We wish to clarify points in your report on Peruvian COVID vaccine trials that could reflect negatively on Cayetano Heredia University in Lima (UPCH) (Nature 592, 174–175; 2021).
The UPCH conducts hundreds of studies every year and is committed to high-quality, ethical research. However, its Sinopharm trial diverged from global standards by including an off-trial vaccine lot “to protect the research-team and trial-related personnel”. This unusual provision was negotiated between governments in the context of countries ordering millions of doses of vaccines that are still not available.
Following international recommendations (see go.nature.com/3tcahvu), the Peruvian government’s National Institute of Health (INS) appointed a national research-ethics committee to provide prompt review and oversight of COVID vaccine trials. This meant that the study protocol was not reviewed or approved by the UPCH’s research-ethics committee.
The protocol was approved by the INS and the national ethics committee. These bodies organized oversight visits during the trial, but did not ascertain whether or how the extra vaccines were used. Had this happened, the whole process could have been called into question.
The UPCH has started a high-level investigation and appointed a new principal investigator for the study. It will ensure that such scenarios cannot reoccur.
Nature 592, 685 (2021)