After various stretches of lockdowns and the related dire political, social, and economic consequences, the world has welcomed the news that several companies – including Moderna, AstraZeneca and Pfizer – are approaching an effective vaccine for Covid-19. Approximately 200 more are in the pipeline, of which 48 in clinical and 164 in pre-clinical stages of development. While there is thus hope on the horizon, for low and lower-middle income countries the roll-out of the vaccine will be enormously expensive, whatever option is eventually selected. As such, the life-saving vaccine may bring ramifications for future prioritization within domestic health budgets as well as allocations in foreign aid budgets.
In terms of ethics considerations, much of the debate so far has either focused on (1) criticizing high-income countries scrambling to secure vaccines for their citizens for lacking in solidarity and for inadequate support of equitable distribution schemes (COVAX) – or (2) on prioritization of population groups (see here, here and here). Contributing to the emergent analysis of the ethics of Covid-19 vaccination schemes while things are still ‘up in the air’ – the coordinated ‘mammoth operation’ led by UNICEF is in the midst of a vaccine tender process (running 6 weeks from November 12) – in this commentary, we suggest that attention must also be paid to the complex ethics challenges arising from the logistical challenges of distributing specific vaccines.
Taking the Pfizer vaccine, with a storage requirement of -70˚C (-94 F) or below, as our case example, we identify a preliminary list of challenges relating to the feasibility and societal impact of a successful roll-out of an ultra-cold chain dependent vaccine. The cost and the probability of logistics failure is extremely high – and even if a program can be successfully implemented, serious ethical issues with chilling effects on global health outcomes will likely arise. We also suggest that laying out some of the issues related to the Pfizer vaccine, if it were to be rolled out globally, can shed some light on medium and long-term ethics challenges for other vaccines as well, even if some probably present fewer challenges in this regard.
With respect to feasibility, ultra-cold chains require special cooling systems in facilities and during transportation. The tradeoffs involved in successful implementation must be carefully considered. Technical challenges greatly increasing risk include time constraints, freezing units, package sizes, and kitting:
- The vaccine puts significant constraints on time: The proposed active plus passive cooling in containers will enable keeping vaccines in the required temperature range for 72 hours, after which the combination of power cells (active cooling) and dry ice (passive cooling) deteriorates. Such a short delivery time calls for air transportation; yet carrying dry ice on airplanes, especially passenger planes, is regulated as it consumes oxygen. The same solution has been used for ultra-cold chains before (e.g., STRIVE Ebola vaccine), but the scale of any Covid-19 vaccination programme will be constrained by the global availability of such containers, and the regulations constraining their use.
- The unaffordability of freezing units is a possible spoiler: The estimated time that vaccines will stay usable after opening a package is 24 hours only. At facilities, including storage, customs, cross-docking, materials handling, and vaccination centers, freezing units will be required to store and appropriately handle the vaccines. In a bidding war, rural, small, and underfunded hospitals will lose out.
- Proposed package sizes are for 5,000 vs 1,000 units. While optimal for transportation, these sizes do not consider usage patterns: the administration of 1,000 vaccines within 24 hours requires huge distribution facilities and massive manpower. Throwing away unused vaccines comes at an exuberant cost. Locations with lower population density may not be able to use such package sizes and de facto be excluded from the distribution of vaccines.
- Vaccination programs have a host of material needs: syringes, gloves, PPE, tents for locations etc. Kitting will be of the essence; yet the other parts of these health kits will differ in their temperature control requirements. Inter-agency health kits have in the past been developed for vaccination programmes as well as emergencies, and include from cholera kits to entire field hospitals as a kit. They are composed in a way that regardless of the administering unit, any humanitarian organisation or health centre would know what to find in which box, and which items would need special processes (such as temperature control) in handling and storage. In the case of COVAX, UNICEF has started to procure and stock up on e.g. syringes and gloves, as to say, items that will for sure be needed to be able to administer vaccines.
In terms of societal impact, the following chilling effects of getting an effective vaccine program rolled out urgently need ethical consideration:
- The Covid-19 response focuses on an increasingly narrow range of options for combatting the pandemic. We are now at a point where the solution – in the form of a vaccine (any of the vaccines) – is steering problem framing. However, even if cold chains can successfully be kept intact in hard-to-reach areas, and the vaccine can be distributed successfully, a vaccine program does not solve the structural problems in public health infrastructure that are greatly exacerbated by the pandemic. Food shortages, lack of access to clean water and basic hygiene, domestic violence and drop-outs will not be magically cured through a vaccine.
- While the Covax Advanced Market Commitment (AMC) scheme will likely be a useful vehicle to secure health outcomes, it should be noted that GAVI explicitly mentions co-payments: “it is likely that the 92 ODA-eligible countries accessing vaccines through the AMC may also be required to share some of the costs of COVID-19 vaccines and delivery, up to US$ 1.60 – US$ 2 per dose – a mirror of the amount paid upfront by self-financing participants.” Taken together, the knock-on effects of the cost of vaccines and ultra-cold chains constrain future decisions about health budget allocations. Already overwhelmed health budgets in poorer regions will be additionally burdened by high-income countries demanding that vaccine coverage is prioritized to combat Covid-19 once and for all. In other words, the countries with the youngest populations and the highest child mortality will be asked to invest their health budgets to rescue the aging West.
- Whichever vaccine or set of vaccines are procured for distribution through global mechanisms, this decision will likely determine pathways for foreign aid. For example, once effective ultra-cold chains have been financed and established, there is a likelihood that allocations for vaccines will tie up a significant portion of donor budgets for the short-to-medium time. We argue that the funding of vaccine initiatives –in particular the financing of the ACT-Accelerator through ODA budgets– needs to be subjected to careful ethics impact assessments.
In conclusion, while a vaccine requiring an ultra-cold chain may be the most daunting one logistically, all options come with their own requirements on temperature ranges, but also with differences in vaccine efficacy, and regimes to administer. Technically, if we can manage the Pfizer one, the other ones should follow. Regardless, the ethics of every single vaccine candidate, including its likely logistics pathways and distributive impact on public health, needs to be carefully mapped out.
This piece was originally posted on International Health Policies and you can find it by clicking here.