COVID-19: Meeting the access challenges, Part 2
By Yvette Madrid, Evan Lee and Jon Bastow
A 5-part series which delves into the challenges and solutions of getting diagnostics, drugs, and vaccines for Covid-19 to all who need them. Previously published:
Part 2 . Vaccines
The first vaccine is credited to Edward Jenner’s use, in 1796, of the pus from cowpox blisters to provide immunity against smallpox. While we now have vaccines against a multitude of infectious diseases, we must urgently develop one, and preferably more, against Covid-19. This is accelerating innovation in vaccine technology.
Urgency and innovation are also driving efforts to ensure rapid and equitable global access to these vaccines. Prior to Covid-19, price and affordability were seen as key determinants of access, but with Covid-19 vaccines, this has shifted to timely supply and volume.
The need to secure vaccine supply for resource-limited countries during pandemic situations became clear during the previous H1N1 pandemic. However, the solution developed, the Pandemic Influenza Preparedness (PIP) Framework, focuses on WHO leveraging information and biological material that is shared by countries to secure access agreements from suppliers. By contrast, for Covid-19, the genetic sequence was rapidly shared without any binding access agreements.
Currently, significant and novel access efforts are being made, but they leave gaps. Select potential suppliers have committed to making their vaccines available through “no profit” pricing in an initial phase, but this carries no commitment on volumes for developing countries or subsequent pricing. Another new initiative is the creation of a social enterprise (VacEquity Global Health) to assure production, affordable pricing, and availability of a vaccine candidate. However, as it covers only one candidate, it cannot meet a substantial portion of developing country demand on its own.
A comprehensive approach, both in terms of stakeholders and scope, has been put forward as the vaccine pillar of the Access to Covid-19 Tools (ACT) Accelerator initiative and the COVAX mechanism it has formed. This effort builds from existing vaccine push and pull mechanisms, specifically CEPI, the Coalition for Epidemic Preparedness Innovations and Gavi.
In a change from the affordability-driven access paradigm, the critical time period to address volume is prior to vaccine licensure. This implies that push efforts must go beyond product development and should seek to expand capacity and the geographical distribution of production. Meanwhile pooled procurement must shift to advanced purchase commitments in a way that supports clarification of demand and further supports investment in adequate capacity. This drives an overlap of push and pull efforts targeted at volume, making it worthwhile to coordinate these efforts more closely to ensure optimal impact.
The ACT Accelerator/COVAX does this and addresses and proposes a pooled advance procurement instrument that seeks to establish agreements with five to ten producers, thereby creating a portfolio to minimize risk. Crucially, it is open to all countries. Previously, Gavi has focused exclusively on the poorest countries, and has used a differentiated pricing structure wherein Gavi countries can be accorded prices not available to other countries. Now, self-financing countries are not only allowed to participate, but are key to the success of the effort. These countries will make upfront payments to COVAX, thereby increasing the financing available for the portfolio. Their participation can reduce the establishment of competitive bilateral supply agreements, although participating countries are not blocked from pursuing these. Because supply would still be limited, this mechanism integrates an allocation mechanism (WHO responsible) which ensures all participating countries receive a share and prioritizes specific target populations in a sequential manner. Notwithstanding its notable strengths, the success of the ACT/COVAX approach is uncertain and some questions remain open:
- Risk. What happens if successful or superior vaccines are not included in the portfolio or if countries where production takes place block export? The upfront investment in this mechanism puts considerable sums at risk (notwithstanding the portfolio to manage it). COVAX incorporates this risk into vaccine purchase in a manner never done before. Do donors and countries have an appetite for this? Early interest is encouraging.
- Price.This still matters. Will there be flat pricing or differentiated pricing according to income? Will this differ by vaccine producer? What happens after volume issues are resolved, particularly if annual booster doses are required, and price re-surges as the key access determinant. Will self-procuring countries benefit from their solidarity over the longer term?
- Allocation. Delegating allocation to a centralized, non-national entity is a politically fraught proposition. The mechanism currently proposes taking a “lighter” approach (focused on the quantity received with further non-binding recommendations) for self-financed countries than for donor financed countries. What about equity? Which countries will get which vaccine (presuming there is more than one)? Furthermore, the equitable sharing of limited supply does not support the rapid establishment of herd immunity in any country. Will self-financing countries prefer approaches that increase their prospects of rapidly reaching herd immunity?
Access is also being impacted by the innovation in vaccine technology. For example, RNA based vaccines can more rapidly be produced in large volumes. However, these and other innovative vaccines often require storage at very cold temperatures (-80 ℃), which are far from norm for the existing cold chains for immunization (2–8 ℃) necessitating further development to improve thermal stability and/or adaptation in vaccine supply systems. Innovative technologies bring advantages with their “plug and play” potential (more rapidly adaptable to address different diseases). Over time, this together with the production advantages, may well result in shifting vaccine market dynamics.
With Covid-19, the need to assure massive numbers of doses extremely rapidly is changing the access paradigm. Mechanisms to improve access have evolved from the successful access initiatives of the past 20 years, but are also taking unprecedented directions. Covid-19 has more closely interlinked vaccine development and access efforts. Its impact on both is dramatic and immediate, but also likely to be far-reaching.
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Yvette Madrid is a Swiss-based, global health consultant with expertise in immunization and health product access. She has worked for the International AIDS Vaccine Initiative (IAVI), PATH, UNITAID, and the World Health Organization (WHO), and has also served as an advisor to the latter. With a background in biomedical engineering, she holds a doctorate from the Massachusetts Institute of Technology.
Evan Lee is a Geneva-based consultant and an expert in global health policy. He has previously worked for pharmaceutical company Eli Lilly, the Foundation for Innovative New Diagnostics (FIND), Management Sciences for Health and Medicines Sans Frontieres. A medically qualified doctor by training, he has a BA in chemistry and physics from Harvard University, a medical degree from New York University School of Medicine and an MBA from Massachusetts Institute of Technology.
Jon Bastow helps organisations accelerate innovation across R & D and Access in healthcare. He brings over 30 years of experience, having led R&D and access projects across multiple diseases. He has held senior roles in pharmaceutical companies and international organisations such as FIND and The Global Fund, building partnerships between private sector healthcare and tech companies, NGO’s and governments addressing major problems of poverty. Jon is a member of the Chartered Institute of Marketing, holds degrees in Biochemistry and Philosophy and has given lectures at IMD, London Business School, INSEAD and the Graduate Institute in Geneva.
