[July 20, 2017] |
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Seqirus Begins Shipping 2017-2018 Influenza Vaccines to the U.S. Market
Seqirus announced today it has begun shipping its portfolio of seasonal
influenza vaccines to customers in the United States for the 2017-2018
influenza season. Seqirus, one of the largest influenza vaccine
companies in the world, expects to distribute over 50 million doses to
the U.S. market this year.
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Seqirus cell-based influenza vaccine manufacturing facility, Holly Springs, North Carolina (Photo: Seqirus).
In response to demand, Seqirus will be delivering both trivalent and
quadrivalent influenza vaccines this season, manufactured using egg and
cell-based technologies. The company will also provide FLUAD®
(Influenza Vaccine, Adjuvanted), the only adjuvanted seasonal influenza
vaccine specifically developed for people aged 65 and older; and
FLUCELVAX QUADRIVALENT® (Influenza Vaccine), the first cell-based
seasonal influenza vaccine licensed in the U.S.
The Seqirus 2017-2018 influenza vaccine portfolio also includes AFLURIA
QUADRIVALENT® (Influenza Vaccine), an egg-based quadrivalent influenza
vaccine, and AFLURIA® (Influenza Vaccine) and FLUVIRIN® (Influenza Virus
Vaccine), egg-based trivalent influenza vaccines. Seqirus also
distributes RAPIVAB® (Peramivir Injection), the first-and-only one-dose
intravenous antiviral treatment for acute influenza.
The complete portfolio of influenza vaccines provides a range of options
for children aged from four years right through to people aged 65 years
and older, presented in pre-filled syringes as well as multi-dose vials.
A needle-free injecting option is also available for AFLURIA and AFLURIA
QUADRIVALENT.
Seqirus produces influenza vaccines across its global manufacturing
network, which includes a state-of-the-art plant in Holly Springs, North
Carolina. This facility utilizes the latest cell culture technology and
was built in partnership with the U.S. Government to support pandemic
preparedness and emergency response.2
"As the only global vaccine company solely dedicated to the prevention
of influenza, Seqirus is committed to providing the broadest range of
influenza vaccine options as early as possible to healthcare providers
and their patients. We are pleased to build on our track record of early
and reliable supply by being one of the first influenza vaccine
manufacturers to ship product to the US market during this influenza
season," said Brent MacGregor, Senior Vice President, Commercial
Operations at Seqirus.
"Millions of people - particularly those 65 and older, children, and
anyone with an underlying medical condition, such as asthma, heart
disease, or diabetes, are at increased risk from influenza and its
associated complications. The CDC recommends annual influenza
vaccination for anyone 6 months of age and older to help prevent
transmission of this serious disease in our communities," said Gregg
Sylvester MD, Vice President of Medical Affairs at Seqirus.3
About the Seqirus Influenza Product Portfolio
FLUAD® (Influenza Vaccine, Adjuvanted)
-
Fluad received approval from the US Food and Drug
Administration (FDA) on November 24, 2015 and is the first and only
adjuvanted seasonal influenza vaccine in the US for adults aged 65 and
older.5
-
Age-related decreases in immune function may cause traditional flu
vaccines to be less effective in adults 65+. Adults 65 years and older
may be less able to fight infection, develop sufficient protective
immune responses or generate immunological memory for future
protection.7
-
Fluad contains an immune-enhancing adjuvant MF59® thought
to boost the immune response.5
-
In a large pivotal trial, Fluad elicited strong immune response in
adults aged 65+ and has a demonstrated safety profile.7
-
The vaccine has an extensive clinical heritage, with more than 87
million doses distributed worldwide since 1997 and licensure in 38
countries.
Please see the accompanying important safety information and the full
prescribing information for FLUAD.
FLUCELVAX QUADRIVALENT® (Influenza Vaccine)
-
Flucelvax Quadrivalent received approval from the FDA on 23 May, 2016,
making it the first US-licensed cell-based quadrivalent influenza
vaccine indicated for people aged four years and older.8
-
The H3N2 component of the 2017-2018 formulation of Flucelvax
Quadrivalent has been produced using a candidate virus that has been
isolated in cells.
