PREPARE FOR INFLUENZA SEASON WITH FLUAD®

An influenza vaccine for adults 65 and older.1

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Covered under Medicare Part B

What makes FLUAD different? It's adjuvanted.1

FLUAD is the first FDA-approved seasonal influenza vaccine made with MF59®, an immune-enhancing adjuvant derived from squalene: a naturally occurring substance found in humans, plants, and animals, which is proven to help provide a strong immune response to the influenza for adults 65 and older.1,2

102 plus million

doses distributed in countries where FLUAD® is licensed3

29

countries approve FLUAD3

MORE THAN 20

years of FLUAD heritage use4

As we age, influenza can be more serious for people 65 and older.5

6x

Influenza-related deaths estimated for adults 65 and older as compared to all other age groups.6

78%

Adults 65 and older account for approximately 54-70% of seasonal influenza-related hospitalization, each season in the United States.5

45%

Increased risk of heart attack for adults 65 and older in the first few weeks after infection6

Help fight influenza. Order FLUAD today.

Review FLUAD information here.

FLUAD® is an influenza vaccine that is clinically proven to generate a strong immune response in adults 65 and older. FLUAD is the first FDA-approved seasonal influenza vaccine in the United States. made with an immune-enhancing adjuvant, MF59®, for people 65 and older. MF59® is derived from squalene, a naturally occurring substance found in humans, plants and animals. Studies suggest MF59® recruits immune cells to the site of injections and enhances their uptake of antigen.1,2,4

The CDC recommends FLUAD® as an acceptable option to other vaccines licensed (or indicated) for people 65 years of age and older for immunization against influenza.5

The CDC has not made a preferential recommendation for any influenza vaccine formulation directed toward this age group.2

In a large pivotal trialb (N=7082), FLUAD elicited a strong immune response in adults 65 and older1,c

Seroconversiond rates:

FLUAD established noninferiority vs AGRIFLUTM (influenza vaccine) at Day 22

Seroconversion rates chart
A/H1N1 A/H3N2 B
Differences in seroconversion ratesg (95% CI) 9.8% (7.5%-12.1%) 13.9% (11.7%-16.1%) 3.2% (1.1%-5.3%)

GMTs and GMT rates:

FLUAD established noninferiority vs AGRIFLUTM at Day 22

GMTs and GMT ratios chart
A/H1N1 A/H3N2 B
GMT ratioh (95%) 1.4 (1.32-1.49) 1.61 (1.52-1.7) 1.15 (1.08-1.21)

CI = confidence interval; GMT = geometric mean antibody titer.
bStudy 1 (NCT01162122) was a multicenter, observer-blind, randomized, controlled study that evaluated the safety and immunogenicity of FLUAD in comparison to AGRIFLU, a US-licensed nonadjuvanted trivalent influenza vaccine. A total of 7082 subjects aged 65 years and older were randomized and vaccinated with FLUAD (n=3541) or AGRIFLU (n = 3541). The primary immunogenicity analysis was performed on all vaccinated subjects who had a blood sample collected at Day 22 (n=3225-3227 [91%] and 3256-3259 [92%] in the FLUAD and AGRIFLU groups, respectively). A determination of noninferiority was made on the basis of predefined thresholds for seroconversion rate differences and GMT ratios. cResults obtained following vaccination with influenza vaccine formulated for the 2010 to 2011 season. dSeroconversion was defined as prevaccination hemagglutination inhibition (HI) titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI from prevaccination HI titer ≥10. 3n = 3225-3227, the number of vaccinated participants with available data for the immunologic endpoint listed. fn = 3256-3259, the number of vaccinated participants with available data for the immunologic endpoint listed. gFLUAD met noninferiority criteria based on seroconversion rate differences if the lower limit of the 95% CI [FLUAD : AGRIFLU] for each strain was >-10%. hFLUAD met noninferiority criteria based on GMT ratios if the lower limit of the 95% CI [FLUAD: AGRIFLU] for each strain was >0.67.

A demonstrated safety profilea

In the pivotal trial, the most common (≥10%) adverse reactions in subjects receiving FLUAD were1:

Icon showing injection site pain

Injection Site Pain (25%)

Icon showing tenderness

Tenderness (21%)

Icon showing myalgia

Myalgia (15%)

Icon showing fatigue

Fatigue (13%)

Icon showing headache

Headache (13%)

While higher rates of solicited adverse reactions were noted with FLUAD, they were typically mild to moderate1

Thea safety analysis included subjects (n = 3545 FLUAD; n = 3537 AGRIFLU) from Study 1 who completed a symptom diary card for 7 days following vaccination.

People graphic
  • For intramuscular injection only
  • FLUAD is supplied as a package of ten, 0.5-mL prefilled needleless syringes
  • Administer FLUAD as a single 0.5-mL intramuscular injection in adults 65 years of age and older
  • Each 0.5-mL dose of FLUAD is preservative free. The syringe, syringe plunger stopper, and tip cap are not made with natural rubber latex.

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.

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Important Safety Information1

INDICATIONS AND USAGE

FLUAD® (Influenza Vaccine, Adjuvanted) 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.

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 should be based on careful consideration of the potential benefits and risks.

ADVERSE REACTIONS

  • 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%).
  • To report SUSPECTED ADVERSE REACTIONS, contact Seqirus at 1-855-358-8966 or VAERS at 1-800-822-7967

For more information, please see US Full Prescribing Information for FLUAD.

FLUAD® is a registered trademark of Seqirus UK Limited or its affiliates.

References

1. FLUAD[package insert]. Holly Springs, NC: Seqirus Inc, 2018. 2. Centers for Disease Control and Prevention. FLUAD® flu vaccine with adjuvant. https://www.cdc.gov/flu/protect/vaccine/adjuvant.htm. Updated July 11, 2016. Accessed May 16, 2017. 3.Seqirus Inc. Data on file. Periodic safety update report (PSUR #41). 2018. 4. O'Hagan D, Ott GS, De Gregorio E, Seubert A. The mechanism of action of MF59 - an innately attractive adjuvant formulation. Vaccine. 2012; 30(29):4341-4348. 5. Centers for Disease Control and Prevention. What you should know and do this flu season if you are 65 years and older. https://www.cdc.gov/flu/about/disease/65over.htm. Updated 2017. Accessed June 5, 2018. 6. National Foundation for Infectious Diseases. Call to action: reinvigorating influenza prevention in US adults age 65 and older. http://nfid.org/flu-older-adults. Published September 2016. Accessed June 4, 2018.

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