Vaccine manufacturing in Africa - DCVMN member briefing - Presentation document
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Vaccine manufacturing in Africa DCVMN member briefing – Presentation document 17 March, 2021 This study has been funded by UK aid from the UK Government; however, the views expressed do not necessarily reflect the UK government’s official policies
What will we discuss today?
Objectives for this
session
Introduction to Vx manufacturing work conducted to date 10 mins
Provide an overview of the current state
of vaccine manufacturing in Africa
Share potential opportunities and
Sharing findings: Our learnings on vaccine 40 mins potential actions required for expanded
manufacturing in Africa local vaccine manufacturing
African Vaccines for Africa: why now? Hear perspectives on the African vaccine
manufcaturing opportunity from DCVMs
Market landscaping across Africa
Potential models and investment opportunities
Potential roadmap
But it is not:
A specific recommendation to be adopted
either for countries, products, or specific
Hearing from you: What are opportunities from here? 40 mins investments
Discussion: Understanding private sector stakeholder priorities
Next steps: How we plan to engage you going forward
2
Four shifts in recent years have re-triggered the conversation around
vaccine manufacturing in Africa, leading to a sense of urgency
The impact of COVID- Strong demand Evolving economics More supportive
19 and Africa-specific growth. driven by new environments.
outbreaks. technologies.
African and global public Not only is Africa’s population Fast pace of technology Recent deepening of the political
health leaders do not want growing faster than most other innovation seen in recent years and regulatory support required to
African countries to be last in regions’, but significant at every step of the manufacture vaccines locally.
line for vital supplies. Nor do immunization coverage gaps biomanufacturing workflow Notable shifts include increased
they want to rely on others remain and new products, may mean that production political commitments from
to make Africa-specific such as vaccines for Lassa costs are no longer a African and global leaders in
outbreak vaccines. fever or malaria, could be showstopper for African steering the local vaccine
licensed and used widely on vaccine production. Small manufacturing agenda, and
the continent. scale disposable technologies, improvements in regionalization
high-density bioreactors, and (e.g., AfCTA) and the integration
innovation in fill-and-finish of vaccine markets across the
steps are boosting yields, continent, largely led by the Africa
and are available to Centres for Disease Control.
smaller manufacturers.
3
There has never been this level of activity around vaccine manufacturing
in Africa
Activities supported by our team Activities not yet confirmed
Broadly discussing
potential and need Aligning on reality on
for vaccine current situation and Mobilising action and
manufacturing on setting the aspiration for identifying specific Implementing immediate priority
the continent Africa opportunities actions
2012 Mid-2020 November Current April onwards
AU / UNIDO developed COVAX Facility established J&J/Aspen COVID-19 manufacturing deal CEPI considering Africa CDC and
Pharmaceutical signed2 conducting a similar AUDA/ NEPAD to
November 2020 – January 2021
Manufacturing Plan for global vaccine take forward
Africa, focused on small FCDO developed comprehensive January 2021 - present manufacturing study championing this
molecules but with some fact-base on vaccine manufacturing initiative
in Africa FCDO driving critical stakeholder1
vaccine
engagements and pushing forward
recommendations Supply/ demand landscaping conversations with, for example, Africa Current Mid-2021
Five models for expanded CDC, AUDA/NEPAD, Gavi, WHO,
2015 CEPI, BMGF, etc. FCDO supporting African vaccine
vaccine manufacturing and
AVMI published the business case manufacturing fact
preliminary investment FCDO supporting to detail out the
Vaccine Manufacturing development and base shared as inputs
opportunities investment pipeline and map potential feasibility assessment for Gavi 5.0 and CEPI
and Procurement in
Africa (VMPA) Study Barriers, and potential unlocks investors for two large Africa Replenishment 2.0
manufacturers (Institut market shaping
Roadmap across short-, 8/9 March Pasteur Dakar in strategy development
medium- and long-term Senegal and Biovac in
objectives, as well as a set of Global COVID-19 Vaccine Manufacturing
SA)
immediate priority actions Summit
COVID-19 classified as Today 12/13 April
global pandemic
1. Includes Africa CDC, GPH actors, MNCs/manufacturers, DFIs and investors, etc. with details on later pages African Vaccine Manufacturing Summit convened
2. Representative example of recent activity and announcements of increased local production in Africa by Africa CDC
4
This study engaged a core group of stakeholders to develop a
perspective on what it will take for Africa to expand Vx manufacturing
1 2 3
Transparency & Assessment Roadmap
landscaping of options development
Developing the fact base: current and Identifying quick wins and longer-term Developing an implementation roadmap
expected supply and demand, cost strategic options Developing the impact/business case for
baselining Stress testing and prioritizing options stakeholders
Understanding major constraints and
unlocks We are now
moving to action
As a part of this effort, stakeholders have been engaged across organizations, including >40 people from >20
organizations who have attended the 3 workshops, as well as >50 that have engaged in individual interviews
Global health actors and funders (agenda-setters, global Pan-African development and Vaccine/ technology players
advocates and funders) – non exhaustive health entities – non exhaustive and partners - non-exhaustive
NON-EXHAUSTIVE
5
Learnings to date: High-level executive summary (1/2)
Why now? Current forces driving a new moment of significant prioritization across stakeholders: vaccine security concerns,
technological developments, and market shifts
Impact potential across public health and economic development targets
The market Large and growing market in Africa: ~$1.3B today, and up to ~$2.3-5.4 Bn by 2030
opportunity Strong growth fundamentals on the continent level: growing populations, improved coverage, new country
introductions, and novel product introductions
Majority of countries supported by Gavi today; significant volumes expected to transition from Gavi by 2030
Most individual countries and regions are likely to have domestic markets too small for manufacturer economies of
scale; manufacturers may need to export
Currently,
Learnings to date: High-level executive summary (2/2)
Moving Five models identified to expand, with different investment opportunities associated with each, depending on
existing facility capacity, timelines, and proposed level of risk and return
forward
These models are: 1) Downstream model, 2) Expanding routine model, 3) Product leapfrog model, 4) Adjacency model,
and 5) Outbreak model
The market currently faces five major barriers to local players. These are: no clear agenda or co-ordination
across efforts, weak regulatory environments, bifurcated market demand dynamics (Gavi vs non-Gavi),
restricted access to finance, and limited local talent
Several efforts are underway to unlock Africa’s enabling environment, which will be critical for the success of any
investment in Vx but some market, project and other risks remain
Emerging It is becoming clear that stakeholders may need to signal interest to the market more clearly to push forward
investment in vaccine manufacturing
insights
Few actors have been willing to take necessary action to de-risk the opportunity; however, many are showing interest if
from others move too
ongoing
There is a mismatch between available financial support and the needs of local vaccine manufacturers - for
stakeholder deal financing to occur, several project development and ecosystem challenges need to be addressed
discussions Limited support exists for upstream development including domestic, regional and continental enabling environments,
and project-specific development. Actors are willing to support but need clear co-ordination and alignment on roles
A clear commercial business case is required; hinges on secured offtake for locally produced vaccines, which requires
commitments from African leaders and global procurers
We are continuing conversations with stakeholders, which is expected to yield additional insights on current
challenges/needs, and associated areas for potential support 7Why now?