-
It is available in multi-dose vials and prefilled syringes, offering
healthcare providers greater flexibility to determine which vaccine
presentation will best meet the needs of their immunization clinics.8
-
Flucelvax Quadrivalent is manufactured at the state-of-the-art
facility in Holly Springs, North Carolina, with cell culture
technology, which allows for the potential to rapidly increase
production of influenza vaccine in response to outbreaks or pandemic.
-
Development of the technology and manufacturing facility that produces
Flucelvax Quadrivalent was supported by strong public-private
partnerships with the U.S. government.6
Please see the accompanying important safety information and the full
prescribing information for FLUCELVAX QUADRIVALENT.
AFLURIA QUADRIVALENT® (Influenza Vaccine)
-
Afluria Quadrivalent received approval from the FDA on August 29, 2016
and is indicated for persons 18 years of age or older.9
-
The vaccine is available in single-dose, preservative-free pre-filled
syringes and multi-dose vials to provide choice and convenience to
patients and caregivers who administer it.
-
It is the only quadrivalent flu vaccine with a needle-free injection
delivery option (PharmaJet® Stratis® 0.5mL Needle-Free Jet Injector)
for persons 18 through 64 years of age.9
Please see the accompanying important safety information and the full
prescribing information for AFLURIA QUADRIVALENT.
AFLURIA® (Influenza Vaccine)
-
Afluria is a trivalent influenza vaccine developed with egg-based
technologies and is indicated for persons aged five or older.10
-
Afluria is available in both prefilled syringes and multi-dose vials
to provide choice and convenience to patients and caregivers who
administer it.10
-
It is the only trivalent flu vaccine with a needle-free delivery
option (PharmaJet® Stratis® 0.5mL Needle-Free Jet Injector) for
persons 18 through 64 years of age.10
Please see the accompanying important safety information and the full
prescribing information AFLURIA.
FLUVIRIN® (Influenza Virus Vaccine)
-
Fluvirin is a trivalent influenza vaccine developed with egg-based
technologies and is indicated for persons four years and older.11
Please see the accompanying important safety information and the full
prescribing information for FLUVIRIN.
RAPIVAB® (Peramivir Injection)
-
Rapivab® is indicated for the treatment of acute uncomplicated
influenza in patients 18 years and older who have been symptomatic for
no more than 2 days.12
Please see the accompanying important safety information and the full
prescribing information for RAPIVAB.
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.1 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.1
Influenza can lead to clinical symptoms varying from mild to moderate
respiratory illness to severe complications, hospitalization and in some
cases death.1 The CDC estimates that 310,000 people in the
United States were hospitalized due to influenza-related complications
during the 2015-2016 influenza season.4 Since it takes about
two weeks after vaccination for antibodies to develop in the body that
protect against influenza virus infection, it is best that people get
vaccinated to help protect them before influenza begins spreading in
their community.1
About Seqirus
Seqirus is part of CSL
Limited (ASX:CSL), headquartered in Melbourne, Australia. The CSL
Group of companies employs more than 16,000 people with operations in
more than 30 countries.
Seqirus was established on 31 July 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 US, the
UK 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 www.pharmajet.com.
References
1. Centers for Disease Control and Prevention (CDC). "Key Facts About
Seasonal Flu Vaccine." Available at: http://www.cdc.gov/flu/protect/keyfacts.htm.
Accessed April 2017.
2. This project has been funded in whole or in part with Federal funds
from the Office of the Assistant Secretary for Preparedness and
Response, Biomedical Advanced Research and Development Authority, under
Contract No. HHSO100200900101C.
3. CDC. "People at High Risk of Developing Flu-Related Complications."
Seasonal Influenza (Flu) 2016. Available at: http://www.cdc.gov/flu/about/disease/high_risk.htm.
Accessed on April 2017.
4. CDC. "Seasonal Influenza-Associated Hospitalizations in the United
States." Available at: https://www.cdc.gov/flu/about/qa/hospital.htm.
Accessed April 2017.
