Foreword
In the aftermath of the acute phase of the Covid-19 pandemic, there is significant momentum for investing in regional vaccine-manufacturing capacity. Leading global and regional health organisations, including the World Health Organisation (WHO), Coalition for Epidemic Preparedness Innovations (CEPI), Gavi – the Vaccine Alliance – and the Africa Centres for Disease Control and Prevention (africa CDC) Partnership for African Vaccine Manufacturing (PAVM), as well as national governments and pharmaceutical companies, have begun to undertake critical investments to expand vaccine-manufacturing capacity, especially in the Global South. To identify common needs and leading practices that facilitate the establishment of regional manufacturing efforts, the World Economic Forum has launched the Regionalised Vaccine Manufacturing Collaborative (RVMC) together with CEPI and the US National Academy of Medicine. Under the leadership of India’s G20 presidency, the G20 is currently considering plans for a global network of vaccine, therapeutic and diagnostic (VTD) R&D and manufacturing hubs. All of these are important initiatives to promote self-reliance of Global South countries, economic development, life-sciences industries, and global public health and health security.
However, the complexity of these endeavours and the speed at which investments are progressing present a risk that the global community may misallocate its resources. Investments need to be balanced and coordinated to meet forthcoming demand for both routine and emergency vaccines. We note that all investors – including governments, pharmaceutical manufacturers, development banks and philanthropists – have the right to make their own investment and risk decisions. However, the global health community has an obligation to shape the market for these investments to increase the likelihood that future regionally distributed manufacturing capacity is financially sustainable and has the capability to make the quality vaccines needed for public health. Success will best be realised through a coordinated global effort.
The global health community has a strong track record of market-shaping for specific products. For example, Gavi, UNICEF and others have successfully negotiated lower prices and diversified the supplier base for many individual vaccines. Similar achievements have improved the availability and affordability of other commodities, such as antiretrovirals, antimalarials, bed-nets and medicines for tuberculosis. We now need to use innovative market-shaping approaches not just for individual commodities and not just for scale efficiencies, but also to achieve a resilient, geographically distributed, technologically diversified and financially sustainable network of vaccine-manufacturing facilities.
As this paper argues, to successfully shape this market, the global community should start with a clear picture of what routine and emergency vaccines a geographically distributed manufacturing network could produce in the future. This should include current and future adult vaccinations, which could contribute to a reduction in 10 million preventable adult deaths per year, as well as childhood vaccines that prevent between 2 and 3 million deaths per year. While well-meaning efforts to invest in manufacturing capacity and a patchwork of demand-forecasting efforts are already under way, the global community still lacks dynamic, scenario-based global-demand forecasts for a broad portfolio of vaccines, including pipeline assets, which could be manufactured in these and other planned facilities.
Therefore, we welcome the One Shot initiative’s call to action for the global health community to fund scenario-based demand forecasts for all vaccines that include pipeline assets and that span all regions, and a coordination mechanism that more directly links forecast demand to investments in supply. We are aware that future procurement of vaccines will vary based on many factors, including evolving epidemiological patterns, fiscal space for public-health programmes, and new vaccines that will receive regulatory approval. Documenting these assumptions in different scenarios will make demand forecasts more valuable to investors.
Demand forecasts should be updated regularly, at least once per year, to account for evolving information, and should be shared openly as a global public good. They should include not just the vaccines procured by a specific funder, programme or country, but the full portfolio of child and life-course immunisations that should be manufactured on a geographically distributed, technologically diversified, and financially sustainable network of vaccine-manufacturing facilities. These demand forecasts should also include vaccines that are still in the R&D pipeline. and, critically, they should forecast not only the demand for doses of individual antigens, but also work backwards to estimate the demand for capacity along the manufacturing value chain (for example, capacity for drug-substance and drug-product manufacturing using different platform technologies, fill/finish capacity, other commodities along the supply chain) to guide investment decisions in manufacturing facilities.
Only with clarity on what products the world needs to manufacture can we hope to build manufacturing facilities that meet this demand in a sustainable way.