Market landscaping
Contents Investment opportunities
Moving forward
Appendix
8Why now? COVID- 19 and other outbreaks have led to a sense of urgency
and renewed public commitments, creating unprecedented alignment around
African Vx manufacturing
… pushing African leaders to … and encouraging some local
COVID-19 has exposed Africa’s accelerate local manufacturing manufacturers to commit
lack of local production capacity… expansion… to new Vx projects
“African countries must invest in the development of Nov 2020: Federal government has Nov 2020: Russian Direct Investment Fund
their own capacity to create the necessary instruments Nigeria announced plans to set up a vaccine Morocco (RDIF) signed a deal with Moroccan
(manufacture of vaccines, diagnostics, medicines…), production company in Nigeria to boost pharmaceutical manufacturer Galenica to
which are essential to guaranteeing the health of their local COVID-19 Vx production produce the Russian COVID-19 vaccine locally
population.”
Aug 2020: Morocco and China National Jan 2021: Aspen Pharmacare could start
- Dr John Nkengasong, Africa CDC Morocco Biotec Group Company Limited (CNBG)
SA production of Johnson & Johnson Covid-19
signed two cooperation agreements on vaccines in South Africa by late March or early
COVID-19 vaccine trials to allow April if all approvals are in place
Morocco to produce a vaccine
Source: Press searches, expert interviews 9Why now?
Market landscaping
Contents Investment opportunities
Moving forward
Appendix
10A: How big is the need and the
opportunity in Africa?
Understanding the
Africa Vx market
B: Which products are most
landscape addresses attractive in terms of value and
3 questions volume?
C: What are the relevant supply-
side dynamics?
11A: How big is the need and the opportunity in Africa?
The African Vx market could grow from $1.3bn today to ~$2.3-5.4B by
2030, as a result of five key drivers
Large upside (~$5.4bn) estimates exists under higher assumptions on novel product entry/coverage
PRELIMINARY DETAILED DESCRIPTIONS OF DRIVERS IN BACKUP
Ongoing refinement of scenarios and market sizing forecasts as COVID-19
epidemiology evolves; private market size currently being estimated Overall expected
Projected public market value, impact on market
$ Mn, 2019 - 2030E (range from scenarios 1 to 3)2 Drivers Examples value
COVID-19 Increased Improvements to country-level vaccine programs through donor and public
access sector investment
Outbreak (e.g., Ebola, Lassa)
Introduction of existing Vx products into new countries (e.g., HPV, rotavirus)
Novel routine (e.g., HIV, malaria)
Expanding routine
Demo- Sustained, if slowing, population growth in most countries
Legacy routine
+6-15% p.a. graphic Declining infant mortality leading to larger population of surviving infants and
adolescents requiring vaccination
2.3-5.4
Pricing Stable prices expected for established products (or growing at inflation), with
0.1-1.2 0-0.6 0 some newer products such as pneumo and HPV experiencing declining prices
Change in dose presentations (e.g. multi vs single dose vaccinations; prefilled
1.7-2.6 syringes) could impact pricing
1.3
0.8 Trans- Impact on price and volumes for transitioning countries not yet clear (given that ?
0.6-1.3 itioning few countries have transitioned)
0.5
2020 2030F from Gavi
Volumes, Emerging Vx Multiple products are under development and may be licensed by 2030
1.0 1.2-1.4
# of doses, Bn products and (e.g. Malaria, HIV)
novel Novel technologies could impact vaccine introductions, for example to reduce ?
Avg. prices1, the overall development time of new vaccines. Initial prices likely to be higher
~1.4 ~2-3.9 technologies
$/dose than legacy products but expected to decline over time
1. Weighted average price per dose of vaccine, across all products, noting that product prices differ significantly (e.g. $0.12/dose for BCG and $23.52 for DTaP hexavalent)
2. Scenarios mainly driven by price tier of transitioning countries (e.g., will they have access to Gavi-negotiated prices or pay LMIC prices?) and emerging vaccine
(e.g.,COVID-19, HIV, malaria) assumptions (detailed in backup) and ; first 2 scenarios included as more conservative forecasts than third
Source: MI4A, Linksbridge GVMM, Gavi Alliance 12A: How big is the need and the opportunity in Africa?
Forecasting scenarios output: ECOWAS and COMESA expected to
continue as largest regional markets given pop. size despite low prices
Ongoing refinement of scenarios and market sizing forecasts as COVID-19
epidemiology evolves; private market size currently being estimated
Public market value, USD mn Avg.
Regional blocs1 (# of Population (2020) prices2,
members) Mn 2020 2030 estimates3 USD 2019 Comments
Ethiopia constitutes 9% of continental value and ~50% of the
EAC
195 138 180-630 0.9 EAC region (due to large volumes of Rota Vx). HIV and
(6)
COVID are ~half of upside value
Includes several self-financing countries paying higher prices,
SADC
363 530 810-1.4B 1.9 e.g., SA, Botswana, Mauritius, Namibia etc. SA constitutes
(15)
43% of SADC value
Region characterized by high volumes due to Nigeria and low
ECOWAS
397 289 430-1.7B 0.9 prices given that all countries are Gavi eligible. Nigeria
(15)
constitutes approx. half of ECOWAS market
IGAD Region characterized by high volumes due to Nigeria and low
290 199 235-640 0.9
(8) prices given that all countries are Gavi eligible
COMESA Large region with large population and mix of Gavi and self-
570 451 940-1.5B 1.1
(19) financing countries (e.g., Egypt, Botswana)
AMU Majority self-financing countries, therefore region is
(5) 104 206 290-335 3.6
characterized by higher prices
2.4- African Vx market is ~6.5% of global vaccine by value, but up
Africa total 1,339 1,310 1.4
5.4B to 25% by volume due to its large birth cohort
Large ranges in value between conservative and upside scenarios driven primarily by assumption on price tier transitioning countries will pay (e.g., Will Nigeria procure at Gavi or LMIC prices?)
Other driver is novel vaccines (e.g., HIV, malaria and COVID-19) with uncertain demand and prices
1. There is some overlap with certain countries considered in more than one region
2. Weighted average price per dose 3. Range is difference between scenarios 1 (conservative) and 3 (upside) - detailed in backup
Source: UN, WHO (M14A), Linksbridge GVMM, expert interviews 13B: Which products are most attractive in terms of value and volume?
