AstraZeneca Announces Renewed Recommendation and Availability of FLUMIST QUADRIVALENT Vaccine in the US
22 February 2018 - 7:07AM
Business Wire
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 meeting.
IMPORTANT SAFETY AND ELIGIBILITY 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 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 www.astrazeneca-us.com and follow us on Twitter
@AstraZenecaUS.
US-18326 Last Updated 2/18
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