a cell-based vaccine
for prevention of
seasonal influenza1

View CPT Text

CPT CODES

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

Reimbursed by Medicare Part B,
Vaccines for Children (VFC) program,
and most major health plans*

*This information does not constitute a guarantee or
warranty of coverage benefits or reimbursement

FLUCELVAX® QUADRIVALENT (Influenza Vaccine)
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 full US 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 type B contained in the vaccine. FLUCELVAX QUADRIVALENT is approved for use in persons 2 years of age and older.

SEASONAL INFLUENZA VACCINE EFFECTIVENESS HAS VARIED CONSIDERABLY OVER THE LAST 10 YEARS


Vaccine effectiveness in the US has ranged from as low as 19% in the 2014-2015 season to 60% in the 2010-2011 season2

Influenza Graph

In the 2019-2020 influenza season, vaccine effectiveness in the US was 39%*3

Lack of confidence in influenza vaccine effectiveness may contribute to low vaccination rates, despite prevalence and severity of disease4,5

Egg adaptation is one of several factors that may impact vaccine effectiveness

While several factors may impact vaccine effectiveness,6
2 that may play an important role include:

antigenic drift

Between the time of strain selection and vaccine availability, circulating influenza virus strains have the potential to mutate, which can impact vaccine effectiveness.7

WHO=World Health Organization

egg adaptation

Mutations can also be introduced during egg-based manufacturing. In addition to injecting the WHO-selected strains 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 an influenza virus that can be different from the intended strain.8-10

Egg-based manufacturing requires the addition of a growth-inducing strain along with the WHO-selected strain, which can cause egg adaptation.8,9

Please Swipe Left to See More >
Egg Process Chart

A strain mismatch occurred in 6 of the last 10 influenza seasons in the US (2010-2011 through 2019-2020*), half of which were caused by egg adaptation in the vaccine strains during manufacturing.9-19

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

A CELL-BASED VACCINE FOR PREVENTION OF SEASONAL INFLUENZA

Cell-based manufacturing is a different production process compared to traditional egg-based manufacturing, and may produce a truer match to the WHO-selected strains.8,20

Implementation of cell-grown virus seeds for the 4 WHO-selected strains avoids egg-adapted changes that can sometimes occur in the egg-based manufacturing process.8,20

Cell-based manufacturing may produce a truer match
to the WHO-selected strains.8,20

Please Swipe Left to See More >
Egg Process Chart

By eliminating egg adaptations, seasonal influenza
vaccine effectiveness may be improved.20,21

the first cell-based
influenza vaccine in the us
1,20

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 seasons22

FLUCELVAX® QUADRIVALENT helps prevent seasonal influenza in patients 2 years and older.1


FLUCELVAX QUADRIVALENT was proven noninferior to FLUCELVAX® (Influenza Vaccine) based on data demonstrating immunogenicity and seroconversion for patients 4 years and older.1

patient 2 years through 17  years1

Efficacy of FLUCELVAX QUADRIVALENT against culture and/or RT-PCR-confirmed influenza was demonstrated in a clinical study over 3 influenza seasons.*1

Vaccine efficacy of FLUCELVAX QUADRIVALENT in those 2 through 17 years*1

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: 45.7-62.11

PATIENTS 18 YEARS AND OLDER1

The efficacy data of FLUCELVAX are relevant to FLUCELVAX QUADRIVALENT, as both vaccines are manufactured using the same process and have overlapping compositions.1

DEMONSTRATED EFFICACY OF FLUCELVAX against
culture-confirmed influenza in those 18 through 49 years
*1

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 3). 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: 55.01

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.1

FLUCELVAX QUADRIVALENT is approved for use in persons 2 years and older.1

Safety Data

Demonstrated safety profile of cell-based FLUCELVAX QUADRIVALENT in patients 2 years and older

The safety of FLUCELVAX QUADRIVALENT was evaluated in children and adolescents in Study 2.1

