Testing an experimental vaccine during a public health emergency: Lessons from a Peruvian case.

Introduction: The Peruvian Government searched for a vaccine as a response to COVID-19. A clinical trial evaluating an inactivated SARS-CoV-2 vaccine was approved. A national news program revealed that Peru's president had received the vaccine outside the clinical trial, generating a national protest. The Peruvian National Academy of Medicine created a commission to identify improper procedures and provide guidance on how to prevent a similar case in the future.

Methods: Commission members reviewed all publicly available documents and information sources and generated a final report.

Results: There were 6 ethical principles violations: 1) 3200 vaccine doses were used to vaccinate individuals outside the clinical trial; 2) prominent individuals were vaccinated outside of the clinical trial; 3) study conduct was monitored by a contract research organization with a conflict of interest; 4) an additional study was conducted with the vaccine without an approved protocol; 5) the placebo-controlled trial was continued when an approved vaccine was available; and 6) results of the clinical trial were not released. There were 5 regulatory procedures ignored: 1) no clinical trial supervision by a high-quality clinical monitoring agency outside Peru; 2) a university acting as a sponsor of a vaccine produced by a foreign company; 3) expedited reviews and approvals; 4) lack of adequate supervision by local regulatory bodies and the study contract research organization (CRO); and 5) no input from the Data Safety Monitoring Board.

Conclusions: The COVID-19 health emergency created an environment where existing regulatory and ethical principles were circumvented under political pressure. Regulatory bodies and agencies should inform countries of the dangers of conducting clinical trials during a public health emergency and proper ethical and regulatory procedures should be followed.