Are Novel Vaccine Placebo-Controlled Trials Ethical Given Existing EUA Options?

Are Novel Vaccine Placebo-Controlled Trials Ethical Given Existing EUA Options TrialsiteN

With emergency use authorization (EUA) declaration by the U.S. Food and Drug Administration (FDA) embraced by the scientific community and society, some question the ethics involved with the use of ongoing placebo controlled novel vaccine trials. After all, critics argue, there is essentially a ready-made and available vaccine therapy, so depriving someone of access due to a placebo just doesn’t make sense from this vantage. Recently, some principal investigators from the South American nation of Ecuador had their institutional review board approve their study protocol thus greenlighting the placebo-controlled clinical trial for what is a novel protein-based platform involved in the study. What was the rationale used by these investigators to justify their study? 

Three principal investigators from this South American country introduce their three key rationale for conducting the placebo controlled study and not succumbing to undue pressure. First, low-income and middle-income countries (LMICs), such as Ecuador, possess less leverage to procure vaccines on the open market. Frankly, shortages based on economics and logistical issues make trials look possibly attractive.  

Second ,a balance of forces makes the case that those vaccines under EUA are not actually approved—e.g. that is, they are not “completely licensed medical products subject to long-term surveillance, especially for safety.” For example, in the past, fully licensed vaccine products have been yanked off shelves for safety concerns as well, and, in this case, they are not fully registered—there are still plenty of unknowns. From this point of view, a fully registered product doesn’t even exist.   

Finally, the clinical research as a care option model would embrace the research as a way to give the highest possible care (and access often for those that don’t have it) for the subjects in the study. From one vantage, the use of a placebo equates to ethical violations. The authors here disagree and argue that a particular set of obligations for any researcher may vary depending on participant and patient, what with proper use of informed consent and everything else safe and by the book—as well as, of course, use of rigorous risk-based analysis—the authors conclude that the conduct of the placebo-controlled study is ethical.

Lead Research/Investigator

Fadya Orozco, College of Health Sciences, Universidad San Francisco de Quito, Ecuador

Estefania Noblecilla, Institutional Review Board, Universidad San Francisco de Quito, Ecuador

Ivan Sisa, College of Health Sciences, Universidad San Francisco de Quito, Ecuador