AstraZeneca provides update on FluMist Quadrivalent vaccine in the US for the 2016-17 influenza season

AstraZeneca today confirmed that the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) has provided its interim recommendation on the use of FluMist® Quadrivalent (Influenza Vaccine Live, Intranasal), a Live Attenuated Influenza Vaccine (LAIV), in the US for the 2016-2017 influenza season. The updated guidance states the vaccine should not be used in any setting, based on CDC vaccine effectiveness data from the last three influenza seasons, which indicated FluMist Quadrivalent did not demonstrate statistically significant effectiveness in children 2-17 years of age.

The US CDC effectiveness data for 2015-2016 season contrast with studies by AstraZeneca as well as preliminary independent findings by public health authorities in other countries. These findings demonstrate FluMist Quadrivalent was 46-58% effective overall against the circulating influenza strains during the 2015-2016 season. As influenza vaccine effectiveness varies from season to season, it is evaluated in annual observational studies. The CDC states that when there is a good match between the strains in the vaccine and those that circulate during the flu season, vaccines are typically 50-60% effective. AstraZeneca is working with the CDC to better understand its data to help ensure eligible patients continue to receive the vaccine in future seasons in the US.

The distribution and use of the vaccine in other countries are progressing as planned for the forthcoming influenza season, pending the annual release process from relevant regulatory authorities.

Financial considerations

The US Product Sales of FluMist Quadrivalent in FY 2015 amounted to $206 million. The ACIP’s updated recommendation is expected to result in very limited US demand in the second half of 2016 and consequently the Company will take an inventory write-down of approximately $80 million in the second quarter of 2016. The Company maintains its financial guidance for 2016.

Important Safety Information

FluMist® Quadrivalent (Influenza Vaccine Live, Intranasal) is a vaccine indicated for active immunization of persons 2-49 years of age for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. FluMist Quadrivalent is for intranasal administration only.

FluMist Quadrivalent is contraindicated in persons who have had a severe allergic reaction (e.g., anaphylaxis) to any vaccine component, including egg protein, or after a previous dose of any influenza vaccine, and in children and adolescents receiving concomitant aspirin or aspirin-containing therapy.

In clinical trials, the risks of hospitalization and wheezing were increased in children <24 months of age who received trivalent FluMist® (Influenza Vaccine Live, Intranasal). Children <5 years of age with recurrent wheezing and persons of any age with asthma may be at increased risk of wheezing following FluMist Quadrivalent administration. FluMist

Quadrivalent has not been studied in persons with severe asthma or active wheezing.

If Guillain-Barré syndrome has occurred within 6 weeks of any prior influenza vaccination, the decision to give FluMist Quadrivalent should be based on careful consideration of the potential benefits and risks. FluMist Quadrivalent has not been studied in immunocompromised persons. The safety of FluMist Quadrivalent in individuals with underlying medical conditions predisposing them to wild-type influenza infection complications has not been established. FluMist Quadrivalent may not protect all individuals receiving the vaccine.

The most common solicited adverse reactions (occurring ≥10% in vaccine recipients and at least 5% greater than in placebo) reported after FluMist were runny nose or nasal congestion in all persons 2-49 years, fever >100°F in children 2-6 years, and sore throat in adults 18-49 years. Among children 2-17 years who received FluMist Quadrivalent, 32% reported runny nose or nasal congestion and 7% reported fever >100°F. Among adults 18-

49 years who received FluMist Quadrivalent, 44% reported runny nose or nasal congestion and 19% reported sore throat.

Please see accompanying complete Prescribing Information for FluMist Quadrivalent, including Patient Information.

 

NOTES TO EDITORS

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; respiratory and autoimmunity; and cardiovascular and metabolic disease. We are also active in infection, neuroscience and inflammatory diseases through collaborations with others. 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

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