
influenza season, vaccine
effectiveness in the US
was reported at only 40%2
in influenza vaccine
effectiveness may contribute
to low vaccination rates,
despite prevalence and
severity of disease3
SEVERAL FACTORS IMPACT SEASONAL
INFLUENZA VACCINE EFFECTIVENESS
selection and vaccine availability,
circulating influenza virus strains
have the potential to mutate, which
can impact vaccine effectiveness.
egg-based manufacturing. In addition to
injecting the circulating seasonal strain into
the egg, a growth-inducing strain is required
to ensure the virus can grow successfully in
eggs. This process can cause mutations,
resulting in a flu virus that can be different
from the intended strain.
strain along with the WHO-selected strain, which can cause egg adaptation.5-7
CAN OCCUR








IN 7 OUT OF THE LAST 10 INFLUENZA SEASONS IN THE US, A STRAIN
MISMATCH HAS OCCURED. ALMOST HALF OF THESE WERE CAUSED BY
EGG ADAPTATION IN THE VACCINE STRAINS DURING MANUFACTURING.8-20
A CELL-BASED VACCINE FOR PREVENTION
OF SEASONAL INFLUENZA
production process to tradional egg-based
manufacturing, produces a truer match to the
WHO-selected strains.21 22
virus seeds eliminates egg-adapted changes
that can sometimes occur in the egg-based
manufacturing process.21 23
NO EGG ADAPTION


CELL-BASED VACCINE IN THE US24,25



immunization for the prevention of influenza disease caused by influenza virus
subtypes A and type B contained in the vaccine.
older. For children and adolescents 4 through 17 years, approval is based on the immune response elicited by
FLUCELVAX QUADRIVALENT. Data demonstrating a decrease in influenza disease
after vaccination of children and adolescents 4 through 17 years of age with FLUCELVAX QUADRIVALENT are not available.
postvaccination with FLUCELVAX QUADRIVALENT (Influenza Vaccine)24

a Seroconversion rate is defined as the percentage of subjects with either a prevaccination hemagglutinin inhibition (HI) titer <1:10 and postvaccination HI titer ≥1:40 or with a prevaccination HI titer ≥1:10 and a minimum 4-fold increase in postvaccination HI antibody titer. Immunogenicity success criteria were met if the lower limit of the 95% confidence interval (CI) of the percentage of subjects with HI titer ≥1:40 is ≥70% and the lower limit of the 95% CI of the percentage of subjects with seroconversion is ≥40%24
bPer protocol set: All subjects in Full Analysis Set, immunogenicity population, who have correctly received the assigned vaccine, have no major protocol deviations leading to exclusion as defined prior to unblinding/analysis and are not excluded due to other reasons defined prior to unblinding or analysis.24
cA/H1N1: 95% CI, 69-75; A/H3N2: 95% CI, 44-50; B1: 95% CI, 63-69; B2: 95% CI, 70-76.1
HI GMTd ratios for TIV1c/TIV2ce to FLUCELVAX QUADRIVALENT in adults aged 18 years and older24

dHI GMT = hemagglutination inhibition geometric mean titer.
f A/H1N1: 95% CI, 0.9-1.11; A/H3N2: 95% CI, 0.9-1.11; B1: 95% CI, 0.8-1.0; B2: 95% CI .0.9-1.0.gSeroconversion rate is defined as the percentage of subjects with either a prevaccination HI titer <1:10 and postvaccination HI titer ≥1:40 or with a prevaccination HI titer ≥1:10 and a minimum 4-fold increase in postvaccination HI antibody titer.hAnalyses were performed on Day 50.24
FLUCELVAX QUADRIVALENT (Influenza Vaccine)24
safety profile similar to comparator trivalent vaccines(TIV1c or TIV2c).24
7 days of vaccination with FLUCELVAX QUADRIVALENT24,i,j
- Injection-site tenderness (46%)
- Injection-site erythema (18%)
- Sleepiness (19%)
- Irritability (16%)
- Injection-site induration (13%)
- Change in eating habits (10%)
- Injection-site pain (54%)
- Injection-site erythema (22%)
- Injection-site induration (16%)
- Headache (14%)
- Fatigue (13%)
- Myalgia (12%)
- Injection-site pain (58%)
- Headache (22%)
- Injection-site erythema (19%)
- Fatigue (18%)
- Myalgia (16%)
- Injection-site induration (15%)
- Injection-site pain (45.4%)
- Headache (18.7%)
- Fatigue (17.8%)
- Myalgia (15.4%)
- Injection-site erythema (13.4%)
- Injection-site induration (11.6%)
- Injection-site pain (21.6%)
- Injection-site erythema (11.9%)
i,jSafety population: all subjects in the exposed population who provided postvaccination safety data. Percentage of subjects with severe adverse reactions are presented in parentheses.
- For intramuscular injection only
- Administer FLUCELVAX QUADRIVALENT as a 0.5-mL dose for people 4 and older
- FLUCELVAX QUADRIVALENT is supplied in 2 product
presentations; as a package of
ten 0.5-mL prefilled, needleless syringes and as a 5-mL multidose vial - FLUCELVAX QUADRIVALENT multidose vial and prefilled
syringe presentations are not
made with natural rubber latex - The FLUCELVAX QUADRIVALENT prefilled syringe presentation is preservative free
from light. Do not freeze. Discard if the vaccine has been frozen. Do not use after expiration date.
PATIENTS 4+ YEARS THIS SEASON. ORDER TODAY.

- Do not administer FLUCELVAX QUADRIVALENT to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine.
- Guillain-Barré Syndrome (GBS): 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.
- 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%), myalgia (15.4%), injection site erythema (13.4%), and induration (11.6%).
- 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%).
- The most common (≥10%) local and systemic reactions in children 4 to <6 years of age 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%).
- The most common (≥10%) local and systemic reactions in children 6 through 8 years of age were pain at the injection site (54%), injection site erythema (22%), injection site induration (16%), headache (14%), fatigue (13%), and myalgia (12%).
- 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%).
To report SUSPECTED ADVERSE REACTIONS, contact Seqirus at 1-855-358-8966 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.
FLUCELVAX QUADRIVALENT is a registered trademark of Seqirus UK limited or its affiliates.
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