Coronavirus company news summary - Monoclonal antibodies reduce risk of Covid-related hospitalisation, studies find - US CDC considers Novavax, AZ trial participants to be fully vaccinated
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Coronavirus company news summary – Monoclonal antibodies reduce risk of Covid-related hospitalisation, studies find – US CDC considers Novavax, AZ trial participants to be fully vaccinated

31 Aug 2021

Two new studies by nference and Mayo Clinic have shown that treatment with monoclonal antibodies could lower hospitalisation rates in high-risk patients with mild to moderate Covid-19. In one study of 696 patients treated with casirivimab and imdevimab, and 696 patients on propensity-matched untreated control, the monoclonal antibodies significantly reduced all-cause hospitalisation. Another study involving 2,335 patients found that treatment with bamlanivimab significantly decreased hospitalisation rates versus usual care.

The US Centers for Disease Control and Prevention (CDC) has updated its guidance for people who receive vaccination as part of a clinical trial in the US. As per the guidance, participants in Novavax’s Phase III PREVENT-19 Covid-19 vaccine trial can be considered fully vaccinated two weeks following completion of the two-dose regimen. This does not indicate that the vaccine is authorised by FDA or recommended by CDC or its Advisory Committee on Immunization Practices (ACIP). The CDC also advised that trial participants who have received two doses of the AstraZeneca (AZ) Covid-19 vaccine can also be considered fully vaccinated two weeks after completion of the regimen. The AZ vaccine is not approved by FDA but is authorised for emergency use by the World Health Organization.

The Therapeutic Goods Administration (TGA) of Australia has advised that intravenous vials of Roche’s tocilizumab (Actemra), which are used as an off-label therapy for hospitalised Covid-19 patients, remain stable for another six months after their labelled shelf-life of 30 months. The guidance on tocilizumab shelf-life is due to the ongoing shortages of the drug amid the Covid-19 pandemic, TGA said. Roche expects shortages of tocilizumab intravenous vials to continue until January 2022. As per the update, the drug’s intravenous vials are stable for up to 36 months in total when stored at temperatures of 2°C to 8°C.