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FLUZONE QUADRIVALENT VACCINE

Influenza… bring it onStand up to influenza with a 4-strain defense that helps protect patients 6 months of age and older1

Fluzone Quadrivalent vaccine is an inactivated quadrivalent influenza virus vaccine indicated for the prevention of influenza disease caused by influenza subtype A and type B viruses contained in the vaccine. Fluzone Quadrivalent vaccine is approved for use in persons 6 months of age and older.

Please click here to see Important Safety Information.

Effectiveness of seasonal influenza vaccines depends on several factors2-4

• Predicting which strains will predominate during a season

– Selections are based on viral surveillance data collected by the WHOa and the CDCb

• Matching of vaccine strains with the circulating strains – Since 2001, 2 distinct B lineages have co-circulated

each season—B Victoria and B Yamagata – Current trivalent influenza vaccines protect against

2 A strains but only 1 B strain

• Varying prevalence of each of the circulating strains

The B strain and the impact of its unpredictability

a WHO = World Health Organization.b CDC = Centers for Disease Control and Prevention.

Since 2001, trivalent vaccines have left patients underprotected due to mismatched B-lineage strains in 6 of the 11 seasons shown below.

>50% of seasons with mismatched B lineage2,3,5-7

0

20

40

60

80

100

Prev

alen

ce o

f co-

circ

ulat

ing

B st

rain

s (%

)

2001

-200

2

2002

-200

3

2003

-200

4

2004

-200

5

2005

-200

6

2006

-200

7

2007

-200

8

2008

-200

9

2009

-201

0

2010

-201

1

2011

-201

2

Seasons with mismatched B strain Yamagata lineage Victoria lineage

Circulation of B strains and frequency of mismatched vaccine B lineage2,5-7

Page 2 of 8 Please click here to see Important Safety Information.

According to the CDC, between 1999 and 2009d QUADRIVALENT INFLUENZA PROTECTION COULD HAVE

POTENTIALLY PREVENTED2:

Broad protection is needed against both B strains2

c Based on data collected from the 2004-2005 through 2010-2011 seasons. Data from the 2009-2010 pandemic season were not included.8

d Based on CDC data from the 1999-2000 through the 2008-2009 seasons.2

Influenza B virus can be devastating• B strains cause epidemics

every 2 to 4 years3

• Influenza B virus represented up to 44% of circulating strains between 2001-2002 and 2010-2011 (excludes the 2009-2010 pandemic)8

• On average, influenza-associated hospitalization and mortality rates are higher with type B influenza than with type A (H1N1)3,8

• The impact of circulating B strains is greater in children and young adults3,8 More than

2.7 million influenza cases

More than 21,000

influenza-relatedhospitalizations

Nearly 1400 influenza-related deaths

On average,

34% of influenza-related deaths in

children up to 18 years of age were due to influenza B8,c

Page 3 of 8 Please click here to see Important Safety Information.

Protection against the B strain is critical

Fluzone Quadrivalent vaccine1

Fluzonevaccine9

Age indication Patients 6 months of age and older Yes Yes

Presentations Prefilled syringe Single-dose vialMulti-dose vial

Prefilled syringe and single-dose vial do not contain preservatives and are not made with natural rubber latexMulti-dose vial is not made with natural rubber latex; contains preservative

Yes Yes

Dosing amount0.25 mL for patients 6 months through 35 months of age0.5 mL for patients 3 years of age and older Yes Yes

Administration route Intramuscular Yes Yes

Dosing schedule• 1 or 2 doses for patients 6 months through 8 years of age depending on

vaccination history; if 2 doses, administer !4 weeks apart • 1 dose for patients who are 9 years of age and older

Yes Yes

Inactivated strains10

Yes Yes

No

In clinical trials, Fluzone Quadrivalent vaccine induced antibody responses that were similar to Fluzone vaccine for the strains contained in each.1

Take on influenza the way you always have, now with more coverage

e CPT (Current Procedural Terminology) is a registered trademark of the American Medical Association.

Appropriate reimbursement with unique CPT®e codes: 90685, 90686, 90687, 90688

H1N1/California/7/2009 H3N2/Texas/50/2012

Brisbane/60/2008 Victoria

Massachusetts/2/2012 Yamagata Only contains

B Yamagata lineage

+

+

Transition to Fluzone Quadrivalent vaccine: the only difference is the 4-strain protection you help provide

Please click here to see Important Safety Information.

