Transcript Decline in Invasive Pneumococcal Disease in the U.S. in 2000

New Vaccines for Preventing
Bacterial Respiratory Infections
Cynthia Whitney
Centers for Disease Control and Prevention
Atlanta, GA
National Immunization Conference March 2007
Bacterial Respiratory Pathogens
Targeted by New Vaccines
• Haemophilus influenzae type b (Hib)
– New pediatric combination (Pentacel®)
• Pertussis
– New pediatric combination (Pentacel®)
– Tdap for adolescents and adults
• Streptococcus pneumoniae
(pneumococcus)
– Conjugate vaccine for children
Hi Incidence* in Children <5
Years, By Year and Serotype
Incidence per 100,000
40
Hib
Other
Unknown
35
30
25
20
15
10
5
0
91
93
95
97
Year
*From CDC’s Active Bacterial Core surveillance (ABCs)
99
01
03
Pentacel ® Introduction
• DTaP-IPV-Hib
• sanofi pasteur submitted a Biological
License Application for 4-dose primary
series in children 2, 4, 6, and 15-18
months
Thanks to Pat Joyce
Pentacel ® in 2007 Childhood
Schedule
Next Steps
• Form ACIP combination vaccines
working group
• Review data on immunogenicity and
safety
• Consider need to update combination
vaccines statement
Global status of countries using Hib vaccine in
their national immunization system, 2006
Routine Hib implementation status
GAVI Fund
No
Yes
Supported
Introduced or plan
to introduce in 2006
92 countries are using Hib vaccine
Source: WHO/IVB database Data as of April 2006
Reported Pertussis Cases –
United States, 1922-2005*
30,000
300,000
25,000
> 18 yrs
20,000
Number of cases
250,000
15,000
DTP
200,000
11-18 yrs
10,000
5,000
< 11 yrs
0
1990
150,000
1995
2000
100,000
DTaP Tdap
50,000
0
1922 1930
1940
1950
1960
1970
1980
1990
2000
Year
*1950-2005, National Notifiable Diseases Surveillance System and 1922-1949,
passive reports to the Public Health Service, courtesy of Kristin Brown
Tdap Products Licensed in the United
States
BOOSTRIX®
ADACEL®
(GlaxoSmithKline (sanofi pasteur)†
Biologicals)*
Date of FDA
licensure
Age Indication
(years)
Usage
May 3, 2005
June 10, 2005
10–18
11–64
Active booster immunization for
prevention of tetanus, diphtheria, and
pertussis as a single dose
*Product label available at http://us.gsk.com/products/assets/us_boostrix.pdf
†Product
label available at http://www.vaccineplace.com/products/
Objectives of Adolescent and Adult
Pertussis Vaccination Policy
• Primary objective - Protect vaccinated
adolescent/adult against pertussis
• Secondary objective - Reduce the reservoir
of pertussis in population
– Decrease exposure of persons at increased
risk for complicated infection
– Reduce the cost and disruption of pertussis in
health-care settings
Tdap Target Groups
•
•
•
•
Adolescents
Adults 18-64 years
Pregnant women/new mothers
Healthcare workers
• Licensed for single dose only
• Not yet licensed for adults 65+ years
Pneumococcal Conjugate Vaccine
Introduction in the U.S.
Feb 2000
7-valent vaccine (PrevnarTM) licensed
Mid-late 2000
Recommendations for vaccine use in
all children <2 + high risk 2-4 years
Government purchasing
Rapid increase in use
Aug 2001-May
2003, 2004
Shortages
2005
83% of children 19-35 months had
received 3 or 4 doses
Active Bacterial Core Surveillance (ABCs)
Emerging Infections Program Network
Established
Areas
OR (3 counties)
CA (1 county)
MN (7 counties)
GA (20 counties)
MD (6 counties)
CT (entire state)
NY (7 counties)
TN (10 counties)
CO (8 counties)
NM (entire state)
Effect in Target Age Group
Invasive Pneumococcal Disease Rates
in Children <5 Years, ABCs, 1998-2005
Cases/100,000 population
250
PCV7
1 yr
200
150
100
50
0
<1 yr
2 yrs
3 yrs
2005 vs baseline
- 77% (<1 yr)
- 82% (1 yr)
- 75% (2 yr)
- 61% (3 yr)
- 26% (4 yr)
4 yrs
1998 1999 2000 2001 2002 2003 2004 2005
Vaccine-Type Invasive Disease in
Children <5 Years
100
81
80
63
98% reduction
60
40
27
9.4
20
4.8
2.4
1.5
CDC unpublished data and MMWR Sep 16, 2005
20
05
20
04
20
03
20
02
20
01
19
98
20
00
0
/9
9
Cases per 100,000
ABCs 1998-2005
What is Herd Immunity?
