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 Live
Attenuated Influenza Vaccine (FluMist Quadrivalent) 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 in the US, which indicated FluMist Quadrivalent did not
demonstrate statistically significant effectiveness in children 2-17 years of

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 influenza 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.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on
the discovery, development and commercialisation 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:

About FluMist Quadrivalent Live Attenuated Influenza Vaccine

FluMistQuadrivalent is the only widely available quadrivalent live attenuated
influenza vaccine (LAIV), which is administered as a nasal spray and contains
four protective strains for the prevention of influenza. FluMistQuadrivalent was
originally approved in the US in 2003 and since then more than 116 million doses
have been distributed around the world. Global Product Sales of Fluenz/FluMist
Quadrivalent in FY 2015 amounted to $290 million.

1 UK:
Influenza_vaccine_effectiveness (
_in_primary_care_in_children.pdf (

2 Finland:

3 US:


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Key: RIA – Respiratory, Inflammation and Autoimmunity, CVMD – Cardiovascular and
Metabolic Disease, ING – Infection, Neuroscience and Gastrointestinal

23 June 2016