Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 May 22:56:127176.
doi: 10.1016/j.vaccine.2025.127176. Epub 2025 Apr 24.

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

Claudio F Lanata  1 , Theresa J Ochoa  2 , Ernesto M Bancalari  3 , Norman W Baylor  4 , Kathryn Edwards  5 , Ruth R Faden  6 , Shabir A Madhi  7 , Hanna Nohynek  8 , Charles Weijer  9
Affiliations
Free article

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

Claudio F Lanata et al. Vaccine. .
Free article

Abstract

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.

Keywords: Covid-19; Ethics; Peru; Public health emergency.; Vaccine.

PubMed Disclaimer

Conflict of interest statement

Declaration of competing interest CFL and TJO declares that they received grants to their institutions from CureVac AG, Germany for the testing of a SARS-CoV-2 experimental vaccine. CFL reports grants to his institution and personal fees from HilleVax Inc. Boston, USA for testing a norovirus vaccine, and reports non-financial support from WHO COVID-19 Vaccine Effectiveness Working Group. EMB has received honoraria from Abbott, GSK and Pfizer. TJO has received honoraria from Moderna and Pfizer for lectures on COVID vaccines in children; and reports been a member of a Data Safety Monitoring Board for Valneva. CW receives consulting income from Eli Lilly & Company. KE reports grant funding from NIH and CDC; been a consultant to Bionet, Dynavax, AstraZeneca and IBM; Member of Data Safety and Monitoring Board for Sanofi, X-4 Pharma, Seqirus, Moderna, Pfizer, Merck, Roche, Novavax, Brighton Collaboration. NB provides regulatory advice to vaccine manufacturers, NGOs and academic investigators.

Substances

LinkOut - more resources