Document 7213748

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Preparing to Protect: Flu
Vaccines From Production to
Consumption
Kristin L. Nichol, MD, MPH, MBA
Professor of Medicine, University of Minnesota
Chief of Medicine, Minneapolis VA Medical Center
2007 National Health Policy Conference
February 12, 2007 Washington DC
Prevention & Control of Seasonal
Influenza is Important
* Substantial annual burden of disease
* Critical element for pandemic influenza
strategy
Selected Challenges

Strategies targeting high risk groups have not
been fully successful




Risk based recommendations difficult to
implement
Ageism ?
Public financing not available for many 18 – 64 YO
in target groups
Vaccine supply has not always been available
in sufficient quantity or in a timely manner
US Influenza Vaccination Rates,
1997 – 2003 NHIS (low & stagnant)
100
2010 Goal Elderly
90
80
70
65+
60
2010 Goal HR < 65
50
HR 50 - 64
40
30
HR 18 - 49
20
10
0
1997
1998
1999
2000
www.cdc.gov/flu/professionals/vaccination [accessed 8/23/06]
2001
2002
2003
Influenza is the #1 Cause of Death Due to
Vaccine Preventable Diseases
Cases & Deaths, US 1989 - 1998
Disease
Cases
Deaths
Influenza
(millions)
> 500,000
Pneumococcal
(millions)
~ 120,000
Hepatitis A
282,650
1013
Hepatitis B
146,644
9694
Measles
60,189
132
Mumps
24,075
7
Rubella
4412
21
Pertussis
53,634
65
Tetanus
486
77
MMWR 2001; 48 (RR-53); Thompson et al. JAMA 2003; 289: 179;
Feikin DR, et al. Am J Public Health 2000; 90: 223-9.
90% in the
elderly
11k from
1989-98
(actual is
5x to 10x
higher)
VPD’s Take the Highest
Death Toll Among Adults
Annual VPD Deaths

Adult
Adults: 99% of VPD
Deaths


Childhood
VPD = Vaccine Preventable Disease
Source: CDC, IOM
30,000 to 70,000
deaths each year
Children: 1% of VPD
Deaths

100 to 300 deaths
each year
Vaccine Supply & Demand
We Need More of Both Now to Assure Adequate Supplies for
Seasonal Influenza and Capacity for Pandemic Influenza
Demand
Supply
Influenza Vaccine
Production is an 8 to 9 Month Process
Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
Sep
Oct
Nov
Eggs
Production of Concentrates
Formulation-Testing
FDA Release
Filling-Testing
Packaging
Distribution
Need to Know:
One or more All strains
strains in
in formula
formula
Administration
Precise
formulation
ACIP
recommendations
for use
Courtesy of the Centers for Disease Control and Prevention.
The characteristics of the strains circulating the previous season
provide the basis for selecting virus strains for the next year’s vaccine.
Dec
Recent Experiences

Changing messages to the public:




Step in line (for high risk) 
Step aside unless really high risk 
Step in line (all)
Frustration among providers

No vaccine, late vaccine, uneven
availability of vaccine (haves and have
nots)
Timing of Influenza Vaccinations & the
Challenge of Extending into Dec & Beyond
Percent of Vaccinations.....
MN Medicare Beneficiaries
100
80
60
40
20
0
Aug
Sep
Oct
1998
www.cms.hhs.gov/preventiveservices/2d3.asp
Nov
1999
Dec
US Influenza Vaccine Supply
Will Demand Keep Up?
200
180
Doses (Million)
160
140
Max Amount
Ever Distributed
120
100
80
60
40
20
0
2004
2005
2006
2007
2008
* National Influenza Vaccine Summit, Jan 2006; sanofi pasteur estimates
2009
2010
2011
2012
2013
2014
2006 – 07 Experience

“New challenges for officials: Maximizing takers for
increased flu shot supply

This season may be one in which there is more than enough
vaccine rather than a shortage”


“Doctors wary about flu vaccine deliveries.

Supplies are supposed to be plentiful, but after several
rough seasons, physicians are dubious”


AMNews Jul 10, 2006
AMNews, Oct 9, 2006
“Distribution gaps appear in flu shot supply

Those involved in dispensing vaccines taking pains to explain
the system’s complexities to physicians”

AMNews Nov 6, 2006
Selected Challenges

Strategies targeting high risk groups have not
been fully successful




Risk based recommendations difficult to
implement
Ageism ?
Public financing not available for many 18 – 64 YO
in target groups
Vaccine supply has not always been available
in sufficient quantity or in a timely manner
US Influenza Vaccination Rates,
1997 – 2003 NHIS (low & stagnant)
100
2010 Goal
80
65+
60
50 - 64, HR
40
18-49, HR
20
1
0
1997
1998
1999
2000
www.cdc.gov/flu/professionals/vaccination [accessed 8/23/06]
2001
2002
2003
VPD Deaths in Adults are Similar to Other
Important Causes of Death in Adults
0
10,000
20,000
30,000
40,000
50,000
60,000
70,000
VPD's Adults
Colorectal CA
Breast CA
Prostate CA
Suicide
Parkinson's
HIV
VPD's Kids
Source: CDC, NCHS (online data for 2000).
Range of
VPD
deaths in
adults