Dr Ahmed Ogwell Ouma
Deputy Director-General, Africa CDC
Dr John-Arne Røttingen
Ambassador for Global Health at Norwegian Ministry of Foreign Affairs
Executive Summary
The Covid-19 pandemic spurred major advancements in our ability to develop, manufacture and distribute vaccines. To deliver the biggest adult-vaccination campaign in history, manufacturing plants dramatically scaled up production, and there was significant investment in new technology and the training of a skilled biomanufacturing workforce. These efforts ultimately prevented an estimated 20 million deaths in one year.
The scientific developments that were accelerated by Covid-19 have led to a robust pipeline of game-changing life-course vaccines and preventative injectables. However, the Covid-19 vaccine rollout also exposed inequities in the geographical distribution of vaccines. Most of the early Covid-19 doses went to countries and regions with existing manufacturing capacity; those without sufficient vaccine infrastructure were forced to wait, and accusations of vaccine hoarding on the part of countries with manufacturing capacity abounded. To use life-course vaccines on a global scale both for routine preventative health and as a strategy for pandemic prevention, preparedness and response (PPR), it is now incumbent on the key players – governments, industry, funders, international norm-setting agencies, civil society and multilateral platforms such as the G20 and G7 – to drive a global effort to harness and deploy these products to significantly reduce mortality and morbidity.
A new model for global vaccine manufacturing is needed. This will require an urgent transition to regionally coordinated manufacturing capabilities, with special consideration given to the Global South and how to develop the viability of manufacturing hubs in these parts of the world. There also needs to be an optimisation of supply and distribution networks to support a programme that can facilitate demand for life-saving vaccines beyond pandemics while remaining resilient enough to ramp up in response to serious pathogen threats.
Governments, industry and global health bodies must act now to ensure strong population health and PPR. Capitalising on the potential of these new products will require a strategic expansion of global manufacturing capacity and diversification of technology, aligned with demand across each region. To establish the right global network of manufacturing capacity, governments, global health organisations and the private sector need to know what types of manufacturing capacity to invest in. These decisions should be informed by robust information about the demand for vaccines, guided by existing and forecasted manufacturing capacity, and supported by clear market signals and assurances whenever possible. We believe that the global community is making significant progress on mapping existing and forecast manufacturing capacity but still has a major gap in long-term demand forecasting, especially for pipeline assets (products that have not yet launched), to guide manufacturing-investment decisions. The Resource List we have compiled below demonstrates some of the most promising efforts towards global mapping of vaccine supply and demand.
The Global Health Security Consortium’s (GHSC) One Shot campaign – an initiative that sets out a roadmap for the development of a permanent and preventative global public-health programme that promotes adult vaccination as a vital part of life-course immunisation and the use of prophylactic injectables – is a response to the current barriers to vaccination and the opportunity to improve global health through universal, equitable access to these life-saving products.
The analysis in this paper represents a first attempt to provide a unified picture of the existing and forthcoming vaccines categorised by manufacturing technology and to map current demand for doses against manufacturing technology. The Technical Deep Dive at the end of this paper presents a summary of current global procurement of vaccines as a step towards forecasting supply and demand efforts.
How Do We Take Action?
A geographically distributed, technologically diversified global manufacturing network starts with a better understanding of demand and supply. This supply-and-demand information will allow global health actors to design the right incentives and policies to achieve a geographically distributed and technologically diversified manufacturing network for future vaccine needs. It will also help governments and the private sector decide how and where to invest their capital in new manufacturing technology.
A manufacturing network that can support robust life-course vaccination will need to be geographically distributed such that each region has a reliable and accessible supply of vaccines, and a key focus is Africa. Prior to Covid-19, Europe, India, China and the United States dominated vaccine production.
For a commercially viable, geographically distributed manufacturing network to be established that meets the demand for vaccines and preventative injectables both between and during outbreaks, the global health community, including national governments, regional organisations, multilateral institutions, regulators, industry, funders and civil society, must:
Increase market information through strategic demand forecasting for products.
Facilitate transparent documentation of existing and forecast manufacturing capacity.
