While waiting for a COVID-19 vaccine, it’s time to focus on gaps in vaccine distribution, cold chain, and uptake
Patricio V. Marquez, Betty Hanan, and Sheila Dutta
As the world waits anxiously for a COVID-19 vaccine to become available, countries have a “window of opportunity” to focus on existing gaps in vaccine distribution and cold chain systems and vaccination demand and uptake constraints. If these gaps are addressed in a timely way, it will facilitate widespread administration, not only of a new COVID-19 vaccine, but will also help revamp the delivery of routine vaccines, particularly those for children, that are part of the Expanded Program on Immunization (EPI). The latter task is of critical importance since over the past 4-6 months, national immunization programs around the world have been disrupted due to the severe health system constraints and physical distancing measures in place to mitigate the ongoing COVID-19 pandemic (Abbas, Procter, van Zandvoort, Clark, Funk, Mengistu, Hogan, Dansereau, Jit, Flasche, LSHTM CMMID COVID-19 Working Group 2020).
The importance of vaccines and vaccination
The development of vaccines is a long, risky, and costly endeavor. On average, it takes 10.7 years to develop a new vaccine, and there is only a 6% success rate for vaccine research—from start to finish (Kuchler, H. Financial Times. Big Read. Medical Science, 2020). Indeed, determining that a vaccine is safe and effective takes time.
The drive and race for a COVID-19 vaccine has picked up with the recent announcement of promising results of ongoing trials conducted in different countries (Jackson, Anderson, Rouphael, Roberts, Makhene, et al. 2020; Folegatti, Ewer, Aley, Angus, Becker, Belij-Rammerstorfer, et al. 2020; Zhu, Guan, Li, Huang, Jiang, Hou, et al. 2020). While there is hope that a COVID-19 vaccine will be available in 12 to 18 months or earlier if the trials are successful, a lot of uncertainty still clouds that optimistic scenario.
While vaccines are important, as experts have observed, what matters is vaccination; that is, the administration of a vaccine to people to help their immune systems develop protection from a disease. Immunization programs often serve as the entry point for primary health care in many countries, often providing the only access to mothers and young children on a regular basis (CDC, 2020). Vaccination not only protects those immunized but can reduce the risk of disease among those not immunized in a community through the development of “herd immunity.” The impact of vaccines in reducing vaccine-preventable disease morbidity and mortality is enormous: for example, in low-income countries, 23.3 million deaths are estimated to have been averted over 2011-2020 (CDC, 2020).
COVID-19 is disrupting life-saving immunization services in both rich and poor countries, putting millions of children at risk from vaccine-preventable diseases like diphtheria, measles, and polio. According to UNICEF, this situation is due in large measure to a massive backlog in vaccine shipments due to unprecedented logistical constraints related to COVID-19 mitigation measures including lockdowns in some countries (UNICEF, 2020). It is estimated that vaccination saves between 2 to 3 million lives a year (CDC, 2020).
Considerations for Strengthening/Reinstating Immunization Services
While the global effort nowadays is centered on containing the spread of the coronavirus and the resulting disease (COVID-19) and mitigating its social and economic impact, it is of critical importance to also maintain essential health service delivery to address other health needs of the population and prevent excess morbidity and mortality in a society (Marquez, Wang, and Ndebele 2020).
Guidelines put forward by WHO can help adopt a balanced response at national, regional, and local levels (WHO, June 2020). WHO advises that, where immunization services are constrained or suspended, countries should reinstate their immunization services, once local transmission of the COVID-19 virus has declined (WHO, March 2020). WHO also notes that if resources for “catch-up” immunization campaigns are limited, priority should be given to outbreak-prone diseases such as measles, polio, diphtheria, and yellow fever.