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Take a stand with 4-strain protection for patients 6 months of age and older1

Fluzonevaccine9 + +

Proven 3-strain immunogenicity

+ + +

Proven 4-strain immunogenicity

Fluzone Quadrivalent vaccine1

In multicenter studies with a total of 4745 participants 6 months of age and older in the per-protocol analysis set, Fluzone Quadrivalent vaccine generated immune responses similar to those following trivalent formulations of Fluzone vaccine for the strains contained in each. Participants received either Fluzone Quadrivalent vaccine or 1 of 2 comparative trivalent vaccine formulations.1 Each trivalent formulation contained either an influenza type B virus of the Victoria lineage (B/Brisbane/60/2008) or the Yamagata lineage (B/Florida/4/2006), which corresponded to 1 of the 2 type B viruses in Fluzone Quadrivalent vaccine.1

H1N1 H3N2 Either Victoria OR Yamagata

H1N1 H3N2 Victoria Yamagata

Fluzone Quadrivalent vaccine induced antibody responses that were similar to Fluzone vaccine for the strains contained in each.1

Please click here to see Important Safety Information.

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Adults 18 years of age and older 65 years of age and olderFluzone

Quadrivalent vaccineNf = 190

Trivalent vaccine 1g

B VictoriaN = 190

Trivalent vaccine 2h

B YamagataN = 190

Fluzone Quadrivalent

vaccineN = 225

Trivalent vaccine 1i

B Victoria N = 225

Trivalent vaccine 2j

B YamagataN = 225

Solicited Injection-site ReactionsPain 47.4% 52.1% 43.2% 32.6% 28.6% 23.1%

Solicited Systemic Adverse ReactionsMyalgia 23.7% 25.3% 16.8% 18.3% 18.3% 14.2%

Headache 15.8% 18.4% 18.0% 13.4% 11.6% 11.6%Malaise 10.5% 14.7% 12.1% 10.7% 6.3% 11.6%

Children 6 through 35 months of age 3 through 8 years of ageFluzone

Quadrivalent vaccineN = 1223

Trivalent vaccine 1i

B VictoriaN = 310

Trivalent vaccine 2j

B YamagataN = 308

Fluzone Quadrivalent

vaccineN = 1669

Trivalent vaccine 1i

B Victoria N = 424

Trivalent vaccine 2j

B YamagataN = 413

Solicited Injection-site ReactionsPaink 57.0% 52.3% 50.3% 66.6% 64.6% 63.8%

Tendernessl 54.1% 48.4% 49.7% NAm NA NAErythema 37.3% 32.9% 33.3% 34.1% 36.8% 35.2%Swelling 21.6% 19.7% 17.3% 24.8% 25.4% 25.9%

Solicited Systemic Adverse ReactionsIrritabilityl 54.0% 52.8% 53.5% NA NA NA

Abnormal cryingl 41.2% 36.5% 29.9% NA NA NAMalaisek 38.1% 35.2% 32.4% 31.9% 32.8% 33.4%

Drowsinessl 37.7% 32.1% 31.9% NA NA NAAppetite lossl 32.3% 33.3% 25.0% NA NA NA

Myalgiak 26.7% 26.6% 25.0% 38.6% 34.1% 38.4%Vomitingl 14.8% 11.3% 13.9% NA NA NA

Fever 14.3% 16.0% 13.0% 7.0% 7.1% 7.6%Headachek 8.9% 9.4% 12.2% 23.1% 21.2% 24.4%

The safety profile for Fluzone Quadrivalent vaccine was comparable to the trivalent formulation of Fluzone vaccine1

f N = Number of participants in the safety analysis set. g 2009-2010 Fluzone vaccine containing A/Brisbane/59/2007 (H1N1), A Uruguay/716/2007 (H3N2), and B/Brisbane/60/2008 (Victoria lineage), licensed. h 2008-2009 Fluzone vaccine containing A/Brisbane/59/2007 (H1N1),

A Uruguay/716/2007 (H3N2), and B/Florida/04/2006 (Yamagata lineage), licensed. i 2010-2011 Fluzone vaccine containing A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), and B/Brisbane/60/2008 (Victoria lineage), licensed.

j Investigational TIV containing A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), and B/Florida/4/2006 (Yamagata lineage), non-licensed. k Assessed in children 24 months through 35 months of age.l Assessed in

children 6 months through 23 months of age. m NA = Not applicable.

Page 6 of 8 Please click here to see Important Safety Information.

Most common adverse reactions !10% across age groups

Endlessly striving to ensure you and your patients do not face the influenza season alone

Solutions to back your immunization efforts:

Heritage of commitment 40 years of influenza experience and expertise to help you better manage the influenza season

Reliability Consistently delivering vaccines and helping to manage the volatility of the influenza season so you can focus on the care of your patients

Innovation Fluzone Quadrivalent vaccine joins the ever-evolving Fluzone Vaccine Family to help further meet the immunization needs of each and every patient

Support From financial savings to educational materials, we provide tools and resources to help with the challenges that come with the influenza season

Year-round savings for vaccine ordering

Patient reminder tools via customizable voice messages

Online ordering and practice support resources Online information about Fluzone vaccine products

Bring on new Fluzone Quadrivalent vaccine.Bring on the influenza season.

