COVAX Manufacturing Taskforce – Workstream 3 Classified as Internal

Objective 1 Expand capabilities of existing Workstream 3 manufacturers in LMICs ambition is to improve long- Objective 2 term LMIC Establish sustainable capacity in regions health security with no significant capacity via two key objectives and enablers Enablers Identify & implement innovations and develop normative frameworks Classified as Internal 3 potential approaches for capacity connector identified, with WHO-led WS3 focusing on multilateral TT hub model

1 2 3 Bilateral technology Multilateral technology transfer technology hub Fill-finish transfer model - including and beyond Covid

Inventors Developers Researchers

Experts IP holders Member States Manufacturer 1 Vaccine Manufacturer 1 Limited filling line Technology transfer hub Vaccine Industrial scale process, Data, Rights Excess bulk vaccine Process transfer Manufacturer 1 Manufacturer 2 Filling line 2 Existing and or Manufacturer 3 Vaccine Filling line 3 Vaccine Manufacturer 2 new LMIC manufacturers Manufacturer 4 Filling line 4 Vaccine Manufacturer 5 Focus of this project Classified as Internal EOI call for mRNA tech hub has been launched in mid-April

Call issued on April 16 to seek seeking expressions of interest from

1 Possible Hubs: Small/middle-size (public or private) manufacturers of medical products (drugs, vaccines or drug substances) which could host a COVID-19 mRNA hub

2 Possible Tech Providers: Owners (public or private) of technology and/or Intellectual Property Rights (IPR) willing to contribute to a technology transfer hub Classified as Internal 50+ EOI received from potential candidates for tech transfer hubs & recipients AS OF 07JUNE2021 30+ Responses from countries/ 20+ Responses from potential tech manufacturers more likely to be possible donors and/or sites for hubs recipients

Preliminary – answers still under review

Potential tech donor only (based in China, UK, USA) Potential interest for establishing recipient site (based in Potential tech donor & hub site (based in , , , , , , , Cuba, , , Thailand) India, , , , , , , , , , , , South Africa, Potential hub site only (based in Argentina, Belgium, , Thailand, , , , , ) Chile, Colombia, , Nigeria, Paraguay, Senegal, , Taiwan) Classified as Internal Detailed due diligence process is ongoing, based on several technical criteria

We developed several criteria to assess potential hub / tech donor and issued a detailed questionnaire to be filled by respondents

Hub criteria Tech criteria Few questions for illustration purpose  Does the technology have clinical data to prove it works ?  Which lipid / formulation is used? How does this affect price, yield, immunogenicity, FTO ?  Are reagents readily available ?  Is formulation scalable ?  Thermostability ?  Is there freedom to operate ?  Doses / sq metre facility ?  Are recipients able to operate independently? (Open access?)  Is the tech licensed / free ? Classified as Internal

Appendix Classified as Internal Context | Our effort sits within the broader COVAX Manufacturing Taskforce as the Workstream 3

Workstream 0 Workstream 1 Workstream 2 Workstream 3

Shared Fact Base / Task Immediate COVAX Short- and Mid-Term New & expanded sustainable Force Coordination Office Response COVAX Response capacity in LMICs  Create aligned supply baseline  Create voluntary input supply  Expand fill & finish match  Expand capabilities of existing  Conduct supply and visibility partnership making mechanisms manufacturers in LMICs manufacturer ecosystem  Accelerate export  Create overview of global  Establish sustainable capacity mapping permits/custom clearance for manufacturing capacities in regions with no significant  Document and share lessons critical SKUs  Better utilize existing capacity learned across focus areas capacities, e.g., voluntary  Enablers: Develop normative bilateral tech transfer policy frameworks, stimulate  Develop regulatory & manufacturing innovations & manufacturing workforce investments Classified as Internal During initial design phase, WS3 explored a range of options and aligned on a hybrid model for tech transfer hub

