NOW AVAILABLE IN A
QUADRIVALENT FORMULATION
Adding an adjuvant
makes a difference1
Low vaccine effectiveness in adults
65+ is largely driven by 2 factors:
Weakened immune system
Adults 65+ experience age-related decline of the immune system and thus may be less able to mount a sufficient immune response to vaccination, leaving them more vulnerable to influenza infection and its complications.3
Strain mismatch
This occurs when circulating influenza strains do not match the World Health Organization (WHO)-selected strains contained in the vaccine.
Most often, it is due to mutations from antigenic drift or egg adaptation. It can also occur when the prevalent circulating influenza strains are different from WHO-recommended vaccine strains.4,5
Use an adjuvanted influenza vaccine to help address challenges in adults 65 years and older
An adjuvant is a substance added to a vaccine to boost the immune response.6
Adjuvants have been used in vaccines for decades.6 Adjuvanted vaccines have been used to help prevent diseases such as shingles, pneumococcal pneumonia, hepatitis A and B, and diphtheria, tetanus, and pertussis (DTaP).7
Adding MF59® adjuvant to an influenza vaccine is designed to strengthen, broaden, and lengthen the duration of the immune response1,8,9
Adding MF59 adjuvant to an influenza vaccine does more than an antigen alone
Antigen + MF59 adjuvant
Strengthens the immune response by stimulating more immune cells to create more antibodies
Broadens the immune response by creating more diverse, cross-reactive antibodies
This may be important if there is a mismatch between the influenza virus strains in the vaccine and the circulating influenza strains.
This is a conceptualization of the mechanism of action (MOA) of an MF59 adjuvanted influenza vaccine.
Reimbursed by Medicare Part B
CPT code 90694
114+ million FLUAD doses across 29 countries over the past 20 years10
Favorable health authority recommendations11-13:
United Kingdom . Australia . Italy
Review FLUAD QUADRIVALENT FLUAD information here
FLUAD QUADRIVALENT
FLUAD
About FLUAD QUADRIVALENT
Indications and Usage
FLUAD QUADRIVALENT is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and types B contained in the vaccine.
FLUAD QUADRIVALENT is approved for use in persons 65 years of age and older.
This indication is approved under accelerated approval based on the immune response elicited by FLUAD QUADRIVALENT.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Clinical Data
FLUAD QUADRIVALENT (Influenza Vaccine, Adjuvanted) with MF59 adjuvant produces robust immune responses
Compared to FLUAD, FLUAD QUADRIVALENT includes an additional B strain to help prevent disease caused by all 4 influenza strains represented in the vaccine.2
For the non-influenza comparator vaccine, the proportion of subjects with HI titers greater than or equal to 1:40 at Day 21 were 46.7% for the A/H1N1 strain, 41.7% for A/H3N2, 21.5% for B/Yamagata and 18.4% for B/Victoria. The seroconversion rates for the non-influenza comparator vaccine were 2.1% for A/H1N1, 3.9% for A/H3N2, 3.6% for B/Yamagata and 2.1% for B/Victoria.
Study 1 evaluated the immunogenicity of FLUAD QUADRIVALENT in a randomized, observer-blind, non-influenza comparator-controlled multicenter efficacy study. Adult subjects 65 years of age and older received 1 dose of either FLUAD QUADRIVALENT (N=3379) or a US-licensed non-influenza comparator vaccine (N=3382).*
*Non-influenza comparator vaccine=combined tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, Boostrix® (GlaxoSmithKline Biologicals)
HI=hemagglutinin inhibition
CI=confidence interval
aSuccess criterion: lower bound of the 95% CI for the % of subjects with HI titer ≥1:40 must be ≥60%
bSeroconversion is defined as a prevaccination HI titer <1:10 and postvaccination HI titer ≥1:40 or at least a 4-fold increase in HI from prevaccination HI titer ≥1:10. Success criterion: lower bound of the 95% CI for the seroconversion rate must be ≥30%
Safety Data
FLUAD QUADRIVALENT has a demonstrated safety profile
The safety of FLUAD QUADRIVALENT was evaluated in 2 multicenter, randomized controlled trials in 4269 adults 65+.2
In Study 1, most common (≥10%) local and systemic adverse reactions observed within 7 days of vaccination with FLUAD QUADRIVALENT or a non-influenza comparator vaccine.*2
N=number of subjects with solicited safety data
aSolicited safety population: all subjects in the exposed population who received a study vaccine and provided postvaccination solicited safety data
bSevere reactions of each type were reported in 1.1% or fewer subjects receiving FLUAD QUADRIVALENT; severe reactions of each type were also reported in the comparator group at similar percentages. Severe definitions: erythema, induration, and ecchymosis=>100 mm diameter; injection-site pain, nausea, fatigue, myalgia, arthralgia, headache, and chills=prevents daily activity; loss of appetite=not eating at all; vomiting=6 or more times in 24 hours or requires intravenous hydration; diarrhea=6 or more loose stools in 24 hours or requires intravenous hydration; fever=≥102.2°F (39°C)
In Study 2, FLUAD QUADRIVALENT demonstrated a similar safety profile to that of FLUAD.2
Solicited local and systemic adverse reactions reported were similar to those reported for Study 1.
