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Pneumococcal conjugate vaccine impact and schedule arithmetic:
3+0 vs 3+1 vs 2+1
Peter McintyreNational Centre for Immunisation Research AustraliaKids Research Institute and University of Sydney
Arithmetic of PCV schedules - outlineThe 7 valent PCV era: IPD
• The “ 3+0 “ story and Australia’s role in it• Aboriginal and Torres Strait Islander peoples
Non-IPD especially pneumonia
The 10 and 13 valent era: IPD Evolution of 2+1 internationally
Rationale for Australian child pneumococcal vaccine schedule
Conjugate vaccine• 3 doses (2,4,6 months) no risk factors
• Cost-benefit • Meningitis most common under 12 months of age
• 4 doses (2,4,6,12) with risk factors• Lesser immune response
Polysaccharide vaccine • @ 18-24 months for Indigenous children in high
incidence areas (NT, WA, SA, Qld)• Equivalent boosting to 7vPCV• Response to additional serotypes
Potential disadvantages of Australian schedule
No routine conjugate booster• Less impact on vaccine type IPD
- waning/breakthrough • Less protection against non-bacteraemic disease• Less herd immunity
23vPPV booster • Effective vs non 7v types? • Hyporesponsiveness?
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The 7v PCV era
Australian data sources to review schedule – criteria
Trends in incidence of IPD • Long-term • Stable surveillance system • All or most isolates serotyped
Trends in incidence of hospitalisation• ICD coded pneumonia
2012/13 meta-analysis: 7vPCV impact/replacement
Australian studies evaluating impact of 3+0 schedule
IPD – direct and indirect • NSW (greater Sydney) only: Lowbridge et al 2015• Indigenous and non-Indigenous children: Jayasinghe et al 2016
ICD-coded pneumonia • Jardine et al 2009• Menzies et al 2015
Middle ear ventilation tube (MVTI) insertions • Jardine et al 2010
Post program impact economic analysis • Newall et al 2015
IPD impact – comparing Australia, UK and US
Pneumonia Impact – ICD codes
Indigenous children in Northern Australia and the 23 v PPV booster
Indigenous vs non-Indigenous children in 7v+23v eraimportance of 19A
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The 10/13v PCV era
Immunization coverage with PCV3 containing vaccines in infants, 2015
The boundaries and names shown and the designations used on this map do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. © WHO 2016. All rights reserved
<50% (15 countries or 8%)
50-79% (22 countries or 11%)
80-89% (26 countries or 13%)
>=90% (57 countries or 29%)
Not available / not in national immunization schedule (65 countries or 34%)
Not applicable
PCV in schedule but no coverage data available (9 countries or 5%)Source: WHO/UNICEF coverage estimates 2015 revision, July 2016. Map production: Immunization Vaccines and Biologicals, (IVB). World Health Organization. 194 WHO Member StatesDate of slide: 02 August 2016
PCV Product Use, Globally(June 2017)
PCV10 (33)
PCV13 (100)
PCV10 and PCV13 (8)
Product Gavi Non-Gavi Total
PCV10 14 19 33PCV13 45 55 100
Purchase of PCV = high % of national spending on vaccines
Source: V3P database - www.who.int/immunization/v3p (2015)Note: This graph is calculated using the price and volumes reported by countries for each vaccine type. Both volume and price can therefore influence the share of a vaccine on the expenditure on vaccine purchase. Moreover, particular events such as campaigns, stock replenishment and shortages can influence these percentage. The graph intends to give an indication of the weigh of a vaccine in the overall vaccine purchases and should be used with caution. Only budget sources from the government can give a clear picture of the overall and detail spending on vaccines in a country. The graph only shows countries reporting 5 or more vaccine types for that year and vaccine types with volumes registered as greater than 1.
Median of 37% of spending on vaccines
In MICs median is at 44%.
Share is much higher than for other newer vaccines
(eg. median for Rota: 16%; Penta 16% ; Hexa 29% )
PCVLMIC UMIC
Share of expenditure on each vaccine type over total expenditure on vaccines in each country, 2015In percentage of total national purchases of vaccines
21 | June 12, 2017 |WHO Technical Expert Consultation on Optimization of PCV I
10- year horizon
• Introduction continues at pace• Coverage enhanced, especially in high need
areas• Additional products on market reduce prices• Serotype replacement is limited
• Countries continue investment in PCV• Maximum health benefit is accrued
• Failure to Achieve Optimized Impact• Serotype Replacement Substantial• Subnational Inequity Persists• Supply Challenges
• Weakened country commitment• Withdrawal of PCV
Alternative 10- year horizon
For PCV administration to infants, WHO recommends 3 primary doses (3+0) or as an alternative 2 primary doses plus a booster (2+1).
