10 November 2020
The US Food and Drug Administration (FDA) granted emergency use authorisation (EUA) for Eli Lilly‘s neutralising antibody bamlanivimab (LY-CoV555). Bamlanivimab is authorised for the treatment of Covid-19 patients suffering from mild to moderate symptoms. The FDA’s decision was based on the results of the Phase II BLAZE-1 study.
Pfizer and BioNTech announced that BNT162b2, their mRNA-based vaccine candidate, has shown efficacy in the treatment of the Covid-19 among individuals without prior evidence of infection by the SARS-CoV-2 virus. The interim analysis showed that the vaccine candidate was more than a 90% effective after two doses.
Novavax announced that it has been granted fast track designation by the FDA for NVX-CoV2373, its Covid-19 vaccine candidate. The vaccine, which is currently in its late-stage development, is a stable, prefusion protein developed using Novavax’ nanoparticle technology including its MatrixM adjuvant.
The Brazilian Health Regulatory Agency Anvisa stopped the clinical study of Sinovac’s CoronaVac vaccine after the occurrence of a serious event on October 29. The agency is looking to evaluate the data and investigate the vaccine’s risks and benefits before allowing the continuance of the study.