Products can be classified into four aggregated categories with unique
demand and supply dynamics
Market dynamics Product dynamics
Manufacturing
Example products complexity of product
Relatively high coverage (e.g., 80-90% for DTP and BCG, 65% for Yellow BCG, measles, rubella,
Group 1 Legacy Fever) due to being established in all national immunisation programs pentavalent, polio, yellow fever1 Low Medium High
routine Primarily produced by Indian players at high volumes with low unit price
(B: Which products are most attractive in terms of value and volume?
High growth products (by value) include those expanding via new or
recent country introductions, such as HPV, IPV, rotavirus and MMR
Total vaccine demand (value) for Africa for existing products1, USD bn, 2020-2030F
SCENARIO 1 (EXCLUDES ALL NOVEL PRODUCTS)3
HPV expected to be introduced to nearly CAGR,
OPV expected to be all countries as supply constraints loosen Product2
’20-30, %
replaced by IPV from 2027
Although OPV and 2.2 2.2
13 HPV
pentavalent values are 2.0 Majority of volume
low, they contribute 16% 13% 9 Rota growth from Gavi-
~20% and 27% of 1.8 15% supported MR
volumes respectively 5 IPV expansion, but
9% 14%
14% includes MMR
11% 10 MMR/MR
12% 8% products supplied in
1.3 9% 9% 4 Men self-financing markets
11% 12%
7% 10% 7 BCG
10% 9% 12% 1%
1% 1% 2% 1%
8% 1% 1% 1% 1% 3% 0 TCV Recent manufacturer
2% 3%
1% 8% commitment to supply
0% 1% 25% 4 PCV PCV at $2.90/dose
23% 22% 26%
28% 6 Hexavalent to Gavi countries
(from $7)
7% 7% 4 Pentavalent
7% 7% 8%
13% 12%
11% 11% -6 YF
9% 8% 11%
5% 3% 4% 3%
2% 2% 2% 2% 3%
0% 1% 0% 1% -8 OCV
2020 23F 25F 28F 2030F -5 bOPV
1. Emerging products (e.g., COVID-19, outbreak, novel routine) excluded here due to high levels of uncertainty in demand forecasting
2. HPV: Human Papillomavirus, IPV: Inactivated Polio vaccine, MMR: Measles, mumps and rubella, Men: Meningitis, PCV: Pneumococcal conjugate vaccine, Hexavalent: DTP, Hib, HepB and IPV, Pentavalent: DTP,
Hib, HepB, YF: Yellow Fever, OCV: Oral cholera vaccine, OPV: Oral polio vaccine, TCV: Typhoid conjugate vaccine 3. In scenario 1, transitioning countries are able to retain Gavi-negotiated prices. Only existing
products modelled annually given uncertainty around novel product authorisation dates (scenario 2 equivalent page in backup)
Source: Linksbridge GVMM Database 15B: Which products are most attractive in terms of value and volume?
Gavi/UNICEF SD play a significant role in the African Vx landscape, but
transitioning countries may shift the demand dynamics
Today, there is significant buyer consolidation in the market, with Gavi/ UNICEF SD financing and By 2030, several African countries
procuring approximately two-thirds of total market value could transition from Gavi4 – it is
currently uncertain how this might
Eligible for Gavi support, with no indication of transitioning by 2030 1 Total value of vaccines, $mn, 2019 influence procurement channels,
Preparatory transition Accelerated transition3 volumes, and prices
Gavi transitioned Never eligible for Gavi support Self-procured UNICEF SD
Transitioning countries may have
different procurement options…
Tunisia
Morocco Gavi-supported 2 769 Maintain procurement via UNICEF SD
771
Algeria countries (0,2%) (99,8%) (maintaining low, Gavi-negotiated pricing)
Libya
Western Sahara Egypt
Self-procure through bilateral contracts
Cape Verde Mauritania
Mali
Transitioning Enter into some other pooled
Niger
Sudan Eritrea countries comprise procurement (e.g., regional)
Gambia
Senegal Chad
Self-financing 417 92 ~30-35% of
426
Follow some mix of the above
Burkina Faso Djibouti
Guinea-Bissau
Guinea
Nigeria Somalia countries (98,0%) (2,0%) today’s Gavi value
Ivory South Ethiopia
Sierra Leone Coast Ghana Central African Sudan
…with unclear price/volume implications:
Benin Republic
Cameroon
Liberia Togo
Equatorial Guinea Uganda
Congo2 Kenya
Democratic
Sao Tome and Principe
Gabon
Republic of
Rwanda
Burundi Burundi
Prices could be driven up if countries no
the Congo
longer leverage UNICEF SD; it is unclear
Tanzania
Implications for manufacturers:
Comoros
whether this would reduce volumes procured
Angola
Malawi Mayotte Overall, suppliers using Gavi channels experience greater
Saint Helena Zambia
demand certainty and larger procurement volumes, often However, countries that have transitioned
Namibia
Zimbabwe
Mozambique Madagascar
including advanced purchases, in exchange for price from Gavi in other markets (e.g., Indonesia)
Botswana
reductions (~2-4X less than self-financed countries) have secured low prices through bilateral
Swaziland contracts with manufacturers
Lesotho
South Africa
1. Provided 3-year GNI per capita remains below the low-income threshold: US$ 995 GNI per capita
2. Congo reached full self-financing status but was reversed in 2019 3. Status maintained for 5 years before transitioning to fully self-financing
4. Expert inputs suggest that 5 countries are likely or somewhat likely to transition (Nigeria, Sao Tome, Ghana, Kenya, Cote d'Ivoire) while others could but are less likely following COVID-19 economic shocks
16
Source: MI4A, Gavi AllianceC: What are the relevant supply-side dynamics?
~70% of volumes procured for Gavi-supported countries originate in
India, but only ~30% of value; this may increase in the coming years
Deep dive on African DCVMs to follow
Other DCVM Other African DCVM MNC Indian DCVM
Share of African vaccines volume by Share of African vaccines value by
manufacturer origin1, doses, mn manufacturer origin1, %
1,076
867
SII supplied Implications
~550mn
doses of Vx
to Gavi-
241 Opportunities exist for
726 (28%)
supported (68%) emerging DCVMs in 4 products
countries in Top MNC- with high concentration of
Africa in supplied
2019 (~50% products
volumes produced by MNCs:
of total by value IPV, pneumococcal, HPV and
volumes but
only 20% of
are: rotavirus – Indian DCVMs are
Pneumoco 412
value) ccal, Rota, 56
already planning expansion
527
Major HPV and
(61%)
(14%) into these products
suppliers of IPV African
247
(23%)
non-Gavi manufacturers This could lead to increased
176 volumes
319 include geographic concentration of
70 include: Biovac,
2 (40%)
43 SII, Sanofi
(77%)
Vacsera, IP
supply, which could be a
100
(0%)
9
(24%) and PT Bio
49
2 10
(2%)
Dakar & IP potential vaccine security risk4
11 Farma3 (0%)
(9%) 43 (5%) (6%) (6%) 7 Tunis
48 20
(25%) (2%)
(6%) (5%)
Gavi Self-financing
Gavi Self-financing
1. Excludes Algeria due to missing manufacturer data
2. Includes: Merck, Sanofi, Pfizer and GSK
3. Indonesian state-owned manufacturer producing OPV, DT and TT
4. For example, India has restricted SII's COVID-19 exports until 1mn doses have first been supplied to meet local demand
Source: MI4A 17C: What are the relevant supply-side dynamics?
