DRAFT FOR DISCUSSION - UNICEF · GAVI PD confirms input ... •GAVI support based on revised...
Transcript of DRAFT FOR DISCUSSION - UNICEF · GAVI PD confirms input ... •GAVI support based on revised...
DRAFT FOR DISCUSSION
Pneumococcal Vaccine SDF
AVI version 3.0
Lauren Franzel
AVI Strategic Vaccine Supply Sub Team
March 10, 2011
AVI Pneumococcal SDF version 3.0
Pneumococcal Vaccine SDF version 3.0
Executive summary
• No financial or supply constraints
• Policy revisions and changes in country
adoption decisions result in 54 introductions by
2015, all but 1 expected applying in 2011-2012
• Up to 20 NVS applications for PCV expected
in May 2011, 26 including the 5 conditionally
approved and 1 resubmission
• AMC demand exceeds 134m doses in 2016 per
SDF v3.0 base case scenario
15-Mar-11 2
AVI Pneumococcal SDF version 3.0 AVI Pneumococcal SDF version 3.0 15-Mar-11 3
Evolution of Pneumo SDF from ADIP to V3 (2009-2030)
Graduating countries and 50% NVS threshold
represent important demand opportunities
Detail 2009-2016
AVI Pneumococcal SDF version 3.0 AVI Pneumococcal SDF version 3.0 15-Mar-11 4
Since AVI in place very limited changes
in countries interest in PCV
AVI Pneumococcal SDF version 3.0 AVI Pneumococcal SDF version 3.0 15-Mar-11 5
SVS benchmarks assumption
Assumption owners provide
input
SVS runs SDF and AF
SVS Sub team & GAVI Focal Point review draft SDF
and AF
SVS incorporates feedback from
subteam
Feedback
Feedback
Director of AVIApproves SDF &
AF and submits to GAVI F&O
GAVI Finance develops financial
forecasts
AVI AMT / GAVI reviews and
endorses SDF & AF
Expenditure Review Board
Approves Forecasts
GAVI Forecast Review Board
convenes
Feedback
GAVI PD confirms input into AF
SVS incorporates feedback from
AMT/GAVI
Feedback
Forecasting process designed to ensure
multiple input and verification points
AVI Pneumococcal SDF version 3.0 AVI Pneumococcal SDF version 3.0 15-Mar-11 6
SDF version 3.0 base case assumptions
(1/3)
Finance &
support*
• No global financial and supply constraints included into the base case strategic demand
forecast;
• GAVI support based on revised eligibility approved by November 2009 Board and pilot
prioritization policy approved by June 2010 Board
• Applications round to re-start as per May 2011 with graduating countries grandfathered
for the first round and NVS threshold at 50% DTP3
• NVS applications evaluated on national metrics (no separate state / sub-national applications)
• After graduation from GAVI support countries assumed to be in condition to fully finance
purchase of PCV
• Co-financing policy revision (December 2010) fully incorporated, effective from 2012
• GNI projections based on 2009 IRBD actual and CGD projections
• PAHO single price clause not impacting negatively manufacturers intention to supply
Target
Population
• Surviving Infants based on 2008 UN population prospect, medium variant for population, birth
& infant mortality rates
• India population at state level based on Indian census (projected with UN growth rate)
AVI Pneumococcal SDF version 3.0 AVI Pneumococcal SDF version 3.0 15-Mar-11 7
SDF version 3.0 base case assumptions
(2/3)
Products • All products WHO pre-qualified, meet or exceed AMC profile and have suitable presentation
• Mix of international and developing countries suppliers ensures no capacity constraint:
• Synflorix available since end Q1 20101, Phase IV study in Kenya and Ethiopia
assumed successful,
• Prevnar13 available since Q3 20102
• First DCMVN products to be available by 20163 and acceptable from countries with their
serotype coverage
• India preference for introduction with local manufacturer can be derogated in the first years
• Schedule = 6, 10 and 14 weeks of age with DTP or Pentavalent / No Booster – some
countries as India may consider different schedule
• Presentation = 1-dose and 2-dose liquid vials (future DCVMN manufacturers may provide
higher number of doses per vial)
• Supply availability sufficient assuming successful call-for-offer in 2011
Logistics • Wastage = 10% based on WHO guidance (to reflect an unknown mix of presentations ranging
from 1 to >2 doses per vial) – for countries introducing Prevnar13 5% wastage assumed
• Buffer stocks = 25% of ∆ between forecast years
• Cold chain up scaling and financing available at central & local level in all countries
1 Synflorix: PQ subject to special conditions accompanying 2 dose vial presentation in March 2010; Kenya and other special
cases only for post-introduction surveillance of 2-dose vial presentation
2 Prevnar13: WHO PQ in August 2010, first shipments commenced in Q4 2010
3 Based on standard development timelines (see backup) of 5 years from phase 1 to pre-registration
15-Mar-11 7
AVI Pneumococcal SDF version 3.0 AVI Pneumococcal SDF version 3.0 15-Mar-11 8
SDF version 3.0 base case assumptions
(3/3)
Introduction • Introduction timing as per WHO Regional calls and other input received from WHO and UNICEF;
introductions separated by 24 months unless documented input
• Applying countries are assumed to introduce the year following application in
absence of national cold chain or other infrastructure limitations
• Delay applied if countries required multiple applications for GAVI support for other
vaccines
• Countries applying for 2 vaccines are assumed to introduce within of 2 years of
approval as not to lose GAVI support
• Twelve months average preparation time required after Board/EC approval (based on Penta
analogue) – preparation time required is expected to decrease to 11 months in 2012 and to
10 months from 2013 onwards.
