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  • www.ncirs.usyd.edu.au

    Pneumococcal conjugate vaccine impact and schedule arithmetic:

    3+0 vs 3+1 vs 2+1

    Peter Mcintyre National Centre for Immunisation Research Australia Kids Research Institute and University of Sydney

  • Arithmetic of PCV schedules - outline The 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?

  • www.ncirs.usyd.edu.au

    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 era importance of 19A

  • www.ncirs.usyd.edu.au

    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

    =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 States Date 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 33 PCV13 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% )

    PCV LMIC UMIC

    Share of expenditure on each vaccine type over total expenditure on vaccines in each country, 2015 In percentage of total national purchases of vaccines

    21 | June 12, 2017 |WHO Technical Expert Consultation on Optimization of PCV I

    http://www.who.int/immunization/v3p%20(2015

  • 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

    NZ 8 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

    5 1

    5 7

    5 5 4 12

    28

    35

    43

    53

    0

    10

    20

    30

    40

    50

    60

    2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

    Co un

    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 < 5y