Real-world evidence

Across 3 consecutive US influenza seasons, RWE studies involving over 11.7 million patients suggest that FLUCELVAX QUADRIVALENT reduced flu-related hospitalizations vs traditional, egg-based vaccines.1-3
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 assessing influenza-related hospitalizations in persons 4 through 64 years of age.This is not inclusive of all peer-reviewed RWE studies, which include different outcomes and age groups. The data of FLUCELVAX QUADRIVALENT are relevant to FLUCELVAX, as both vaccines are manufactured using the same process and have overlapping compositions.FLUCELVAX received FDA approval for patients 6 months and older in October 2021, after these studies were conducted.CI=confidence interval; rVE=relative vaccine effectiveness; RWE=real-world evidence
Download Full RWE Data Download
Look to both clinical trial and RWE data when choosing an influenza vaccine
The continuous cycle of influenza strain change, new vaccine formulations, and annual vaccine requirements
Influenza varies each year, so it's important to continuously assess vaccine effectiveness.
Randomized clinical trials (RCTs) provide an important basis for evaluating flu vaccines, yet the data is limited to a snapshot in time. RWE presents a complementary approach to assess vaccine effectiveness by offering4-6:
  • Ever-growing data
  • Large, diverse patient populations outside clinical trials
Real Implications
The CDC estimates that a 5% increase in absolute vaccine effectiveness could prevent an additional 25,000 influenza-related hospitalizations.*7
*CDC modeling estimates based on the 2017-2018 US influenza season, which was a high severity season.
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  • Available through VFC*
  • Covered by most health plans and Medicare Part B†
  • CPT reimbursement codes
    • Single-dose syringe: 90661
    • Multi-dose vial: 90661
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FLUCELVAX QUADRIVALENT packages
*Confirm availability with your state's Vaccines for Children (VFC) program.
*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 or AFLURIA to anyone with a history of a 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 to anyone with a history of severe allergic reaction (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 previous influenza vaccine, the decision to give FLUAD, FLUCELVAX, or AFLURIA should be based on careful consideration of the potential benefits and risks.

Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of FLUAD, FLUCELVAX, or AFLURIA.

Syncope (fainting) may occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting.

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

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

ADVERSE REACTIONS

FLUAD:

The most common (≥ 10%) local and systemic adverse reactions in adults 65 years of age and older who received FLUAD were injection site pain (25%), injection site tenderness (21%), myalgia (15%), fatigue (13%) and headache (13%). Other adverse events may occur.

FLUCELVAX:

Data for FLUCELVAX QUADRIVALENT are relevant to FLUCELVAX because both vaccines are manufactured using the same process and have overlapping compositions.

In children 6 months through 3 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were tenderness (28%), erythema (26%), induration (17%) and ecchymosis (11%). The most common systemic adverse reactions were irritability (28%), sleepiness (27%), diarrhea (18%) and change of eating habits (17%).

In children 4 through 8 years of age who received FLUCELVAX, the most commonly reported local injection-site adverse reactions were pain (29%) and erythema (11%). The most common systemic adverse reaction was fatigue (10%).

In children and adolescents 9 through 17 years of age who received FLUCELVAX, the most commonly reported injection-site adverse reactions were pain (34%) and erythema (14%). The most common systemic adverse reactions were myalgia (15%) and headache (14%).

In adults 18 through 64 years of age who received FLUCELVAX, the most commonly reported injection-site adverse reactions were pain (28%) and erythema (13%). The most common systemic adverse reactions were headache (16%), fatigue (12%), myalgia (11%) and malaise (10%).

In adults ≥ 65 years who received FLUCELVAX the most commonly reported injection-site reaction was erythema (10%). The most common systemic adverse reactions were fatigue (11%), headache (10%) and malaise (10%).

Other adverse events may occur.

AFLURIA:

Data for AFLURIA QUADRIVALENT are relevant to AFLURIA because both vaccines are manufactured using the same process and have overlapping compositions.

Administered by needle and syringe (AFLURIA QUADRIVALENT data):

In children 6 months through 35 months of age, the most commonly reported injection-site reactions were pain and redness (≥ 20%). The most common systemic adverse reactions were irritability (≥ 30%), diarrhea and loss of appetite (≥ 20%).

In children 36 through 59 months of age, the most commonly reported injection site reactions were pain (≥ 30%) and redness (≥ 20%). The most commonly reported systemic adverse reactions were malaise and fatigue, and diarrhea (≥ 10%).

In children 5 through 8 years, the most commonly reported injection-site adverse reactions were pain (≥ 50%), redness and swelling (≥ 10%). The most common systemic adverse reaction was headache (≥ 10%).

In children 9 through 17 years, the most commonly reported injection-site adverse reactions were pain (≥ 50%), redness and swelling (≥ 10%). The most common systemic adverse reactions were headache, myalgia, and malaise and fatigue (≥ 10%).

In adults 18 through 64 years, the most commonly reported injection-site adverse reaction was pain (≥ 40%). The most common systemic adverse reactions were myalgia and headache (≥ 20%).

In adults 65 years of age and older, the most commonly reported injection-site adverse reaction was pain (≥ 20%). The most common systemic adverse reaction was myalgia (≥ 10%).

Administered by the PharmaJet Stratis Needle-Free Injection System:

In adults 18 through 64 years of age, the most commonly reported injection-site adverse reactions were tenderness (≥ 80%), swelling, pain, redness (≥ 60%), itching (≥ 20%) and bruising (≥ 10%). The most common systemic adverse reactions 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, FLUCELVAX and AFLURIA.

PharmaJet® and STRATIS® are registered trademarks of PharmaJet.

References: 1. Divino V, Krishnarajah G, Pelton SI, et al. A real-world study evaluating the relative vaccine effectiveness of a cell-based quadrivalent influenza vaccine compared to egg-based quadrivalent influenza vaccine in the US during the 2017-18 influenza season. Vaccine. 2020;38(40):6334-6343. doi:10.1016/j.vaccine.2020.07.023 2. Krishnarajah G, Divino V, Postma MJ, et al. Clinical and economic outcomes associated with cell-based quadrivalent influenza vaccine vs. standard-dose egg-based quadrivalent influenza vaccines during the 2018-19 influenza season in the United States. Vaccines (Basel). 2021;9(2):80. doi:10.3390/vaccines9020080 3. Divino V, Anupindi VR, DeKoven M, et al. A real-world clinical and economic analysis of cell-derived quadrivalent influenza vaccine compared to standard egg-derived quadrivalent influenza vaccines during the 2019-2020 influenza season in the United States. Open Forum Infect Dis. 2021;9(1):ofab604. doi:10.1093/ofid/ofab604 4. 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 5. Frieden TR. Evidence for health decision making - beyond randomized, controlled trials. N Engl J Med. 2017;377(5):465-475. doi:10.1056/NEJMra1614394 6. US Food and Drug Administration. Real-world evidence. Accessed March 13, 2024. https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence 7. Hughes MM, Reed C, Flannery B, et al. Projected population benefit of increased effectiveness and coverage of influenza vaccination on influenza burden in the United States. Clin Infect Dis. 2020;70(12):2496-2502. doi:10.1093/cid/ciz676 8. FLUCELVAX. Package insert. Seqirus Inc.