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November 10, 2020

Coronavirus company news summary – Pfizer, BioNTech announce promising results for Covid-19 vaccine – FDA grants EUA to Lilly for neutralising antibodies in mild and moderate patients

By Allie Nawrat

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.

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