Important Safety Information


SEASONAL INFLUENZA VACCINE
EFFECTIVENESS HAS VARIED CONSIDERABLY
OVER THE LAST 10 YEARS1
Vaccine effectiveness in the US has ranged from as low as 19% in the 2014-2015 season to 60% in the 2010-2011 season1
In the 2017-2018
influenza season, vaccine
effectiveness in the US
was reported at only 40%2
Lack of confidence
in influenza vaccine
effectiveness may contribute
to low vaccination rates,
despite prevalence and
severity of disease3


SEVERAL FACTORS IMPACT SEASONAL

INFLUENZA VACCINE EFFECTIVENESS


        Some of which may include:
ANTIGENIC DRIFT4
Between the time of strain
selection and vaccine availability,
circulating influenza virus strains
have the potential to mutate, which
can impact vaccine effectiveness.
EGG ADAPTATION5-7
Mutations can also be introduced during
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.


Egg-based manufacturing requires the addition of a growth-inducing
strain along with the WHO-selected strain, which can cause egg adaptation.5-7
EGG ADAPTATION
CAN OCCUR

WHO-selected strain
>
<
>
Growth-inducing strain
<
>
Manufacturing of egg-adapted virus strains
<
Egg-adapted vaccine
Who-selected strain
+
Growth-inducing strain
WHO-selected strain combined with growth-inducing strain
Manufacturing of egg-adapted virus strains
Egg-adapted vaccine

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

Cell-based manufacturing, an alternative
production process to tradional egg-based
manufacturing, produces a truer match to the
WHO-selected strains.21 22
Implementation of FDA-approved, cell-grown
virus seeds eliminates egg-adapted changes
that can sometimes occur in the egg-based
manufacturing process.21 23
CELL-BASED-
NO EGG ADAPTION
>
WHO-selected strain
WHO-selected strain
WHO-selected strain prepped in cells
Manufacturing of cell -based virus strains (truer match to WHO-selected strain)
A truer match to WHO-selected strain in cell-based vaccine
BY REMOVING EGG ADAPTATIONS FROM THE INFLUENZA VIRUS, VACCINE EFFECTIVENESS MAY BE IMPROVED23

THE FIRST AND ONLY
CELL-BASED VACCINE IN THE US24,25

Reimbursed through CPT codes
Single-Dose:90674
Multidose:90756

50+
MILLION DOSES
in the US across 3 seasons26


A CELL-BASED VACCINE
THAT HELPS PREVENT SEASONAL
INFLUENZA IN YOUR PATIENTS24
FLUCELVAX® QUADRIVALENT (Influenza Vaccine) was proven noninferior to FLUCELVAX® (Influenza Vaccine) based on data demonstrating immunogenicity and seroconversion for patients 4 years and older. 24

The efficacy data of FLUCELVAX are relevant to FLUCELVAX QUADRIVALENT, as both vaccines are manufactured using the same process and have overlapping compositions.24

Efficacy of FLUCELVAX against culture-confirmed influenza.24


Efficacy against antigenically matched culture-confirmed influenza strains
Efficacy against all culture-confirmed influenza strains

In a multinational, randomized, observer-blind, placebo-controlled trial, the clinical efficacy and safety of FLUCELVAX were assessed during the 2007-2008 influenza season in adults aged 18 through 49 years. 11,404 subjects were enrolled to receive FLUCELVAX (N=3828), AGRIFLU (N=3676), or placebo (N=3900) in a 1:1:1 ratio.24
FIRST-OF-ITS-KIND MANUFACTURING CAPABILITIES
FLUCELVAX QUADRIVALENT is manufactured in Holly Springs, NC, in partnership with the US government (US Biomedical Advanced Research and Development Authority)24 25
Review FLUCELVAX QUADRIVALENT information here.
About FLUCELVAX QUADRIVALENT
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.

FLUCELVAX is approved for use in persons 4 years of age and
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.
Immunogenicity Data
Demonstrated immunogenicity in children and adults24

Percentage of children and adolescents aged 4 through 17 years with seroconversiona-c
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.
e The comparator vaccines for noninferiority comparisons were 2 formulations of FLUCELVAX® (influenza vaccine), each containing a different influenza B strain. TIV1c contained A/H1N1, A/H3N2, and B1 and TIV2c contained A/H1N1, A/H3N2, and B2.24
The immunogenicity of FLUCELVAX QUADRIVALENT was evaluated in 2 randomized, double-blind, controlled studies conducted in the United States in adults 18 years and older (Study 1) and children 4 through 17 years of age (Study 2).24 In Study 1, subjects received FLUCELVAX QUADRAVALENT or 1 of the 2 formulations of comparator trivalent influenza vaccine (FLUCELVAX QUADRIVALENT [N = 1334], TIV1c [N = 669]), or TIV2c [N=669]).24 In Study 2, 1159 subjects received FLUCELVAX QUADRIVALENT. The immune response to each of the vaccines was assessed 21 days after vaccination.24,f
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
Safety Data
Demonstrated safety of cell-based
FLUCELVAX QUADRIVALENT (Influenza Vaccine)24

Approved for use in person 4 years and older, FLUCELVAX QUADRIVALENT has a proven
safety profile similar to comparator trivalent vaccines(TIV1c or TIV2c).24
Most common (≥10%) local and systemic adverse reactions observed within
7 days of vaccination with FLUCELVAX QUADRIVALENT24,i,j

CHILDREN 4 TO 5 YEARS
  • Injection-site tenderness (46%)
  • Injection-site erythema (18%)
  • Sleepiness (19%)
  • Irritability (16%)
  • Injection-site induration (13%)
  • Change in eating habits (10%)
CHILDREN 6 TO 8 YEARS
  • Injection-site pain (54%)
  • Injection-site erythema (22%)
  • Injection-site induration (16%)
  • Headache (14%)
  • Fatigue (13%)
  • Myalgia (12%)
CHILDREN 9 TO 17 YEARS
  • Injection-site pain (58%)
  • Headache (22%)
  • Injection-site erythema (19%)
  • Fatigue (18%)
  • Myalgia (16%)
  • Injection-site induration (15%)
ADULTS 18 to 64 YEARS
  • Injection-site pain (45.4%)
  • Headache (18.7%)
  • Fatigue (17.8%)
  • Myalgia (15.4%)
  • Injection-site erythema (13.4%)
  • Injection-site induration (11.6%)
ADULTS 65 AND OLDER
  • 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.
Dosing and Administration
  • 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
Storage and Handling
Store FLUCELVAX QUADRIVALENT refrigerated at 2°C to 8°C (36°F to 46°F). Protect
from light. Do not freeze. Discard if the vaccine has been frozen. Do not use after expiration date.
OFFER A CELL-BASED INFLUENZA VACCINE FOR
PATIENTS 4+ YEARS THIS SEASON. ORDER TODAY.



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