1 Decentralized & flexible 2 Centralized & normative 3 Optimized model Preferred option

Hub Hub Hub

Partner site 1 Partner Partner Partner site 3 site 1 Partner site 4 Affiliate Affiliate Affiliate Affiliate Partner Affiliate Affiliate site 2 Partner site 1 site 1 site 1 site 1 site 2 Partner site 1 site 1 site 3 site 4 Hub(s) at 1+ existing sites, recipients are 1 hub & several new, identical "affiliate" Build 1 hub & some new "affiliate" sites; other existing "partner" sites, gain TT & vs sites; affiliates receive normative tech recipients are both partner & affiliate sites; hub know-how for novel tech transfer & broader capability training offers distinct training module for each

+ Easy and fast to implement + Adds significant new capacity + Combines pros of both models and + Low cost, empowers existing LMIC + Enables rapid responses during ensures flexibility manufacturers pandemics and more control on + Pragmatic, case-by-case approach to network determine best model by country/region - Low capacity & capability add - Most challenging / longer to implement - Slower TT process during pandemics - Highest cost - Requires robust governance to handle 2 and lower chances of success - Low agency for LMICs in approach types of "recipients"

"Hub" = center for multilateral TT & training (plus semi- to full-manufacturing scale production in Options 2 & 3); "Partner" site = existing LMIC manufacturer that receives TT; "Affiliate" site = newly built facility affiliated with hub & recipient of TT; TT = Tech Transfer Classified as Internal Manufacturers with approved products and bilateral tech transfers could be leveraged to accelerate pathway

Rest of 2021 2022 2023+

Select the Build Hub Initial Tech Conduct Ph Select & transfer Support long Expanded and techs (mRNA, Transfer to I/II/III trials at tech and know- term New VV, Proteins Hub, scale-up, the hub how to recipients sustainability sustainable EOIs) develop Either new build with other manufacturing SOPs/training (affiliates) or routine Vx and capacity in expanding capacity Tx transfers LMICs Lever 1: Leverage of existing manufacturers manufacturer with (partners) approved product Fast initial TT to hub at Build Hub or Need strong connection between WS2/3 to for 1 or more tech large scale from suite for given map bilat. TT and offer long term COVAX approved product of continuity/support tech large manufacturer Align on Terms Lever 2: Prioritized manufacturers having received TT and Conditions for access Bilateral deals conducted in LMICs within context of COVAX/WS2, or bilateral deals outside of this context can be prioritized as partners and benefit from Hub training, network and sustainable model Classified as Internal Due Diligence process | Criteria assessed for potential hubs

Vaccine know-how Infrastructures Tech transfer exp. Workforce & training  Previous works on mRNA  Key infrastructures  Experience in tech transfers  Number and expertise vaccines  Existing pilot facilities  Possibility to allocate staff to  Vaccines currently in  Approximate cost per year to establishing and maintaining a development allocate a pilot plant to mRNA technology transfer hub training  Suitability for industrial scale production

Access to regional Ecosystem & Regulatory markets & Equity gap financing  Regulatory department  Accessibility to regional  Accessibility to funds  Recent filings for clinical populations in order to sustain  Sustainability of funding studies and/or approval inter-pandemic demand  Partnerships with relevant  Site qualification  Exportations to other markets public or private sector players Classified as Internal Due Diligence process | Criteria assessed for potential tech donors

Development stage Intellectual property Mfg. Process Mfg. Inputs  Approach used (e.g., mRNA,  Patent number if any  Manufacturing process  Required reagents self-amplifying RNA)  Requirement to access any  Largest scale at which  Supply constraints (e.g.,  Clinical trial number(s) and other IP1 production has been proprietary) summary data implemented (DS2 and DP3)  Data demonstrating efficiency  Scalability to larger scale of vaccines  Predicted cost of goods at full  Pros & Cons of the tech. manufacturing scale  Estimated size of DS facility4

Deliverability Access & incentives Mfg. Plants Tech transfer exp.  Route of delivery  Ability to provide access to the  Interest in serving as a tech.  Experience in tech transfers  Current and final intended tech. training center presentation for DP/final filled  Type of agreement needed  Ownership of a GMP facility container  Licensing of the tech. to other  Ownership of a facility suitable  Thermostability recipients for industrial scale production  Ownership of staff able to provide training

1. Intellectual Property 2. Drug Substance 3. Drug Product 4. For 50M doses per year on a campus with existing water, utilities, analytical labs, etc.