Almost all Gavi products are highly concentrated by supplier and / or
region
>80% 60-80%C: What are the relevant supply-side dynamics?
There are 10 known existing local vaccine value chain players in Africa,
mostly concentrated in North Africa, South Africa, and Nigeria
Africa’s vaccine value chain players by Africa’s vaccine value chain players by value chain step5 Current Planned
country1, 2020, total = ~10 2020, total = ~10
2 1 No producer
Drug Fill & Pack & Import for Insights
Institut Pasteur Algeria R&D substance mfg finish label distribution
Manufacturer Products The African
Institut
Pasteur Morocco
1
Institut Pasteur Tunis Institut Pasteur Dakar Yellow Fever vaccine
du Maroc Algeria Tunisia Egy Vac
1 1
(Vacsera) Egy Vac (Vacsera) BCG-T, Tuberculin, Tetanus, manufacturing
Egypt
1 DTP, Typhoid, Cholera landscape is
Institut Pasteur Tunis2 BCG mostly focused
EPHI: Eth Public
Senegal 1
Health Institute Biovac BCG6, Measles6, Pneumococcal on fill / finish, and
Nigeria conj.3, Hepatitis B3, Hexavalent, packaging /
Insitut 2 Ethiopia GBS7
Pasteur 1 labelling
Dakar Aspen Pharmacare Covid-19 candidate
Biovaccines Opportunities for
Institut Pasteur Morocco BCG, DT, Yellow Fever, Typhoid
Innovative Biotech
Fever, Influenza, Rabies
existing Vx
EPHI: Eth Public Plan to produce vaccines4
manufacturers
Health Institute exist to expand
Biovaccines Plan to produce Hep-B along the value
Plan to produce Tetanus chain into DS
Plan to produce DTP+Hep-B
Plan to produce Yellow Fever
manufacturing
South Africa
Biovac
2 Plan to produce Measles and/or introduce
Aspen Pharmacare
Innovative Biotech HIV new product lines
Institut Pasteur Algeria Rabies
1. Local companies have ownership and headquarter in respective country of Africa, Others (n=24) touch the manufacturing value chain (e.g., import and distribution, some packaging steps), but are part of international
MNC pharmaco operations and are not locally owned 2. Very small scale API manufacturing 3. Currently only visual inspection, labelling and packaging of imported vials or pre-filled syringes
4. Planned vaccine portfolio is not confirmed yet or construction not completed 5. Kenya and Ghana have indicated some interest in entering vaccine manufacturing but with no firm commitments to date
6. Limited to import for distribution steps 7. Group B streptococcus (GBS) vaccine currently under development
19
Source: Capital IQ, Press search, Companies websites, VMPA studyWhy now?
Market landscaping
Contents Investment opportunities
Moving forward
Appendix
20Five models have been identified as potentially viable across different
products /process advancement opportunities
De-prioritized based on low feasibility ranking
Level of
technology/ Potential overlap to produce outbreak products (e.g., influenza, Ebola,
process Lassa) utilising novel platforms (e.g., DNA, mRNA, viral vector)
innovation
Products currently produced at Cost of process re-design unlikely 5 Outbreak Model 3 Platform Leapfrog 4 Adjacency Model
very high scale and very low cost to be justified for existing
Model
by legacy DCVM players; African products Focus on Africa-specific outbreak Start with adjacent products first
manufacturers are highly unlikely products, potentially complemented Focus on emerging platforms (e.g., mAbs) that build similar
to be cost-competitive (disruptive with routine products, with (e.g., mRNA) that present new capabilities before migrating to
Disruptive, tech innovation unlikely justifiable opportunities for leapfrogging and
opportunity for tech. disruption. May vaccines in long-term.
innovative given cost of process re-design) require global collaboration to smaller scale processing. May be
attractive for novel Vx or small Investment into process
technologies secure stockpile demand and
innovation possibly justified in
technically-advanced skill sets scale production if developers are
able to facilitate tech transfer to some markets given high margins
Given inconsistent and small-scale local manufacturers and if tech (e.g., mAbs) and multiple
demand, production would likely risks can be mitigated products with single technology
require most efficient, low footprint 1
process technologies
Downstream Model
Expanding Routine Some outbreak products (e.g., No existing production processes Existing technology processes, Focus on a) package
2
Model cholera or influenza) have yet developed for emerging which could be tech-transferred, and labelling and/or
Focus on not-yet-commoditised established manufacturing products supporting production of multiple b) fill/finish steps for
Traditional routine products with opportunity processes requiring tech-transfer adjacent products
multiple products.
