Assessment of the COVID-19 vaccine market landscape in 2021 relative to challenges in low- and middle-income countries

Abstract

To evaluate the early vaccine landscape relative to challenges faced by low- and middle-income countries (LMIC), we conducted a cross-sectional study of all COVID-19 vaccines in clinical trials in 2021 (n = 123) using a structured 13-point analytic framework. Supply sustainability was defined as a composite metric of four manufacturing and regulation variables. Vaccine desirability was defined as a composite metric of nine development and distribution variables. Ten vaccines in phases 2/3, 3, or 4 and five vaccines in phases 1 and 1/2 had a sustainability score equal to or above 0.5. Ten vaccines in phases 2/3, 3, or 4 and seven vaccines in phases 1 and 1/2 had a desirability score equal to or above 0.5. No vaccines in Phases 2/3, 3, or 4 met more than one distribution criterion. Structured assessment COVID-19 vaccine candidates in clinical trials in 2021 revealed numerous challenges to adequate access in LMICs. Key policy recommendations included increasing technology transfer to LMICs, developing international legal mechanisms to prevent export bans, and increasing investment in vaccine candidates with more favorable distribution profiles.

Lessons learnt from COVID-19 to reduce mortality and morbidity in the Global South: addressing global vaccine equity for future pandemics

“…The WHO, the Medicines Patent Pool, Africa Centres for Disease Control and Prevention, Afrigen, the South African Medical Research Council and Biovac partnered to set up an mRNA vaccine manufacturing centre in South Africa, which succeeded in reproducing Moderna’s mRNA vaccine based on publicly available information 33. To date, mRNA vaccine manufacturers have facilities located in 15 middle-income countries 32–35. WHO, donors and universities in the Global North and Global South could develop a transparent, web-based system to monitor the raw materials supply chain that supports developers and manufacturers of vaccines 34.…”

“…33 To date, mRNA vaccine manufacturers have facilities located in 15 middle-income countries. [32][33][34][35] WHO, donors and universities in the Global North and Global South could develop a transparent, web-based system to monitor the raw materials supply chain that supports developers and manufacturers of vaccines. 34 Countries of the Global South can continue to develop their capacities and expertise to scale up vaccine trials, with scientific integrity and transparency that is independent of political pressures.…”

“…[32][33][34][35] WHO, donors and universities in the Global North and Global South could develop a transparent, web-based system to monitor the raw materials supply chain that supports developers and manufacturers of vaccines. 34 Countries of the Global South can continue to develop their capacities and expertise to scale up vaccine trials, with scientific integrity and transparency that is independent of political pressures. 35 Donations of vaccines from the Global North are a short-term, not perfect solution that creates a dependency on donors.…”

Global Disparities in Access to Vaccine Clinical Trials: A Review of the Literature

“…The process is lengthy, taking between 2 and 5 years, but seeks to identify ways in which regulatory programs can be strengthened to effectively conduct clinical trials (among other endeavors). Investment in this effort may allow efficient and equitable implementation of clinical trials in LMICs [16].…”