuffy nose; sore throat; and fever over 100 degrees F. It should not be used in people with a severe allergy to eggs, gentamicin, gelatin, or arginine; have ever had a life-threatening reaction to influenza vaccinations; or are 2 through 17 years old and take aspirin or medicines containing aspirin. Also, children under 2 years old have an increased risk of wheezing (difficulty with breathing) after getting FluMist Quadrivalent.

Please see accompanying complete Product Information, including Patient Information
at www.medimmune.com.

About MedImmune

MedImmune, the worldwide biologics arm for AstraZeneca PLC, has approximately 3,500 employees worldwide and is headquartered in Gaithersburg, Maryland.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com

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