for marginal tech innovation (e.g., from MNCs/DCVMs to local
processes manufacturers, with opportunity May be most
HPV, Rota) of established
with processed. May be attractive if for incremental improvement attractive for
incremental large-scale demand pooling can gains domestic markets
be achieved and/or there is with ability to export
innovations commitment to initially pay
somewhat higher than market regionally, if quality
prices compliance could be
assured
Routine (legacy EPI) Routine (expanding EPI) Outbreak Novel routine Adjacent
Vx/ Vx-like product categories
Source: Expert interviews, desktop research 21These models translate into various pathways for potential investors
Optional path Model reference Investment opportunity
NON-EXHAUSTIVE
Today’s starting Shorter term: Initial transition Longer-term: End-state transition
position investment opportunities investment opportunities
Set-up a product agnostic packaging facility i Expand to existing downstream capacity to include full value iii
chain production (incl. drug substance production)
Examples: Biovac
Downstream model Example: Biovac Expanding Routine model
Greenfield: No
existing capacity
Establish new site producing full product(s) iv Expand to include outbreak products in existing plants v
using novel platforms (e.g., mRNA)
Platform leapfrog model Outbreak model
Brownfield: iii v
Existing Vx Expand existing downstream capacity to include full Expand to existing downstream capacity to include iii
capacity (e.g., value chain production (incl. drug substance production) full value chain production (incl. drug substance production)
package/label Examples: Biovac, IP Dakar Expanding Routine model Example: Biovac
and/or fill/finish) Outbreak model Expanding Routine model
Brownfield: ii
Existing Vx-related Expansion of downstream capacity (fill/finish, visual inspection v
Expand to include outbreak products in existing plants
capacity (e.g., and package/labelling) of existing manufacturers (non-vx)
Sterile injectables, Example: Aspen
Examples: Aspen, Serum Institute Outbreak model
mAbs etc.) Downstream model
22Investment opportunities have different timelines, which may appeal to
different investors based on timeframe and risk of investment
NUMBERS PRELIMINARY
Scale of plant was set to 60 mn doses p.a. to be in a Initial high level evaluation of economics
competitive range to current market prices for Vx; specific Investment NPV (not risk
Investment values for countries in scope are covered within range; IRR (pre tax), size (per adjusted, Risk Low
Timeframe1
Model reference opportunity Description evaluation can look different if parameters are changed facility), $ mn 10 yrs), $ mn level High for setting up
%
Short- i Downstream model Greenfield: Setup a Facility imports unlabeled/labeled filled vaccines (e.g., vials, syringes) from 4 years
with pack/label only product agnostic MNCs/DCVMs and handles labelling, packaging and distribution of several
term
packaging facility finished product with capacity of >60 mn doses p.a. 30-35 50 50-60
Secondary packaging materials sourced locally, competitively priced
Facility has strong local ties with distributors and regulators
ii Downstream model Brownfield: Expansion Reverse integration of packaging and labeling activities towards Fill and Finish 4-6 years
with fill/finish and of downstream using existing vaccine or mAbs manufacturers capacity of >60 mn doses p.a.
packaging/labelling capacity (F/F, VI and Brownfield expansion of facility that is focused on downstream steps for routine 25-30 80 40-50
P/L) of existing immunization products or has sterile filling capabilities for non-Vx products (e.g.,
manufacturers due to mAbs production)
iii Routine model with Brownfield: Expand Expansion of existing facility to include domestic drug substance production 5-10 years
3
full domestic existing downstream capabilities with aspiration to setup large-scale, end-to-end plant (e.g., >60mn
production capacity to include doses p.a.) that achieves cost competitiveness for routine products
end-to-end value chain 25-30 190 90-120
Significant additional CAPEX required for drug substance production (Bioreactors
production (incl. drug and purification line) as well as need for additional skilled employees (e.g.,
substance production) microbiologists etc.)
iv Leapfrog model with Greenfield: Establish Smaller footprint facility producing products on novel vaccine technology using 5-10 years
full domestic new site producing (e.g., mRNA, DNA) that requires lower CAPEX investment for drug substance
production end-to-end product(s) production due to process efficiency of novel technologies (e.g., smaller
leveraging novel bioreactors) capacity of >60 mn doses p.a.
30-40 190 170-210
platform technology Highly-skilled labour necessary given novel, complex technologies (e.g., mRNA,
(e.g., mRNA) DNA)
v Addition of small- Brownfield: Expansion Introduce additional production line to existing facility that focuses on outbreak 5-10 years
scale Outbreak model of existing products (e.g. Ebola) for stockpile production with capacity of >0.5 mn doses
to full domestic manufacturers to p.a.. Possibility to further ramp-up production quickly if necessary. Add-on to existing Vx
production2 incorporate outbreak 20-25 25 10-15
Upskilling and training of labour required to manufacture novel products / work production
Long products into existing across products. Ideally developed alongside manufacturers with existing
plants (incremental production on same platform technology as the outbreak product
term investment)
Disclaimer: methodology is based on initial high level assumptions and represent an average given the difference in multiple parameters (e.g., productivity, purchasing cost of raw material, scale, etc); calculations do not include disruptive
technology innovations that can change the evaluation
1. Assuming enabling factors (e.g., NRA strengthening) are developed along this time 2. Economics shown for Nigeria and Ethiopia only 23Country perspective on investment opportunities
Country opportunity overview: 9 countries have been profiled for their
potential for Vx manufacturing, each with their own opportunities and risks
Deep dives on each country to follow
Tunisia
Established Vx manufacturing capacity with history
Tunisia
Morocco of export, recent discussions with Chinese MNCs to
Morocco mfg. COVID-19 Vx, knowledge of vaccine
Recent announcement by Institut Pasteur du Maroc manufacturing through Institut Pasteur Tunisia
to establish new manufacturing site, established Small domestic market, limited regional
Egypt
manufacturers with sterile capabilities harmonization; NRA not ML3 certified, limited air
connections to the continent
Logistics and distribution challenges, small domestic
market; NRA1 not ML32 certified Senegal
Egypt
Strong existing facility and knowledge, recent
Senegal Nigeria
Nigeria announcement by MOH to locally manufacture
Ethiopia
WHO PQ’d manufacturing capacity, knowledge of COVID-19 Vx
Ghana
vaccine manufacturing through Institut Pasteur Dakar Limited regional harmonization (in Africa), NRA not
Kenya ML3 certified (but actively working on it)
Logistics and distribution challenges, relatively
smaller domestic market; NRA not ML3 certified but
actively working on it
Ethiopia
Ghana Large and growing domestic market, strong support
and favorable industrial policy for pharmaceuticals,
Strong engagement from leaders, recent
air transport hub
announcement for Vx mfg. facility in Accra; NRA is
ML3 certified; expected to transition from Gavi Recent security challenges, continued forex
Logistics and distribution challenges, small domestic constraints; NRA not ML3 certified but has begun
market, no existing Vx capacity South Africa initial work, limited existing Vx capacity
Kenya
Nigeria South Africa Strong support and favorable industrial policy, high
Large domestic market to secure volumes expected investment in infrastructure, good connections with
Home to large facility with experience across full MNCs, expected transition from Gavi in next 10 yrs
to transition from Gavi, Nigerian companies working
value chain, limited government transitions with
towards Vx manufacturing
experience in self-procurement, strong ties and trust Medium-sized domestic market, no existing Vx
Currency fluctuations, no existing manufacturing with MNCs, Zazibona access capabilities; NRA not ML3 certified but has begun
capacity in place; NRA not ML3 certified (but actively initial work
working on it) NRA not ML3 certified (but actively working on it)
Disclaimer: There may be other interested or relevant countries; these nine were selected based off expert perspectives or communicated opportunity/interest