Vaccine Logistics, Cold Chain, Tracking, and Communication
Building and sustaining safe and effective immunization programs are essential components of health delivery systems. Successful programs are built on functional, end-to-end supply chain and logistics systems. The role of the supply chain is to ensure effective vaccine storage, handling, and stock management; rigorous temperature control in the cold chain; and maintenance of adequate logistics management information systems. The ultimate goal is to ensure the uninterrupted availability of quality vaccines from manufacturer to service-delivery levels, so that opportunities to vaccinate are not missed because vaccines are unavailable (WHO, accessed on July 26, 2020).
The maintenance of cold chain is essential for vaccine effectiveness (WHO, accessed on July 26, 2020). A cold chain is a temperature-controlled supply chain from the point of manufacture to the point of use. It involves an uninterrupted series of refrigerated production, storage, and distribution activities, along with associated equipment and logistics, including uninterrupted access to electrical or solar energy, to maintain the vaccines within a low-temperature range to ensure their potency.
Maintaining the cold chain requires that vaccines and diluents be consistently transported and stored between 2-8◦C at all stages, including in primary/central/intermediate vaccine stores and health facilities and also during outreach immunization sessions (WHO, accessed on July 26, 2020). In addition to temperature sensitivity, some vaccines (e.g., BCG and measles) also are sensitive to light. Any loss of potency due to heat or light is cumulative, permanent, and irreversible, meaning that the vaccine is rendered ineffective.
Tracking and monitoring vaccine coverage is also critical, as data and information inform decision-making and outreach priorities. To this end, well-established arrangements need to be in place to record and report every vaccine dose administered, adverse effects, and assess the population served.
Cold Chain Challenges and Solutions
Some cold chain challenges that merit immediate review and attention include insufficient and sub-optimal cold chain capacity that hampers availability of safe vaccines; limited freezing and storage capacity; inadequate temperature monitoring and maintenance systems; and costs.
As assessed in different countries, often cold chain systems are unable to ensure availability of safe and potent vaccines (Ashok, Brison, and LeTallec, 2017). To address key performance gaps, the authors recommend the following actions: (i) development of an accurate picture of cold chain capacity gaps based on current and future needs (including in-country piloting of new equipment and a full understanding of equipment trade-offs); (ii) improvement of planning and programming (particularly to ensure that vaccination covers hard-to-reach populations); (iii) mobilization of resources to adequately fund programs; and (iv) effectively monitoring the cold chain during implementation. In addition, to control temperature variations and equipment failures, the introduction of temperature monitoring and control devices and practices is recommended, in addition to strengthening human resources for equipment repair and the availability of spare parts.
Well-trained vaccinators at vaccination sites are also critical for the delivery of this intervention. Hence, strengthening health workers’ knowledge, skills, and practices is of upmost importance for the effective administration of vaccines. Human resources are the backbone of any system and the key enabler for all other functions to perform effectively. It is no different with vaccination programs, and more so in the current environment in which there is a need to have ready capacity to manage the introduction and administration of a potential new COVID-19 vaccine, while at the same time revamping the delivery of existing EPI vaccines.
Ensuring demand and uptake of vaccines, as well as their affordability
It should be clear that the ready availability of vaccines will not automatically generate their demand and uptake in all population groups. This reality reflects a lack of trust in government action and in some cases is the result of misinformation campaigns that are not backed by scientific evidence. So, serious community outreach and engagement to provide transparent information about the importance of vaccines needs to be mounted to protect people, particularly the most vulnerable. The communications effort, however, needs to address knowledge, attitudes, and beliefs about vaccination particular to the social and cultural characteristics of different societies.
Another option for increasing vaccine uptake is to require it. As observed in a recent article (Mello, Silverman, and Omer, 2020), mandatory vaccination has proven effective in ensuring high childhood immunization rates in many high-income countries. However, except for influenza vaccination of health care workers, mandates have not been widely used for adults. The operationalization of a vaccination mandate, for example for some high-risk groups such as health workers, the elderly, and those with preexisting conditions, would require that (i) the supply of the vaccine is sufficient to cover the population groups for which a mandate is being considered; (ii) available evidence about the safety and efficacy of the vaccine has been transparently communicated; and (iii) established infrastructure to provide access to vaccination without financial or logistic barriers, compensation to those who suffer adverse effects from a required vaccine, and real-time surveillance of vaccine side effects.
