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MedImmune (AZN)'s FluMist® Quadrivalent (Influenza Vaccine Live, Intranasal), Four-Strain, Nasal-Spray Flu Vaccine, Ships for 2013-2014 Influenza Season  
7/29/2013 8:26:48 AM

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GAITHERSBURG, Md., July 26, 2013 /PRNewswire/ -- MedImmune the global biologics arm of AstraZeneca announced today that it began shipping FluMist Quadrivalent to influenza distributors across the United States for the 2013-2014 influenza season. This marks the first shipments of FluMist Quadrivalent, the first and only nasal-spray quadrivalent flu vaccine approved by the Food and Drug Administration (FDA) to help protect against four influenza strains contained in the vaccine: two influenza A strains and two influenza B lineages.[1]

All vaccine provided by MedImmune this season in the United States will be FluMist Quadrivalent. The company made the decision to offer quadrivalent vaccine as it provides protection against an additional influenza strain that may circulate during the 2013-2014 influenza season. FluMist Quadrivalent replaces MedImmune's trivalent influenza vaccine, FluMist® (Influenza Vaccine Live, Intranasal). As a needle-free option for eligible individuals and entire families alike (2-49 years of age), FluMist Quadrivalent was developed from the foundation of FluMist. FluMist Quadrivalent is administered as a gentle mist sprayed into the nose, where the influenza virus usually enters the body. The most common side effects of FluMist Quadrivalent are runny or stuffy nose, sore throat, and fever over 100 degrees F.

"The introduction of FluMist Quadrivalent reinforces MedImmune's continued commitment to patient health and innovation within the area of infectious disease," said Chris Ambrose, M.D., MedImmune's Vice President of Medical & Scientific Affairs. "MedImmune is one of the first manufacturers to ship quadrivalent vaccine to customers. MedImmune continues to collaborate with healthcare providers, the public health community, and select retail pharmacies to deliver vaccine as early as possible to eligible children and adults."

The 2013-2014 influenza season is the first time that quadrivalent influenza vaccines will be available in the United States. Previously, only trivalent influenza vaccines were available, which contained two influenza A strains and one influenza B strain. Since 2001, influenza B strains from two different lineages (B/Yamagata and B/Victoria) have co-circulated each influenza season in the United States.[2] Trivalent vaccine formulations rely on predictions of which influenza B strains will be dominant in the upcoming season.[3] However, B strain circulation has been difficult to predict correctly, and in 6 of the last 12 flu seasons, the vaccine B strain did not match the dominant circulating B strain.[4]

The Centers for Disease Control and Prevention (CDC) recommends everyone 6 months and older get vaccinated against influenza as soon as vaccine is available.[5] The CDC encourages people to get vaccinated each year, regardless of whether or not the viruses in the vaccine have changed since the previous season, because immunity can wane over time.[6] Not all influenza vaccines are approved for all persons. Individuals should check with their healthcare provider regarding eligibility for FluMist Quadrivalent.

FluMist Quadrivalent will be available through private healthcare practices, public health departments, select retail pharmacies including Target and Walgreens, school-located vaccination programs, military bases, and other sites. Visit www.flumistquadrivalent.com to find when and where FluMist Quadrivalent will be available.

FluMist Quadrivalent is covered by over 99 percent of health insurance plans with immunization benefits; therefore, most patients who have health insurance for immunizations have coverage for FluMist Quadrivalent.[7] People should consult their health insurance plan for more information.

For more information, please visit www.flumistquadrivalent.com.

Important Safety and Eligibility Information for FluMist Quadrivalent (Influenza Vaccine Live, Intranasal)

What is FluMist Quadrivalent?
FluMist Quadrivalent is a vaccine that is sprayed into the nose to help protect against influenza. It can be used in eligible children, adolescents, and adults ages 2 through 49. FluMist Quadrivalent is similar to MedImmune's trivalent influenza vaccine FluMist, except FluMist Quadrivalent provides protection against an additional influenza strain. Like all influenza vaccines, FluMist Quadrivalent may not prevent influenza in everyone who gets vaccinated.

Who should not get FluMist Quadrivalent?
You should not get FluMist Quadrivalent if you have 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 children or adolescents should not be given aspirin for 4 weeks after getting FluMist or FluMist Quadrivalent unless your healthcare provider tells you otherwise.

Children under 2 years old have an increased risk of wheezing (difficulty with breathing) after getting FluMist Quadrivalent.

Who may not be able to get FluMist Quadrivalent?
Tell your healthcare provider if you or your child are currently wheezing; have a history of wheezing if under 5 years old; have had Guillain-Barre syndrome; have a weakened immune system or live with someone who has a severely weakened immune system; have problems with your heart, kidneys, or lungs; have diabetes; are pregnant or nursing; or are taking Tamiflu®, Relenza®, amantadine, or rimantadine.

Your healthcare provider will decide if FluMist Quadrivalent is right for you or your child.

What are the most common side effects of FluMist Quadrivalent?
The most common side effects are runny or stuffy nose, sore throat, and fever over 100 degrees F.

Please see complete Product Information, including Patient Information for more information.

For more information, please visit www.flumistquadrivalent.com.

About MedImmune
MedImmune, the global biologics arm for AstraZeneca, has approximately 3,500 employees worldwide and is headquartered in Gaithersburg, Maryland. For more information, visit MedImmune's website at www.medimmune.com.

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, visit AstraZeneca's website at: www.astrazeneca.com.

[1] FluMist Quadrivalent [package insert]. Gaithersburg, MD: MedImmune.
[2] Shaw MW, Xu X, Li Y, et al. Reappearance and global spread of variants of influenza B/Victoria/2/87 lineage viruses in the 2000-2001 and 2001-2002 seasons. Virology. 2002;303:1-8.
[3] Belshe RB. The need for quadrivalent vaccine against seasonal influenza. Vaccine. 2010;28S:D45-D53.
[4] Centers for Disease Control and Prevention. Seasonal influenza (flu): past weekly surveillance reports.
http://www.cdc.gov/flu/weekly/pastreports.htm. Accessed June 12, 2013.
[5] Centers for Disease Control and Prevention. Key Facts about Influenza (Flu) & Flu Vaccine. http://www.cdc.gov/flu/keyfacts.htm. Accessed June 10, 2013.
[6] Centers for Disease Control and Prevention. Key Facts About Seasonal Flu Vaccine. http://www.cdc.gov/flu/protect/keyfacts.htm. Accessed June 10, 2013.
[7] Data on File. MedImmune. Gaithersburg, MD.

SOURCE MedImmune



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