Ethics and execution of developing a 2nd wave COVID vaccine – Our interim phase I/II VSV-SARS-CoV2 vaccine experience

• Published in: Vaccine Vol. 39; no. 21; pp. 2821 - 2823
• Main Authors: Levin, Yotam, Balakirski, Noa Madar, Caraco, Yoseph, Ben-Ami, Eytan, Atsmon, Jacob, Marcus, Hadar
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 18.05.2021; Elsevier Limited
• Subjects: Adverse events; COVID-19; COVID-19 Vaccines; Ethics; FDA approval; Humans; Immunization; Medical ethics; mRNA; Pandemics; Placebos; RNA, Viral; SARS-CoV-2; Severe acute respiratory syndrome coronavirus 2; Vaccine efficacy; Vaccines; Viral diseases; Viral Vaccines; United States > US; Israel
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2021.04.017

[...]which vaccines should be offered to such unblinded placebo subjects – the investigational one they originally volunteered for, or a commercial/EUA vaccine that is (or will soon be) available to them? Replicating viral vector vaccines such as rVSV may continue to be an important complimentary vaccine platform for COVID-19 and other future pandemic threats because of their seemingly benign safety profile, as well as potentially their breadth of protection. [...]a strategic decision was taken to continue the development into Phase II despite Israel being supplied with a very efficacious mRNA vaccine. [...]Day 56 enables capture of most acute phase adverse events for any vaccine, probably including COVID vaccines. [...]the study was not structured as a Phase III efficacy study for which long term placebo controls are indispensable for directly estimating Vaccine Efficacy (VE).