In November 2022 the WHO shared its Global Market Vaccine Report for the year 2022. It is the “first report to capture the implications of COVID-19″ on vaccine markets. It also highlights the “dynamics” that are at play that prevent or hinder the “development, supply, and access” of vital vaccines. In this post we unpack the report and examine some of the calls to action for the future.
The report begins with a foreword by Dr Tedros Adhanom Ghebreyesus. He describes immunisation as one of the “most iconic global health success stories”. However, this is denied to millions of people across the world as access continues to be a major barrier. For example, 20 million infants miss out on key vaccinations each year. Although COVID-19 “reminded the world of the immeasurable power of vaccines as key public goods” it also served as a reminder of “inequities in access” that are the “rule rather than the exception globally”.
Dr Tedros identifies the HPV vaccine as an example of this, introduced in “only 41% of lower-income countries”. In 83% of high-income countries, it is “saving lives”. Clearly the implication is not that we need to strip it back from these high-income countries but accelerate and improve efforts to raise the percentage across the world.
“We will not recover from the historic backsliding in essential immunisation if we continue to allow market dynamics alone to shape global vaccine priorities. Nor will we achieve equitable access to vaccines globally unless we have more transparency and active government oversight.”
Dr Tedros calls for a “more favourable intellectual property landscape” and “proactive technology transfers” as well as increased “building and retention of technical, manufacturing, and regulatory capacity in every region”. We have seen great strides in this direction in recent months in Africa, but the importance of maintaining momentum on this front is evident.
“WHO is calling on governments, industry, international institutions and partners to act now to improve sustainable and equitable access to vaccines. I trust this report will also be used to inform ongoing negotiations on a new international accord on pandemic prevention, preparedness and response, which will allow us to respond to and end future pandemics rapidly.”
Ups, downs, and pandemics
The report continues with a summary of “important progress” and “significant challenges”. For example, there were “many new vaccines developed” such as meningococcal meningitis A, and malaria, which “translate into millions of lives saved”. However, not every dangerous disease is associated with markets of commercial value. They therefore remain “neglected”.
Although there is an “expanding manufacturing base”, with over 90 manufacturers supplying vaccines to Member States in 2021, supply continues to be “highly dependent on fewer than 10 manufacturers”. Additionally, for specific vaccines, a couple of vaccine suppliers dominate the scene. Despite “positive” trends, the “African and Eastern Mediterranean Regions” experience “market health issues and regional supply insecurity”.
More effort (and investment) is also needed to facilitate broader vaccination programmes and “counter the growing threat of vaccine hesitancy”. What we can learn from COVID-19 is that “some of these challenges can be overcome”. For example, the rapid development of vaccines with “innovative technology platforms” came as a result of “unprecedented public investment” as well as “investment in clinical development and manufacturing capacity, and the streamlining of regulatory processes”.
“This incredible achievement in the face of a public health emergency of international concern made stark the long-standing need to reconsider the value of vaccines as a fundamental and cost-effective public good rather than a commodity.”
However, alongside recognised successes during the pandemic, there have been “highly problematic” access issues due to “dynamics repeatedly experienced in other vaccine markets”. Take the “lack of transparency along the value chain of vaccine manufacturing and distribution, and the lack of government oversight” for example, which made it difficult for governments to implement vaccination programmes nationally and internationally.
“We need to enhance government oversight of vaccine production and distribution and strike a much better balance between serving national interests and global public health objectives.”
How can we do this? The report indicates that the “only means” to this is “high-level diplomacy” and “pre-defined and binding rules”. Taking on board the lessons we were taught by the pandemic, we have an “opportunity” to “establish a new paradigm for vaccine development and access”.
As part of this, the following government commitments are recommended:
- Establish early, evidence-informed strategic goals and leadership that serve the collective global health interest and to shoulder risks and invest aggressively in order to address the needs of today and prepare for future emergencies.
- Strengthen market preparedness by investing in new vaccine technologies, regional research and development and manufacturing hubs, and by enabling regulatory harmonisation.
- Ensure transparency and oversight along the vaccine value chain towards enhanced health impact, as well as define principles and operational mechanisms for collaboration across countries in times of scarcity, including for intellectual property and the circulation of inputs and goods.
Industry is called upon with the following commitments:
- Ensure that activities are aligned with WHO’s guidance: research and development efforts focused on the WHO list of priority pathogens and target product profiles, more clinical trials performed in low-income countries, and targeted to inform global policy needs and expedited data submissions for regulatory approvals and prequalification.
- Establish provisions for technology transfer and ensure transparency along the vaccine value chain.
- Commit to specific measures allowing for equity-driven allocation of products.