24
1. National Regulatory Authority 2. Maturity Level 3 (WHO certification)Why now?
Market landscaping
Contents Investment opportunities
Moving forward
Appendix
25Current state: Additional work to support five cross-cutting enablers impacting
the enabling environment will be required
Barriers Ongoing efforts
A Agenda- No current unified and operational continental strategy with Some national governments have shown political commitment for local pharma production
setting and unclear ownership and roles for stakeholders
Some Pan-African entities have vaccine-specific strategies, but these are not fully
coordination coordinated across organizations
B Regulatory Continent-wide harmonization is not yet implemented under Continental and regional regulatory reform related to the COVID-19 Vx is ongoing in
strengthening AMA; regional harmonization not yet expanded to joint critical areas (e.g., marketing authorization, reliance, post-market surveillance)
approval for vaccines
Pan-African initiatives (e.g., AVAREF) have streamlined pre-market authorization activities
National regulators facing capacity and capabilities for emergency-use for COVID-19 vaccines
constraints
C Demand Low demand volumes and uncertainty unless for Gavi- Opportunity for demand certainty in some regions and/or large domestic markets (e.g.,
certainty supported countries, but these markets require low prices Nigeria). Some development of very nascent forms of regional pooled procurement,
and strict regulatory hurdles mostly for non-Vx products (e.g., medicines, medical supplies) and mostly in response to
stockpile threats during emergencies
D Access to Limited financing for local manufacturing in Africa, primarily Initial investments made in local Vx manufacturing, including using non-traditional
finance due to perceptions of high risk and unclear business case financing models (e.g., PPPs and joint ventures – like Biovac in South Africa and
articulation Biovaccines in Nigeria)
Several announcements of partnerships and investments related to COVID-19 Vx
manufacturing have been made recently
E Talent and Skills shortages of pharmaceutical, biotechnology, and Experience from a few ongoing tech transfers (e.g., Pneumococcal Vx at Biovac) is
know-how industrial talent driven by scarcity and brain drain of local growing, but the need for know-how transfers may increase as novel vaccine products,
talent, resulting in the reliance on foreign expertise platforms, and technological processes are introduced
26Should Africa wish to access this opportunity, stakeholders will need to
initiate several immediate actions to develop the enabling environment
Potential activities – immediate priorities for next 6 months Higher priority
Agenda- Identify champion organization, develop initiative structure and governance and generate momentum among key political leaders
setting and
Mobilize key regional / national leaders, clarify Africa-wide aspiration and strategy (clear articulation of success metrics)
coordination
Confirm network of partners across sectors and align on clear priorities, roles, and responsibilities across stakeholders
Regulatory Support finalization of AMA strategic plan, including Vx-specific plan, and identify gaps
strengthening
Institutionalize and expand emerging COVID-Vx regulatory harmonization (e.g., Africa Regulatory Task Force) to broader Vx scope
Develop NRA-strengthening plans to achieve ML3 certification where needed
Demand
Engage with funders (e.g., Gavi) on market shaping strategies for Vx procurement
certainty
Access to Conduct investor roundtables and prepare for roadshows for preliminary Vx-investment opportunities
finance
Conduct MNC/DCVM engagement to clarify interest in African Vx opportunities
Conduct robust investor and pipeline mapping, facilitate individual conversations
Identify needs for technical assistance and transaction facilitation to support investments
Talent and Identify existing programs that provide Vx-specific trainings and determine scalability
know-how
Develop strategy for taskforce on African Vx talent strengthening
27How has your perception of local vaccine
manufacturing in Africa changed in the past months?
What has made you excited about African vaccine
Discussion manufacturing opportunities? What has previously
held you back?
questions
What do you think will be important topics to discuss
at the Summit?
How best could African manufacturers and DCVMs
work together? What opportunities exist for
collaboration and partnerships?
28Next steps: We would be interested in having some 1:1 conversations with
select DCVMs to understand opportunities for African Vx manufacturers
Leading up to the African Vaccine Manufacturing Summit, we would
appreciate offers for 1:1 conversations with you to better understand… How we plan to reach out
1. Potential for Assess the appetite of DCVMs to We will share a follow-up mail after this
collaboration and partner/collaborate with existing or potential African session requesting time with you
partnerships in vaccine manufacturers
Please feel free to connect us to the most
African Vx Understand the roadblocks and challenges that appropriate individuals in your
manufacturing could prevent partnership/collaboration organisations with whom we could speak
Understand what would be required for DCVMs to Please reach out to us and Tertia Bailey
consider partnering with local African players (FCDO) if you have any further questions
on our work to date, findings or if you
wish to share your perspectives with us
2. Lessons Understand the approach and process to securing
learned and case successful technology transfers with vaccine
studies from other developers
DCVMs Develop lessons learned potentially applicable for
Africa
All specific company information shared through conversations will be kept
confidential, unless consent is provided 29Backup
30Why now?
Market landscaping
Contents Investment opportunities
Moving forward
Appendix
31African Vx: recent announcements related to local vaccine
manufacturing are mostly connected with COVID-19 Vx production
PRELIMINARY
LAST UPDATED 29 JANUARY 2021
Ghana South Africa Nigeria Egypt Morocco Angola
April 2018: New July 2020: South Africa plans to Nov 2020: Federal July 2020: Egypt’s Aug 2020: Morocco and China National Oct 2020: The Russian
vaccine manufacturing build a coronavirus vaccine plant. government has Health Ministry Biotec Group Company Limited (CNBG) government has submitted a
facility is planned to be Higher Education, Science and announced plans to set announced it has began signed two cooperation agreements on proposal to the Angolan
setup in Accra, Ghana Technology minister Blade up a vaccine production preparing to COVID-19 vaccine trials to allow Morocco government for construction of
by Merck to streamline Nzimande said that the plant would company in Nigeria to manufacture a to produce a vaccine a factory to manufacture
the value stream be headed up by both government boost local COVID-19 coronavirus vaccine vaccines, the Russian
Nov 2020: Russian Direct Investment
(currently on hold) officials, pharmaceutical companies vaccine production once proven to be ambassador to Angola
Fund (RDIF) signed a deal with Moroccan
and private-sector vaccine effective in trials, in announced on Wednesday in
pharmaceutical manufacturer Galenica to
specialists. cooperation with the Luanda
produce the Russian COVID-19 vaccine
Chinese government
Nov 2020: Aspen’s South African locally. A delivery of 8 million doses of
subsidiary Aspen Pharmacare has Russia’s Sputnik-V vaccine is expected
signed a preliminary agreement with during the first half of 2021
two Johnson & Johnson (J&J)
Jan 2021: The Pasteur Institute of
subsidiaries for the technical transfer
Morocco is set to establish an industrial
and proposed commercial
unit for the manufacturing of vaccines and
manufacture of their COVID-19
other biomedical products (antidotes
vaccine candidate
against snakebites and scorpion stings)
Jan 2021: Aspen Pharmacare could near Casablanca. The planned industrial
start production of Johnson & unit is very likely to produce COVID-19
Johnson Covid-19 vaccines in South vaccines together with the Chinese
Africa by late March or early April if pharmaceutical company Sinopharm
all approvals are in place
The above profiles vaccine-specific announcements (other pharma-related events have occurred recently but are not included unless specifically relevant for vaccine production)
which have to be noted with reservation as it does not guarantee the success of the projects
Source: Press Search 32A: How big is the need and the opportunity?
