Adding an adjuvant
makes a difference

View CPT *
Code

REIMBURSED by MEDICARE PART B cpt code 90653 *CPT=Current Procedural Terminology

Important Safety Information


Low vaccine effectiveness
in adults 65+ years is
largely driven by:


Weakened immune system2

due to aging, reducing the body's ability to produce
a sufficient protective immune response.

Strain mismatch3,4

occurs when circulating influenza strains do not match
the WHO-selected strains contained in the vaccine.


Most often, it is because of strain mutations from antigenic
drift or egg adaptation. It can also occur when the prevalent
circulating influenza strains are different from WHO predictions.



Use an adjuvanted influenza
vaccine to help address
challenges in
adults 65+ years


An adjuvant is a substance added to a vaccine to boost the immune
response. Adjuvants have been used in vaccines for decades.5

Adding MF59® adjuvant to an influenza vaccine
does more than antigen alone

Conceptualization of the mechanism of action of an
MF59 adjuvanted influenza vaccine6,7


Antigen + MF59 adjuvant


Strengthens 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 circulation influenza strains

Adding MF59 adjuvant to an influenza vaccine is
designed to strengthen, broaden, and lengthen
the duration of the immune response.7-9





First-and-only adjuvanted

Seasonal influenza vaccine

Reimbursed by MEDICARE PART B
CPT code: 906531

100+

million doses

across 29 countries over 20 years 8,11

Favorable health authority recommendations11:
United Kingdom . Australia . Italy

Review FLUAD information here.



About FLUAD

INDICATION 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.



Immunogenicity Data

The first-and-only adjuvanted
seasonal influenza vaccine approved
for adults 65+ years

10
FLUAD elicited a strong immune response, meeting noninferiority criteria for all 3 vaccine strains based on predefined thresholds for seroconversion rate differences and geometric mean titer (GMT) ratios, compared to a non-adjuvanted, standard-dose vaccine11,a

Seroconversionb rates:

FLUAD vs non-adjuvanted, standard-dose influenza vaccine at Day 22*

Seroconversion rates chart

GMTs and GMT ratios:

FLUAD vs non-adjuvanted, standard-dose influenza vaccine at Day 22*

GMTs and GMT ratios chart
*AGRIFLU is a US licensed comparator.
*Differences in seroconversion rate (95% CI).
Study 1 (NCTO1162122) evaluated the safety and immunogenicity of FLUAD in comparison to AGRIFLU. 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.
aResults obtained following vaccination with influenza vaccine formulated for the 2010-2011 season. bSeroconversion was defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI from prevaccination HI titer ≥10. cFLUAD met noninferiority criteria based on seroconversion rate differences if the lower limit of the 95% Cl [FLUAD-AGRIFLU] for each strain was >-10% dFLUAD met noninferiority criteria based on GMT ratios if the lower limit of the 95% Cl (FLUAD-AGRIFLU) for each strain was >0.67,

A/H3N2 is known to be highly virulent, and while it affects the entire population, it is responsible for substantial morbidity and mortality among people over 65 years of age.11


Safety Data

FLUAD has a demonstrated safety profile


FLUAD has a similar safety profile to 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 vaccine10,a



aN = number of subjects with safety data. bModerate: 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." Severe: 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." dpotentially life-threatening (PLT) reaction defined as requiring emergency room visit or hospitalization.
While more frequent injection-site-related events were reported for FLUAD, most were mild to moderate.
10


Dosing and Administration
  • 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, plunger, and tip cap are not made with natural rubber latex.


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.



Help prevent seasonal influenza in
Adults 65+ years. Order today.

References: 1.Immunization Action Coalition. Influenza Vaccine products for the 2019-2020 influenza season.
http://www.immunize.org/catg.d/p4072.pdf. Accessed September 12, 2019. 2. Monto AS, Ansalid F, Aspinall R, et al. Influenza control in the 21st century:optimizing protection of older adults. Vaccine 2009:(37):5043-5053. 3. 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. 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.Garcon N, Leroux-Roles G, Cheng WF. Vaccine adjuvants.Understanding Modern Vaccines: Perspectives in Vaccinology. 2011:89-113. 6. 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. 7. 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):13-30.8. 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. 9. Frey SE, Reyes MR, Reynales H, et al. Comparison Of the safety and immunogenicity Of an MF59®-adjuvanted with a non-adjuvanted seasonal influenza vaccine in elderly subjects. Vaccine. 2014:32(39):5027-5034. 10. FLUAD [package insert]. Holly Springs, NC: Seqirus Inc: 2019. 11. Data on file. Seqirus Inc: 2019. 12. National Health Service England.Vaccines for 2019/20 seasonal flu vaccination programme. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/757784/Vaccines_for_2019_20_seasonal_flu_vaccination_programme.pdf. Accessed September 26, 2019.

Important Safety Information

INDICATION 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 and www.vaers.hhs.gov.

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

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

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