Pfizer has commenced the Phase II/III EPIC-PEP study to assess the safety and efficacy of investigational oral antiviral candidate PF-07321332 in preventing Covid-19 when co-administered with a low dose of ritonavir. The study will recruit adult individuals who live in the same household with a confirmed symptomatic SARS-CoV-2 infection. Pfizer plans to enrol up to 2,660 participants. PF-07321332 is an oral antiviral SARS-CoV-2-3CL protease inhibitor. Earlier trials showed that the candidate is safe and well tolerated.
The Russian Direct Investment Fund (RDIF) has reported positive data from a small study that assessed the combined use of the AstraZeneca vaccine and the first component of the Sputnik V vaccine. The assessment is based on data collected from the first 20 participants of a 100-person study in Azerbaijan. According to the RDIF statement, there was a fourfold or higher increase in neutralising antibodies to the spike protein of the SARS-CoV-2 in 85% of the participants. The interim results are based on the data collected on the 57th day of the study.
Sanofi and GSK have secured approval for a Phase III clinical study of their adjuvanted recombinant-protein Covid-19 vaccine candidate in Nepal. The study, led by the International Vaccine Institute (IVI), will assess the safety, efficacy and immunogenicity of the vaccine candidate. IVI aims to enrol around 4,000 volunteers in three sites for the study. In a separate development, GSK and Vir Biotechnology’s Covid-19 antibody treatment sotrovimab has secured emergency approval in Japan.