4TH MERIAL FORUM

HAVE WE GOT PCVD &

SWINE INFLUENZA UNDER

CONTROL?

INFLUENZA IN HUMAN AND PIGS:

WHAT ARE THE DIFFERENCES?

Influenza in Humans epidemiology and control by vaccination

Sam Lee, PhD

Sr. Director, Pandemic Influenza Strategy

Franchise & Global Marketing Strategy

Sanofi Pasteur

Airborne Transmission of Respiratory Pathogens

Steinhoff, Johns Hopkins School of Public Health, EID_lect13_Steinhoff.pdf

Influenza Highly contagious respiratory illness caused by frequently changing virus

http://www.cdc.gov/flu/images.htm

http://en.wikipedia.org/wiki/Influenza

Antigenic Drift vs. Antigenic Shift

http://www.niaid.nih.gov/topics/flu/understandingflu/Pages/default.aspx

http://gamapserver.who.int/mapLibrary/Files/Maps/GISRS_20120426_1.png

Influenza Virus Antigenic & Genetic Drift

http://www.who.int/entity/influenza/vaccines/virus/recommendations/201202_recommendation.pdf

http://www.who.int/entity/influenza/vaccines/virus/201202_h5_h9_vaccinevirusupdate.pdf

http://www.antigenic-cartography.org/

Annual Impact of Seasonal Influenza in the United States

Deaths 36,0001

Hospitalizations 114,0002

Direct medical costs >$10 billion4

Infections and illnesses 50–60 million3

Physician visits 25 million3

1 Thompson WW et al. JAMA. 2003;289:179-186. 2 CDC. MMWR Recomm Rep. 2003;58(RR-8):1-34.

3 Chow A, et al. Emerg Infect Dis. 2006 Jan;12(1):114-21. 4 Molinari NA, et al. Vaccine. Jun 28 2007;25(27):5086-5096.

5 Szucs T. J Antimicrob Chemother. Nov 1999;44 Suppl B:11-15.

In-Direct medical costs >$50 billion5

10 10

Goals for Influenza Vaccination

Primary Goal: Prevent severe disease and complications,

and to prevent death

Secondary Goal: Prevent any mild form of the

disease or mild complications

Public Health Goal: Reduce disease

burden and medical costs for society

Vaccination provides effective protection against flu at all ages

In Healthy Adults

Influenza vaccination prevents influenza illness

in 70 – 90% of healthy adults aged < 65 years 4

Vaccination of healthy working adults was shown

to reduce work absenteeism by up to 78% 5

In Children

Vaccination reduces influenza

illness in children by 60 to 90% 2

Vaccination of children reduces

disease transmission

Demonstrated 61% indirect

protection (herd effect) of non-

vaccinated persons 3

*Influenza vaccination is most effective when circulating viruses are well-matched with vaccine viruses

In the Elderly Flu vaccination among the elderly has

been shown to reduce severe

illness and complications by up to

60%, and deaths by up to 80% 1

1 http://www.who.int/mediacentre/factsheets/fs211/en/Accessed July 2, 2010. 2 Nichol K. Vaccine ,2003;21(16):1769-75.

3 Loeb M, et al.. JAMA, 2010;303(10):943-50. 4 CDC. MMWR, 2009;58(RR8).

5 Samad AH, et al. J Occup Health, 2006;48(1):1-10.

Influenza Vaccine Strain Changes WHO Recommendations 1969-2012

Reichelderfer PS, et al. Influenza surveillance in the pacific basin. In: Current topics in medical virology 1988:412-38

J F M A M J J A S O N D

Southern hemisphere

Tropical

Northern hemisphere

Seasonal Occurrence of Influenza

Potential Benefit of Quadrivalent Vaccines B lineage circulation in Europe (2003-2011)

Victoria

Yamagata

Victoria Yamagata Yamagata Yamagata Yamagata Yamagata Victoria Vaccine

P P P X X X X Match with

dominant

circulating lineage

20%

44%

91% 92%

69%

94%

80%

56%

9% 8%

99%

31%

6%

1% 0%

 10%

 20%

 30%

 40%

 50%

 60%

 70%

 80%

 90%

 100%

2003-2004 2004-2005 2005-2006 2006-2007 2007-2008 2008-2009 2010-2011

Human-Animal Interface

http://www.nationalgeographic.de/thumbnails/lightbox/66/34/00/ea-khamjean-saugt-blut-aus-der-wunde-seines-kampfhahns-3466.jpg

http://www.swineflupandemicblog.info/

● Our Vision

● A world in which no one suffers or dies from a

vaccine preventable disease

● Our Mission

● To protect and improve human health

worldwide by providing superior, innovative

vaccines for the prevention and treatment of

disease and by playing an active role in the

immunization community to maximize

vaccination

SANOFI PASTEUR WORLDWIDE LEADER IN HUMAN VACCINES

Val de Reuil

Marcy-l’Etoile

Toronto

Shenzhen

Swiftwater (PA)

