The overall objective of the project is to provide technical cooperation to strengthen regional manufacturing capacities of quality-assured, safe, and effective vaccines in Latin America and the Caribbean (LAC). The project started in January 2023 with an initial 18-month duration and has been extended until June 2025.
The ultimate outcome of the project is to decrease COVID-19 and other immuno-preventable diseases related to mortality and morbidity in the Americas. To contribute to this ultimate outcome, intermediate outcomes were defined, centered on increasing supply of quality-assured vaccines, and strengthening vaccine production ecosystems.
To impact these intermediate outcomes, four workstreams are in place, focused on vaccine manufacturing, value-chain strengthening, regulatory strengthening and support for policies and dialogues. These workstreams, named as Immediate Outcomes, include an array of activities that are currently being executed by the Pan American Health Organization (PAHO). It is worth noting that gender, equity, and human rights have a special consideration as cross-cutting themes, included across the Outcomes. The four immediate outcomes and their corresponding activities are described below.
Outcome 1110: Improved development and production capacity for mRNA vaccines in LAC
Objective: Build capacities for mRNA and other technologies vaccine, for the development and production of vaccines, impacting the Region with increased supply.
Key activities & impact:
- Build mRNA vaccine ecosystems in Argentina and Brazil, to strengthen the local production ecosystem, develop know-how and reduce import dependency.
- In Argentina, development of the national mRNA vaccine production ecosystem. A public-private collaboration agreement has been signed integrating strategic components of the value chain and ensuring real-time emergency vaccine access through the Revolving Fund at production cost-linked prices.
- In Brazil, support BioManguinhos to develop pre-clinical trials for the development of a novel mRNA vaccine. If the studies are successful, the technology will be licensed to regional manufacturers at no cost.
- Support the participation of manufacturers in WHO mRNA Vaccine Technology Transfer Program; currently, Sinergium Biotech (Argentina) and BioManguinhos (Brazil) are part of the network.
- Promote strategic technology transfer of vaccines to Latin American manufacturers by support the identification of opportunities; exploratory research on technology transfer models is being conducted.
- An analysis of Gender Equity within vaccine producers in the Region is being conducted.
Outcome 1120: Strengthening capacity of key stakeholders for the development of regional value chains for vaccine inputs and supplies
Objective: Strengthening of regional value chains to ensure vaccine supplies are available throughout the Region, to increase the manufacturing base for vaccines in LAC.
Key activities & impact:
- A sub-regional multisectoral meeting (July 2023, Brasilia) with representatives from thirteen State Members, and members of the academia, and the private sector to gather and exchange information regarding the situation of the regional value chains for the development, manufacture, and delivery of vaccines; other sessions will be organized throughout the project to receive further input from stakeholders, and a document with recommendations will be released.
- A multinational workshop with six State Members representatives was convened, to discuss policies to foster national productive ecosystems. A research paper is expected to be released during 2024.
- Course on vaccine development and production for MERCOSUR countries developed and conducted, jointly with FIOCRUZ and Butantán, for MERCOSUR and associated Member States. Hybrid modality, 90 lecture hours and visits to Butantán, Bio-Manguinhos, Farmanguinhos, and Nortec Química facilities.
Outcome 1210: Strengthened regulatory systems, other enabling functions and staff for vaccine production, including the provision of gender equitable access components
Objective: Strengthen national regulatory systems and harmonization and convergence networks through a regional approach.
Key activities & impact:
- Developed a training itinerary in PAHO Virtual Campus to improve the human resources capacities of the regional National Regulatory Agencies.
- Support countries with the evaluation of their regulatory systems using the Global Benchmarking Tool, leading to the establishment of Institutional Development Plans (IDPs).
- An analysis of Gender Equity within regulatory systems in the Region is being conducted.
Outcome 1220: Improved multisectoral policies, information and dialogue among vaccine production stakeholders, including women scientists, considering gender equality and equitable access components
Objective: Regional dialogue facilitation and information exchange within national and regional stakeholders
Key activities & impact:
- Production of strategic studies in critical areas, including patent landscape and mapping financial sources for development and manufacturing of health technologies
- Advisory Committee of the Regional Platform to Advance the Manufacturing of Covid-19 Vaccines and other Health Technologies in the Americas. Representatives from diverse sectors and backgrounds. Articulation of cooperation actions, promoting intersectoral initiatives and dialogue, and avoiding duplication of efforts. with three meetings convened; originally conceived to address COVID-19 related vaccine technologies, the original Committee has been finalized following the end of the pandemic emergency, and a new Call for Interest is underway to invite new members to a Strategic Advisory Group, to discuss vaccines´ policy recommendations not limited to COVID-19.
- Organized a series of technical webinars to disseminate content, including value-chain strengthening opportunities, sustainability and financing, intellectual property and innovation, policies to increase the productive capacity, and gender approach in the development and production of vaccines.