Dosing and Administration
- For intramuscular injection only2
- FLUAD QUADRIVALENT is supplied as a package of ten 0.5 mL prefilled needleless syringes2
- Administer FLUAD QUADRIVALENT as a single 0.5 mL intramuscular injection in adults 65 years of age and older2
- Each 0.5 mL dose of FLUAD QUADRIVALENT does not contain a preservative. The syringe, plunger, and tip cap are not made with natural rubber latex.2
Storage and Handling
Store FLUAD QUADRIVALENT at 2°C to 8°C (36°F to 46°F). Protect from light. Do not freeze. Discard if the vaccine has been frozen. Do not use after expiration date.2
About FLUAD
Indications and Usage
FLUAD is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
FLUAD is approved for use in persons 65 years of age and older.
Approval is based on the immune response elicited by FLUAD.
Data demonstrating a decrease in influenza disease after vaccination with FLUAD are not available.
Clinical Data
FLUAD (Influenza Vaccine, Adjuvanted) with MF59 adjuvant produces a strong immune response in adults 65+
FLUAD met non-inferiority criteria for the 2 influenza A strains and the influenza B strain represented in the vaccine, compared to a non-adjuvanted, standard-dose influenza vaccine.a,14,15
Study 1 (NCT01162122) evaluated the safety and immunogenicity of FLUAD in comparison to AGRIFLU. A total of 7082 subjects were randomized and vaccinated with FLUAD (N=3541) or AGRIFLU (N=3541). The primary immunogenicity analyses were conducted on all vaccinated subjects with a blood sample collected at Day 22 (N=3225-3227 [91%] and 3256-3259 [92%] in the FLUAD and AGRIFLU groups, respectively).
*AGRIFLU
N=the number of vaccinated participants with available data from the immunologic endpoint listed
GMT=geometric mean antibody titer
CI=confidence interval
aResults obtained following vaccination with influenza vaccine formulated for the 2010-2011 season
bSeroconversion was defined as prevaccination hemagglutinin inhibition (HI) titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI from prevaccination HI titer ≥10
cFLUAD met non-inferiority criteria based on seroconversion rate differences if the lower limit of the 95% CI [FLUAD–AGRIFLU] for each strain was >-10%
dFLUAD met non-inferiority criteria based on GMT ratios if the lower limit of the 95% CI [FLUAD–AGRIFLU] for each strain was >0.67
Safety Data
FLUAD has a demonstrated safety profile
FLUAD has a similar safety profile to that of a non-adjuvanted, standard-dose influenza vaccine.
