AstraZeneca’s FluMist® Quadrivalent (Influenza Vaccine Live, Intranasal) nasal-spray flu vaccine begins shipping for 2015-2016 season

Thursday, 3 September 2015

Nearly 15 million doses will be distributed in the US to help protect eligible individuals 2 to 49 years of age against influenza

AstraZeneca began shipping its first doses of FluMist® Quadrivalent (Influenza Vaccine Live, Intranasal), developed by MedImmune, our global biologics research and development arm, for the 2015-2016 flu season today. FluMist Quadrivalent, the first and only needle-free, nasal spray flu vaccine approved by the Food and Drug Administration, helps protect against four influenza strains contained in the vaccine: two influenza A strains and two influenza B lineages.1,2

A needle-free, nasal spray option for eligible individuals 2 to 49 years of age, FluMist Quadrivalent is administered as a mist sprayed into the nose, where the influenza virus usually enters the body. People who have a severe allergy to eggs or other vaccine ingredients, anyone who has had life-threatening reactions to flu vaccines, and children or teens taking aspirin or products containing aspirin should not receive FluMist Quadrivalent. The most common side effects of FluMist Quadrivalent are runny or stuffy nose, sore throat, and fever over 100°F.1Please see Important Safety and Eligibility Information and accompanying full Prescribing Information, including Patient Information.

“The US Centers for Disease Control and Prevention (CDC) says the single best way to prevent influenza is to get an annual influenza vaccination,” said Chris Ambrose, Vice President, US Medical Affairs, Infectious Disease at AstraZeneca. “We are proud to continue our work with healthcare providers, retailers, and the public health community by providing eligible patients with FluMist Quadrivalent for the upcoming flu season.”3

The 2015-2016 flu season will be the third year that a quadrivalent influenza vaccine will be available in the US as a nasal spray.4 Unlike trivalent vaccines, quadrivalent vaccines include a second B strain to help provide additional protection against influenza B strains that may circulate.5

A study from a previous flu season found children ages 2 – 5 who received FluMist® (Influenza Vaccine Live, Intranasal) were about half as likely to get the flu compared to those who received the traditional flu shot.*1,5,6 Not all influenza vaccines are approved for all persons. Individuals should check with their healthcare provider regarding eligibility for FluMist Quadrivalent. FluMist Quadrivalent does not protect all individuals receiving the vaccine.

AstraZeneca is planning to produce and deliver nearly 15 million doses of FluMist Quadrivalent this influenza season, with product initially becoming available at the point of service in early September, followed by regular shipments to distributors throughout the end of the influenza season, as opposed to prior seasons when supply has been largely allocated during the season’s earlier months.

FluMist Quadrivalent will be available through private healthcare practices, public health departments, school-located vaccination programs, military bases, and select local and national retail pharmacies. Families can track where FluMist Quadrivalent is available in their local area via an online vaccine locator tool.

FluMist Quadrivalent is covered by most health insurance plans with immunization benefits; therefore, most patients who have health insurance for immunizations have coverage for FluMist Quadrivalent. People should consult their health insurance plan for more information.1

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

*Since influenza strains change each year, past clinical trial results do not guarantee future flu season results. Data is representative of the indicated population; full study population is represented in the Prescribing Information
 

Important Safety and Eligibility Information

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 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.

Who should not get FluMist Quadrivalent?

You should not get FluMist Quadrivalent if you have a severe allergy (e.g. anaphylaxis) to eggs or any component of FluMist Quadrivalent, including egg protein, or after a previous dose of any influenza vaccine; 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 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-Barré 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°F.

Please see accompanying (if printed) complete Product Information, including Prescribing Information.

Tamiflu and Relenza are registered trademarks of their respective owners.

NOTES TO EDITORS

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit www.astrazeneca-us.com.

CONTACTS

Media Inquiries  
   
Melissa Garcia +1 301 398 6470
Abigail Bozarth +1 302 885 2677

 

References
1. FluMist Quadrivalent [Package Insert]. Gaithersburg, MD: MedImmune.
2. U.S. Food and Drug Administration. Vaccines, Blood & Biologics.http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm293952.htm. Accessed August 26, 2015.
3. Centers for Disease Control and Prevention. Key Facts about Influenza (Flu) & Flu Vaccine.http://www.cdc.gov/flu/keyfacts.htm. Accessed August 26, 2015.
4. Centers for Disease Control and Prevention. Quadrivalent Influenza Vaccine: Questions & Answers.http://www.cdc.gov/flu/protect/vaccine/quadrivalent.htm. Accessed August 26, 2015.
5. Belshe RB, Edwards KM, Vesikari T, et al. Live Attenuated versus Inactivated Influenza Vaccine in Infants and Young Children. N Engl J Med. 2007;356(7):685-696.
6. Belshe RB, Ambrose CS, Yi T. Safety and efficacy of live attenuated influenza vaccine in children 2-7 years of age. Vaccine. 2008;26S:D10-D16.

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