5. U.S. Food and Drug Administration. "FDA Approves First Seasonal
Influenza Vaccine Containing an Adjuvant." Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm474295.htm.
Accessed June 2016.
6. US Department of Health & Human Services. A milestone in protection
from influenza. US Department of Health and Human Services website.
Available at: https://wayback.archive-it.org/3926/20150618190057/http://www.hhs.gov/news/press/2014pres/06/20140617a.html.
Accessed April 2017.
7. FLUAD (Influenza Vaccine) [prescribing information]. Cambridge, MA:
Seqirus; 2016.
8. FLUCELVAX QUADRIVALENT (Influenza Vaccine) [prescribing information].
Cambridge, MA: Seqirus, Inc. 2016.
9. AFLURIA QUADRIVALENT [prescribing information]. King of Prussia, PA:
Seqirus, Inc. 2016.
10. AFLURIA (Influenza Vaccine) [prescribing information]. Cambridge,
MA: Seqirus; 2016.
11. FLUVIRIN (Influenza Vaccine) [prescribing information]. Cambridge,
MA: Seqirus; 2016.
12. RAPIVAB (Peramivir Injection) [prescribing information]. Durham, NC:
BioCryst Pharmaceuticals, Inc. 2014.
FLUAD® (Influenza Vaccines, Adjuvanted) Indication
FLUAD is an inactivated influenza vaccine indicated for active
immunization against influenza disease caused by influenza virus
subtypes A and type B contained in the vaccine.7 FLUAD is
approved for use in persons 65 years of age and older.7
Important Safety Information
CONTRAINDICATIONS
-
Severe allergic reaction to any component of the vaccine, including
egg protein, or after a previous dose of any influenza vaccine.7
WARNINGS AND PRECAUTIONS
-
If Guillain-Barré Syndrome (GBS) has occurred within six weeks of
previous influenza vaccination, the decision to give FLUAD should be
based on careful consideration of the potential benefits and risks.7
-
The tip caps of the prefilled syringes contain natural rubber latex
which may cause allergic reactions in latex sensitive individuals.7
ADVERSE REACTIONS
-
The most common (= 10%) local (injection site) adverse reactions
observed in clinical studies were injection site pain (25%) and
tenderness (21%).7
-
The most common (= 10%) systemic adverse reactions observed in
clinical studies were myalgia (15%), headache (13%) and fatigue (13%).7
Please see full prescribing information for FLUAD here.
FLUCELVAX QUADRIVALENT® (Influenza Vaccine) Indication
FLUCELVAX QUADRIVALENT is an inactivated vaccine indicated for active
immunization for the prevention of influenza disease caused by influenza
virus subtypes A and type B contained in the vaccine.8 FLUCELVAX
QUADRIVALENT is approved for use in persons four years of age and older.8
Important Safety Information
CONTRAINDICATIONS
-
History of severe allergic reaction (e.g. anaphylaxis) to any
component of the vaccine.
