3. Influenza in Humans
epidemiology and control by vaccination
Sam Lee, PhD
Sr. Director, Pandemic Influenza Strategy
Franchise & Global Marketing Strategy
Sanofi Pasteur
4. Airborne Transmission of Respiratory
Pathogens
Steinhoff, Johns Hopkins School of Public Health, EID_lect13_Steinhoff.pdf
9. Annual Impact of Seasonal Influenza in the
United States
Deaths
Hospitalizations 36,0001
114,0002
Physician visits
25 million3
Infections and illnesses
50–60 million3
Direct medical costs
>$10 billion4
In-Direct medical costs
>$50 billion5
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.
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
10
11. Vaccination provides effective protection
against flu at all ages
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
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
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
1 http://www.who.int/mediacentre/factsheets/fs211/en/Accessed July 2, 2010.
*Influenza vaccination is most effective when circulating viruses are well-matched with vaccine viruses
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.
13. Seasonal Occurrence of Influenza
Northern hemisphere
Tropical
Southern hemisphere
J F M A M J J A S O N D
Reichelderfer PS, et al. Influenza surveillance in the pacific basin. In: Current topics in medical virology 1988:412-38
14. Potential Benefit of Quadrivalent Vaccines
B lineage circulation in Europe (2003-2011)
100%
9% 8% 6%
90%
31%
80%
70% 56%
60% 80%
50% 99% Yamagata
91% 92% 94%
40% Victoria
69%
30%
20% 44%
10% 20%
1%
0%
2003-2004 2004-2005 2005-2006 2006-2007 2007-2008 2008-2009 2010-2011
Vaccine Victoria Yamagata Yamagata Yamagata Yamagata Yamagata Victoria
Match with
dominant
circulating lineage
X P X X P X P
16. SANOFI PASTEUR
WORLDWIDE LEADER IN HUMAN VACCINES
● 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
17. 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
10 sites plus 3 under
construction
Val de Reuil
Marcy-l’Etoile
More than
Toronto 50% of total staff
in industrial operations
Shenzhen
More than 1 billion doses
Swiftwater (PA)
of vaccine produced each
Canton (MA) year
Rockville (MD)
Nearly 2 billion invested in
Hyderabad production infrastructures
Chachoengsao
over the
Pilar past 5 years
Sites under construction: Ocoyoacac (Mexico), Neuville (France), Shenzhen (China)
18. SANOFI PASTEUR
THE BROADEST RANGE OF VACCINES WORLDWIDE
Viral diseases Bacterial diseases 20 diseases
Yellow fever Pertussis
Mumps Diphtheria
Poliomyelitis Haemophilus influenzae type b infections
Measles Meningococcal meningitis
Rubella Pneumococcal infections
Influenza Tetanus
Hepatitis A Tuberculosis
Hepatitis B Typhoid fever
Rabies Cholera
Japanese encephalitis and against one eradicated disease
(*) This vaccine is produced in response to the
Chickenpox Smallpox (*) threat of bioterrorism using strains of the
smallpox virus.
21. Influenza Vaccine Manufacturing Timeline
Northern Hemisphere
Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov
Strain Selection Annual
License
FDA
Produce & Approval
Standardize Reagents
Vaccination
WHO
Surveillance &
Reassortants
Production Strain
Production
(at risk) Balancing
Production
(may be at risk) Formulation
Produce Production
Working
Seed
Filling &
Packaging
Distribution
22. The A(H1N1) 2009 Pandemic: Key dates
250 14000
12000
200
First case in Europe
Epidemic
10000
150 27
New influenza A virus First case in Africa 8000
identified by CDC in
samples from Mexico 02 6000
100 and USA First case in Asia
208 countries and territories
24 02 reported cases 4000
50
11 2000
Apr 09 May 09 Jun 09 Jul 09 Aug 09 Sep 09 Oct 09 Nov 09 Dec 09 Jan 10
Who / CDC / ECDC
26
26
WHO: Level of influenza
pandemic alert WHO: recommended WHO, CDC, ECDC 24
strain for any vaccine Stop reporting the WHO: A/California/7/2009 (H1N1)-like virus
from phase 3 to 4 A/California/7/2009 (H1N1)v number of cases recommended for 2010 southern
27 11 07 hemisphere seasonal influenza vaccines
WHO: Level of influenza WHO: Level of influenza WHO, ACIP, ECDC
pandemic alert pandemic alert List of priority groups
from phase 4 to 5 from phase 5 to 6 for pandemic vaccination
Vaccine Manufacturing
23
13
and registration
26 15 European Medicines Agency
recommends 3 A(H1N1) French Afssaps licensed Sanofi Pasteur's
Sanofi Pasteur began large-scale production US FDA licensed Sanofi Pasteur's
2009 pandemic vaccines pandemic influenza non-adjuvanted vaccine
of the novel H1N1 vaccine in the US and France pandemic influenza vaccine
for an EU-wide marketing
29 1-8
Sanofi Pasteur announced preliminary results
Sanofi Pasteur begins shipping
from US and European clinical trials in adults
pandemic influenza vaccine in US
following one dose of influenza A (H1N1) 2009 vaccine
Vaccination campaign
09
21 Vaccination campaign
China: first country to start 20 began in Russia
pandemic vaccine immunization, in students Vaccination campaign
began in France and UK
30 05
Vaccinatiion campaign Vaccination campaign
began in Australia began in the USA
23. Public Health Impact of Influenza Disease
Numbers of Excess Pneumonia & Influenza
Virus
Epidemics Hospitalizations (US, 1969-95)
A/H1N1 2 35,000-49,000
A/H3N2 12 85,000-220,000
B 4 56,000-114,000
Mean Annual Numbers of Deaths (US, 1976-99)
Pneumonia & Respiratory &
Virus All Causes
Influenza Circulatory
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
