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 Belgium, India, Argentina, Bangladesh, Brazil, Chile, Colombia, Cuba, Egypt, South Africa, Thailand) India, Indonesia, Kenya, Morocco, Nicaragua, Nigeria, Pakistan, Paraguay, Peru, Philippines, Rwanda, Senegal, South Africa, Potential hub site only (based in Argentina, Belgium, Canada, Thailand, Tunisia, Uganda, Uruguay, Venezuela, Vietnam) Chile, Colombia, Italy, Nigeria, Paraguay, Senegal, South Korea, 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.