Finally, international organisations and partners are asked to commit to:
- Prioritise the achievement of global public health priorities as per the Immunisation Agenda 2030 as an umbrella for individual organisational strategies, priorities and interests.
- Support country-driven initiatives and projects consistently with organisations’ missions and avoid the creation of duplicate efforts.
- Continue to call for technology transfer and for the application of resolutions on market transparency for health products.
Vaccine portfolio and regulation
The key takeaway from this section is that “significant progress has been achieved in the development of new vaccines”, but that “diseases associated with markets with less commercial value remain neglected”. Diseases that “primarily affect lower-income countries” have been addressed.
Secondly, COVID-19 proved that with “large public investments, joint planning of clinical development, regulation and manufacturing capacity, and leveraging innovative platforms”. The report suggests that “political pressure” contributed to the amazing work in developing COVID-19 vaccines at breakneck speed. However, before the emergence of COVID-19, work on viral-vectored platforms could be “quickly leveraged”. This innovative work is “set to increase in the coming years”.
Regulation remains a challenge, despite “years of harmonisation efforts”.
“Vaccines are medical products that are routinely administered to healthy people, and, as a result, real or perceived quality issues can compromise trust in immunisation, rapidly erasing progress”.
Thus, “quality assurance” is critical to vaccine development. During the pandemic, we made progress in regulatory “strengthening and harmonisation”. However, the “divergence in vaccine registration requirements” across the world has been highlighted. Filling gaps is particularly “cumbersome for manufacturers in developing countries”, which creates further access issues. In markets with “less commercial value” delays are caused by “suboptimal investment and few pipeline products”. Diseases prioritised by the WHO R&D Blueprint, are “still missing a vaccine”. For the Africa, Eastern Mediterranean, and South-East Asian regions, there is tension between “demographics” and “market value”.
Although manufacturers continue to emerge and grow across the world, the supply base remains “highly concentrated”. The report cites “country data”, which indicate that 10 manufacturers provide 70% of non-COVID-19 vaccine doses and 85% of the global value. Some “clear causes” are identified: vaccine development has “high costs of entry” and yields “lower profits relative to the entry costs” in comparison with other pharmaceutical products”.
What does this mean for market health? For “high impact” vaccines, each market is “highly dependent on one or two manufacturers”. Furthermore, for 6 vaccines that may be needed in emergencies, the health market is “concerning”. On top of this, manufacturing bases are located mostly in the “European Union, Indonesia, Japan, and the United States of America”.
Demand puts further pressure on vaccine supply, and this has had consequences throughout vaccine history. Examples include shortages of the HPV vaccines and inactivated polio vaccines. Although “technology transfer” and manufacturing changes can tackle these issues, they are “costly and take time”. To counteract this, “large public contracts” and “guarantee of purchase” have made a “significant difference”. The vaccine market, the report suggests, is “highly complex” and therefore “less attractive”.
- The market requires “advanced know-how”
- It is protected by intellectual property rights.
- Expansion of capacity “implies non-linear production costs”.
- Demand is “very uncertain”.
Allocation of scarce supply
This section suggests that in order to promote “equitable and efficient distribution of vaccines” within and across borders we need a “much higher level of transparency, public oversight over production and distribution, commitment from manufacturers, and high-level diplomacy”.
Another lesson that COVID-19 taught us is that “governments could have played a more active role” in overseeing vaccine supply”. Without this oversight, leaders found themselves in difficult positions regarding “informed, rapid, and strategic decisions”.
“Inequitable distribution, although not unique to COVID-19 vaccines, was a moral and global security failure with health and economic consequences.”
With “substantial progress” towards vaccine equity through initiatives such as the PAHO Revolving Fund, UNICEF, and Gavi, there are still constraints. This is particularly important in paediatric vaccines. COVAX reminded us that “financing and procurement mechanisms” cannot achieve equitable vaccine distribution alone. Despite efforts to “coordinate global demand and supply”, most volumes have “sat outside” the Facility.
“We need to strike a much better balance between serving national interests, global public health objectives and commercial interests.”
Country demand for vaccines
Central to guiding investments is “predictable country demand”. Thus, in “tackling affordability, planning and procurement issues, and by boosting political will and fortifying health systems” we might be able to enhance its predictability. The causes for unpredictable vaccine demand across countries supposedly range from “insufficient political will to inadequate infrastructure and market segmentation due to different products”.
Attempts to address demand issues are both global and regional. For example, “pooled procurement attaints lower prices for 14 of the 18 vaccines most widely used in middle-income countries” compared to self-procurement.
Conclusions and calls to action
As explored above in the early suggestions section, the report contains a call for stakeholders to “assume their shared but differentiated responsibilities”. With suggestions for government, industry, and international organisations, the hope is that this paradigm will serve “both equity and national interests” through a “more coordinated and more equitable global response”.