In choosing between the schedules, countries should consider the epidemiology of the disease, coverage and timeliness of doses.
If disease incidence peaks in young infants (< 32 weeks), a 2+1 schedule might not offer optimal individual protection
In contrast, higher antibody levels are induced by the 3rd dose in a 2+1 schedule. This may be important for duration of protection
If a 2+1 schedule is selected, the 2 primary doses should be given with an interval preferably of 8 weeks or more; one booster dose should be given between 9-15 months of age
CHOICE OF SCHEDULE
24 | June 12, 2017 |WHO Technical Expert Consultation on Optimization of PCV Impact
What may have changed
Additional data availability• On PCV 10 and PCV 13, including large observational
studies• From low and middle-income countries using different
schedules Programmatic issues
• Increasing use of second year of life platform for vaccination
Financing and sustainability issues• Changes in vaccine price and supply
25 | June 12, 2017 |WHO Technical Expert Consultation on Optimization of PCV Impact
Studies evaluating impact of 3+0 schedule
IPD – direct and indirect • NSW (greater Sydney) only: Lowbridge et al 2015• Indigenous and non-Indigenous children: Jayasinghe et al 2016• All ages 2002-2014: Jayasinghe et al 2017
ICD-coded pneumonia • Jardine et al 2009• Menzies et al 2015
Middle ear ventilation tube (MVTI) insertions • Jardine et al 2010
Post program impact economic analysis • Newall et al 2015
Only study Including
PCV 13 era
Impact of PCV7 & 13 2002-2014 – Australia
IPD in NZ in post PCV – ESR report
All IPD: reductions in Australia1 and New Zealand2 by age group
Age group Australia 9 yrs post PCV
NZ8 years post PCV
< 2 years - 82 % - 88%
2-4 years - 69% - 77%
> 65 years - 40% - 28%
All ages - 47% - 40%
1. Jayasinghe et al 2. ESR report to 2015
13vPCV & 7vPCV 3+0 schedule VE – paper in press Sanjay Jayasinghe NCIRS
Albania, Latvia……….Australia Albania introduced PCV universally in March 2011 but
switched from 3+0 to 2+1 in 2015• PCV Coverage 99% reported each year from 2011-15
Latvia introduced PCV universally in 2010 but switched from 3+0 to 2+1 in 2012• PCV2 coverage increased from 76% (2012) to 90%
(2015)
Out of the 13 countries that switched schedules, 11 countries from 3+1 to 2+1
Moving from 3+0 to 2+1 in Australia
7vPCV & 13vPCV breakthrough cases,2006-2016
51
57
5 5 412
28
35
43
53
0
10
20
30
40
50
60
2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Coun
t
Diagnosis year
7vPCV 13vPCV
Data source: National Notifiable Diseases Surveillance System
Consultation document
Breakthrough IPD cases due to 13vPCV serotypes
Estimated IPD cases in older age groups: 3+0 vs 2+1
IPD data by ethnicity - NZ
IPD incidence in Indigenous children* < 5yrs of age 2002-2015
In Northern Territory, Queensland, South Australia & Western Australia
IPD incidence in Non-Indigenous children < 5yrs of age, 2002-2015
Incidence of invasive pneumococcal disease notifications (/100,000) for Indigenous Australians by age group 2002-2014
IPD incidence rates (/100,000) for Indigenous and non-Indigenous Australians by age group, 2002-14
42
Summary
PCVs are not one vaccine, but several Schedule appears to make a difference especially
for serotype 19A Move to 2+1 with PCV13 for Australia and major
push for 2+1 PCV schedules internationally NZ moves back to the future with PCV 10
“ We live in interesting times”
Acknowledgements Sanjay Jayasinghe NCIRS Laboratories
• CIDM, Westmead – NSW• ,MDU, Doherty Institute – Victoria• QHPSS, Queensland• Referring laboratories Australia wide
Enhanced IPD Surveillance Working Group• Vicki Krause, Heather Cook, CDC NT• Kristina Barry Surveillance DoHA• Robin Gilmour, Mark Bartlett, NSW Health• David Cole, DHHS Tasmania• Craig Davis, Queensland Health• Ros Holland, DHS SA• Carolien Giele, WA Health• Riemke Kampen, DHCC ACT• James Fielding, DHS Victoria