Improving Middle-Income Countries Access to Vaccines. A Blueprint to Overcome Current Challenges

Carlos Espinal; Francisco Becerra-Posada; Jaime R. Torres

doi:10.5334/aogh.4151

Figures & Tables

Table 1a

All-embracing barriers and specific issues constraining vaccine development in low-and middle-income countries (LMCs).

ALL-EMBRACING BARRIER	SPECIFIC ISSUES
Financial and economic constraints	Economic restrictions worsened by COVID-19 pandemic Insufficient funding for scientific research and development (R&D) Low advocacy for vaccines budget
Political focus is short term	Politicians tend to favor near-term results, but investments in vaccine capabilities take years to bear fruit Easier to pursue near-term fill and finish manufacturing capabilities than investing in a long-term vaccine R&D strategy Changes in administrations and governments can cause shifting focus and funding
Over-reliance on Multinational Corporations (MNCs) and global actors	Historical reliance on MNCs and global actors as drivers of vaccine innovation was further accentuated during the COVID-19 pandemic Partnerships with MNCs are not balanced enough for MICs MNCs are not as focused on developing vaccines for NTDs
Competition from other health priorities	Vaccines compete against other health-related topics for limited funds and resources

Table 1b

Front-end and downstream barriers and specific issues constraining vaccine development in low-and middle-income countries (LMCs).

FRONT-END BARRIER	SPECIFIC ISSUES	DOWNSTREAM BARRIER	SPECIFIC ISSUES
Undertaking of an R&D approach for vaccine development by a MIC may not be justified based on its expected commercial benefit	• A novel vaccine must pay for itself Belief that it is cheaper to buy a vaccine than to develop one	*MICs single country markets are small; therefore, sustaining local production requires access to other countries markets*	MIC production will need demand and volume from multiple countries It will take time for new MIC output to achieve competitive scale and pricing, leading to higher prices in the short term which may constrain access to export markets Technology transfer agreements are often bound to one country, disallowing exportation
Gaps in R&D and scientific capabilities	Limited know-how for basic science Academic structure needs to be modernized Training is needed for researchers	*Focus on low price by pooled procurement agencies will constrain new vaccines developed by MICs*	Pooled procurement agencies may limit exportation opportunities for new vaccines from MICs because of higher prices
Perception bias that MICs do not have sufficient R&D capabilities	MICs are not seen as a reliable partner for conducting R&D MICs are mainly engaged by MNCs when there is a specific need (e.g., local clinical trial)	*Lack of capabilities and capacity for sustainable post-clinical trial production*	It takes significant time to develop infrastructure, build and train a workforce, license technologies, and secure government contracts
Favorable intellectual property (IP) environment is not supporting or driving more innovation	MICs with good IP laws are not seeing increases in technology transfer agreements or approval of new products	*Vaccine implementation challenges*	Health system difficulties in turning available supply into application in target populations Training healthcare workers for vaccine implementation Concerns about increasing the complexity of the immunization schedule by adding more vaccines to the EPI/NIP Vaccine distrust and hesitancy hinders routine immunization rates and uptake of novel vaccines

Table 2

Regulatory barriers limiting MICs stakeholders from achieving better results to foster vaccine innovation and access.

REGULATORY BARRIER

SPECIFIC ISSUES

Regulatory limitations delay vaccine approval and access for MICs

Lack of stringent regulatory agencies in the Global South*, affects timing to review and approve vaccines, which vaccines countries have access to, availability of vaccines for exportation, and impacts the willingness of stakeholders to invest in R&D. In Latin America at least six countries (Argentina, Brazil, Chile, Colombia, Cuba and Mexico) with level 4 regulatory agencies, could be further strengthened to become a stringent supervisory body for the region
Pooled procurement agencies^ may paradoxically limit exportation opportunities for new vaccines from MICs because of regulatory aspects and WHO prequalification process

Table 3

End-to-end Solution Framework to Help MICs Increase Access to Future Novel Vaccines.

CATEGORIES	FRONT END DRIVERS OF R&D CAPABILITIES	REGULATORY DRIVERS	DOWNSTREAM MARKET DRIVERS
Objectives	1: Create a long-term government strategy & vision for access to vaccine innovation 2: Strengthen R&D know-how and capabilities throughout a MIC 3: Collaborate for specific infectious diseases 4: Spur vaccine R&D through investment, funding, and other incentives/mechanisms	1: Strengthen regulatory processes in and across MICs 2: Create regulatory incentives to accelerate vaccine innovation	1: Create incentives through procurement commitments 2: Leverage regional pooled models for innovation 3: Create incentives through tiered pricing 4: Support sustainable access and vaccine implementation

Table 4

Case for action.

CATEGORIES	INFECTIOUS DISEASES ARE SEEN AS A PRIORITY BY THE GOVERNMENT	VACCINE SELF-RELIANCE AS AN ESSENTIAL ENABLER OF HEALTH AND ECONOMIC SECURITY	VACCINES AND BIOTECHNOLOGY ARE STRATEGIC PRIORITIES FOR COUNTRY OR REGIONAL ECONOMIC GROWTH
Relevant comments	Government stakeholders must be convinced that the burden of an infectious disease makes preventing it a high priority. Decision makers must have access to data and projections to understand the full impact and value of prevention. This requires a strong evidence-based business case and health economic modeling to support MIC government decision making.	Throughout the pandemic, MICs were reliant on MNCs, NGOs, and HICs for COVID-19 vaccines and had to either wait their turn or fend for themselves to receive supply. MICs want the ability to develop novel vaccines for future pandemics/endemics, and to produce several vaccines on their EPI/NIP. This is motivating MICs to make investments and deepen partnerships to improve their end-to-end vaccine value chain capabilities.	Some MIC governments view science, biotechnology, and vaccines as strategic enablers of economic growth. These MICs want to diversify their economic output beyond their historical base and shift toward a more knowledge-based economy.