- Expanded AFLURIA QUADRIVALENT age
indication offers protection against four influenza virus strains
for people five years of age and older, and increases vaccine
options for health care providers and their patients.
- Both AFLURIA QUADRIVALENT (Influenza
Vaccine) and AFLURIA (Influenza Vaccine), are available in the US
for the 2017-2018 influenza season.
- As the only global vaccine company
solely dedicated to the prevention of influenza, the complete
Seqirus portfolio includes both trivalent and quadrivalent options,
manufactured using egg and cell-based technologies.
Seqirus announced today that the U.S. Food and Drug
Administration (FDA) has approved AFLURIA QUADRIVALENT (Influenza
Vaccine) for use in people five years of age and older, extending
the company’s broad portfolio of influenza vaccine offerings.
AFLURIA QUADRIVALENT, which was first approved in the U.S. in
August 2016 for people aged 18 and older, helps protect against two
influenza A strain viruses and two B strain viruses.3,10
“Pediatric health care providers now have a new vaccine option
to help protect children five years and older against influenza,”
said Gregg Sylvester MD, Vice President of Medical Affairs at
Seqirus. “As the only global vaccine company solely dedicated to
influenza, we are committed to providing health care professionals
and their patients with the broadest range of vaccine options
available.”
The traditional seasonal influenza vaccine is a trivalent
formula consisting of two strains of influenza A virus and a single
strain of influenza B virus.4 However, since 1985, two distinct
lineages of influenza B virus have co-circulated with varying
dominance. The use of a four-strain influenza vaccine like AFLURIA
QUADRIVALENT may now provide protection against both B
lineages.5
The U.S. Centers for Disease Control and Prevention (CDC)
recommends annual influenza vaccination for everyone six months of
age and older.6 Recently, the CDC’s Advisory Committee on
Immunization Practices (ACIP) voted to include AFLURIA® (Influenza
Vaccine) as one of the recommended trivalent influenza vaccine
options for people aged five years and older for the upcoming
2017-2018 season.11 The CDC has accepted the ACIP recommendation in
its 2017-2018 influenza recommendations published in the August 25,
2017 Morbidity and Mortality Weekly Report.9 As a result, both
AFLURIA and AFLURIA QUADRIVALENT are now both licensed and
recommended for people aged five years and older.
AFLURIA QUADRIVALENT and AFLURIA are both available in the U.S.
for the 2017-2018 influenza season as part of the extensive Seqirus
influenza vaccine portfolio. Both are presented in pre-filled
syringes as well as multi-dose vials, and are the only influenza
vaccines with a needle-free injection delivery option (PharmaJet®
Stratis® 0.5ML Needle-Free Jet Injector) for people aged 18 to 64
years.1,2
As the only global vaccine company solely dedicated to the
prevention of influenza, the complete Seqirus portfolio of seasonal
influenza vaccines includes both trivalent and quadrivalent
options, manufactured using egg and cell-based technologies, to
provide a wide range of options for people aged four years and
older. The portfolio also includes the only adjuvanted seasonal
influenza vaccine specifically developed for people 65 years and
older.12
Demonstrated Immunogenicity of AFLURIA QUADRIVALENT
(Influenza Vaccine)
In a randomized, double-blind, active-controlled clinical trial
conducted in 3,395 subjects aged 18 years and older, AFLURIA
QUADRIVALENT demonstrated non-inferiority to two TIV comparators
for all influenza strains contained in the vaccine. Additionally,
non-inferiority was demonstrated for both endpoints in both age
sub-groups, adults aged 18 through 64 years and 65 years and older
for all strains. Superiority of the immune response to each of the
influenza B strains contained in AFLURIA QUADRIVALENT was shown in
relativity to the antibody response after vaccination with TIV
formulation not containing B lineage strains for subjects 18 years
of age and older. Superiority against the alternate B strain was
also demonstrated for each of the influenza B strains in both age
sub-groups; 18 through 64 years and 65 years and older.1
In a randomized, comparator-controlled study that enrolled 1,250
subjects aged 18 through 64 years of age, the trivalent formulation
of AFLURIA (Influenza Vaccine) administered by the PharmaJet
Stratis Needle-Free Injection System compared to administration of
AFLURIA by needle and syringe demonstrated non-inferiority in the
immunogenicity population for all strains. Post-hoc analyses of
immunogenicity by age showed that younger subjects (18 through 49
years) elicited higher immunological responses than older subjects
(50 through 64 years).1
In a randomized, observer-blinded, comparator-controlled trial
conducted in the U.S. in 2,278 children five through 17 years of
age, AFLURIA QUADRIVALENT demonstrated non-inferiority to that of a
comparator vaccine containing the same recommended virus
strains.1
About Seasonal Influenza
Influenza is a common, highly contagious infectious disease that
can cause severe illness and life-threatening complications in many
people. To reduce the risk of more serious outcomes, such as
hospitalization and death, resulting from influenza, the CDC
encourages annual vaccination for all individuals aged six months
and older.4 Because transmission to others may occur one day
before symptoms develop and up to five to seven days after becoming
sick, the disease can be easily transmitted to others.7
Influenza can lead to clinical symptoms varying from mild to
moderate respiratory illness to severe complications,
hospitalization and in some cases death.7 The CDC estimates that
310,000 people in the United States were hospitalized due to
influenza-related complications during the 2015-2016 influenza
season.8 Since it takes about two weeks after vaccination for the
antibodies that protect against influenza virus infection to
develop inside the body, it is best that people get vaccinated to
help protect them before influenza begins spreading in their
community.4
About Seqirus
Seqirus is part of CSL Limited (ASX:CSL),
headquartered in Melbourne, Australia. The CSL Group of companies
employs more than 20,000 people with operations in more than 60
countries.