1. Immunisation coverage established routine products has plateaued,
but saturation compared to global average has not yet been reached
PRELIMINARY
Africa immunisation coverage rates over time
Takeaways
% of target population
Aggregate coverage in Africa has
90%
stagnated in recent years due to:
Global DTP3 coverage, 2019 85%
80% Challenges securing sustainable
funding and resources
70% Stock-outs and supply shortages
(e.g., HPV, Yellow Fever,
60% cholera)
Logistics challenges in
50% vaccinating hardest-to-reach
populations
40% Africa-wide immunisation coverage
remains below global average,
30% indicating that saturation has not
yet been reached, even for routine
20% products
Recently scaled products such as
10%
Pneumo and Rota are expected to
continue to grow, but at current
0%
1980 85 90 95 2000 05 10 15 20 25E1 2030E growth rates, will only reach 80%
coverage well beyond 2030
BCG HIB3 Measles 2nd dose Polio Rota
DTP3 IPV1 Pneumo Rubella YFV
1. Grown at 3-year historical CAGR, except IPV which reaches 82% coverage in ‘20 and then assumed to stagnate
Source: UNICEF, Mihigo R, Okeibunor J, Anya B, Mkanda P, Zawaira F. Challenges of immunization in the African Region. Pan Afr Med J. 2017;27(Suppl 3):12. Published 2017 Jun 21. doi:10.11604/pamj.supp.2017.27.3.12127 33A: How big is the need and the opportunity?
1: In addition to increased coverage within countries, new country
introductions are expected to drive demand for vaccines in Africa
Disease prevalence is low1 Current program in place Opportunity to introduce program2
HPV Rotavirus Pneumococcal Meningococcal Takeaways
Africa is yet to reach
full saturation for
vaccine demand given
that not all countries
have introduced likely
immunisation programs
- the next 10 years
could see largescale
growth in HPV and
rotavirus vaccines if
introductions continue
HPV vaccination has been rolled 13 countries currently do not Gavi’s pneumococcal AMC Meningococcal outbreaks
out in 22 African countries, with have routine Rotavirus facilitated rapid expansion of common in the so-called
opportunity to expand coverage to programs, but may increasingly pneumococcal vaccine ‘meningitis belt’ are largely
32 others in the next 10 years, see Rotavirus Vx roll-outs given programs across Africa, with reduced by the MenAfriVac
provided sufficient supply is made WHO recommendation for all only 9 countries not currently initiative which has scaled
available. Additional countries3 are countries to immunise infants rolling out pneumococcal vaccines to 16 countries so far,
conducting pilots with Gavi support against Rotavirus vaccinations with only 13 outstanding with
some regional prevalence of
meningitis
1. Countries with low prevalence of disease and where routine immunisation is not recommended by WHO
2. Countries where disease is endemic and there is no existing immunisation program
3. E.g., Burkina Faso, Cameroon, Ghana, Madagascar, Niger, Nigeria, Mozambique etc.
Source: Gavi Alliance, MI4A, WHO, HPV Centre 34A: How big is the need and the opportunity?
2: Africa’s share of global population is expected to reach 20% by 2030,
with older people (65+) population expected to grow fastest
Age dependency growth: difference in growth
Population distribution by age group (mn) 10 year CAGR, % between oldest and youngest populations
65+ ‘10-20 Est. ‘20-30 0-2% 2-4% 4-6%
4-65 years Tunisia
0-4 years 1.686 2.5 2.3 Morocco
68 Algeria
Libya
Western Sahara Egypt
1.339 (4%) 3.2 3.7
47 Cape Verde Mauritania
Mali
Niger
Eritrea
(4%) Gambia
Senegal Chad Sudan
34 1.039 Guinea-Bissau
Guinea
Burkina Faso Djibouti
Nigeria Somalia
(3%) 1.391 2.7 2.5 Sierra Leone
Ivory
Coast Ghana Central African
South
Sudan
Ethiopia
Republic
1.092 (82%) Liberia Togo
Benin Cameroon
Equatorial Guinea Uganda
839 (82%) Gabon
Congo2
Democratic
Rwanda
Kenya
Sao Tome and Principe Republic of
Burundi Burundi
(81%) the Congo
Tanzania
Comoros
166 200 228 1.6 1.3 Angola
Malawi Mayotte
Saint Helena Zambia
(16%) (15%) (14%) Zimbabwe
Mozambique Madagascar
Namibia
2010 20 Est. 2030 Botswana
Africa share of Swaziland
global 15% 17% 20% Lesotho
South Africa
population (%)
By 2030, Africa is expected to need childhood vaccinations for approx. 230 million Vaccines for older people, particularly in North Africa,
children per year (from 0 to 4 years of age) Ghana, Kenya, and Botswana, may become increasingly
important given relatively high expected growth of the
elderly
Source: United Nations (World Population Prospects) 35A: How big is the need and the opportunity?
3: Self-financing countries typically see prices 2-4 times higher than Gavi
countries, and more volatility in price
Gavi Self-financing1
Human Papillomavirus (HPV) Pneumococcal Rotavirus
2016: Merck introduces Gardasil 2019: GSK Synflorix 2012: Gavi secured two-thirds
(quadrivalent) which protects available in addition price reduction with Rotavirus
against 4 strains of HPV to Pfizer’s Prevnar vaccine manufacturers
20 25 12
20 10
15
8
2016: Gavi introduces 15
10 6 Indian Gx players
HPV support 10 enter (SII, Bharat)
4
5 5 2
0 0 0
2015 16 17 18 2019 2015 16 17 18 2019 2015 16 17 18 2019
Greater demand certainty and larger procurement volumes for manufacturers have gone hand-in-hand with price reductions
“Advance” purchases: Mid-term market certainty: Pooling volumes: Long-term view of the market:
Prepaying a portion of the vaccine To increase security of demand, By pooling country volumes together, Gavi signals viable market to future
supply, allowing manufacturers to manufacturers can enter extended manufacturers are able to secure large- manufacturers, and therefore
recoup their fixed costs earlier deal periods (up to five years in the volume orders, but at a reduced price encouraging developing country
case of rotavirus) manufacturers to join the market (e.g.,
1. Never eligible for Gavi support SII, Bharat etc.)
Source: Gavi Alliance, MI4A 36A: How big is the need and the opportunity?
