Current Projects

VMPA Study Report

Vaccine Manufacturing and Procurement in Africa (VMPA) Study

Background

In 2012 a multi-stakeholder effort led by the African Union Commission (AUC) and the United Nations Industrial Development Organization (UNIDO) published the Pharmaceutical Manufacturing Plan for Africa (PMPA), Business Plan (2012). The rationale being that a viable pharmaceutical industry in Africa would not only positively impact the African health systems and capacity to respond to the health needs of the people but will also contribute to the overall socioeconomic development of the continent.

Within this context it was acknowledged that vaccines are a cornerstone of any primary healthcare programme and an essential tool in preventing disease.

Feasibility Study and Strategic Plan Development for Africa Vaccine Manufacturing

Vaccine manufacturing is a complex, time-consuming exercise requiring considerable commitment, and financial and technical resources. The capital investment required is considerable and a long-term future view is essential. While the potential benefits are clear the practical implementation and realization of the desired outcome are not without challenges.

With the support of the United Nations Industrial Development Organization (UNIDO) and the World Health Organization (WHO), AVMI held an expert consultation in October 2014 to discuss options for the development of a strategic approach to this issue.

As a result of this consultation an African-wide study was commissioned. The Vaccine Manufacturing and Procurement in Africa (VMPA) study, initiated in 2015, is an analytical assessment of vaccine manufacturing capacity and procurement mechanisms in Africa focusing on four priority areas:

1. Current and future Vaccine market dynamics.

2. Vaccine procurement mechanisms and associated financing mechanisms.

3. Technical feasibility of establishing sustainable Vaccine manufacturing capacity.

4. Financing and funding mechanisms to establish Vaccine manufacturing

The outputs and outcomes of the study will be utilized to consult and advocate with key stakeholders to advance the development of African vaccine manufacturing considerations. The next steps in the study involve a series of country specific case studies that will further substantiate the final evidence-based report.

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White Paper

WHITE PAPER

Establishing Manufacturing Capabilities for Human Vaccines

Key cost drivers and factors to consider when planning the establishment of a vaccine production facility

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.

Case Study: South Africa

WHITE PAPER

Commercialising vaccines:
A methodology to identify potential market opportunities and conduct outline assessments

Case study: South Africa

This paper describes a methodology to perform an initial evaluation to decide which vaccines, if any, may be worth manufacturing for a particular market. These methods do not constitute a comprehensive market analysis but instead form part of an initial concept level business case analysis.

This step wise approach is demonstrated using a real life example, South Africa, as a country case study.

The document outlines each of the three phases which collectively comprise the methodology, and also details the next steps that would need to be taken to validate a business case.

Publicly available information on the existing South African vaccine manufacturer indicate that the conclusions drawn by this document relating to the South African market do in fact identify the key market opportunities there. This indicates that the methodology has delivered a valid assessment result in this particular case study, thus endorsing the approach taken. The results of the analysis may even provide insight as to why certain strategic decisions were made by the existing South African manufacturer, however further discussion on this point is beyond the remit and focus of this study.

The document supports and expands upon the white paper “Establishing Manufacturing Capabilities for Human Vaccines” published in 2017 and assumes the reader is familiar with the concepts introduced therein. This white paper was designed to give a basic overview of the vaccines industry and summarize key cost drivers and factors to consider when planning the establishment of a vaccine production facility.

The objective of the current paper is to demonstrate how a person endowed with knowledge of the vaccine industry and basic market data can determine the high level feasibility of potential commercial vaccine opportunities in a market.