Reductions in flu and its complications*
Strain mismatch can impact vaccine effectiveness, representing a significant challenge for already vulnerable patients 65+.13,14 FLUAD QUADRIVALENT is designed to strengthen, broaden, and lengthen the immune response to address strain mismatch + weakened immune systems.15-17
See FLUAD results during flu seasons impacted by antigenic mismatch, defined as antigenic drift or strain selection mismatch.
The RWE studies for FLUAD are relevant to FLUAD QUADRIVALENT because both products are manufactured using the same process and have overlapping compositions.18
7%
fewer influenza-related medical encounters1
(rVE 6.9%; 95% CI 3.1, 10.6)
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1 SEASON MISMATCHED (2018-2019)
STUDY DESIGN:
Retrospective cohort study of over 4.8 million adults ≥65 years from the US
KEY LIMITATIONS:
  • Results were not adjusted by unmeasurable confounders
  • Lack of laboratory confirmation
7%
fewer influenza-related office visits2
(rVE 6.6%; 95% CI 2.7, 10.3)
2%
fewer influenza-related hospitalizations and ER visits2
(rVE 2%; 95% CI -3.7, 7.3)
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1 SEASON MISMATCHED (2018-2019)
STUDY DESIGN:
Retrospective cohort study of over 2.2 million ≥65 years from the US
KEY LIMITATIONS:
  • Results were not adjusted by unmeasurable confounders
  • Lack of laboratory confirmation
3%
fewer influenza-related hospitalization encounters3
(rVE 3%; 95% CI 0, 6.1)
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1 SEASON MISMATCHED (2018-2019)
STUDY DESIGN:
Retrospective cohort study of over 10 million adults ≥65 years from the US
KEY LIMITATIONS:
  • Potential for residual confounding
  • Lack of laboratory confirmation
2%
fewer influenza-related hospitalization encounters4
(rVE 1.6%; 95% CI -1.6, 4.8)
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1 SEASON MISMATCHED (2019-2020)
STUDY DESIGN:
Retrospective cohort study of over 9.7 million adults ≥65 years from the US
KEY LIMITATIONS:
  • Potential for residual confounding
  • Lack of laboratory confirmation
Single-season studies:
63%
fewer laboratory-confirmed influenza illnesses7
(rVE 63%; 95% CI 4-86)
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1 SEASON MISMATCHED (2011-2012)
STUDY DESIGN:
Prospective, community-based, case-control study of 227 adults ≥65 years from Canada
KEY LIMITATIONS:
  • Small study population
  • Low numbers prevented the evaluation of hospitalizations
28%
fewer influenza-related medical encounters1
(rVE 27.8%; 95% CI 25.7-29.9)
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1 SEASON MISMATCHED (2018-2019)
STUDY DESIGN:
Retrospective cohort study of over 1.9 million adults ≥65 years from the US
KEY LIMITATIONS:
  • Results were not adjusted by unmeasurable confounders
  • Lack of laboratory confirmation
8%
fewer influenza hospitalization encounters3
(rVE 7.7%; 95% CI 3.9-11.14)
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1 SEASON MISMATCHED (2018-2019)
STUDY DESIGN:
Retrospective cohort study of over 3.5 million adults ≥65 years from the US
KEY LIMITATIONS:
  • Potential for residual confounding
  • Lack of laboratory confirmation
8%
fewer influenza hospitalization encounters4
(rVE 8.2%; 95% CI 4.2-12)
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1 SEASON MISMATCHED (2019-2020)
STUDY DESIGN:
Retrospective cohort study of over 4.1 million adults ≥65 years from the US
KEY LIMITATIONS:
  • Potential for residual confounding
  • Lack of laboratory confirmation
Results shown from studies that span multiple flu seasons reflect the aggregate results of antigenically mismatched and matched seasons.
39%
fewer hospitalizations for pneumonia and cerebrovascular and/or cardiovascular events5
(rVE 39%; 95% CI 4-61)
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15 SEASONS, 8 MISMATCHED (2001-2002 through 2016-2017)
STUDY DESIGN:
Retrospective, case-controlled study of 43,000 vaccine-naive adults ≥65 years from Italy
KEY LIMITATIONS:
  • Underutilization of laboratory influenza diagnostics
  • Lower frequency of events
25%
fewer influenza or pneumonia-related hospitalizations6
(rVE 25%; 95% CI 2-43)
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3 SEASONS, 1 MISMATCHED (2006-2007 through 2008-2009)
STUDY DESIGN:
Prospective, observational, population-based cohort study of 107,661 adults ≥65 years from Italy
KEY LIMITATIONS:
  • Underestimated rVE as FLUAD subjects were more frail
  • Results did not account for all the residual confounding
33%
fewer hospitalizations for pneumonia8
(rVE 33%; 95% CI 25-41)
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6 SEASONS, 2 MISMATCHED (2011-2012 through 2016-2017)
STUDY DESIGN:
Retrospective cohort study of over 479,397 adults ≥65 years from Italy
KEY LIMITATIONS:
  • Lack of unvaccinated control group
  • Lack of laboratory confirmation
*The outcomes reported in these publications contain information not included in the Prescribing Information. The data being shown are based on peer-reviewed RWE studies during seasons where antigenic mismatch occurred. If the rVE was estimated across multiple seasons, it is included if 1 or more of those seasons were antigenically mismatched. This is not inclusive of all peer-reviewed RWE studies, which include data from additional seasons. CI=confidence interval; ER=emergency room; rVE=relative vaccine effectiveness.
Learn about the clinically meaningful outcomes evaluated in adults 65+ across 20+ influenza seasons.1-12
Download Full RWE Data Download
Look to both clinical trial and RWE data when choosing an influenza vaccine
Influenza varies year to year, so it's important to continuously assess vaccine effectiveness.19-21
Randomized clinical trials (RCTs) provide an important basis for evaluating flu vaccines, but the data are limited to a snapshot in time. RWE provides a complementary approach to assess vaccine effectiveness by offering:
  • Ever-growing data
  • Large, diverse patient populations outside clinical trials
ACIP conducted a rigorous analysis of both RCT and RWE data prior to preferentially recommending FLUAD QUADRIVALENT for patients 65+22
Download Summary of ACIP DecisionDownload
Choose FLUAD QUADRIVALENT for your eligible patients 65+ years18
  • Covered by Medicare Part B and by most Medicare Advantage Plans with no copay*
  • CPT reimbursement code
    • Single-dose syringe: 90694
ORDER NOWNext screen
*This information does not constitute a guarantee or warranty of coverage benefits or reimbursement.

