COVID-19 research in LMICs

We read with interest the Correspondence by Irene Torres and colleagues,¹ and agree that the current scarcity in low-income and middle-income countries (LMICs) of vaccine to combat the COVID-19 pandemic is a failure of local governments, global solidarity, and multilateral instruments. However, regarding Torres and colleagues' comment that approving placebo-controlled trials in LMICs “sets the wrong precedent because approving such a trial should show that evidence can only be reached with this design”,¹ we would like to extend this extremely important discussion. We note an unfruitful divide between the medical and public health communities on how to prioritise resources to address the pandemic; Torres and colleagues' comment feeds this scenario, especially in LMICs. Historically, LMICs are poor generators of their own biomedical research, and this pandemic is no exception (appendix). COVID-19 research produced in LMICs has been weak for reasons such as funding, ethical, and regulatory issues.² Therefore, being able to host and catalyse the local execution of cutting-edge and socially valuable research could have a positive effect in the long term across the fragile health systems of LMICs. This approach would also enable doing other kinds of much-needed research, such as clinical trials on repurposed commonly used drugs, disease surveillance through genomic studies, short-term and long-term effects of COVID-19 on all-cause morbidity and mortality, and policy evaluation studies of implemented strategies in LMICs to contain the COVID-19 pandemic. These efforts should be led by LMIC researchers, who should be given global scientific support.³ As of May 28, 2021, the US Food and Drug Administration and the European Medicines Agency have granted an Emergency Use Authorisation (EUA) to five COVID-19 candidate vaccines.4, 5 Importantly, regulators issue EUAs on the basis of promising early interim data only; thus long-term safety and effectiveness monitoring phases are crucial to the final registration or licensure of a candidate vaccine. Furthermore, according to the Declaration of Helsinki (article 33), Council for International Organizations of Medical Sciences (article 5), and WHO Expert Panel, an EUA candidate vaccine cannot yet be considered a gold standard or the best-proven intervention.⁶

We recognise the ethical dilemma about doing blinded, placebo-controlled trials in the middle of having EUA vaccines. Nevertheless, technically speaking, an alternative research design would provide suboptimal evidence and could even delay the accumulation of pivotal data to properly tackle the COVID-19 pandemic. Overall, there are more benefits than drawbacks in promoting COVID-19 research in LMICs, even if using a placebo-controlled trial design. It is key that LMICs should be able to do high-quality clinical trials to be less dependent on high-income countries. Also, doing high-quality clinical trials could lead to important projects of innovation and the transfer of health-related technologies, which would make LMICs increasingly self-sufficient. We must learn from our current national and global failures in tackling the COVID-19 pandemic; otherwise, we will have wasted invaluable lessons learned for the next pandemic.

We declare no competing interests.