AstraZeneca ships FLUMIST® QUADRIVALENT vaccine in the US for 2018-2019 flu season

Appropriate patients can receive the only needle-free, nasal spray flu vaccine from physicians as soon as late September

AstraZeneca today announced the first shipment of FLUMIST® QUADRIVALENT (Influenza Vaccine Live, Intranasal) doses in the US for the 2018-2019 influenza season. FLUMIST QUADRIVALENT, or the live attenuated influenza vaccine (LAIV), 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 may not prevent influenza in everyone who gets vaccinated.

Tosh Butt, Vice President, US Respiratory, AstraZeneca, said, “FLUMIST QUADRIVALENT is the only CDC recommended needle-free, nasal spray flu vaccine and has been approved in the US since 2012. AstraZeneca believes vaccination is the best way to protect against the flu and recognizes the importance of vaccine options to both patients and providers. Today, we are excited to begin shipping FLUMIST QUADRIVALENT for the 2018-2019 flu season.”

Earlier this year, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) reinstated the recommendation for the use of FLUMIST QUADRIVALENT/LAIV as an option for flu vaccination in the US for the 2018-2019 flu season. The recommendation states there is no preference for one flu vaccine product over another, including FLUMIST QUADRIVALENT/LAIV, inactivated influenza vaccine (IIV) and recombinant influenza vaccine (RIV). This was published in the Morbidity and Mortality Weekly Report (MMWR) in June 2018.

Following the 2018 reinstated ACIP recommendation, Public Health England published provisional end-of-season adjusted vaccine effectiveness estimates from the 2017-2018 flu season. The provisional results demonstrated FLUMIST QUADRIVALENT (known as FLUENZ™ TETRA in the European Union) provided statistically significant vaccine effectiveness against A/H1N1 strains during the 2017-2018 season in children 2 to 17 years of age. The study used a test-negative case control design through five primary care influenza sentinel swabbing surveillance schemes in England, Scotland, Wales and Northern Ireland. These data support the real-world effectiveness of the new FLUMIST QUADRIVALENT A/H1N1 strain.

FLUMIST QUADRIVALENT/FLUENZ TETRA is approved for use in the US, Canada, Israel, Hong Kong and the European Union. Those interested in receiving FLUMIST QUADRIVALENT should talk to their healthcare provider about their vaccination options.

 

IMPORTANT SAFETY INFORMATION

Who should not get FLUMIST QUADRIVALENT?
You should not get FLUMIST QUADRIVALENT if you have a severe allergy to eggs or to any inactive ingredient in the vaccine; 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 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.

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, except FLUMIST QUADRIVALENT provides protection against an additional influenza strain. FLUMIST QUADRIVALENT may not prevent influenza in everyone who gets vaccinated.

Please see complete Product Information, including Prescribing Information.

Tamiflu® and Relenza® are registered trademarks of their respective owners and are not trademarks of MedImmune, LLC.

NOTES TO EDITORS

About the Provisional Public Health England 2017-2018 Flu Vaccine Effectiveness Results
On July 18, 2018, Public Health England released provisional end of season vaccine effectiveness (VE) data from the recent 2017-18 influenza season. Influenza VE was measured using a test-negative case control design through five primary care influenza sentinel swabbing surveillance schemes in England, Scotland, Wales and Northern Ireland.

The provisional end-of-season adjusted VE estimates showed an adjusted all age overall VE of 15.0% (95% CI: -6.3, 32.0) and an all adjusted VE in children aged 2-17 years for quadrivalent live attenuated influenza vaccine (LAIV4) of 26.9% (-32.6, 59.7). There was no significant effectiveness against circulating influenza A/H3N2 strains demonstrated by any vaccine type or for any age group during the season. The adjusted VE estimate for LAIV4 against A/H3N2 in children aged 2-17 years old was -76% (95% CI: -289.6, 21).

Adjusted VE estimates for LAIV4 in children aged 2-17 years was 90.3% (95% CI: 16.4, 98.9) against A/H1N1pdm09 and 60.8% (95% CI: 8.2, 83.3) against influenza B.

About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. 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 and follow us on Twitter @AstraZenecaUS.

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US-22915 Last Updated 9/18