Jul 2026· Microbes & Immunity· pp. 026180041· 0 citations
TL;DR
Translational virology encompasses all stages from basic research through clinical evaluation and final registration and drug/vaccine approval, and vaccine re-engineering has been required as part of translational virology due to emerging SARS-CoV-2 variants.
Abstract
Translational virology, characterized as “from bench to bedside,” encompasses all stages from basic research through clinical evaluation and final registration and drug/vaccine approval. The objectives are to accelerate and streamline the innovation process at all stages. It includes identifying disease causes; screening prophylactic and therapeutic candidates; evaluating them in preclinical models and clinical trials; and addressing manufacture, distribution, regulatory review, and authorization. The recent coronavirus disease 2019 (COVID-19) pandemic represents a perfect example of translational virology, demonstrating unprecedented cooperation from the identification of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to the rapid development of potential repurposed and novel drugs, monoclonal antibodies, and vaccines for both prophylactic and therapeutic applications. After confirmation of therapeutic and prophylactic efficacy in animal models, phase I–III clinical trials were conducted with partially overlapping timelines, thereby significantly reducing development time. Both drugs and monoclonal antibodies have been approved for the treatment of patients with COVID-19. Convalescent plasma, mainly used in immunocompromised patients, has been suggested to provide potential benefits. Vaccines based on whole viruses, protein and peptide subunits, viral vectors, and nucleic acids were developed in parallel. Based on good safety profiles and robust immune responses, COVID-19 vaccine candidates were granted emergency use authorization worldwide, enabling mass vaccination. More than 13.6 billion COVID-19 vaccine doses have been administered, and although severe adverse events have been registered, millions of lives have been saved. Due to emerging SARS-CoV-2 variants, vaccine re-engineering has been required as part of translational virology. Vaccine production, storage, transport, and distribution have also been given attention.
The human monoclonal antibody MR191N provides complete post-exposure protection in non-human primates and necessitates adaptive trial designs, expanded diagnostic models, and synergistic combination therapies to address MVD.
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