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December 1, 2021

Coronavirus company news summary – US FDA committee backs Merck’s Covid-19 oral antiviral – Regeneron warns of decreased Covid-19 drug efficacy against Omicron

By Darcy Jimenez

The US Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) has recommended the use of Merck and Ridgeback Biotherapeutics’ oral Covid-19 antiviral molnupiravir. The panel voted 13 to 11 to endorse emergency use of the oral pill for treating mild to moderate Covid-19 in adults who are at higher risk of severe disease or hospitalisation. The FDA is not obligated to follow AMDAC’s recommendation.

Regeneron Pharmaceuticals has warned that its Covid-19 antibody drug may be less effective against the emerging variant Omicron. According to a Reuters report, the company said that it can lead to reduced neutralisation of “both vaccine-induced and monoclonal antibody-conveyed immunity activity”. This is based on a study of Omicron’s mutations. Currently, the company is conducting additional studies using the variant’s genetic sequence to determine potential impact of Omicron. Earlier, Moderna CEO Stephane Bancel raised similar concerns regarding its vaccine.

US FDA has announced that it is working to assess the potential impact of emerging Covid-19 variant Omicron on currently available diagnostics, therapeutics, and vaccines. The agency will primarily evaluate the effectiveness of authorised vaccines against the variant. Omicron was first detected in South Africa, and triggered concerns that available vaccines may not be effective in neutralising it. However, FDA added that current vaccines are highly effective in preventing Covid-19 and serious associated illnesses.

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