• India phased introduction financed locally beyond GAVI cap – 11 states (same 10 states
Introducing Penta + Orissa pilot) to introduce in 2016, remaining states after 2 yrs; graduation as
country in 2020
• Chad and Somalia cannot apply for NVS because of low DTP coverage
• Ethiopia to introduce Q3 2011; Pakistan introduce in Q4 2011
• Nigeria to introduce in 2014 after taking advantage of 50% DTP3 NVS threshold for Penta
and Pneumo
• Indonesia loses eligibility in 2011 and is not expected to apply before graduating; locally
financed introduction from 2018
Uptake • Time to match reference coverage aligned with HepB/Penta analogue (Pneumo introduced with
same schedule as Penta): 24 months for small countries / 36 for medium/large countries (>1 mln
SI) / 48 months for very large countries (>3.5 mln SI)
Coverage • Reference coverage: DTP2 linear extrapolation based on DTP3/1 WHO/UNICEF 2010 estimates;
Nigeria assumption for reference coverage is 63% in 2010
• Projected coverage: based on standard AVI coverage projections rules
AVI Pneumococcal SDF version 3.0
1 1 14
40
71 96
112 116 122 125 125 124 124 112 108 107 105 106
89 90 88 88
16 26
47 57 61 61 60 59 59 58 57
56 55 54 54
2
2
5 5 8 8
21 26 29 30 31 48 48 50 50
1
7 11 12 14 13 13 13 13 13 13 13 13 13
1 1 14
40
71
96
112
134
151
184 198
205 207 206 207 207 207 207 206 206 205 205
50
100
150
200
250
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030
Mil
lio
ns o
f D
os
es
AVI SDF v3.0 BASE CASE - Total required supply from GAVI 72 including graduating countries
Eligible India India graduated*
Other countries graduated* Graduating before introduction AVI SDF v2.0
Call for offer
reference year
15-Mar-11 9
Demand from GAVI 72 to peak at 207m doses in
2021
Countries that introduced prior to graduation assumed to continue purchasing
vaccines with their own funds when commitment ends
2009 2010 2011 2012 2013 2014 2015 2009-2015
Introductions 2 1 15 12 18 4 2 54
AVI Pneumococcal SDF version 3.0 15-Mar-11 10
1 1 12
30
57
77 87 91 96 102 104 105 105 106 106 107 107 108 108 108 108 108
- -
-
-
-
-
-
16
26
47 57 61 61 60 59 59 58 57 56 55 54 54
5
8 9 11 11 11 11 11 11 11 11 11 11
- -
-
-
-
2
7
10
12
13
13 13 13 13 13 13 14 14 14 14 14 15
- -
2
7
11
14
15
15
15
15
15 15 15 15 15 15 15 15 15 15 15 15
1 1
14
40
71
96
112
134
151
184
198 205 207 206 207 207 207 207 206 206 205 205
-
50
100
150
200
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030
Mill
ions
Pneumococcal Vaccine - AMC Required Supply (72 GAVI eligible countries) by large country
Other Countries India Indonesia Nigeria Pakistan PAHO
From 2019, 4 large countries constitute
almost 50% of demand
AVI Pneumococcal SDF version 3.0
Importance of large countries can be
seen now
15-Mar-11 11
8 20
36
50 58
78
3
6
8
8
8
8
1
5
7
9
9
9
2
7
11
14
15
15
2
7
10
11
10
14
40
71
96
112
134
18
30
48
52 54 55
0
10
20
30
40
50
0
20
40
60
80
100
120
140
2011 2012 2013 2014 2015 2016
Millio
ns o
f d
oses
Pneumo Strategic Demand Forecast Detail – 2011-2016
All other countries DRC Ethiopia Pakistan Afghanistan Nigeria Bangladesh Total Introduce Countries (cumulative)
AVI Pneumococcal SDF version 3.0 AVI Pneumococcal SDF version 3.0 15-Mar-11 12
GAVI commitments > SDF because of time to peak,
coverage, and target population assumptions
Adjusted GAVI demand • Demand for approved countries based on GAVI commitments matching applications requested volumes
• Commitments cover only limited number of years (depending on cMYP), for outer years projections based on yearly
growth rate from SDF applied to latest available committed volumes
− Year 1 of commitment assumed including 25% buffer stock. Projections for countries with only one year of demand
based on year 1 values w/o buffer stocks and steady state growth rate.
