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- Trial Stops Enrollment after Tpoxx Fails to Speed Clade 2 Mpox Healing or Pain Relief
Patients are no longer being enrolled in the Study of Tecovirimat for Mpox (STOMP) randomized clinical trial (RCT) after an interim analysis showed that the antiviral drug (brand name, Tpoxx) didn't speed lesion healing or pain relief in adults with mild to moderate clade 2 mpox at low risk for severe illness, report the study sponsor, the National Institute of Allergy and Infectious Diseases (NIAID), and Tpoxx developer Siga Technologies, Inc. While no safety signals were detected during the study, the study's Data Safety and Monitoring Board recommended halting enrollment after an additional assessment showed the chance was less than 1% that the study would demonstrate efficacy if enrollment and follow-up were completed. The NIAID also closed enrollment into an open-label study arm for patients at high risk for severe disease, which was not designed to estimate Tpoxx's effectiveness.
https://www.cidrap.umn.edu/mpox/trial-stops-enrollment-after-tpoxx-fails-speed-clade-2-mpox-healing-or-pain-relief
- Relative Effectiveness of Homologous NVX-CoV2373 and BNT162b2 COVID-19 Vaccinations in South Korea
To estimate the relative effectiveness of NVX-CoV2373 versus BNT162b2 (Pfizer-BioNTech) in preventing SARS-CoV-2 infection and severe COVID-19 disease during the Omicron variant dominance in South Korea, these investigators conducted a retrospective cohort-study among ≥12-year-olds. Among homologous primary-series NVX-CoV2373 versus BNT162b2 recipients at Day 180 post-vaccination, the aHR was 0.90 (95% CI: 0.87-0.93) for all laboratory-confirmed and 0.65 (95% CI: 0.48-0.88) for severe infections. Among homologous first-booster recipients, it was 1.15 (95% CI: 1.01-1.30) for all laboratory-confirmed and 0.39 (95% CI: 0.20-0.75) for severe infections.
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