Canton (MA)

Rockville (MD)

Pilar

Chachoengsao Hyderabad

17

SANOFI PASTEUR GLOBAL PRODUCTION FOR GLOBAL HEALTH

● To produce vaccines in large quantities, meeting the highest quality

standards, to help fulfill public health needs

Sites under construction: Ocoyoacac (Mexico), Neuville (France), Shenzhen (China)

10 sites plus 3 under

construction

More than

50% of total staff

in industrial operations

More than 1 billion doses

of vaccine produced each

year

Nearly 2 billion invested in

production infrastructures

over the

past 5 years

(*) This vaccine is produced in response to the

threat of bioterrorism using strains of the

smallpox virus.

SANOFI PASTEUR THE BROADEST RANGE OF VACCINES WORLDWIDE

Smallpox (*)

Yellow fever

Mumps

Poliomyelitis

Measles

Influenza

Hepatitis A

Rabies

Japanese encephalitis

Hepatitis B

Rubella

Pertussis

Diphtheria

Haemophilus influenzae type b infections

Meningococcal meningitis

Pneumococcal infections

Tetanus

Tuberculosis

Typhoid fever

Cholera

Bacterial diseases

Viral diseases

Chickenpox

and against one eradicated disease

20 diseases

Creating Vaccines

Protecting Life

Back-up Slides

Influenza Vaccine Manufacturing Timeline Northern Hemisphere

Jan Dec Nov Feb Mar Apr May Jun Jul Aug Sep Oct

Surveillance &

Reassortants

Vaccination

Distribution

Produce &

Standardize Reagents

Production

(at risk)

Production

(may be at risk)

Production

Strain

Balancing

Filling &

Packaging

Formulation

Produce

Working

Seed

Production

Annual

License

Approval

Strain Selection

FDA

WHO

Wh

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DC

/ E

CD

CV

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The A(H1N1) 2009 Pandemic: Key dates

14000

12000

10000

8000

6000

4000

2000

250

200

150

100

50

Apr 09 May 09 Sep 09Aug 09Jul 09Jun 09 Nov 09Oct 09 Dec 09 Jan 10

24

New influenza A virus

identified by CDC in

samples from Mexico

and US A

27

First case in Europe

02

First case in Asia

02

First case in Africa

26 WHO: Level of influenza

pandemic alert

from phase 3 to 4

27 WHO: Level of influenza

pandemic alert

from phase 4 to 5

26 WHO: recommended

strain for any vaccine A/California/7/2009 (H1N1)v

WHO: Level of influenza

pandemic alert

from phase 5 to 6

1 1 07 WHO, ACI P , ECDC

List of priority groups

for pandemic vaccination

WHO, CDC, ECDC

Stop reporting the

number of cases

15 US FD A licensed Sanofi Pasteur's

pandemic influenza vaccine

13 French Afssaps licensed Sanofi Pasteur's

pandemic influenza non-adjuvanted vaccine

1-8 Sanofi Pasteur announced preliminary results

from US and European clinical trials in adults

following one dose of influenza A (H1N1) 2009 vaccine

26 Sanofi Pasteur began large-scale production

of the novel H1N1 vaccine in the US and France

29 Sanofi Pasteur begins shipping

pandemic influenza vaccine in US

23 European Medicines Agency

recommends 3 A(H1N1)

2009 pandemic vaccines

for an EU-wide marketing

24 WHO: A/California/7/2009 (H1N1)-like virus

recommended for 2010 southern

hemisphere seasonal influenza vaccines

11

208 countries and territories

reported cases

China: first country to start

pandemic vaccine immunization, in students

21 20 V accination campaign

began in France and UK 05 V accination campaign

began in the US A

09 V accination campaign

began in Russia

V accinatiion campaign

began in Australia

30

Public Health Impact of Influenza Disease

Mean Annual Numbers of Deaths (US, 1976-99)

Virus Pneumonia &

Influenza

Respiratory &

Circulatory All Causes

A/H1N1 381 1960 2836

A/H3N2 6613 28940 40017

B 1103 5255 8349

Simonsen, et al., JID 2000;181:831

Thompson, et al., JAMA 2003;289:179

Virus Numbers of

Epidemics

Excess Pneumonia & Influenza

Hospitalizations (US, 1969-95)

A/H1N1 2 35,000-49,000

A/H3N2 12 85,000-220,000

B 4 56,000-114,000