• If a country has no approved supply, SVS SDF v3.0 forecast is used
15-Mar-11 12
14
40
71 96
112 132
148 172
183
124
32 50 44
9 10
20 27
68 70
5 25
46 60
160 176
200 210
151
32
75
96
123
140
160
176
200 210
151
50
100
150
200
2011 2012 2013 2014 2015 2016 2017 2018 2019 2020
Do
se
s (
Mil
lio
ns)
AVI Version 3.0 – Adjusted Demand vs. Strategic Demand Forecast GAVI-Eligible Supply Only
SDF - GAVI required supply Commitments Extensions New Requests Balance of Demand
Drop in GAVI
required supply due
to India graduation
AVI Pneumococcal SDF version 3.0
1
30
64
93 111 120 117
127 124 126 124 124 112 109 107 105 106
89 90 88 88
35 28
71 62 62 61
60 59 59 58 57
56 55 54 54
2 4
21 19 21 21
34 40 42 44 44 61 61 63 63
1
30
64
93
111 120
154 159
216 207 206 207 206 208 207 207 207 206 206 205 205
50
100
150
200
250
2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030
Mil
lio
ns o
f D
os
es
AVI SDF v3.0 1 YEAR UPTAKE - Total required supply from GAVI 72 including graduating countries
Eligible India India graduated* Other countries graduated* AVI SDF v3.0 - BASE CASE
15-Mar-11 13
If countries are able to reach reference coverage in
year 1, reference year demand grows by 13%
Call for offer
reference year
AVI Pneumococcal SDF version 3.0
1 15
49
83 102
115 116 120 125 125 124 124 112 108 107 105 106
89 90 88 89
16 26
47 57 61 61 60 59 59 58 57
56 55 54 54
2
5
12 16 20 22
34 39 41 43 43 60 60 62 62
1 15
49
83
102 115
134
151
184
198 205 207 206 207 207 206 206 205 205 205 204
50
100
150
200
250
2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030
Mil
lio
ns o
f D
os
es
AVI SDF v3.0 AGGRESSIVE - Total required supply from GAVI 72 including graduating countries
Eligible India India graduated* Other countries graduated* AVI SDF v3.0 - BASE CASE
15-Mar-11 14
2009 2010 2011 2012 2013 2014 2015 2009-2015
Introductions
(BASE CASE) 2 1 15 12 18 4 2 54
Introductions
(AGGRESIVE
CASE) 2 1 15 26 6 4 0
54
If cold chain and past application success delays
are removed, demand materializes earlier
AVI Pneumococcal SDF version 3.0
1 1
58
97 102 120 118 119 124 124 126 124 124
112 109 107 105 106 89 90 88 89
35 28
71 62 61 61
60 59 59 58 57
56 55 54 54
2 6
21 19 21 21
34 39 41 43 43 60 60 62 62
1 1
58
97 102
120 118
157 159
216 207 206 207 206 207 206 206 206 205 205 205 204
50
100
150
200
250
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030
Mil
lio
ns o
f D
os
es
AVI SDF v3.0 AGGRESSIVE & 1 YEAR UPTAKE - Total required supply from GAVI 72 including graduating countries
Eligible India India graduated* Other countries graduated* AVI SDF v3.0 - BASE CASE
15-Mar-11 15
Aggressive scenario and 1 year uptake assumption
yield peak of 216 in 2018 for GAVI 72
Countries that introduced prior to graduation assumed to continue purchasing
vaccines with their own funds when commitment ends