Flucelvax Pre-Book | Seqirus US

CELL-BASED VACCINE

FOR PREVENTION OF

SEASONAL INFLUENZA

Important Safety Information

See Prescribing 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 ADAPTATION^5-7

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 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 US^24,25

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 seroconversion^a-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 GMT^d ratios for TIV1c/TIV2c^e 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 QUADRIVALENT^24,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.

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References: 1. Centers for Disease Control and Prevention. CDC seasonal flu vaccine effectiveness studies. https://www.cdc.gov/flu/professionals/vaccination/effectiveness-studies.htm. Updated September 25, 2018. Accessed June 17, 2019. 2. Centers for Disease Control and Prevention. Summary of the 2017-2018 Influenza Season. https://www.cdc.gov/flu/about/season/flu-season-2017-2018.htm. Accessed September 17, 2019. 3. Nowak GJ, Cacciatore MA, Len-Ríos ME. Understanding and increasing influenza vaccination acceptance: insights from a 2016 national survey of U.S. adults. Int J Environ Res Public Health. 2018:15(4). 4. Boni MF. Vaccination and antigenic drift in influenza. Vaccine. 2008:26(Suppl 3):C8-C14. 5. Paules, CI, Sullivan SG, Subbarao K, Fauci AS. Chasing seasonal influenza—the need for a universal influenza vaccine. N Engl J Med. 2018:378:7-9. 6. Centers for Disease Control and Prevention. Making a candidate vaccine virus (CVV) for a HPAI (bird flu) virus. https://www.cdc.gov/flu/avianflu/candidate-vaccine-virus.htm. Accessed September 17, 2019. 7. Skowronski DM, Janjua NZ, De Serres G, et al. Low 2012-13 influenza vaccine effectiveness associated with mutation in the egg-adapted H3N2 vaccine strain not antigenic drift in circulating viruses. PLoS One. 2014:9(3):e92153. 8. Zost SJ, Parkhouse K, Gumina ME, et al. Contemporary H3N2 influenza viruses have a glycosylation site that alters binding of antibodies elicited by egg-adapted vaccine strains. Proc Natl Acad Sci USA. 2017:114(47):12578-12583. 9. Schnirring L. WHO changes 2 strains for 2018-19 flu vaccine. Centers for Infectious Disease Research and Policy News. http://www.cidrap.umn.edu/news-perspective/2018/02/who-changes-2-strains-2018-19-fl u-vaccine. Accessed September 17, 2019. 10. Xie H, Wan XF, Ye Z, et al. H3N2 Mismatch of 2014-15 Northern Hemisphere influenza vaccines and head-to-head comparison between human and ferret antisera derived antigenic maps. Sci Rep. 2015:5:15279. 11. Chambers BS, Parkhouse K, Ross TM, Alby K, Hensley SE. Identification of hemagglutinin residues responsible for H3N2 antigenic drift during the 2014-2015 influenza season. Cell Rep. 2015:12(1):1-6. 112. Cobey S, Gouma S, Parkhouse K, et al. Poor immunogenicity, not vaccine strain egg adaptation, may explain the low H3N2 influenza vaccine effectiveness in 2012-2013. Clin Infect Dis. 2018:67(3):327-333. 13. Ohmit SE, Thompson MG, Petrie JG, et al. Influenza vaccine effectiveness in the 2011-2012 season: protection against each circulating virus and the effect of prior vaccination on estimates. Clin Infect Dis. 2014:58(3):319-327. 14. Davlin SL, Blanton L, Kniss K, et al. Influenza activity—United States, 2015-16 season and composition of the 2016-17 influenza vaccine. MMWR Morb Mortal Wkly Rep. 2016:65(22):567-575. 15. Epperson S, Blanton L, Kniss K, et al. Influenza activity—United States, 2013-14 season and composition of the 2014-15 influenza vaccines. MMWR Morb Mortal Wkly Rep. 2014:63(22):483-490. 16. Centers for Disease Control and Prevention. Influenza activity—United States, 2012-13 season and composition of the 2013-14 influenza vaccine. MMWR Morb Mortal Wkly Rep. 2013:62(23):473-479. 17. Centers for Disease Control and Prevention. Update: influenza activity—United States, 2011-12 season and composition of the 2012-13 influenza vaccine. MMWR Morb Mortal Wkly Rep. 2012:61(22):414-420. 18. Centers for Disease Control and Prevention. Update: influenza activity—United States, 2010-11 season, and composition of the 2011-12 influenza vaccine. MMWR Morb Mortal Wkly Rep. 2011:60(21):705-712. 19. Centers for Disease Control and Prevention. Update: influenza activity—United States, 2009-10 season. MMWR Morb Mortal Wkly Rep. 2010:59(29):901-908. 20. Centers for Disease Control and Prevention. Update: influenza activity—United States, September 28, 2008-April 4, 2009, and composition of the 2009-10 influenza vaccine. MMWR Morb Mortal Wkly Rep. 2009:58(14):369-374. 21. Mabrouk T, Ellis RW. Influenza vaccine technologies and the use of the cell-culture process (cell-culture influenza vaccine). Dev Biol. 2002:110:125-134. 22. Wu NC, Zost SJ, Thompson AJ, et al. A structural explanation for the low effectiveness of the seasonal influenza H3N2 vaccine. PLoS Pathog. 2017:13(10):e1006682. 23. Centers for Disease Control and Prevention. Cell-based flu vaccines. https://www.cdc.gov/flu/protect/vaccine/cell-based.htm. Accessed September 17, 2019. 24. FLUCELVAX QUADRIVALENT [package insert]. Holly Springs, NC: Seqirus Inc: 2019. 25. US Department of Health and Human Services. First U.S. cell-based flu vaccine plant set for dedication facility’s ability to produce cell-based pandemic flu vaccine marks historic change. https://www.phe.gov/Preparedness/news/Pages/cellflu-111212.aspx. Accessed September 17, 2019. 26. Seqirus Inc. Data on file. 2019.

IMPORTANT RESOURCES & LINKS

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IMPORTANT SAFETY INFORMATION

Indication and Usage for FLUCELVAX^® QUADRIVALENT (Influenza Vaccine)
FLUCELVAX QUADRIVALENT is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. FLUCELVAX QUADRIVALENT is approved for use in persons 4 years of age and older.

Contraindications

Do not administer FLUCELVAX QUADRIVALENT to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine.

Warnings & Precautions

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.

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%), 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.

Please see US Full Prescribing Information for FLUCELVAX QUADRIVALENT.

FLUCELVAX QUADRIVALENT is a registered trademark of Seqirus UK limited or its affiliates.

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