Rely on 4-strain coverage for your patients 6 months of age and older, from Sanofi Pasteur, your vaccine expert.

To order Fluzone Quadrivalent vaccine, log onto VaccineShoppe.com or call 1-800-VACCINE (1-800-822-2463).

Sanofi Pasteur has your back with 4-strain protection and years of dedication

Page 7 of 8 Please click here to see Important Safety Information.

FLUZONE PARTNERS PROGRAMFLUZONE INTRADERMAL

VACCINE

FLUZONE HIGH-DOSE

VACCINE

FLUZONE QUADRIVALENT

VACCINE

CPT Codes: 90685, 90686, 90687, 90688

Fluzone and Fluzone Quadrivalent vaccines are manufactured and distributed by Sanofi Pasteur Inc.

IMPORTANT SAFETY INFORMATIONINDICATIONFluzone Quadrivalent vaccine is an inactivated quadrivalent influenza virus vaccine indicated for the prevention of influenza disease caused by influenza subtype A and type B viruses contained in the vaccine. Fluzone Quadrivalent vaccine is approved for use in persons 6 months of age and older.

SAFETY INFORMATIONThe most common local and systemic adverse reactions to Fluzone Quadrivalent vaccine include pain (tenderness in young children), erythema, and swelling at the injection site; myalgia, malaise, headache, and fever (irritability, abnormal crying, drowsiness, appetite loss, and vomiting in young children). Other adverse reactions may occur. Fluzone Quadrivalent vaccine should not be administered to anyone with a known hypersensitivity (eg, anaphylaxis) to any vaccine component, including egg protein or thimerosal (the multi-dose vial is the only presentation containing thimerosal), or to a previous dose of any influenza vaccine. If Guillain-Barré syndrome has occurred within 6 weeks of receipt of previous influenza vaccination, the decision to give Fluzone Quadrivalent vaccine should be based on careful consideration of the potential benefits and risks. Vaccination with Fluzone Quadrivalent vaccine may not protect all individuals. Before administering Fluzone Quadrivalent vaccine, please click here to see full Prescribing Information.

To order Fluzone Quadrivalent vaccine or to learn about the Fluzone Partners Program, please log onto VaccineShoppe.com or call 1-800-VACCINE (1-800-822-2463). Learn more about Fluzone Quadrivalent vaccine at Fluzone.com.

SANOFI  PASTEUR.  Discovery  Drive.  Swiftwater,  Pennsylvania  18370.  www.sanofipasteur.us

MKT26390-­1   ©  2014  Sanofi  Pasteur  Inc.   2/14

References: 1. Fluzone Quadrivalent vaccine [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc.; 2013. 2. Reed C, Meltzer MI, Finelli L, Fiore A. Public health impact of including two lineages of influenza B in a quadrivalent seasonal influenza vaccine. Vaccine. 2012;30:1993-1998. 3. Belshe RB. The need for quadrivalent vaccine against seasonal influenza. Vaccine. 2010;28(suppl):D45-D53. 4. Skowronski DM, De Serres G, Dickinson J, et al. Component-specific effectiveness of trivalent influenza vaccine as monitored through a sentinel surveillance network in Canada, 2006-2007. J Infect Dis. 2009;199:168-179. 5. Centers for Disease Control and Prevention (CDC). Seasonal influenza (flu): 2009-2010 influenza season summary. http://www.cdc.gov/flu/weekly/weeklyarchives2009-2010/09-10summary.htm. Accessed January 21, 2014. 6. CDC. Seasonal influenza (flu): 2010-2011 influenza season summary. http://www.cdc.gov/flu/weekly/weeklyarchives2010-2011/10-11summary.htm. Accessed January 21, 2014. 7. Michigan Department of Community Health. Michigan influenza surveillance summary 2011-2012 influenza season. http://www.michigan.gov/documents/mdch/2011-2012_Influenza_Season_Summary_394188_7.pdf. Accessed January 21, 2014. 8. Ambrose CS, Levin MJ. The rationale for quadrivalent influenza vaccines. Hum Vaccin Immunother. 2012;8:81-88. 9. Fluzone vaccine [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc.; 2013. 10. CDC. FluView: 2012-2013 influenza season week 15 ending April 13, 2013. http://www.cdc.gov/flu/weekly/pdf/External_F1315.pdf. Accessed January 21, 2014.

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