Use this market information to translate demand for products into upstream demand for manufacturing capacity and to identify potential gaps in manufacturing capacity. This information can act as a common point of reference to inform government and industry investments as they create a geographically distributed and viable manufacturing footprint.
Demand Forecasting
Clear demand and supply forecasts are a prerequisite for estimating the manufacturing capacity, technologies and investments required in a given region. Centralised, scenario-based demand forecasting for the quantities and types of products needed for a region must be the driver of the manufacturing supply required to fulfil routine demand and surge needs during a pandemic; this centralised forecasting should build on the work of organisations including: Gavi, the Vaccine Alliance; the United Nations Children’s Fund (UNICEF); the Coalition for Epidemic Preparedness Innovations (CEPI) and the Developing Countries Vaccine Manufacturers Network (DCVMN); the Africa Centres for Disease Control and Prevention’s (Africa CDC) Partnerships for African Vaccine Manufacturing (PAVM) Framework for Action; the Global Vaccine Market Model (GVMM); and Market Information for Access to Vaccines (MI4A). This transparent forecasting will be critical for building manufacturing capacity in the right technologies and ensuring that product supply chains are better coordinated, especially during a public-health emergency.
Long-term demand forecasts can also support efforts to create an investment case for donors and governments to support broader life-course vaccination programmes. By forecasting potential demand, donors and governments can begin to estimate the budgets needed for expanded vaccination programmes, and their potential economic and population-health benefits.
Supply Planning
Equally important for informing manufacturing-investment decisions is an understanding of the existing and forecast manufacturing capacity. As with demand forecasting, individual companies already undertake global forecasting for supply. While some individual global health organisations such as CEPI, DCVMN and MI4A have begun publishing their own mapping and forecasting exercises, greater collaboration to forecast supply is required. This collaboration should be facilitated by a neutral broker of information, such as an independent global health organisation, so that companies are not asked to share confidential information with each other.
Global health organisations such as the World Health Organisation (WHO), Gavi, CEPI or a consortium of regional organisations such as the Africa CDC, the Pan American Health Organisation (PAHO) and the Association of Southeast Asian Nations (ASEAN) are among the candidates who could act as a neutral broker with governments, industry and industry associations to facilitate the sharing of an agreed-upon set of supply information from pharmaceutical manufacturers in a manner that does not violate anti-trust rules.
These same global health and regional organisations could conduct global, long-term demand forecasts and integrate demand and supply information to inform the planning of a geographically distributed, technologically diversified and financially sustainable vaccine-manufacturing network. Industry, industry associations and global health organisations should leverage their data, information and existing demand-forecasting expertise to guide investments in manufacturing capacity.
Using Demand Forecasts and Supply Plans to Shape Markets
Increased market information is necessary but not sufficient to create financially sustainable manufacturing capacity for vaccines and injectables. Market-shaping activities to guarantee demand for manufacturing capacity will be a key driver for additional investment. Such forecasting can increase the market information available to governments, global health actors and industry in their pursuit of reducing commercial risks and shaping a viable manufacturing network at the regional and global levels. This is especially important for adult vaccines, many of which are not publicly funded in many low- and middle-income countries (LMICs) and are often sold in relatively small private markets. approaches to develop, aggregate, consolidate and finance the demand based on these forecasts include:
Creating a mechanism to review and ensure inclusion of products in essential-medicines lists (EML) and other guidelines.
Harmonising registration systems and strengthening quality-assurance systems that will allow for exports of quality-assured products across borders.
Providing advance market commitments (AMCs) and volume guarantees for manufacturing capacity or specific products, potentially at specific prices.
Investing in resilience payments to subsidise or offset the costs of manufacturing in countries with more nascent capabilities.
Setting up or leveraging an existing pooled procurement mechanism for these products.
Investing in demand-creation programmes for vaccines and preventative injectables, including use of clinical data to demonstrate the impact of new and established technologies as the portfolio of vaccines and target pathogens is broadened.
Implementing some or all of these interventions will help to futureproof investments and create a geographically distributed manufacturing network that is better aligned to the new pipeline of vaccines and injectables and promotes diversification and commercial self-sufficiency so that the network is agile.