Most common (≥10%) local and systemic adverse reactions observed within 7 days of vaccination with FLUAD or non-adjuvanted, standard-dose influenza vaccine.14
While more frequent injection-site-related events were reported for FLUAD, most were mild to moderate.14
N=number of subjects with solicited safety data
aModerate: pain, tenderness, myalgia, fatigue, headache, arthralgia, chills, nausea, vomiting defined as "some limitation in normal daily activity," diarrhea defined as "4 to 5 stools a day"
bSevere: pain, tenderness, myalgia, fatigue, headache, arthralgia, chills, nausea, vomiting defined as "unable to perform normal daily activity," diarrhea defined as "6 or more watery stools a day"
cPotentially life-threatening (PLT) reaction defined as requiring emergency room visit or hospitalization
Dosing and Administration
- For intramuscular injection only14
- FLUAD is supplied as a package of ten 0.5 mL prefilled needleless syringes14
- Administer FLUAD as a single 0.5 mL intramuscular injection in adults 65 years of age and older14
- Each 0.5 mL dose of FLUAD does not contain a preservative. The syringe, plunger, and tip cap are not made with natural rubber latex.14
Storage and Handling
Store FLUAD at 2°C to 8°C (36°F to 46°F). Protect from light. Do not freeze. Discard if the vaccine has been frozen. Do not use after expiration date.14
Help prevent seasonal influenza
in adults 65+. Order today.
Reimbursed by Medicare Part B
CPT code 90694
References: 1. 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. 2. FLUAD QUADRIVALENT [package insert]. Holly Springs, NC: Seqirus Inc: 2020. 3. Monto AS, Ansaldi F, Aspinall R, et al. Influenza control in the 21st century: optimizing protection of older adults. Vaccine. 2009:27(37):5043-5053. 4. 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. 5. 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. 6. Garcon N, Leroux-Roels G, Cheng WF. Vaccine adjuvants. Understanding Modern Vaccines: Perspectives in Vaccinology. 2011:1(1):89-113. 7. US Food and Drug Administration. Common ingredients in U.S. licensed vaccines. https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/common-ingredients-us-licensed-vaccines. Accessed August 23, 2019. 8. 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. 9. 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. 10. Data on file. Seqirus Inc: 2019. 11. National Health Service England. Vaccines for 2019/20 seasonal flu vaccination programme. https://assets.
Important Resources & Links
IMPORTANT SAFETY INFORMATION for FLUAD® (Influenza Vaccine, Adjuvanted) and FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted)
INDICATIONS AND USAGE
FLUAD and FLUAD QUADRIVALENT are inactivated influenza vaccines indicated for active immunization against influenza disease caused by influenza virus subtypes A and types B contained in the vaccine. FLUAD and FLUAD QUADRIVALENT are approved for use in persons 65 years of age and older.
This indication is approved under accelerated approval based on the immune response elicited by FLUAD and FLUAD QUADRIVALENT. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Data demonstrating a decrease in influenza disease after vaccination with FLUAD or FLUAD QUADRIVALENT is not available.
CONTRAINDICATIONS
Severe allergic reaction to any component of the vaccine, including egg protein, or after a previous dose of any influenza vaccine.
WARNINGS AND PRECAUTIONS
- If Guillain-Barré Syndrome (GBS) has occurred within six weeks of previous influenza vaccination, the decision to give FLUAD or FLUAD 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.
- The immune response to FLUAD or FLUAD QUADRIVALENT in immunocompromised persons, including individuals receiving immunosuppressive therapy, may be lower than in immunocompetent individuals.
- Syncope (fainting) may occur in association with administration of injectable vaccines including FLUAD and FLUAD QUADRIVALENT. Ensure procedures are in place to avoid injury from falling associated with syncope.
ADVERSE REACTIONS
FLUAD administered by needle and syringe:
- The most common (≥10%) local (injection site) adverse reactions observed in clinical studies were injection site pain (25%) and tenderness (21%).
- The most common (≥10%) systemic adverse reactions observed in clinical studies were myalgia (15%), headache (13%), and fatigue (13%).
FLUAD QUADRIVALENT administered by needle and syringe:
- The most common (≥ 10%) local and systemic reactions 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. For a comprehensive list of local and systemic adverse reactions, please see full Prescribing Information.
To report SUSPECTED ADVERSE REACTIONS, contact Seqirus at 1-855-358-8966 or VAERS at 1-800-822-7967 and www.vaers.hhs.gov.
Before administration, please see the full Prescribing Information for FLUAD and FLUAD QUADRIVALENT.
FLUAD® and FLUAD® QUADRIVALENT are registered trademarks of Seqirus UK Limited or its affiliates.
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