NOW AVAILABLE IN A

QUADRIVALENT FORMULATION

Adding an adjuvant
makes a difference1

FLUAD® QUADRIVALENT is the first-and-only adjuvanted quadrivalent seasonal influenza vaccine approved for adults

65 Older Logo

Reimbursed by Medicare Part B

CPT code 90694

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.

FLUAD® QUADRIVALENT is the first-and-only adjuvanted quadrivalent seasonal influenza vaccine approved for adults

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

FLUAD QIV Graphic FLUAD QIV Graphic

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

FLUAD QIV Safety Table FLUAD QIV Safety Table

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

FLUAD QIV Graphic FLUAD QIV Graphic

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

FLUAD QIV Safety Table FLUAD QIV Safety Table

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

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