This white paper aims to serve as a primer for entities that are new to human vaccine manufacturing and interested in developing production capacity for the first time in a new location. This primer does not cover developing a new vaccine from scratch, but rather building a facility to produce existing vaccines. Bold terms are further explained in the Glossary.

First, new producers must understand that the global vaccine market is unique. The vast majority of the global sales volume is purchased on a tender basis by large governmental and non-governmental organizations rather than on the private market by individuals. Next, this guide gives an overview of the different steps of vaccine production and the key aspects a new producer should understand.

Most importantly, this primer aims to give an accurate representation of the challenges within the sector so potential producers can accurately determine if vaccine manufacturing is right for them. Compared to other products and even pharmaceuticals, vaccine manufacturing faces relatively high costs, long timelines and significant barriers to entry.

Finally, this primer indicates some next steps potential producers should take as they hone their business cases and begin their concept-level feasibility assessments. The white paper forms part of a series of publications that have been produced in collaboration between UNIDO, WHO, and AVMI. Currently, two other documents in this series can also be consulted. They are:

VMPA Study: Vaccine Manufacturing and Procurement in Africa (2017). This provides a comprehensive overview and assessment of the case for vaccine manufacturing on the African continent and covers four core areas: the vaccine market, vaccine procurement, issues related to the manufacturing capability itself and lastly financing considerations.

Commercialising vaccines: A methodology to identify potential market opportunities and conduct outline assessments (2017). This paper outlines a process for conducting an initial evaluation to determine the financial viability of setting up a new facility to supply vaccines to a particular market using real market data; in this instance South Africa was used as a country case study.