This progress report summarizes tasks to establish a cGMP compliant vaccine manufacturing facility in Ethiopia. Key activities discussed include identifying priority vaccines, negotiating with potential partners, drafting regulations to form a public enterprise company, and developing an organizational structure and timeline. The report evaluates investment modalities like a fully government-run facility or joint venture. It also addresses next steps such as finalizing funding, engaging a consultancy firm, contacting vaccine manufacturers, and acknowledging supporting organizations. The overall goal is to expedite technology transfer, boost local capacity, and increase vaccine access and supply in Ethiopia.

1. Progress report on tasks to establish cGMP
Compliant Vaccine Manufacturing Facility
in Ethiopia
1
Task Team
April, 2023

2. Outline
 List of vaccine manufacturing companies
 Priority vaccines (& criteria) of EtVac
 Negotiation document
 Consultancy firm – WB no objection response
 Proposal to IPDC
 Company formation
 Benchmarking and high level organizational structure
 Draft regulation (as a public enterprise)
 Project status/timeline
 Next steps/Way forward
 Acknowledgment
2

3. Potential manufacturers for partnership/JV
 List of vaccine manufacturing companies-Hyperlink
 What to do with it? Which countries/companies to
prioritize other than compatibility as criteria?
 Sharing assignments to make contact- Dr Lia,
MoFA/Ambassadors, Task force?
3

4. Priority vaccines (& criteria)
Considerations/Criteria:
Technologically simpler (inactivated, attenuated, recombinant, etc),
Formulation (liquid, lyophilized, conjugated),
Facility requirement (dedicated, shared),
Procurement (GAVI vs gov’t),
Volume needed, Cost (per dose),
Market (Local and global),
Public health importance (immediate need and impact level)
Procurement (GAVI vs gov’t)
Immediate need?
Technology (for formulation and for upstream)
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5. Suggested Priority vaccines- we may
need further discussion?
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6. Negotiation document
 Investment modalities: Fully Gov’t or JV (d/t %)
 Fully gov’t
 Government will cover all costs, establish, own and run EtVac.
Technology secured through procurement
 Pros:
 Independence (self-sufficiency)
 Keeps its benefit to the maximum
 Sustainability
 Cons:
 Limited capacity
 Lack of expertise
 Difficulty to penetrate the market
 Lack of credibility
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7. Negotiation document
 Joint V: the Ethiopian government will have either major share or
significant share
 Pros:
 Expedite technology transfer
 Training to local staff
 Sharing risks and costs
 access to new knowledge and expertise, including specialized
staff
 Enhanced credibility
 Boost productivity
 Access to new market and distribution network
 Flexibility in the sense that the arrangement can have limited life
span
 Limited commitment
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8. Negotiation document
 Joint V: the Ethiopian government will have either major share or
significant share
 Cons:
 Dependency
 Agreement might be complex
 Potential conflicts
 Conflicting work culture
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9. Negotiation document
 Joint V: the Ethiopian government will have either major share or
significant share: two options
 Option 1 (Government with Major share, ≥80%):
 Pros:
 More decision powers
 Cons:
 May not be attractive for the partner
 Doesn’t encourage long-term commitment and partnership
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10. Negotiation document
 Joint V: Option 1 (government with major share)
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11. Negotiation document
 Joint V: the Ethiopian government will have significant share:
 Option 2 (Government with Significant share, 50%<X<80%
 Pros:
 Encourages partnership
 Facilitate technology transfer
 Training of local staff
 Shared risks and costs
 Cons:
 Dependency
 Sustainability in the event of agreement breach
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12. Negotiation document
 Joint V: Option 2 (government with significant share)
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13. Consultancy firm TOR
 WB no objection response delayed
 Points raised (comments from WB) include:
 To include diagnostics and other pharmaceuticals
 The context of Regional integration (IGAD)
 Who will own the plant
 Level of gov’t commitment
 Sustainability
 Construction vs renovation
 Construction under 3rd AF than the new application
 Technology partner before consulting firm
 Include HR training and other preparatory activities
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14. Proposal to IPDC
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15. Company formation
 Benchmarking and high level organizational structure
 Ethiopian Airlines group
 Ethio Engineering group
 MIDROC group
 Adami Tulu chemicals
 PEHAA-regulatory
 EIH- owner
15

16. Benchmarking:
Adami Tulu Pesticide Processing Factory
 It used to be under PHEAA
 It was none of the five companies under Chemical
Industry Corporation (not clear!)
 As of August 2022 (eight months), it is part of EIH
 Led by a Board of Directors (is it while they were
within PEHAA or now under EIH?)
 The company runs by a CEO with delegation from the
Board.
 It has five deputies for Quality, Production, Marketing
etc.
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17. Company formation
 Ethiopian Airlines group – Liya
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18. Company formation
 MIDROC group- Fasika
18

19. Company formation
 Ethio-Engineering group – Amha (please extract from the
regulation and summarize the company that are relevant for
ours)
19

20. Benchmarking: PEHAA
Public Enterprises Holding and Administration Agency
 Two modalities are possible under PEHAA-NVI
1. EthioBioPharma group will be established to accommodate the
existing NVI (without any change) and a newly established EtVac.
EtVac and EthioBioPharma group will be established by
regulation at the same time. This will allow formation of other
sister companies/subsidiary
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21. Benchmarking: PEHAA
Public Enterprises Holding and Administration Agency
 2) First EtVac will be established by regulation to have the same
status with NVI and then be managed by one board with NVI
under PEHAA
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22. Company formation
 EIH - Herani
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23. Company formation
 PEHAA - NVI
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24. Company formation
 Draft regulation (as a public enterprise)
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25. Objectives of the Enterprise
 The Enterprise shall have the following objectives:
1. Conduct Research and Development on vaccines and biologics
of priority public health diseases
2. Manufacture quality assured vaccines, sera and other biologics to
satisfy local needs and export to other countries
3. Serve as a hub for knowledge and technology transfer in vaccine
and biologics development and manufacturing
4. ?
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26. Powers and Duties of the Enterprise
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 The Enterprise shall have the powers and duties to:
1. conduct preclinical research for the development of vaccines
and other biologics based on national priority public health issues
2.formulate and manufacture vaccines, sera, and other biologics
of international standard for various human diseases;
3. engage in the activities of technology transfer useful for its
activities
4. produce reagents to be used for diagnostics, production and
research on human diseases;
5. conduct market needs and post marketing assessment
6. sell its products in local and international markets;

27. Powers and Duties of the Enterprise
27
7. collaborate with other institutions locally or internationally for
the conduct of clinical trials
8. form joint venture for technology transfer
9. employ highly skilled personnel from international market for
technology transfer as deemed necessary;
10. establish subsidiary companies areas as necessary
11. engage in other related activities conducive to the attainment
of its goals.
12. Contribute to the development of human resource in its
sector by conducting customized training and providing
consultancy service

28. Project status/timeline
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Gantt Chart - hyper link

29. Next steps/Way forward
 Finalize agreement/contract with IPDC
 Follow up TOR consultancy with WB/No objection
 Upon no objection, float the TOR, select contractor
 Contact vaccine manufacturing countries/companies
(how to approach- EOI/Letters)
 direct contact to companies if not government owned
 Contact government if government owned
 Both can be approached through Ministry of Foreign Affairs
and Embassies
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30. Acknowledgment
 NVI management and board
 IPDC CEO and management
 Benchmarked organizations
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