Medico-legal integration of molnupiravir rapid deployment during the COVID-19 pandemic: Emergency use authorization, clinical evidence, and risk of viral mutagenesis
, T., One Health, doi:10.1016/j.onehlt.2026.101621, Dec 2026
Review of evidence from the MOVe-OUT and PANORAMIC trials, genomic surveillance datasets, regulatory filings, and pharmacokinetic studies examining molnupiravir's emergency authorization and deployment during COVID-19.
The MOVe-OUT trial initially showed ~50% risk reduction in hospitalization or death at interim analysis, which was the basis for FDA EUA in December 2021; the final analysis reduced this to ~30%. The large PANORAMIC trial (n=25,708) found no reduction in hospitalization or mortality (aOR=1.06, 95% CI 0.81-1.41).
The EMA refused marketing authorization in 2023, citing lack of demonstrated clinical benefit, with teratogenicity, skeletal toxicity, and viral mutational signatures as concerns. Molnupiravir retains US EUA. Authors argue that eight statutory instruments (Bayh-Dole Act, PAHPRA, CARES Act, Project BioShield, FD&C Act §564, PREP Act, Defense Production Act, and CICP) reduced development time but created accountability gaps, including inadequate pharmacovigilance for population-level viral mutagenesis.
Potential risks of molnupiravir include the creation of dangerous variants, and mutagenicity, carcinogenicity, teratogenicity, and embryotoxicity1-15. Multiple analyses have identified variants potentially created by molnupiravir16-20. Studies show significantly increased risk of acute kidney injury21, cardiovascular toxocity22, and neurological symptoms21. Treatment may increase viral rebound23,24.
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Tsai et al., 31 Dec 2026, peer-reviewed, 1 author.
Contact: thtsai@nycu.edu.tw.
Abstract:
Contents lists available at ScienceDirect
One Health
journal homepage: www.elsevier.com/locate/onehlt
Medico-legal integration of molnupiravir rapid deployment during the COVID-19 pandemic: Emergency use authorization, clinical evidence, and risk of viral mutagenesis
Tung-Hu Tsai a,b,*
- a Graduate Institute of Law and Interdisciplinary Studies, College of Law, National Chengchi University, Taipei 116, Taiwan
- b School of Chinese Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei 112, Taiwan
A R T I C L E I N F O
Keywords: Molnupiravir COVID-19 Emergency Use Authorization PREP Act One Health Pandemic preparedness
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