Most common (≥10%) local and systemic adverse reactions observed in childreN AND ADOLESCENTS within 7 days of any dose of vaccination*1

*The solicited safety population included a total of 4509 children and adolescents 2 through 17 years of age who received FLUCELVAX QIV (N=2255) or a non-influenza comparator vaccine (N=2254). The rates of antipyretic or analgesic use for prophylaxis or treatment of high temperature or pain were as follows: 2 through 8 years of age, FLUCELVAX QUADRIVALENT 11.0%, compared with 7.7% non-influenza comparator vaccine; 9 through 18 years of age, FLUCELVAX QUADRIVALENT 6.7% compared with 7.1% non-influenza comparator vaccine.1

FLUCELVAX QUADRIVALENT has a safety profile similar to comparator trivalent vaccines (TIV1c or TIV2c) in adults 18 years and older.1

Most common (≥10%) local and systemic adverse reactions
observed in ADULTS within 7 days of vaccination
*1

*The immunogenicity and safety of FLUCELVAX QUADRIVALENT in adults 18 years and older was evaluated in Study 1, a randomized, double-blind, controlled study conducted in the US (Study 1). 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 ≥1:401

Dosing and Administration

  • For intramuscular injection only1
  • Administer FLUCELVAX QUADRIVALENT as a 0.5 mL dose for people 2 years and older*1
  • 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 vial1
  • FLUCELVAX QUADRIVALENT multi-dose vial and pre-filled syringe presentations are not made with natural rubber latex1
  • FLUCELVAX QUADRIVALENT contains no egg protein and no antibiotics1

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.1

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 type B contained in the vaccine. FLUCELVAX QUADRIVALENT is approved for use in persons 2 years 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 adults 18 through 64 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were pain (≥ 40%), erythema and induration (≥ 10%). The most common systemic adverse events were headache, fatigue and myalgia (≥ 10%).

In adults ≥ 65 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were pain (≥ 20%) and erythema (≥ 10%).

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%).

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. FLUCELVAX QUADRIVALENT. Package insert. Seqirus Inc; 2021. 2. Centers for Disease Control and Prevention. Past seasons vaccine effectiveness estimates. Accessed September 25, 2020. https://www.cdc.gov/flu/vaccines-work/past-seasons-estimates.html 3. Centers for Disease Control and Prevention. US flu VE data for 2019-2020. Accessed March 4, 2021. https://www.cdc.gov/flu/vaccines-work/2019-2020.html 4. Centers for Disease Control and Prevention. Flu vaccination coverage, United States, 2019-20 influenza season. Accessed March 4, 2021. https://www.cdc.gov/flu/fluvaxview/coverage-1920estimates.htm 5. Nowak GJ, Cacciatore MA, Len-Rios 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):711. doi:10.3390/ijerph15040711 6. Mameli C, Cocchi I, Fumagalli M, Zuccotti G. Influenza vaccination: effectiveness, indications, and limits in the pediatric population. Front Pediatr. 2019;7:317. doi:10.3389/fped.2019.00317 7. Paules CI, 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 8. Rajaram S, Boikos C, Gelone DK, Gandhi A. Influenza vaccines: the potential benefits of cell-culture isolation and manufacturing. Ther Adv Vaccines Immunother. 2020;8:2515135520908121. doi:10.1177/2515135520908121 9. 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:10.1371/journal.pone.0092153 10. 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. doi:10.1073/pnas.1712377114 11. 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. 12. 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 13. 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 14. 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 15. 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 16. 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;377(6):534-543. doi:10.1056/NEJMoa1700153 17. 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:10.15585/mmwr.mm6706a2 18. 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 19. 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. 20. Centers for Disease Control and Prevention. Cell-based flu vaccines. Accessed February 11, 2021. https://www.cdc.gov/flu/prevent/cell-based.htm 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. Data on file. Seqirus Inc; 2021.

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