WARNINGS AND PRECAUTIONS
-
Guillain-Barré Syndrome: If GBS has occurred within 6 weeks of receipt
of a prior influenza vaccine, the decision to give FLUCELVAX
QUADRIVALENT should be based on careful consideration of the potential
benefits and risks.8
-
Preventing and Managing Allergic Reactions: Appropriate medical
treatment and supervision must be available to manage possible
anaphylactic reactions following administration of the vaccine.8
-
Syncope: Syncope (fainting) can occur in association with
administration of injectable vaccines, including FLUCELVAX
QUADRIVALENT. Syncope can be accompanied by transient neurological
signs such as visual disturbance, paresthesia, and tonic-clonic limb
movements. Procedures should be in place to avoid falling injury and
to restore cerebral perfusion following syncope by maintaining a
supine or Trendelenburg position.8
-
Altered Immunocompetence: After vaccination with FLUCELVAX
QUADRIVALENT, immunocompromised individuals, including those receiving
immunosuppressive therapy, may have a reduced immune response. 8
-
Limitations of Vaccine Effectiveness: Vaccination with FLUCELVAX
QUADRIVALENT may not protect all vaccine recipients against influenza
disease.8
ADVERSE REACTIONS
-
The most common (=10%) local and systemic reactions in adults 18-64
years of age were injection site pain (45.4%) headache (18.7%),
fatigue (17.8%) and myalgia (15.4%), injection site erythema (13.4%),
and induration (11.6%).8
-
The most common (=10%) local and systemic reactions in adults =65
years of age were injection site pain (21.6%), and injection site
erythema (11.9%).8
-
The most common (=10%) local and systemic reactions in children 4 to
<6 years of age after first dose of vaccine were tenderness at the
injection site (46%), injection site erythema (18%), sleepiness (19%),
irritability (16%), injection site induration (13%) and change in
eating habits (10%).8
-
The most common (=10%) local and systemic reactions in children 6
through 8 years of age after first dose of vaccine were pain at the
injection site (54%), injection site erythema (22%), injection site
induration (16%), headache (14%), fatigue (13%) and myalgia (12%).8
-
The most common (=10%) local and systemic reactions in children and
adolescents 9 through 17 years of age were pain at the injection site
(58%), headache (22%), injection site erythema (19%), fatigue (18%)
myalgia (16%), and injection site induration (15%).8
Please see full prescribing information for FLUCELVAX QUADRIVALENT here.
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 persons 18 years of age and older.9
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.9
WARNINGS AND PRECAUTIONS
-
Guillain-Barré Syndrome: 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.9
-
The 1976 swine influenza vaccine was associated with an increased
frequency of GBS. Evidence for a causal relation of GBS with
subsequent vaccines prepared from other influenza viruses is unclear.
If influenza vaccine does pose a risk, it is probably slightly more
than one additional case per 1 million persons vaccinated.9
-
Preventing and Managing Allergic Reactions: Appropriate medical
treatment and supervision must be available to manage possible
anaphylactic reactions following administration of the vaccine.9
-
Altered Immunocompetence: If AFLURIA QUADRIVALENT is
administered to immunocompromised persons, including those receiving
immunosuppressive therapy, the immune response may be diminished.9
-
Limitations of Vaccine Effectiveness: Vaccination with AFLURIA
QUADRIVALENT may not protect all individuals.9
ADVERSE REACTIONS
-
In adults 18 through 64 years, the most commonly reported
injection-site adverse reaction when AFLURIA QUADRIVALENT was
administered by needle and syringe was pain (=40%). The most common
systemic adverse events were myalgia and headache (=20%).9
-
In adults 65 years of age and older, the most commonly reported
injection-site adverse reaction when AFLURIA QUADRIVALENT was
administered by needle and syringe was pain (=20%). The most common
systemic adverse event was myalgia (=10%).9
-
In adults 18 through 64 years of age, the most commonly reported
injection-site adverse reactions when AFLURIA® (trivalent formulation)
was administered by the PharmaJet Stratis Needle-Free Injection System
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%).9
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.10 AFLURIA is
approved for use in persons 5 years of age and older.
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.10
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 5 years as compared to
previous years.10
-
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.10
-
Appropriate medical treatment and supervision must be available to
manage possible anaphylactic reactions following administration of the
vaccine.10
-
Immunocompromised persons may have a diminished immune response to
AFLURIA.10
ADVERSE REACTIONS
-
In children 5 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%).10
-
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%) and headache, malaise (=20%).10
-
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%).10
-
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.10
Please see full prescribing information for AFLURIA here.
