EFFICACY AND SAFETY PROFILE
FLUCELVAX is the first and only cell-based influenza vaccine in the US and the only non-egg option available for 6+ months.1
PROVEN FOR USE IN CHILDREN AND ADULTS
Published in The New England Journal of Medicine
Efficacy against culture and/or RT-PCR-confirmed influenza: 2 through 17 years1
Non-influenza vaccine comparator
FLUCELVAX QUADRIVALENT
The efficacy and immunogenicity data of FLUCELVAX QUADRIVALENT are relevant to FLUCELVAX as both vaccines are manufactured using the same process and have overlapping compositions..1
IMMUNE RESPONSE IN CHILDREN
Based on immunogenicity and seroconversion, FLUCELVAX QUADRIVALENT was proven to be noninferior to a US-licensed comparator quadrivalent influenza vaccine in children 6 months through 3 years (Study 1).1
Efficacy against culture-confirmed influenza: 18 through 49 years1
Placebo
FLUCELVAX
IMMUNE RESPONSE IN ADULTS
Based on immunogenicity and seroconversion, FLUCELVAX was proven noninferior to a trivalent, egg-based vaccine (AGRIFLU) in adults 18 years and older (Study 6).1
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Absolute efficacy of FLUCELVAX QUADRIVALENT was evaluated in Study 4, a multinational, randomized, observer-blind, non-influenza vaccine comparator-controlled (meningococcal ACWY vaccine) study across 3 influenza seasons (2017-2019) in children and adolescents 2 through 17 years. FLUCELVAX QUADRIVALENT met the pre-defined success criterion defines as the lower limit of the 2-sided 95% CI of absolute vaccine efficacy greater than 20%.
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A multinational, randomized, observer-blind, placebo-controlled efficacy and safety trial of FLUCELVAX during the 2007-2008 influenza season in adults aged 18 through 49 years (Study 5). 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%.
Demonstrated safety profile IN CHILDREN AND ADULTS
Evaluated in children 6 months through 17 years in 4 clinical studies
Most common (>10%) local and systemic adverse reactions observed in children and adolescents within 7 days of any dose of vaccination1
Information on the safety of FLUCELVAX administered to 3346 children and adolescents 4 through 17 years of age is available from two multinational, randomized controlled clinical studies (Studies 2 and 3). Additionally in Study 4, serious adverse events (SAEs) were reported by 1.1% of the subjects who received FLUCELVAX QUADRIVALENT‡. In all of these studies, no SAEs were considered related to the study vaccine.
The safety of FLUCELVAX was evaluated in 7 randomized, controlled studies conducted in the US, Europe and New Zealand. The safety population includes 5709 adults 18 through 64 years of age and 572 adults 65 years of age and older administered FLUCELVAX.
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*Study 1 was a randomized, observer-blind, multicenter safety and immunogenicity study of FLUCELVAX QUADRIVALENT. The solicited safety population included a total of 2348 children 6 months through 3 years.
†Study 2 was a randomized observer-blind multicenter safety and immunogenicity study of FLUCELVAX. The solicited safety population included a total of 3123 children 4 through 17 years.
‡See Study 4 details in pediatric efficacy section. The solicited safety population included a total of 4509 children and adolescents 2 through 17 years.
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*Study 5 was a randomized, double-blind, placebo-controlled study that evaluated the safety of FLUCELVAX. The solicited safety population included a total of 7707 adults 18 through 49 years of age.
†Study 6 was a randomized, double-blind, conrolled immunogenicity and safety trial of FLUCELVAX. The solicited safety population included a total of 2654 adults 18 years of age or older.
Get the cell-based solution today1
- Available through VFC*
- Covered by most health plans and Medicare Part B†
- CPT reimbursement codes
- Single-dose syringe: 90661
- Multi-dose vial: 90661
*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.
Reference: 1. FLUCELVAX. Package insert. Seqirus Inc.