Influenza Vaccine Technology Transfer: A Mixed-Methods Study with Vaccine Manufacturers and Global Experts to Assess...

Technology transfer (TT) has been identified as a global health priority due to its impact on improving access to vaccines, including for pandemic influenza preparedness and response through bilateral and multilateral mechanisms. This study aimed to (1) characterize examples of influenza vaccine TT (IVTT) and (2) identify key lessons learned that may inform future activities relevant for next-generation influenza vaccine technologies.

Using a contingent effectiveness model, a convergent mixed-methods study was conducted with vaccine manufacturers and global experts to capture quantitative survey data on IVTT activities and enablers and qualitative data on successes, challenges, and opportunities for IVTT through interviews, complemented by secondary data from peer-reviewed and grey literature to characterize additional IVTT observations.

This study included 24 participants, including 14 representatives from 13 vaccine manufacturers and 10 experts. Interviews were conducted with representatives from eight manufacturers and seven experts. Eighteen IVTT observations were identified through the surveys and interviews, of which 15 IVTT transfers were completed and 13 resulted in an approved vaccine. Secondary data provided additional evidence on eight IVTT recipients and one supplier, expanding the range of institutional and programmatic contexts assessed. Shorter IVTT completion and vaccine approval timelines were observed in association with prior TT experience and private management structures for manufacturers, for pre-pandemic/pandemic influenza vaccines versus seasonal influenza vaccines, and among bilateral transfer mechanisms (versus multilateral mechanisms) and fill/finish transfer methods. Manufacturers also described spillover benefits, including the use of IVTT-related know-how for the development of COVID-19 and routine vaccines. Both manufacturers and experts generally agreed on a list of 17 enablers for successful IVTT and ranked government commitment to vaccine production and procurement as the top enabler. Findings from the literature-based observations were consistent with primary data and included additional public sector recipient experiences, evidence of widespread human capital development, and a commentary on the importance of the demand environment.

Assessed IVTT activities across primary and secondary data sources yielded commercial and spillover benefits as described in the contingent effectiveness model and provided a triangulated analysis of IVTT experiences across manufacturers, experts, and documented cases. Participants agreed that effective technology transfer is contingent upon a host of determinants. Using a systematic application of the contingent effectiveness model to IVTT, this study provided an exploratory analysis of past activities among vaccine manufacturers and experts. While certain nuances for influenza were identified, the lessons learned from this study may be applicable for other TT activities, including those to support pandemic preparedness. The contingent effectiveness model is a useful tool to inform and evaluate future TT activities.