The Cost of Procuring and Delivering COVID-19 Vaccines in Low- and Middle-Income Countries: A Model of Projected Resource Needs (preprint)

Background: Ending the COVID-19 pandemic requires effective implementation of vaccination programs in all countries. Information on the cost of vaccine procurement and delivery is paramount for effective planning and budgeting, especially in low- and middle-income countries (LMICs) given their budget constraints.Methods: We estimated regional and national costs to scale up COVID-19 vaccinations in 132 LMICs under different scenarios. We defined three priority groups: 1) healthcare workers; 2) population at high risk of severe COVID-19; and 3) adults with low risk of mortality and morbidity. We assumed that 70% of the population needs to be vaccinated to reach vaccine herd immunity. We used publicly available data on procurement pricing, delivery costs, and population size. We compared the price tag estimates to the countries’ historical annual immunization spending.Findings: We estimated a total cost of US$74 billion to reach vaccine herd immunity in LMICs. Of this total, 67% (US$50 billion) is for vaccine procurement, 33% (US$24 billion) is for vaccine delivery, 6% (US$4·2 billion) is to vaccinate high-risk populations, and 0.6% (US$0·46 billion) is to vaccinate healthcare workers. Twenty percent of LMICs have a price tag that is at least 10 times their baseline annual immunization spending.Interpretation: COVID-19 vaccination will have a major impact on LMIC national healthcare budgets. Substantial investments by governments and donors are needed for vaccine procurement and vaccine delivery infrastructure.Funding: Duke Global Health Institute pilot grant.Conflict of Interest: Dr. Dixit reports grants from Bill & Melinda Gates Foundation, outside the submitted work, all other authors have nothing to disclose.

Developing an Aggregator Mechanism for Late-Stage Clinical Trials of Neglected Disease Product Candidates (preprint)

There have been significant improvements in recent years in the early stage development of products for poverty-related and neglected diseases (PRNDs). However, there are still major challenges in the funding of late-stage clinical trials of candidate products for these diseases. For vaccine development specifically, Rappuoli and colleagues recently concluded that “these improvements in the early development process have revealed a new, and possibly more perilous, Valley of Death in the late vaccine development phase.” There are three major challenges in conducting phase III trials for PRND product development. First, such trials are expensive and companies often shy away from investing in them because there is no commercial market for most PRNDs. Second, there is poor coordination on late-stage trials across R&D initiatives. At present, there is no overarching global mechanism that is “steering the ship”—there is no universally agreed-upon process for prioritizing R&D investments for PRNDs, for selecting the most promising candidates, or for coordinating the multiple, overlapping research programs worldwide. The result is duplication, waste, and ultimately delays in the development of products. Third, current R&D efforts for PRNDs are “top-down”—they are controlled by high-income countries (HICs) and have generally done poorly at including decision-makers from high-burden countries. It is policymakers in low- and middle-income countries (LMICs) who are in the trenches when it comes to controlling PRNDs—yet they are often not at the table when it comes to deciding on what gets funded, where research is conducted, who gets access to intellectual property, and where and how the technologies end up being manufactured. All these steps need to be “globalized” if we are to develop and deploy new control tools.