Seqirus was established on July 31, 2015 following CSL’s
acquisition of the Novartis influenza vaccines business and its
subsequent integration with bioCSL. As the second largest influenza
vaccine provider in the world, Seqirus is a major contributor to
the prevention of influenza globally and a transcontinental partner
in pandemic preparedness.
Seqirus operates state-of-the-art production facilities in the
U.S., the U.K. and Australia, and manufactures influenza vaccines
using both egg-based and cell-based technologies. It has leading
R&D capabilities, a broad portfolio of differentiated products
and a commercial presence in more than 20 countries.
For more information
visit www.seqirus.com and www.csl.com.
About PharmaJet
Based in Golden, Colorado, PharmaJet’s mission is worldwide
acceptance of PharmaJet® needle-free devices as a standard of care
in the vaccine delivery market. PharmaJet’s devices are also
integral in the development of multiple novel pharmaceuticals. The
innovative Stratis® device has U.S. FDA 510(k) marketing clearance,
CE Mark and WHO PQS certification to deliver medications and
vaccines either intramuscularly or subcutaneously. In August 2014,
the PharmaJet Stratis® device was cleared for delivery of an
influenza vaccine to deliver needle-free flu shots. The Tropis®
device for intradermal injections received authorization to apply
the CE Mark in May 2016. The PharmaJet Needle-free devices are
safe, fast and easy-to-use. They eliminate needlestick injuries,
needle reuse and cross contamination, and help reduce sharps waste
disposal. For more information, visit http://pharmajet.com/.
References
1. AFLURIA QUADRIVALENT (Influenza Vaccine) [prescribing
information]. King of Prussia, PA: Seqirus, Inc. 2017.
2. AFLURIA (Influenza Vaccine) [prescribing information].
Cambridge, MA: Seqirus; 2017.
3. U.S. Food & Drug Administration (FDA). “Influenza Virus
Vaccine for the 2017-2018 Season.” Available at:
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Post-MarketActivities/LotReleases/ucm567865.htm.
Accessed July 2017.
4. Centers for Disease Control and Prevention (CDC). “Key Facts
About Seasonal Flu Vaccine.” Available at:
http://www.cdc.gov/flu/protect/keyfacts.htm. Accessed July
2017.
5. Hartvickson R, et al. Non-inferiority of mammalian
cell-derived quadrivalent subunit influenza virus vaccines compared
to trivalent subunit influenza virus vaccines in healthy children:
a phase III randomized, multicenter, double-blind clinical trial.
International Journal of Infectious Diseases. 2015;41:65-72.
http://dx.doi.org/10.1016/j.ijid.2015.11.004. Accessed July
2017.
6. CDC. “Recommendations of the Advisory Committee on
Immunization Practices — United States, 2016–17 Influenza Season.”
Available at: https://www.cdc.gov/mmwr/volumes/65/rr/rr6505a1.htm.
Accessed July 2017.
7. CDC. “Key Facts About Influenza (Flu).” Available at:
https://www.cdc.gov/flu/keyfacts.htm. Accessed July 2017.
8. CDC. “Seasonal Influenza-Associated Hospitalizations in the
United States.” Available at:
https://www.cdc.gov/flu/about/qa/hospital.htm. Accessed July
2017.
9. CDC. “Prevention and Control of Seasonal Influenza with
Vaccines: Recommendations of the Advisory Committee on Immunization
Practices — United States, 2017–18 Influenza Season”Available at:
https://www.cdc.gov/mmwr/volumes/66/rr/rr6602a1.htm?s_cid=rr6602a1_e.
Accessed August 2017.
10. PR Newswire. “Seqirus receives FDA approval for AFLURIA
QUADRIVALENT® (Influenza Vaccine) for people 18 years of age and
older.” Available at:
http://www.prnewswire.com/news-releases/seqirus-receives-fda-approval-for-afluria-quadrivalent-influenza-vaccine-for-people-18-years-of-age-and-older-300319234.html.
Accessed July 2017.
11. American Academy of Pediatrics News. “Core flu vaccination
recommendations carry over for 2017-’18.” Available at:
http://www.aappublications.org/news/2017/06/21/ACIP062117. Access
July 2017.
12. Business Wire. “Seqirus Begins Shipping 2017-2018 Influenza
Vaccines to the U.S. Market.” Available at:
http://www.businesswire.com/news/home/20170720005327/en/Seqirus-Begins-Shipping-2017-2018-Influenza-Vaccines-U.S.
