An updated methodology to review developing-country vaccine manufacturer viability

Abstract

Highlights8 factors predict the viability of vaccine manufacturers in developing countries.These factors have evolved as the vaccine landscape has changed over 2 decades.A new analysis updates a framework first published in 1997 to assess viability.The updated framework is useful for assessing investments in vaccine manufacturers.

Advancing innovation for vaccine manufacturers from developing countries: Prioritization, barriers, opportunities

“…The next most prominent barrier to investment in novel vaccines, reported by 50% of respondents, was a lack of technical expertise, which can include, and is not limited to, scientific, regulatory, and strategic expertise. However, to attain sufficient scientific and technical skills for vaccine manufacturing, low-resource countries are frequently required to import skilled labor, which greatly increases costs [12] , [16] . Further research is required to pinpoint the specific technical areas for which support would most benefit DCVMs.…”

“…Importantly, the sampled manufacturers have innovative strategies targeted for low- and middle-income markets, where infectious diseases’ burden is the greatest. However, the lack of commercial case often limits investments and stalls the development of needed novel and improved vaccines [13] , [16] . Moving forward manufacturers could enhance the capacity to build more detailed commercial insights, such as business cases and demand forecasting and careful cost structuring to incentivize more funding.…”

Roadmap for strengthening the vaccine supply chain in emerging countries: Manufacturers' perspectives

“…The ability and capacity to embrace opportunities remain a goal for many emerging vaccine manufacturers, but they often lack resources for significant changes to their operations [12] . While up-front investments (subsidies) are one response, this should be weighed against manufacturers' ability and capacity to adapt and adopt new technology [13] . Technology transfers constitute another option to support capacity building for manufacturers with scientific knowledge facilitating the transfer process [14] .…”

Recommendations for acceleration of vaccine development and emergency use filings for COVID-19 leveraging lessons from the novel oral polio vaccine

“…The best approach should be discussed early with the WHO PQ unit. Technology transfer Vaccine technology transfer requires extensive time and resources 64 . The process includes extensive documentation, asset transfers and training, as well as significant negotiations around intellectual property, liability, and data ownership.…”