INDICATION AND IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Do not administer FLUAD QUADRIVALENT or AFLURIA QUADRIVALENT to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine, including egg protein, or to a previous influenza vaccine.

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 (GBS) has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give FLUAD QUADRIVALENT, FLUCELVAX QUADRIVALENT, or AFLURIA 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) may occur in association with administration of injectable vaccines. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Ensure procedures are in place to avoid falling injury and to restore cerebral perfusion following syncope by maintaining a supine or Trendelenburg position.

The immune response to FLUAD QUADRIVALENT, FLUCELVAX QUADRIVALENT, or AFLURIA QUADRIVALENT in immunocompromised persons, including individuals receiving immunosuppressive therapy, may be lower than in immunocompetent individuals.

Vaccination with FLUAD QUADRIVALENT, FLUCELVAX QUADRIVALENT, or AFLURIA QUADRIVALENT may not protect all vaccine recipients against influenza disease.

ADVERSE REACTIONS

FLUAD QUADRIVALENT:

The most common (≥ 10%) local and systemic reactions with FLUAD QUADRIVALENT in elderly subjects 65 years of age and older were injection site pain (16.3%), headache (10.8%) and fatigue (10.5%). Other adverse events may occur.

FLUCELVAX QUADRIVALENT:

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 reactions 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 reactions 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%).

Other adverse events may occur.

AFLURIA QUADRIVALENT:

AFLURIA QUADRIVALENT administered by needle and syringe:

In children 6 months through 35 months of age, the most frequently reported injection site reactions in the clinical study with AFLURIA QUADRIVALENT administered by needle and syringe were pain and redness (≥ 20%). The most common systemic adverse events were irritability (≥ 30%), diarrhea and loss of appetite (≥ 20%).

