A CELL-BASED FLU VACCINE
DESIGNED TO PRODUCE
AN EXACT MATCH TO THE
WHO-SELECTED STRAINS1-3

View CPT Text

CPT CODES

REIMBURSED THROUGH CPT CODES:
90674 - SINGLE-DOSE SYRINGE
90756 - MULTI-DOSE VIAL
CPT=Current Procedural Terminology

Available through Vaccines for Children
(VFC) and reimbursed by medicare
Part B and most major health plans*

*This information does not constitute a guarantee or
warranty of coverage benefits or reimbursement.
Confirm availability with your state's VFC program.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS

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

See Prescribing Information


INDICATION AND USAGE


FLUCELVAX QUADRIVALENT is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and types B contained in the vaccine. FLUCELVAX QUADRIVALENT is approved for use in persons 6 months of age and older.

RECENT SEASONAL INFLUENZA VACCINE EFFECTIVENESS HAS VARIED CONSIDERABLY


For US influenza seasons 2010-2011 through 2019-2020, vaccine effectiveness has ranged from as low as 19% in the 2014-2015 season to 60% in the 2010-2011 season.5

Influenza Graph

THERE ARE SEVERAL FACTORS THAT IMPACT VACCINE EFFECTIVENESS

One of them is strain mismatch, when circulating influenza strains do not
match the WHO-selected strains contained in the vaccine, often due to
antigenic drift or egg adaptation. Another factor can be characteristics
of the vaccine recipient, such as health status and age.1,6-8

antigenic drift

After vaccine strain selection, circulating influenza virus strains have the potential to mutate, which can impact vaccine effectiveness.6

egg adaptation

Mutations are also introduced during egg-based influenza vaccine production. In order for human viruses to grow well in eggs, the hemagglutinin (HA) surface protein must adapt to bind to avian receptors.1,7,8

CELL-BASED INFLUENZA VACCINES AVOID EGG ADAPTATION

Egg adaptation occurs when the HA in the vaccine strain selected by the WHO adapts to bind to avian receptors in order to grow in eggs. These changes may result in strain mismatch.1

A strain mismatch occurred in 6 of the 10 influenza seasons between 2010-2011 and 2019-2020* in the US; half of them were caused by egg adaptation in the vaccine strains during vaccine production.7-17

Cell-based influenza vaccines are designed to produce
an exact match to the WHO-selected strains.1-3




*Preliminary end of season estimates for the 2019-2020 influenza season by the Centers for Disease Control and Prevention.

A CELL-BASED FLU VACCINE DESIGNED
TO PRODUCE AN EXACT MATCH TO THE WHO-SELECTED STRAINS
1-3

Approved For Patients 2+ Years

reimbursed through cpt codes:

90674 - SINGLE-DOSE SYRINGE

90756 - MULTI-DOSE VIAL

100+ million

estimated doses
distributed across

5 US influenza seasons18

A CELL-BASED VACCINE CAN HELP PREVENT INFLUENZA IN YOUR PATIENTS


Children and adolescents 6 months through 17 years of age

FLUCELVAX® QUADRIVALENT (Influenza Vaccine) was proven noninferior to a US-licensed comparator quadrivalent influenza vaccine for patients 6 months through 3 years (Study 1) and noninferior to FLUCELVAX® (Influenza Vaccine) for patients 4 through 17 years (Study 5) based on data demonstrating immunogenicity and seroconversion4


Efficacy of FLUCELVAX QUADRIVALENT against culture and/or RT-PCR-confirmed influenza was demonstrated in a clinical study over 3 influenza seasons (Study 2).*4

Vaccine efficacy of FLUCELVAX QUADRIVALENT
in those 2 through 17 years
*4

efficacy against
first occurrence
antigenically matched
culture-confirmed
influenza*

efficacy against
first occurrence
all culture-confirmed
influenza*

efficacy against
first occurrence
RT-PCR or
culture-confirmed
influenza*

* Absolute efficacy of FLUCELVAX QUADRIVALENT was evaluated in Study 2, a multinational, randomized, observer-blind, non-influenza vaccine comparator-controlled study during the following 3 influenza seasons: Southern Hemisphere 2017, Northern Hemisphere 2017-2018, and Northern Hemisphere 2018-2019. A total of 4513 children and adolescents 2 through 17 years received FLUCELVAX QUADRIVALENT (N=2258) or a non-influenza (meningococcal [Groups A, C, Y, and W-135] oligosaccharide diphtheria CRM197 conjugate) comparator vaccine (N=2255). Children 2 through 8 years of age received either 1 or 2 doses (separated by 4 weeks) of FLUCELVAX QUADRIVALENT or comparator vaccine depending on the subject’s prior influenza vaccination history. Children in the 2-dose comparator group received non-influenza comparator as the first dose and saline placebo as the second dose. Children and adolescents 9 through 17 years of age received a single dose of FLUCELVAX QUADRIVALENT or non-influenza comparator vaccine. The full analysis set (FAS) for efficacy consisted of 4509 children and adolescents. FLUCELVAX QUADRIVALENT met the pre-defined success criterion defined as the lower limit of the 2-sided 95% CI of absolute vaccine efficacy greater than 20%. Antigenically matched, culture-confirmed influenza 95% CI: 53.6-71.5; culture-confirmed influenza 95% CI: 51.3-68.5; RT-PCR or culture-confirmed influenza 95% CI: 45.7-62.14

