Making History: COVID-19 Vaccine Rollout
The Pfizer-BioNTech vaccine is the first to have been granted emergency use authorization in both the United States and the United Kingdom. Many more vaccines are expected to receive approval as they pass through clinical trials, with around 200 potential candidates in total and more than 40 currently in Phase III clinical trials.
Wealthy nations have purchased doses from various candidates in advance of these approvals. But low- and middle-income countries (LMICs) will depend upon the COVID-19 Vaccine Global Access Facility (COVAX Facility), co-led by the World Health Organization (WHO), the Coalition for Epidemic Preparedness Innovations (CEPI) and Gavi, the Vaccine Alliance.
The COVID-19 pandemic has put the global economy in crisis. The International Monetary Fund (IMF) estimates the impact of the pandemic will cause to a US$9-trillion loss of global GDP over 2020 to 2021. The World Bank predicts COVID-19 will also contribute to as many as 150 million people living in extreme poverty by 2021.
“It is a globalized world and economies are intertwined,” Dr. Tedros Adhanom Ghebreyesus, director-general of WHO, said. “For the world to recover faster it has to recover together.”
The COVID-19 Vaccine Equity Project (CVEP) is rapidly assessing the distribution landscape in LMICs and enabling vaccine delivery. Initial pilot programs have begun in Latin America, Africa and Asia.
The project, led by consultancy firm Dalberg along with the Sabin Vaccine Institute and JSI Research and Training Institute (JSI), is in coordination with WHO’s Access to COVID-19 Tools Accelerator (ACT-A), which supports the development of tools to fight the virus. It complements the approach taken by the COVAX Facility.
The role of the PMO
To identify gaps these countries will need to address, a Country Readiness and Delivery Project Management Office (CRD PMO) has been set up and is being managed by Dalberg for the COVAX Facility.
“This includes everything from demand forecasting to assessing readiness,” Trevor Zimmer, co-lead of the CVEP and the CRD PMO at Dalberg, said. “Also, how to socialize populations, healthcare workers, how to identify target populations and how to deploy surge support and capabilities to address equity needs and gaps in country-level capacity.”
The COVAX Facility and the World Bank have developed a COVID-19 Vaccine Introduction Readiness Assessment Tool (VIRAT/VRAF 2.0) to evaluate each country’s risk.
“It guides users through questions like, ‘Do I have the right ultra-cold chain requirements in place?’” Zimmer said. “‘Am I able to map out priority target populations?’ Along with National Deployment and Vaccination Plans (NDVPs), countries have actionable tools to assess readiness and create plans for receiving vaccines.”
Like climbing Mount Everest
But according to WHO, the whole process of developing a vaccine, getting it approved and then distributing it is like climbing Mount Everest.
Getting LMICs prepared for the COVID-19 vaccine has been a struggle. A challenge for CVEP in delivering the program has been a mismatch between country capacity, capability and resources. There needs to be a coordinated system for the various partners, bilateral organizations and donors to distribute the vaccines.
“The aim is to map and match country needs, both in regard to technical assistance and the resources available,” Zimmer said. “Our work is focused on revealing the gaps, mapping out priorities, and creating a clear understanding of what is required from each actor.”
Nothing like this has ever been done and it can be a difficult process for the project management office (PMO) to coordinate all the different partners to work together. Although bilateral organizations know what needs to be done, they are constrained by public sector funds and have to answer to governments.
“As a result, they are not always known for being the most nimble and agile in decision-making,” Zimmer said. “This is because interests are not completely aligned and people face intense pressure and sensitivities. The reason it hasn't been done before is because it's really hard."
“Countries don't have the time for duplicative requests to share their data with myriad requests from donors. It's not that people set out to create barriers, but it’s just hard to figure out how to align interests and coalesce on the best way to manage such a complex set of tasks, particularly when time and capacity are extraordinarily limited. This is one of the big struggles.”
Recent WHO analysis of the country readiness data in Africa showed only 49% have identified the priority populations for vaccination and have plans in place to reach them, and just 44% have the coordination structures in place.
On top of that, only 24% have adequate plans for resources and funding, 17% have data collection and monitoring tools ready and just 12% have plans to communicate with communities to build trust and drive demand for immunization.
Zimmer, however, sees the challenges as an opportunity. “The urgency of the pandemic is requiring people to innovate on the fly and talk through what were previously considered to be insurmountable sticking points,” he said.
A path to fair distribution
By the end of 2021, WHO hopes to immunize 2 billion people and has adopted a Fair Allocation Framework to ensure equitable distribution.
Initially, however, supplies will be limited. In the first phase countries will receive doses to cover 20% of their population size. These will be for high-priority members of their communities, while the second phase will cover additional populations according to national priorities.
The program also requires approval of several different vaccines that all have different storage characteristics to work efficiently. The Pfizer-BioNTech vaccine requires an ultra-cold chain or a temperature-controlled supply chain of -70 degrees Celsius (-94 degrees Fahrenheit) or below, and many LMICs lack the infrastructure needed to support this, although some countries do have the knowledge.
“We do have one other vaccine that has required that degree of temperature and that is the Ebola vaccine,” Dr. Kate O’Brien, director of the Department of Immunization, Vaccines and Biologicals at WHO, said. “We do have experience in a number of countries, specifically Africa, of being able to deploy a vaccine with that ultra-cold chain requirement.”
A special shipping container has been developed by Pfizer-BioNTech that can be used to maintain the temperature of the vaccine for 10–15 days, depending upon how often you open the box. It can then be kept at refrigerator-freezer temperatures for up to five days.
O’Brien thought countries would choose to only use vaccines that require an ultra-cold chain for certain portions of the population such as healthcare workers.
Although COVID-19 vaccines give us hope that the world will eventually return to normal, there is still a long way to go.
Zimmer is optimistic that project managers of the future will be able to learn from their work at CVEP. “At a time when the challenges confronting humanity require collective action and problem-solving, the mechanisms we have relied on in the past to collectively problem-solve and create action are frayed and distrusted,” he said.
“Our hope is that CVEP is a bright spot, that this shows that we can still not only solve big, intractable challenges across countries, institutions, interests and perspectives, but also come together and create the mechanisms to do so.”
Digital Exclusive article developed for Project Management Institute, Inc. by Joanne Frearson. Frearson is a U.K.-based business reporter.