Safety of BIOMODULINA T® in the Cuban population before and after its use for COVID-19 prevention

Abstract

Introduction: BIOMODULINA T® is a biologic immune-modulator composed of specific fractions of bovine Thymus. This paper addresses the safety data on the use of the product, primarily in the period up to December 2019, in comparison with the data collected from 2020 during the COVID 19 pandemic, in which the product was widely used prophylactically in elderly people at risk. Objective: The objective of this work was to evaluate the safety of BIOMODULINA T® in the Cuban population in clinical practice. Material and Methods: Documentary review compiling information from spontaneous notification systems, clinical studies and published literature. Patient exposure was estimated from the distributed units. Descriptive statistics were applied to process the results. Results: Until 2019, with an estimate of almost 35,000 patients exposed to the drug, there was a report of 62 ADRs for a frequency of 0.18%. From January 2020 to June 2022, with an estimate of 238,000 exposed patients, 260 ADRs were reported for a frequency of 0.11%, being significantly lower than in the previous period (p<0.001). According to these frequencies in both periods, ADRs were classified as occasional or infrequent. No serious reactions were reported and no new safety problems were found. Local reactions at the administration site, headache and fever continue to be the most frequent ADR. Conclusions: Even with the unprecedented widespread use of BIOMODULINA T® during the COVID-19 pandemic, the excellent safety profile of this product was maintained.

Keywords

• biomodulina t®
• farmacovigilancia
• reacciones adversas