Influenza… bring it on

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.

FLUZONE QUADRIVALENT VACCINE Stand up to influenza with a 4-strain defense that helps protect patients 6 months of age and older1

Please click here to see Important Safety Information.

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The B strain and the impact of its unpredictability

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

60

40

20

a b

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

Seasons with mismatched B strain

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Yamagata lineage

2011-2012

2010-2011

2009-2010

2008-2009

2007-2008

0

2001-2002

• Varying prevalence of each of the circulating strains

80

2006-2007

– Current trivalent influenza vaccines protect against 2 A strains but only 1 B strain

100

2005-2006

– Since 2001, 2 distinct B lineages have co-circulated each season—B Victoria and B Yamagata

Prevalence of co-circulating B strains (%)

• Matching of vaccine strains with the circulating strains

2004-2005

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

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

2003-2004

• Predicting which strains will predominate during a season

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

2002-2003

Effectiveness of seasonal influenza vaccines depends on several factors2-4

Victoria lineage

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Protection against the B strain is critical Influenza B virus can be devastating

Broad protection is needed against both B strains2

• B strains cause epidemics every 2 to 4 years 3

According to the CDC, between 1999 and 2009d

QUADRIVALENT INFLUENZA PROTECTION COULD HAVE POTENTIALLY PREVENTED2:

• 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

More than

influenza cases

influenza-related hospitalizations

2.7 million

On average,

21,000

34%

of influenza-related deaths in children up to 18 years of age were due to influenza B8,c

Nearly

c

d

1400 influenza-related deaths

Based on data collected from the 2004-2005 through 2010-2011 seasons. Data from the 2009-2010 pandemic season were not included.8 Based on CDC data from the 1999-2000 through the 2008-2009 seasons.2

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Please click here to see Important Safety Information.

Take on influenza the way you always have, now with more coverage Transition to Fluzone Quadrivalent vaccine: the only difference is the 4-strain protection you help provide In clinical trials, Fluzone Quadrivalent vaccine induced antibody responses that were similar to Fluzone vaccine for the strains contained in each.1

Fluzone Quadrivalent vaccine1

Fluzone vaccine9

Yes

Yes

Yes

Yes

0.5 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

Yes

Yes

Yes

Yes

Age indication

Presentations Prefilled syringe Single-dose vial Multi-dose vial

Dosing amount

Patients 6 months of age and older Prefilled syringe and single-dose vial do not contain preservatives and are not made with natural rubber latex Multi-dose vial is not made with natural rubber latex; contains preservative 0.25 mL for patients 6 months through 35 months of age

• 1 dose for patients who are 9 years of age and older

+ H1N1/California/7/2009

H3N2/Texas/50/2012

Inactivated strains10

+ Brisbane/60/2008 Victoria

OnlyNo contains B Yamagata lineage

Massachusetts/2/2012 Yamagata

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

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

Please click here to see Important Safety Information.

Take a stand with 4-strain protection 1 for patients 6 months of age and older Fluzone Quadrivalent vaccine induced antibody responses that were similar to Fluzone vaccine for the strains contained in each.1 Proven 3-strain immunogenicity

Fluzone vaccine9

+ H1N1

+ H3N2

Either Victoria OR Yamagata

Proven 4-strain immunogenicity

Fluzone Quadrivalent vaccine1

+ H1N1

+ H3N2

+ Victoria

Yamagata

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

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Please click here to see Important Safety Information.

The safety profile for Fluzone Quadrivalent vaccine was 1 comparable to the trivalent formulation of Fluzone vaccine Most common adverse reactions ≥10% across age groups

Adults

18 years of age and older Fluzone Quadrivalent vaccine

65 years of age and older

Trivalent vaccine 1g Trivalent vaccine 2h

Fluzone Quadrivalent vaccine

Trivalent vaccine 1i

Trivalent vaccine 2j

B Victoria N = 225

B Yamagata N = 225

B Victoria N = 190

B Yamagata N = 190

47.4%

52.1%

43.2%

32.6%

28.6%

23.1%

23.7% 15.8% 10.5%

25.3% 18.4% 14.7%

16.8% 18.0% 12.1%

18.3% 13.4% 10.7%

18.3% 11.6% 6.3%

14.2% 11.6% 11.6%

N = 190 f

N = 225

Solicited Injection-site Reactions Pain

Solicited Systemic Adverse Reactions Myalgia Headache Malaise

Children

6 through 35 months of age Fluzone Quadrivalent vaccine

3 through 8 years of age

Trivalent vaccine 1i

Trivalent vaccine 2j

B Victoria N = 310

B Yamagata N = 308

57.0% 54.1% 37.3% 21.6%

52.3% 48.4% 32.9% 19.7%

50.3% 49.7% 33.3% 17.3%

54.0% 41.2% 38.1% 37.7% 32.3% 26.7% 14.8% 14.3% 8.9%

52.8% 36.5% 35.2% 32.1% 33.3% 26.6% 11.3% 16.0% 9.4%

53.5% 29.9% 32.4% 31.9% 25.0% 25.0% 13.9% 13.0% 12.2%

N = 1223

Fluzone Quadrivalent vaccine

Trivalent vaccine 1i

Trivalent vaccine 2j

B Victoria N = 424

B Yamagata N = 413

66.6% NA m 34.1% 24.8%

64.6% NA 36.8% 25.4%

63.8% NA 35.2% 25.9%

NA NA 31.9% NA NA 38.6% NA 7.0% 23.1%

NA NA 32.8% NA NA 34.1% NA 7.1% 21.2%

NA NA 33.4% NA NA 38.4% NA 7.6% 24.4%

N = 1669

Solicited Injection-site Reactions Paink Tendernessl Erythema Swelling

Solicited Systemic Adverse Reactions Irritabilityl Abnormal cryingl Malaisek Drowsinessl Appetite lossl Myalgiak Vomitingl Fever Headachek

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.

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Please click here to see Important Safety Information.

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

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

Heritage of commitment

Innovation

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

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

Reliability

Support

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

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

Solutions to back your immunization efforts:

Year-round savings for vaccine ordering

Online ordering and practice support resources

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

Patient reminder tools via customizable voice messages Rely on 4-strain coverage for your patients 6 months of age and older, from Sanofi Pasteur, your vaccine expert.

Online information about Fluzone vaccine products

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

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Please click here to see Important Safety Information.

FLUZONE QUADRIVALENT

FLUZONE INTRADERMAL

FLUZONE HIGH-DOSE

VACCINE

VACCINE

VACCINE

FLUZONE PARTNERS PROGRAM

IMPORTANT SAFETY INFORMATION INDICATION 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.

SAFETY INFORMATION The 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. 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. Componentspecific effectiveness of trivalent influenza vaccine as monitored through a sentinel surveillance network in Canada, 2006-2007. J Infect Dis. 2009;199:168179. 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.

CPT Codes: 90685, 90686, 90687, 90688 Fluzone and Fluzone Quadrivalent vaccines are manufactured and distributed by Sanofi Pasteur Inc. SANOFI  PASTEUR.  Discovery  Drive.  Swiftwater,  Pennsylvania  18370.  www.sanofipasteur.us MKT26390-­1  

©  2014  Sanofi  Pasteur  Inc.  

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