It is also important that countries implement effective communication strategies to allay concerns and re-establish the demand for vaccinations within communities.The need to build public trust requires that state officials implement vaccination policy through transparent and inclusive processes, involving local health officers, health professional and hospital associations, representatives of high-risk population groups, and groups concerned about vaccine safety. As was observed during the Ebola response in West Africa in 2014-2015, building trust by engaging citizens and community leaders is critical to the success of delivering health services (UNDP, UN Agencies, World Bank Group, European Union, and African Development Bank, in consultation with the African Union and Economic Community of West African States and Mano River Union, 2015).
Finally, equitable access to and utilization of vaccines is of paramount importance, particularly for ensuring that all countries, including the poorest, have equal access to a new COVID-19 vaccine once they become available. A key question that needs to be clarified across the world, therefore, is how to make the new COVID-19 vaccines available free of charge or affordable to large segments of the world population that lack or have limited access to essential public health services and related financial protection arrangements, such as social health insurance coverage.
This issue merits careful consideration and assessment of options given the negative impact of the pandemic on countries’ macroeconomic situation, which might cascade down to health systems. Indeed, World Bank Group's baseline forecast envisions a 5.2% contraction in global GDP in 2020—the deepest global recession in eight decades, despite unprecedented policy support. Per capita incomes in the vast majority of emerging market and developing economies (EMDEs) are expected to shrink in 2020, tipping many millions back into poverty. Under the baseline scenario, World Bank Group estimates show that COVID-19 will push more than 70 million people into extreme poverty, measured at the international poverty line of $1.90 per day (Gerszon Mahler, Lakner, Castaneda Aguilar, Wu 2020). Tighter fiscal space and shrinking revenue for employment-based insurance schemes may enlarge the financial gap for investing in the health system.
One option that should be considered for expanding the tax base and mobilizing additional fiscal resources for health, while helping reduce associated health risks, is the adoption of higher tax rates for tobacco and alcohol products, introducing or hiking taxes on sugary drinks, and phasing out fuel subsidies. There is significant accumulated experience in different countries of the world on the use of pro-health taxes, particularly to reduce tobacco use, and evidence on the positive health, fiscal, and equity gains that are generated by this policy measure.
While the world is going through a “perfect storm” caused by the coronavirus, we should not despair. We have evidence that proper application and population acceptance of basic public health measures, such as testing, isolation of those infected, contact tracing, quarantines for those people suspected of having being exposed to the virus, use of a cloth face covering in public spaces, hand hygiene, and social distancing provisions, help prevent the spread of the coronavirus.
Also, recent developments in treatments, such as antivirals (Remdesivir), glucocorticoids (dexamethasone), and antibodies (blood injections from patients who have recovered from COVID-19), are showing that they can help improve outcomes for COVID-19 patients (Beigel,Tomashek, Dodd, Mehta, Zingman, et al. 2020; The RECOVERY Collaborative Group 2020; Casadevall and Pirofski 2020).
Even if a COVID-19 vaccine is only 60% or 70% effective, it could have a significant impact in reducing the contagiousness of the virus. Similarly, revamping and expanding the coverage of essential health services will help address the larger health needs to the population, and reduce the risk of the onset of other vaccine-preventable infectious diseases.
History is full of examples that suggest that the prevention, containment, mitigation, and eventual suppression of COVID-19 is possible if political commitment, the alignment of resources, and determined scientific, technological and operational efforts converge around a common objective. Indeed, as told by Dr. William Foege in “House on Fire”, his memoire about the fight to eradicate smallpox in the 1960s and 1970s, well-structured and supported programs such as the one for smallpox eradication illustrates that “humanity does not have to live in a world of plagues, disastrous governments, conflict, and uncontrolled health risks” because “the coordinated action of a group of dedicated people can plan for and bring about a better future.”