In children 36 through 59 months of age, the most commonly reported injection site reactions in the clinical study with AFLURIA QUADRIVALENT administered by needle and syringe were pain (≥ 30%) and redness (≥ 20%). The most commonly reported systemic adverse events were malaise and fatigue, and diarrhea (≥ 10%).

In children 5 through 8 years, the most commonly reported injection-site adverse reactions when AFLURIA QUADRIVALENT was administered by needle and syringe were pain (≥ 50%), redness and swelling (≥ 10%). The most common systemic adverse event was headache (≥ 10%).

In children 9 through 17 years, the most commonly reported injection-site adverse reactions when AFLURIA QUADRIVALENT was administered by needle and syringe were pain (≥ 50%), redness and swelling (≥ 10%). The most common systemic adverse events were headache, myalgia, and malaise and fatigue (≥ 10%).

In adults 18 through 64 years of age, the most commonly reported injection-site adverse reaction observed in clinical studies with AFLURIA QUADRIVALENT administered by needle and syringe was pain (≥ 40%). The most common systemic adverse events observed were myalgia and headache (≥ 20%).

In adults 65 years of age and older, the most commonly reported injection-site adverse reaction observed in clinical studies with AFLURIA QUADRIVALENT administered by needle and syringe was pain (≥ 20%). The most common systemic adverse event observed was myalgia (≥ 10%).

AFLURIA (trivalent formulation) administered by PharmaJet Stratis Needle-Free Injection System:

The safety experience with AFLURIA (trivalent formulation) is relevant to AFLURIA QUADRIVALENT because both vaccines are manufactured using the same process and have overlapping compositions.

In adults 18 through 64 years of age, the most commonly reported injection-site adverse reactions observed in a clinical study with AFLURIA (trivalent formulation) using the PharmaJet Stratis Needle-Free Injection System were tenderness (≥ 80%), swelling, pain, redness (≥ 60%), itching (≥ 20%) and bruising (≥ 10%). The most common systemic adverse events were myalgia, malaise (≥ 30%) and headache (≥ 20%).

Other adverse events may occur.

To report SUSPECTED ADVERSE REACTIONS, contact CSL 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 FLUAD QUADRIVALENT, FLUCELVAX QUADRIVALENT and AFLURIA QUADRIVALENT.

FLUAD® QUADRIVALENT, FLUCELVAX® QUADRIVALENT, AFLURIA® and AFLURIA® QUADRIVALENT are registered trademarks of Seqirus UK Limited or its affiliates.

PharmaJet® and STRATIS® are registered trademarks of PharmaJet.

