The FDA expanded the emergency use authorization for remdesivir to include treatment of any hospitalized adult or pediatric patients with suspected or laboratory-confirmed COVID-19, irrespective of their severity of disease. The expansion was based on evidence demonstrating a benefit in patients with mild-to-moderate disease.
AstraZeneca initiated a 48 patient, Phase I trial in August, to evaluate its two monoclonal antibody combination, AZD7442, as a treatment for hospitalized COVID-19 patients (NCT04507256). The trial is being sponsored by DARPA and BARDA.
Vir and GSK initiated the Phase II/III, COMET-ICE trial in August to evaluate VIR-7831 as a treatment for COVID-19. The Phase II part of the trial will evaluate the safety and tolerability of VIR-7831 in 20 non-hospitalized, COVID-19 patients. The 29-day, 1,300 patient, Phase III part of the trial will evaluate whether VIR-783 prevents mild or moderate COVID-19 patients from worsening as indicated by an increase in hospitalizations or death.
The FDA’s Vaccine Advisory Committee will meet on October 22 for a general discussion on the development, authorization and/or licensure of vaccines to prevent COVID-19. No specific vaccine will be discussed at the meeting. The FDA plans to offer a free live broadcast of the meeting and make background material and slides available before the meeting.
CanSino has canceled a Phase II/III trial in Canada, after the Chinese government refused to allow the company to ship the vaccine to Canada for the trial. The CanSino COVID-19 vaccine, Ad5-nCoV, is based on technology developed by Canadian firm NRC.
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