Specifically, NIAID funded preclinical studies of tecovirimat to determine its mechanism of action, safety, and efficacy. Subsequently, NIAID and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services, funded Phase 1, and Phase 2 clinical trials to test the safety and pharmacokinetics of an oral formulation of the investigational drug. The Food and Drug Administration (FDA) approved tecovirimat in 2018 for the treatment of smallpox in adults and children; and the drug has been added to the U.S. Strategic National Stockpile for use in the event of an outbreak. It is available in both an oral and intravenous formulation. Although the antiviral was only approved for the treatment of smallpox, its FDA approval was based on studies in nonhuman primates infected with monkeypox.
Imagine getting *B426* approved using ONLY 8 mice in a trial and no human testing. No problem for BPs new experimental Covid cure to be approved using 8 blind mice for a trial. No human testing needed.