Adults 18 years and older


FLUCELVAX QUADRIVALENT® (Influenza Vaccine) was proven noninferior to FLUCELVAX in adults 18 years and older (Study 3) based on data demonstrating immunogenicity and seroconversion4


The efficacy data of FLUCELVAX are relevant to FLUCELVAX QUADRIVALENT, as both vaccines are manufactured using the same process and have overlapping compositions.4

DEMONSTRATED EFFICACY OF FLUCELVAX against
culture-confirmed influenza in those 18 through 49 years
*4

efficacy against
antigenically matched
culture-confirmed
influenza*

efficacy against
all culture-confirmed
influenza*

* A multinational, randomized, observer-blind, placebo-controlled trial was performed to assess clinical efficacy and safety of FLUCELVAX during the 2007-2008 influenza season in adults aged 18 through 49 years (Study 4). A total of 11,404 adults were enrolled to receive FLUCELVAX (N=3828), AGRIFLU (N=3676), or placebo (N=3900) in a 1:1:1 ratio. FLUCELVAX met the pre-defined success criterion defined as the lower limit of the 1-sided 97.5% CI for the estimate of the vaccine efficacy relative to placebo >40%. Antigenically matched influenza lower limit of the 1-sided 97.5% CI: 61.0; all culture-confirmed influenza lower limit of the 1-sided 97.5% CI: 55.04

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 types B contained in the vaccine.4

FLUCELVAX QUADRIVALENT is approved for use in persons 6 months and older.4

Safety Data

Demonstrated safety profile in children and adolescents 6 months through 17 years

The safety of FLUCELVAX QUADRIVALENT was evaluated in children and adolescents in two clinical studies, Studies 1 and 2.4

Most common (≥10%) local and systemic adverse reactions observed in childreN AND ADOLESCENTS within 7 days of any dose of vaccination*†4

*Study 1 was a randomized, observer-blind, multicenter study in children 6 months through 3 years of age. The solicited safety population consisted of 2348 subjects who received FLUCELVAX QUADRIVALENT (N=1564) or a US-licensed quadrivalent influenza vaccine comparator (N=784).4
†Study 2 was a multiseason, multinational, randomized, observer-blind study in children 2 through 17 years of age. The solicited safety population included a total of 4509 children and adolescents 2 through 17 years of age who received FLUCELVAX QUADRIVALENT (N=2255) or a non-influenza comparator vaccine (N=2254).4

Demonstrated safety profile in adults 18+ years

FLUCELVAX QUADRIVALENT has a demonstrated safety profile similar to comparator trivalent influenza vaccines (TIV1c or TIV2c).4

Most common (≥10%) local and systemic adverse reactions
observed in ADULTS within 7 days of vaccination
*4

*The immunogenicity and safety of FLUCELVAX QUADRIVALENT in adults 18 years and older was evaluated in Study 3, a randomized, double-blind, controlled study conducted in the US. In this study, adults received FLUCELVAX QUADRIVALENT or 1 of 2 FLUCELVAX trivalent formulations (FLUCELVAX QUADRIVALENT, N=1334, TIV1c, N=677, or TIV2c, N=669). The safety population included a total of 2680 adults 18 years of age and older; 1340 adults 18 through 64 years of age; and 1340 adults 65 years of age and older. The immunogenicity endpoints were the percentage of adults who achieved seroconversion and the percentage of adults with a postvaccination HI titer ≥1:404

Dosing and Administration

  • For intramuscular injection only4
  • Administer FLUCELVAX QUADRIVALENT as a 0.5-mL dose for people 6 months and older*4
  • FLUCELVAX QUADRIVALENT is supplied in 2 product presentations: as a package of ten 0.5-mL pre-filled, needleless syringes and as a 5-mL multi-dose vial4
  • FLUCELVAX QUADRIVALENT multi-dose vial and pre-filled syringe presentations are not made with natural rubber latex4
  • FLUCELVAX QUADRIVALENT is free of eggs and antibiotics4

Whether children 6 months through 8 years receive 1 or 2 doses depends on vaccination history as per Advisory Committee on Immunization Practices annual recommendations on prevention and control of influenza with vaccines.

Storage and Handling

Store FLUCELVAX QUADRIVALENT refrigerated at 2 ºC to 8 ºC (36 ºF to 46 ºF). Protect from light. Do not freeze. Discard if the vaccine has been frozen. Do not use after expiration date.4

FLUCELVAX® QUADRIVALENT (Influenza Vaccine)
IMPORTANT SAFETY INFORMATION

INDICATION AND USAGE

FLUCELVAX QUADRIVALENT is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and types B contained in the vaccine. FLUCELVAX QUADRIVALENT is approved for use in persons 6 months of age and older.