Accessed July 2017.
AFLURIA QUADRIVALENT is a trademark of Seqirus U.K. Limited or
its affiliates.
PHARMAJET and STRATIS are trademarks of PharmaJet.
AFLURIA® QUADRIVALENT (Influenza Vaccine) Indication
AFLURIA QUADRIVALENT is an inactivated influenza vaccine
indicated for active immunization against influenza disease caused
by influenza A subtype viruses and type B viruses contained in the
vaccine. AFLURIA QUADRIVALENT is approved for use in individuals
five years of age and older.1
Important Safety Information
CONTRAINDICATIONS
- Known severe allergic reactions (e.g.,
anaphylaxis) to any component of the vaccine including egg protein,
or to a previous dose of any influenza vaccine.1
WARNINGS AND PRECAUTIONS
- If Guillain-Barré Syndrome (GBS) has
occurred within 6 weeks of previous influenza vaccination, the
decision to give AFLURIA QUADRIVALENT should be based on careful
consideration of the potential benefits and risks.1
- Appropriate medical treatment and
supervision must be available to manage possible anaphylactic
reactions following administration of the vaccine.
ADVERSE REACTIONS
AFLURIA QUADRIVALENT administered by needle and syringe:
- In adults 18 through 64 years, the most
commonly reported injection-site adverse reaction was pain (≥40%).
The most common systemic adverse events were myalgia and headache
(≥20%).1
- In adults 65 years of age and older,
the most commonly reported injection-site adverse reaction was pain
(≥20%). The most common systemic adverse event was myalgia
(≥10%).1
- In children five through eight years,
the most commonly reported injection-site adverse reactions were
pain (≥50%), redness and swelling (≥10%). The most common systemic
adverse event was headache (≥10%).1
- In children nine through 17 years, the
most commonly reported injection-site adverse reactions were pain
(≥50%), redness and swelling (≥10%). The most common systemic
adverse events were headache, myalgia, and malaise and fatigue
(≥10%).1
AFLURIA (trivalent formulation) administered by the PharmaJet
Stratis Needle-Free Injection System:
- In adults 18 through 64 years of age,
the most commonly reported injection-site adverse reactions were
tenderness (≥80%), swelling, pain, redness (≥60%), itching (≥20%)
and bruising (≥10%). The most common systemic adverse events were
myalgia, malaise (≥30%), and headache (≥20%).1
Please see full prescribing information for AFLURIA
QUADRIVALENT here.
AFLURIA® (Influenza Vaccine) Indication
AFLURIA is an inactivated influenza vaccine indicated for active
immunization against influenza disease caused by influenza virus
subtypes A and type B present in the vaccine.2 AFLURIA is
approved for use in persons five years of age and older.2
Important Safety Information
CONTRAINDICATIONS
- Severe allergic reaction (e.g.,
anaphylaxis) to any component of the vaccine including egg protein,
or to a previous dose of any influenza vaccine.2
WARNINGS AND PRECAUTIONS
- Administration of CSL’s 2010 Southern
Hemisphere influenza vaccine has been associated with increased
rates of fever and febrile seizures in children predominantly below
the age of five years as compared to previous years.2
- If Guillain-Barré Syndrome (GBS) has
occurred within 6 weeks of previous influenza vaccination, the
decision to give AFLURIA should be based on careful consideration
of the potential benefits and risks.2
- Appropriate medical treatment and
supervision must be available to manage possible anaphylactic
reactions following administration of the vaccine.2
- Immunocompromised persons may have a
diminished immune response to AFLURIA.2
ADVERSE REACTIONS
- In children five through 17 years of
age, the most common injection-site adverse reactions when
administered by needle and syringe were pain (≥60%), redness (≥20%)
and swelling (≥10%). The most common systemic adverse events were
headache, myalgia (≥20%), irritability, malaise and fever
(≥10%).2
- In adults 18 through 64 years of age,
the most common injection-site adverse reactions when administered
by needle and syringe were tenderness (≥60%), pain (≥40%), swelling
(≥20%), and redness, itching (≥10%). The most common systemic
adverse events were muscle aches (≥30%) headache and malaise
(≥20%).2
- In adults 18 through 64 years of age,
the most common injection-site adverse reactions when administered
by the PharmaJet Stratis Needle-Free Injection System up to 7 days
post-vaccination were tenderness (≥80%), swelling, pain, redness
(≥60%), itching (≥20%) and bruising (≥10%). The most common
systemic adverse events within this period were myalgia, malaise
(≥30%), and headache (≥20%).2
- In adults 65 years of age and older,
when administered by needle and syringe the most common
injection-site adverse reactions were tenderness (≥30%) and pain
(≥10%). No systemic adverse events occurred in ≥10% of subjects in
this age group. 2
Please see full prescribing information for AFLURIA
here.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170914005874/en/
PadillaDani Jurisz,
612-455-1726Dani.Jurisz@PadillaCo.com
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