Susceptible Population
Herd immunity: Partially
Vaccinated Population
x
x
x
Evidence of herd immunity reducing
disease among children
• Drop in VT disease in children outside
vaccinated age group (~50% reduction in
infants <2 mos and children 5-17 years)
Poehling K et al, JAMA 2006
• Observed reduction in VT disease in children
<5 yrs (98%) >> expected (77%)
– Expected reduction = vaccine coverage
(83% 3+ doses) X vaccine efficacy (92%)
Replacement
(ri‘ pleys munt)
1. [n] a person or thing that takes or can
take the place of another
2. [n] an event in which one thing is
substituted for another
www.hyperdictionary.com
Relative Magnitude of Changes by
Serotype in <2 year olds, ABCs
1998/1999 (Baseline) vs. 2005
Type
Vaccine
Cases/100,000 pop
%
Baseline
2005 change
160
2
-99
95%
CI
Rate
Diff.
-99, -98
-158
VR* w/o
19A
13
1
-93
-96, -77
-12
19A
5
15
+180
+95, +303
+10
13
21
+66
+28,+116
+8
Other
nonvaccine
*Same serogroup as vaccine type
Transmission from Children to
Adults
+
VT
VT
Herd Effect in Adults
Invasive Pneumococcal Disease Rates over Time
ABCs, 1998-2005
PCV7
Cases/100,000 population
70
65+ years
2005 vs.
baseline
60
50
40
30
20
- 34%
40-64 yrs
- 16%
18-39 yrs
- 48%
10
0
1998
1999
2000
2001
2002
2003
2004
Lexau et al. JAMA 2004 and unpublished data
2005
Herd Effect in Adults 65+ Years
PCV7 types vs. nonvaccine types
ABCs 1998/99 average vs. 2005
Serotype
Vaccine
Nonvaccine
Cases/100,000 pop
Baseline
2005
34
6
26
33
Percent
change
95% CI
-82
-85, -78
+26
+14, +39
Lexau et al. JAMA 2005 and unpublished data
Next steps
• Improve coverage in the U.S.
• Continue to track replacement
disease
• Introduction of conjugate vaccines
in more countries
• Evaluate how results in other
settings compare to the U.S.
Vaccine Supply Environment
Pneumococcal vaccine pipeline
Development
Stage
Pre-clinical
stage
Clinical trial
Phase I
13-valent
Multinational
~20 vaccines
in research/
Pre-clinical
stage
(includes
conjugate &
protein-based
vaccines)
Clinical trial
Phase II
Clinical trial
Phase III
9-valent
GSK1 10valent
Launched
Prevnar
(7-valent)
Expected
launch
2008
11-valent
7-valent
Emerging
suppliers
>5 mulit-valent conjugate
vaccine projects
Source: BCG Global Supply Strategy 2005
PneumoADIP team analysis
Discontinued
Acknowledgements
ABCs Surveillance
CDC
ABCs sites
Monica Farley
Wendy Baughman
David Stephens
Nana Bennett
Shelley Zansky
Nancy Barrett
Jim Hadler
Lee Harrison
Lauri Thompson Sanza
Karen Stefonek
Paul Cieslak
Art Reingold
Pam Daily
Ruth Lynfield
Catherine Lexau
John Besser
Sue Johnson
Pam Gahr
Allen Craig
Bill Schaffner
Brenda Barnes
Matt Finke
Ken Gershman
B. Koziol
B. Juni
UTHSC San Antonio
Jim Jorgensen
Lettie McElmeel
Sharon Crawford
Emory University
Keith Klugman
Chris Van Beneden
Anne Schuchat
Elizabeth Zell
Tamara Pilishvili
Moe Kyaw
Katherine Robinson
Tami Skoff
Carolyn Wright
Brendan Noggle
John Walls
Dick Facklam
LaShondra Shealey
Dee Jackson