Market Overview

AstraZeneca Announces Renewed Recommendation and Availability of FLUMIST QUADRIVALENT Vaccine in the US


Positive study results presented at the February 2018 ACIP meeting
show that the new H1N1 LAIV strain induces improved antibody responses

AstraZeneca today announced that the Advisory Committee on Immunization
Practices (ACIP) of the Centers for Disease Control and Prevention (CDC)
has voted in favor of a renewed recommendation for the use of FLUMIST®
QUADRIVALENT (Influenza Vaccine Live, Intranasal) in the US for
the 2018-2019 season. The recommendation follows the presentation of
positive results from a US study in children between the ages of 2 to <4
years evaluating the shedding and antibody responses of the H1N1 strain
in the live attenuated influenza vaccine (LAIV)/FLUMIST QUADRIVALENT.

Study results demonstrated that the new 2017-2018 H1N1 LAIV
post-pandemic strain (A/Slovenia) performed significantly better than
the 2015-2016 H1N1 LAIV post-pandemic strain (A/Bolivia), which was
previously associated with reduced effectiveness. The antibody response
induced with the new H1N1 LAIV strain was comparable to earlier data
seen with the highly effective H1N1 LAIV strain included in the vaccine
before the 2009 influenza pandemic.

Gregory Keenan, Vice President, US Medical Affairs, AstraZeneca, said:
"This study validates the improvements we've made to our strain
selection process and confirms an improved H1N1 LAIV strain was included
in the 2017-2018 formulation. We are pleased that the ACIP has voted in
support of a renewed recommendation for FLUMIST QUADRIVALENT in the US
and look forward to continuing to work with public health authorities to
optimize protection against influenza."

FLUMIST QUADRIVALENT is approved for use in the US, Canada and the
European Union. Limited quantities of FLUMIST QUADRIVALENT continue to
be available the US for the current 2017-2018 season. FLUMIST
QUADRIVALENT will be available in the US for the 2018-2019 influenza
season, pending annual strain approval from the US Food and Drug
Administration (FDA). The vaccine has remained recommended for use and
available in Canada and EU.

The full results of AstraZeneca's US pediatric clinical study evaluating
the shedding and antibody responses of the H1N1 strain in the
LAIV/FLUMIST QUADRIVALENT will be presented at a forthcoming medical


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

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.


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.


About the Study

AstraZeneca initiated a clinical study in 200 US children between the
ages of 2 to <4 years evaluating the shedding and antibody responses of
the new 2017-2018 H1N1 LAIV vaccine (containing the A/Slovenia strain)
and the 2015-2016 H1N1 LAIV vaccine (containing the A/Bolivia strain).
After the first dose of FLUMIST QUADRIVALENT, 23% of children vaccinated
with the 2017-2018 H1N1 LAIV strain developed a 4-fold antibody rise,
compared to 5% with the 2015-2016 H1N1 LAIV strain. After the second
dose, those results increased to 45% and 12% respectively. The data also
demonstrate that the new 2017-2018 H1N1 LAIV strain resulted in
increased vaccine virus replication in vaccinated children.

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
therapy areas – Oncology, Cardiovascular & Metabolic Diseases 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
and follow us on Twitter @AstraZenecaUS.

US-18326 Last Updated 2/18

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