4. The share of value procured via UNICEF SD could decline by 2030
from 64% today, as countries open their procurement channels
Eligible for Gavi support, with no indication of transitioning by 20301
Total value of vaccines, $mn 2019
Preparatory transition Accelerated transition3 Fully self-financed
771 UNICEF SD Self-procured
Tunisia
Morocco
Algeria
92 426 Western Sahara
Libya
Egypt
769
(99,8%) (2,0%) Cape Verde Mauritania
Mali
417 Senegal
Niger
Chad Sudan Eritrea
Gambia
2 (98,0%) Guinea-Bissau
Guinea
Burkina Faso Djibouti
Nigeria Somalia
(0,2%) Sierra Leone
Ivory
Coast Ghana Central African
South
Sudan
Ethiopia
Republic
Benin Cameroon
Liberia Togo
Gavi-supported countries Self-financing countries1 Equatorial Guinea
Congo2
Uganda
Kenya
Gabon Democratic
Rwanda
Sao Tome and Principe Republic of
the Congo Burundi Burundi
Tanzania
Gavi-supported countries almost entirely procure through UNICEF Angola
Comoros
SD, which has existing procurement relationships and contracts in Saint Helena Zambia
Malawi Mayotte
place with international suppliers Namibia
Zimbabwe
Mozambique Madagascar
Although a small portion of market volumes, self-procured
Botswana
Swaziland
channels represent ~1/3 of the African market ($419mn in 2019) It is currently unclear how countries’ Lesotho
procurement behaviours will change upon
As countries transition from Gavi, they may choose whether transitioning, but it is possible that this could
South Africa
change the share of value procured via
to procure via UNICEF or self-procure, suggesting this share UNICEF could reduce, especially if Nigeria
shifts procurement channels
could decline
1. Morocco, Algeria, Tunisia, Egypt, Namibia, Botswana, South Africa, Mauritius, Equatorial Guinea, eSwatini, Gabon, Libya, Cabo Verde, Seychelles
2. Includes: Botswana, Cabo Verde, Equatorial Guinea, eSwatini, Gabon, Morocco & Seychelles
Source: MI4A, Gavi Alliance Website 37A: How big is the need and the opportunity?
4: Within the next 10 years, some African countries could transition from
Gavi support, which could impact the Vaccine market in Africa
Eligible for Gavi support, with no indication of transitioning by 20301 It is currently unclear exactly how Gavi transitioning is expected to
Preparatory transition4 Accelerated transition3 Fully self-financed impact demand for vaccines and market value
Morocco
Tunisia
It will be important to understand how transitioning countries procure
Algeria
vaccines post-transition:
Libya
Western Sahara Egypt
Maintain procurement via UNICEF SD (maintaining low, Gavi-negotiated pricing)
Cape Verde Mauritania
Mali
Niger
Primarily self-procure, which could increase pricing but not necessarily given
Gambia
Senegal Chad Sudan Eritrea
manufacturer commitments for some products in post-Gavi transition
Burkina Faso Djibouti
Enter into some other pooled procurement (e.g., regional)
Guinea-Bissau
Guinea
Nigeria Somalia
Ivory South Ethiopia
Central African
Follow some mix of the above
Sierra Leone Coast Ghana Sudan
Republic
Benin Cameroon
Liberia Togo
Equatorial Guinea
Country transition remains uncertain given that Gavi’s eligibility criteria is
Uganda
Congo2 Kenya
Gabon Democratic
Rwanda
Sao Tome and Principe Republic of
the Congo Burundi
Tanzania
Burundi
dependent on gross national income
Comoros
Angola
Saint Helena Zambia
Malawi Mayotte
Country choice of procurement channel can have varied impacts on prices
Namibia
Zimbabwe
Mozambique Madagascar
and volumes:
Botswana
Swaziland
Prices could be driven up if countries no longer leverage UNICEF SD; it is unclear
Lesotho whether this would reduce volumes procured
South Africa
However, some large manufacturers have made commitments to maintain low
prices for transitioning countries, and self-financing countries may choose to form
1. Provided 3-year GNI per capita remains below the low-income threshold: US$ 995 GNI per capita
2. Congo reached full self-financing status but was reversed in 2019 their own procurement pools
3. Status maintained for 5 years before transitioning to fully self-financing
4. Status could be adjusted based on revised GNI/capita forecasts due to COVID-19 economic impact which would impact when these countries might
transition. Countries considered most likely to transition by 2030 include: Nigeria, Sao Tome, Ghana, Kenya and Cote d'Ivoire
Source: MI4A, Gavi Alliance 38A: How big is the need and the opportunity?
4: In the past, most countries that have transitioned from Gavi continued
procuring Vx via UNICEF SD while also adding other channels
PRELIMINARY Primary Other
channel channel Weighted average price by tracer product
16 countries that have
and channel, $, 2019 (not to scale)
transitioned out of Gavi Year of
support graduation 2019 procurement channel Tracer product
Self Other 5 5
HPV
Angola 2018
Armenia 2018
4
Azerbaijan 2018
MMR 1 1
Bhutan 2016
Bolivia 2018 N/A 16
Cuba 2018 Pneumo 4
Georgia 2019
Guyana 2017 0.22
BCG 0.14 0.16
Honduras 2016 N/A
Indonesia 2017
Kiribati 2017 N/A Penta + 0.8
0.4 0.5
Mongolia 2016 polio
Moldova 2017
Self
Sri Lanka 2016
Timor-Leste 2018 Indonesia, Sri Lanka and Vietnam have succeeded in
1.
Vietnam
low-income threshold US$ 995 GNI per capita
2019 successfully securing low-price deals on some routine
2. Largest value channel products with Indian Gx players
Source: MI4A, Gavi Alliance 39A: How big is the need and the opportunity?
5: New vaccines are under development, some of
which could reach the African market by 2030
NON-EXHAUSTIVE – OTHER PIPELINE CANDIDATES EXIST
Potential Disease
vaccination burden,
Disease Manufacturer Phase Platform strategy1 % of total DALYs
Malaria GSK Phase 3 Virus-like particle Routine 7.5%
Novavax/ SII Phase 2 Recombinant protein Takeaways
University of Oxford Phase 2 Recombinant viral vector
Effective and safe vaccines
Sanaria Phase 2 Inactivated whole target organism
against malaria and HIV have the
HIV Janssen Vaccines & Prevention B.V Phase 3 Recombinant viral vector Routine, targeted 6.2% potential to address ~13% of
Sanofi Pasteur Phase 3 Recombinant protein
vulnerable Africa’s total disease burden,
populations
GSK Phase 2 Recombinant protein and could fundamentally shift
Africa’s vaccine market if/when
Zika GeneOne Life Science Inc / Innovio Phase 1 DNA Outbreak N/A
commercially available
Themis Bioscience Phase 1 Recombinant viral vector
Takeda Phase 1 Inactivated Despite multiple products in Phase
Moderna Therapeutics Phase 2 mRNA 2/3 clinical trials for malaria and
HIV, it is unclear exactly if/when
Lassa fever Themis Bioscience Phase 1 Recombinant viral vector Routine forYou can also read
