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