Pandemic Vaccine Trials in Low- and Middle-Income Countries and Global Health Security
Authors: Gavin Yamey, Richard Gordon, Glenda E. Gray
Journal: JAMA Network Open (2021)

During the COVID-19 pandemic, we have seen the best of international collective action and its limitations.COVID-19 vaccine development showed global cooperation at its finest.Multiple safe, highly effective vaccines were licensed in record time through an unprecedented collaborative effort.Chinese scientists shared the SARS-CoV-2 sequence on January 10, 2020, 63 days later the first human trial began in the US, and trials have been conducted or are ongoing in low-income countries (LICs), middle-income countries (MICs), and high-income countries (HICs).Unfortunately, when it came to sharing the fruits of this scientific enterprise, collective action fell woefully short.Rich nations, and those that funded the clinical development of vaccines, used their power to enter into bilateral deals with vaccine manufacturers, leading to monopolization of the supply and hoarding of excess doses that sometimes have ended up being wasted.By the end of 2021, rich countries are on course to have 1 billion unused doses. 1 Australia, Canada, the European Union, New Zealand, and the United Kingdom have bought enough doses to vaccinate all their citizens 3 to 6 times over. 2 These countries are debating whether to provide a third dose, while most less wealthy nations still seek to secure their first.When it comes to being able to buy doses, COVAX, a multilateral solidarity mechanism that promotes vaccine equity, "is still getting pushed to the back of the queue." 3 LICs and many MICs may not have the finances to buy doses directly themselves; even if they do, companies have sometimes charged them higher prices than what they charge rich countries.The result is a profound global inequity in access to vaccines.Across the US and Canada, 67% of people have had at least 1 dose, but the proportion across sub-Saharan Africa is just 7.7%. 4To redress this imbalance, more than 100 countries backed a proposal to temporarily waive intellectual property protection on COVID-19 technologies so that vaccine manufacturing can be globalized.However, waiver discussions at the World Trade Organization have been blocked by many rich nations and vaccine companies.Ramachandran and colleagues 5 now shine a spotlight on another form of COVID-19 vaccine inequity: when less wealthy nations conduct vaccine trials, this may not guarantee them access to the tested vaccine.In a cross-sectional study that-to our knowledge-is the first of its kind, the authors identified completed and ongoing trials and examined whether countries that tested a specific COVID-19 vaccine went on to authorize and have access to that vaccine.The authors 5 found 25 completed trials, 11 in HICs, 11 in upper MICs, and 3 in lower MICs (they found no completed trials in LICs).Authorization rates for the tested vaccine were high across all income groups-10 of the 11 HICs (90.9%), 10 of the 11 upper MICs (90.9%), and all 3 of the lower MICs (100.0%) that completed trials.Yet, HICs received proportionately more doses, receiving enough doses to vaccinate 51.7% of their population, compared with just 14.9% for upper MICs and 31.0%for lower MICs.When the authors examined completed and ongoing trials, they found 37 in total, including 18 in HICs, 12 in upper MICs, 6 in lower MICs, and 1 in a LIC.Among nations that had hosted such trials, they found that COVAX delivered a median of 15.4%, 48.8%, and 78.8% of procured doses of tested vaccines in LICs, lower MICs, and upper MICs, respectively. 5These are important findings.The Universal Declaration of Human Rights states that everyone has the right "to share in scientific advancement and its benefits." 6This right is important to uphold when trials are conducted in LICs and MICs.Too often, trials conducted in less wealthy nations "result in treatments that the host community cannot afford and often cannot access for decades, even