DRAFT FOR DISCUSSION - UNICEF · GAVI PD confirms input ... •GAVI support based on revised eligibility approved by November 2009 Board and pilot prioritization policy approved by

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


Since AVI in place very limited changes

in countries interest in PCV


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


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)



(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



(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


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


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)


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


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


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


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


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


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

AVI Pneumococcal SDF version 3.0 15-Mar-11 16

Thank you

•Courtesy of PATH

Documents

DRAFT FOR DISCUSSION - UNICEF · GAVI PD confirms input ... •GAVI support based on revised eligibility approved by November 2009 Board and pilot prioritization policy approved by