CONTRAINDICATIONS

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

WARNINGS AND PRECAUTIONS

If Guillain-Barré syndrome 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.

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.

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.

After vaccination with FLUCELVAX QUADRIVALENT, immunocompromised individuals, including those receiving immunosuppressive therapy, may have a reduced immune response.

Vaccination with FLUCELVAX QUADRIVALENT may not protect all vaccine recipients against influenza disease.

ADVERSE REACTIONS

In children 6 months through 3 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were tenderness (27.9%), erythema (25.8%), induration (17.3%) and ecchymosis (10.7%). The most common systemic adverse reactions were irritability (27.9%), sleepiness (26.9%), diarrhea (17.9%) and change of eating habits (17.4%).

In children 2 through 8 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were tenderness (28.7%), pain (27.9%) and erythema (21.3%), induration (14.9%) and ecchymosis (10.0%). The most common systemic adverse events were sleepiness (14.9%), headache (13.8%), fatigue (13.8%), irritability (13.8%) and loss of appetite (10.6%).

In children and adolescents 9 through 17 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were injection site pain (21.7%), erythema (17.2%) and induration (10.5%). The most common systemic adverse events were headache (18.1%) and fatigue (17.0%).

In adults 18 through 64 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were pain (45.4%), erythema (13.4%) and induration (11.6%). The most common systemic adverse reactions were headache (18.7%), fatigue (17.8%) and myalgia (15.4%).

In adults ≥65 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were pain (21.6%) and erythema (11.9%).

To report SUSPECTED ADVERSE REACTIONS, contact Seqirus at 1-855-358-8966 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

Before administration, please see the full US Prescribing Information for FLUCELVAX QUADRIVALENT.

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

REFERENCES: 1. Rajaram S, Boikos C, Gelone DK, Gandhi A. Influenza vaccines: the potential benefits Of cell-culture isolation and manufacturing. Ther Adv vaccines Immunother. 2020;8:2515I35520908121 doi:101177/2515135520908121 2. Centers for Disease Control and Prevention. Cell-based flu vaccines, Accessed August 3, 2021, https://wwwcdc.gov/flu/prevent/cell-based.htm 3. 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. 4. FLUCELVAX QUADRIVALENT. package insert. Seqirus Inc;2021. 5. Centers for Disease Control and Prevention, Past seasons vaccine effectiveness estimates. Accessed September 24, 2021. https://www.cdc.gov/flu/vaccines-work/past-seasons-estimates.htm1 6. Paules Cl, Sullivan SG, Subbarao K, Fauci AS. Chasing seasonal influenza-the need for a universal influenza vaccine. N Engl J Med. 2018;378(1):7-9. doi:10.1056/NEJMp1714916 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. doi:101371/journal.pone.0092153 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-adopted vaccine strains. Proc Natl Acad Sci USA. 2017:114(47)12578-12583. doi:10.1073/pnas1712377114 9. Centers for 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 10. 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. doi:10.1093/cid/cit736 11. McLean HQ, Thompson MG, Sundaram ME, et al. Influenza vaccine effectiveness in the United States during 2012-2013: variable protection by age and virus type. J Infect Dis. 2015:211(10):1529-1540. doi:10.1093/infdis/jiu647 12. Gaglani M, Pruszynski J, Murthy K, et al Influenza vaccine effectiveness against 2009 pandemic influenza A(H1N1) virus differed by vaccine type during 2013-2014 in the United States. J Infect Dis. 2016:213(10): 1546-1556 doi:10.1093/infdis/jiv577 13 Zimmerman RK, Nowalk MP, Chung J, et al. 2014-2015 influenza vaccine effectiveness in the United States by vaccine type. Clin Infect Dis. 2016:63(12)1564-1573, doi:10.1093/cid/ciw635 14 Jackson ML, Chung JR, Jackson LA, et al. Influenza vaccine effectiveness in the United States during the 2015-2016 season. N Engl J Med. 2017:337(6)534-543 doi:0.1056/NEJMaa1700153 15.Flannery B, Chung JR, Belongia EA, et al. Interim estimates of 2017-18 seasonal influenza vaccine effectiveness - United States, February 2018. MMWR Morb Mortal Wkly Rep. 2018:67(6):180-185, doi:1015585/mmwr.mm6706a2 16. Flannery B, Kondor RJG, Chung JR, et al. Spread of antigenically drifted influenza A(H3N2) viruses and vaccine effectiveness in the United States during the 2018-2019 season. J Infect Dis. 2020:221(1)8-15. doi:10:1093/infdis/Jiz543 17. Dawood FS, Chung JR. Kim SS. et al Interim estimates of 2019-20 seasonal influenza vaccine effectiveness - United States, February 2020. MMWR Morb Mortal Wkly Rep. 2020:69(7):177-182 18. Data on file. Seqirus Inc: 2021.

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