References: 1. Boikos C, Fischer L, O’Brien D, Vasey J, Sylvester GC, Mansi JA. Relative effectiveness of adjuvanted trivalent inactivated influenza vaccine versus egg-derived quadrivalent inactivated influenza vaccines and high-dose trivalent influenza vaccine in preventing influenza-related medical encounters in US adults ≥ 65 years during the 2017-2018 and 2018-2019 influenza seasons. Clin Infect Dis. 2021;73(5):816-823. doi:10.1093/cid/ciab152 2. Pelton SI, Divino V, Postma MJ, et al. A retrospective cohort study assessing relative effectiveness of adjuvanted versus high-dose trivalent influenza vaccines among older adults in the United States during the 2018-19 influenza season. Vaccine. 2021;39(17):2396-2407. doi:10.1016/j.vaccine.2021.03.054 3. Izurieta HS, Chillarige Y, Kelman J, et al. Relative effectiveness of influenza vaccines among the United States elderly, 2018-2019. J Infect Dis. 2020;222(2):278-287. doi:10.1093/infdis/jiaa080 4. Izurieta HS, Lu M, Kelman J, et al. Comparative effectiveness of influenza vaccines among US Medicare beneficiaries ages 65 years and older during the 2019-2020 season. Clin Infect Dis. 2021;73(11):e4251-e4259. doi:10.1093/cid/ciaa1727 5. Lapi F, Marconi E, Simonetti M, et al. Adjuvanted versus nonadjuvanted influenza vaccines and risk of hospitalizations for pneumonia and cerebro/cardiovascular events in the elderly. Expert Rev Vaccines. 2019;18(6):663-670. doi:10.1080/14760584.2019.1622418 6. Mannino S, Villa M, Apolone G, et al. Effectiveness of adjuvanted influenza vaccination in elderly subjects in northern Italy. Am J Epidemiol. 2012;176(6):527-533. doi:10.1093/aje/kws313 7. Van Buynder PG, Konrad S, Van Buynder JL, et al. The comparative effectiveness of adjuvanted and unadjuvanted trivalent inactivated influenza vaccine (TIV) in the elderly. Vaccine. 2013;31(51):6122-6128. doi:10.1016/j.vaccine.2013.07.059 8. Cocchio S, Gallo T, Del Zotto S, et al. Preventing the risk of hospitalization for respiratory complications of influenza among the elderly: is there a better influenza vaccination strategy? A retrospective population study. Vaccines (Basel). 2020;8(3):344. doi:10.3390/vaccines8030344 9. Izurieta HS, Chillarige Y, Kelman J, et al. Relative effectiveness of cell-cultured and egg-based influenza vaccines among elderly persons in the United States, 2017-2018. J Infect Dis. 2019;220(8):1255-1264. doi:10.1093/infdis/jiy71 10. Pelton SI, Divino V, Shah D, et al. Evaluating the relative vaccine effectiveness of adjuvanted trivalent influenza vaccine compared to high-dose trivalent and other egg-based influenza vaccines among older adults in the US during the 2017-2018 influenza season. Vaccines (Basel). 2020;8(3):E446. doi:10.3390/vaccines8030446 11. McConeghy KW, Davidson HE, Canaday DH, et al. Cluster-randomized trial of adjuvanted vs. non-adjuvanted trivalent influenza vaccine in 823 U.S. nursing homes. Clin Infect Dis. 2020;ciaa1233. doi:10.1093/cid/ciaa1233 12. van Aalst R, Gravenstein S, Mor V, et al. Comparative effectiveness of high dose versus adjuvanted influenza vaccine: a retrospective cohort study. Vaccine. 2020;38(2):372-379. doi:10.1016/j.vaccine.2019.09.105 13. 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 14. 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 15. O’Hagan DT, Ott GS, De Gregorio E, Seubert A. The mechanism of action of MF59 - an innately attractive adjuvant formulation. Vaccine. 2012;30(29):4341-4348. doi:10.1016/j.vaccine.2011.09.061 16. O’Hagan DT, Ott GS, Nest GV, Rappuoli R, Giudice GD. The history of MF59® adjuvant: a phoenix that arose from the ashes. Expert Rev Vaccines. 2013;12(1):13-30. doi:10.1586/erv.12.140 17. Banzhoff A, Pellegrini M, Del Giudice G, Fragapane E, Groth N, Podda A. MF59-adjuvanted vaccines for seasonal and pandemic influenza prophylaxis. Influenza Other Respir Viruses. 2008;2(6):243-249. doi:10.1111/j.1750-2659.2008.00059.x 18. FLUAD QUADRIVALENT. Package insert. Seqirus Inc. 19. Katkade VB, Sanders KN, Zou KH. Real world data: an opportunity to supplement existing evidence for the use of long-established medicines in health care decision making. J Multidiscip Healthc. 2018;11:295-304. doi:10.2147/JMDH.S160029 20. Frieden TR. Evidence for health decision making - beyond randomized, controlled trials. N Engl J Med. 2017;377(5):465-475. doi:10.1056 NEJMra1614394 21. US Food and Drug Administration. Real-world evidence. Accessed April 21, 2023. https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence 22. Grohskopf LA, Blanton LH, Ferdinands JM, et al. Prevention and control of seasonal influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices — United States, 2022-23 influenza season. MMWR Recomm Rep. 2022;71(1):1-28. doi:10.15585/mmwr.rr7101a1