The Government of Peru has issued a supreme decree that establishes the measures to secure free access to COVID-19 vaccine doses for volunteers who participated in the clinical trials.
"The clinical trial sponsor (the pharmaceutical company) can administer the vaccine under investigation to the subjects enrolled in the clinical trial who did not receive it," the document reads.
To that end, the sponsor shall submit to the General Office for Research and Technology Transfer of the National Health Institute (INS) a report supporting the national and international evidence generated from clinical trials.
Moreover, the principal investigator of the clinical trial shall open the "blind" according to its contingency plan, and the sponsor shall ask the National Authority for Pharmaceutical Products, Medical Devices and Health Products (ANM) for authorization of its use as a research product.
It should be noted that the term "blind" refers to those trials in which patients do not know whether they are receiving a placebo or the active treatment.
Such methodology is used to avoid bias until the entire trial is complete.
The decree also provides that the clinical trial sponsor must meet a series of requirements to receive authorization from the ANM.
Published: 4/2/2021