FLUVIRIN® (Influenza Virus Vaccine) Indication
FLUVIRIN® is an inactivated influenza virus vaccine indicated for active
immunization of persons 4 years of age and older against influenza
disease caused by influenza virus subtypes A and type B contained in the
vaccine.9 FLUVIRIN® is not indicated for children less than 4
years of age because there is evidence of diminished immune response in
this age group.11
Important Safety Information
CONTRAINDICATIONS
-
History of severe allergic reactions (e.g., anaphylaxis) to egg
proteins, or any component of FLUVIRIN, or life-threatening reactions
to previous influenza vaccinations.11
WARNINGS AND PRECAUTIONS
-
If Guillain-Barré syndrome has occurred within 6 weeks of receipt of
prior influenza vaccine, the decision to give FLUVIRIN should be based
on careful consideration of the potential benefits and risks.11
-
Immunocompromised persons may have a reduced immune response to
FLUVIRIN.11
-
The tip caps of the FLUVIRIN prefilled syringes may contain natural
rubber latex which may cause allergic reactions in latex sensitive
individuals.11
ADVERSE REACTIONS
-
The most frequently reported adverse reactions are mild
hypersensitivity reactions (such as rash), local reactions at the
injection site, and influenza-like symptoms.11
Please see full prescribing information for FLUVIRIN here.
RAPIVAB® (Peramivir Injection) Indication
RAPIVAB® (peramivir injection) is indicated for the treatment of acute
uncomplicated influenza in patients 18 years and older who have been
symptomatic for no more than 2 days.12
-
Efficacy of Rapivab was based on clinical trials in which the
predominant influenza virus type was influenza A; a limited number of
subjects infected with influenza B virus were enrolled.12
-
Influenza viruses change over time. Emergence of resistance
substitutions could decrease drug effectiveness. Other factors (for
example, changes in viral virulence) might also diminish clinical
benefit of antiviral drugs. Prescribers should consider available
information on influenza drug susceptibility patterns and treatment
effects when deciding whether to use Rapivab.12
-
Efficacy could not be established in patients with serious influenza
requiring hospitalization.12
Important Safety Information
CONTRAINDICATIONS
-
RAPIVAB is contraindicated in patients with known serious
hypersensitivity or anaphylaxis to peramivir or any component of the
product. Severe allergic reactions have included anaphylaxis, erythema
multiforme and Stevens-Johnson Syndrome.12
WARNINGS AND PRECAUTIONS
-
Rare cases of serious skin reactions, including erythema multiforme,
have been reported with RAPIVAB in clinical studies and in
postmarketing experience. Cases of anaphylaxis and Stevens-Johnson
Syndrome have been reported in postmarketing experience with RAPIVAB.
Discontinue RAPIVAB and institute appropriate treatment if anaphylaxis
or a serious skin reaction occurs or is suspected. The use of RAPIVAB
is contraindicated in patients with known serious hypersensitivity or
anaphylaxis to RAPIVAB.12
-
Patients with influenza may be at an increased risk of hallucinations,
delirium, and abnormal behavior early in their illness. There have
been postmarketing reports (from Japan) of delirium and abnormal
behavior leading to injury in patients with influenza who were
receiving neuraminidase inhibitors, including Rapivab. Because these
events were reported voluntarily during clinical practice, estimates
of frequency cannot be made, but they appear to be uncommon. These
events were reported primarily among pediatric patients. The
contribution of Rapivab to these events has not been established.
Patients with influenza should be closely monitored for signs of
abnormal behavior.12
-
Serious bacterial infections may begin with influenza-like symptoms or
may coexist with or occur as complications during the course of
influenza. Rapivab has not been shown to prevent such complications.12
ADVERSE REACTIONS
-
The most common adverse reaction was diarrhea (8% Rapivab vs 7%
placebo).12
-
Lab abnormalities (incidence = 2%) occurring more commonly with
Rapivab than placebo were elevated ALT 2.5 times the upper limit of
normal (3% vs 2%), elevated serum glucose greater than 160 mg/dL (5%
vs 3%), elevated CPK at least 6 times the upper limit of normal (4% vs
2%) and neutrophils less than 1.0 x 109/L (8% vs 6%).12
CONCURRENT USE WITH LIVE ATTENUATED INFLUENZA VACCINE
-
Antiviral drugs may inhibit viral replication of a live attenuated
influenza vaccine (LAIV). The concurrent use of Rapivab with LAIV
intranasal has not been evaluated. Because of the potential for
interference between these two products, avoid use of Rapivab within 2
weeks after or 48 hours before administration of LAIV unless medically
indicated.12
Please see full prescribing information for RAPIVAB here.
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