Monoclonal Antibodies for COVID 19 Update: EUA Revoked
In this 148th update video, Roger Seheult, MD of MedCram discusses the FDA decision to limit emergency use authorization (EUA) for some monoclonal antibody interventions in the presence of the Omicron variant. There are currently 3 monoclonal antibody infusions that have previously been given emergency authorization for use by the FDA from Lilly, Regeneron and GSK for use in reducing hospitalization and severe illness related to COVID-19 infection.
The doctor then explains how monoclonal antibodies work by binding to the spike protein of the virus, thereby neutralizing the virus and rendering it unable to attach to the ACE-2 receptors of the cell. He notes that due to changes in the spike protein of the virus, such as in a variant like Omicron, the monoclonal antibodies may not be able to bind and lose efficacy in neutralizing the Omicron variant. See this MedCram video on Monoclonal Antibodies: Omicron Update for more information.
Due to the recent surge of the Omicron variant, testing has been done on the effectiveness of the monoclonal antibodies in vitro using a pseudovirus to determine how effective each of the three monoclonal antibodies are at limiting the virus’s ability to infect based on the variant.
This research has found that the monoclonal antibody infusions from both Lilly and Regeneron have no significant efficacy against the Omicron variant, whereas the GSK infusion does neutralize the Omicron variant. He then analyzes the FDA decision to limit the emergency use authorization (EUA) for Lilly and Regeneron while allowing GSK to maintain its EUA for sotrovimab, the only monoclonal antibody that has been shown to still be effective against the Omicron variant.
For more information on the topics covered in this video, please see the following links and references:
LINKS / REFERENCES:
Rates of laboratory-confirmed COVID-19 hospitalizations by vaccination status (CDC) | https://covid.cdc.gov/covid-data-trac…
Eric Topol (Twitter) | https://twitter.com/EricTopol/status/…
Trends in Number of COVID-19 Cases and Deaths in the US Reported to CDC, by State/Territory (CDC) | https://covid.cdc.gov/covid-data-trac…
COVID Data Tracker (CDC) | https://covid.cdc.gov/covid-data-trac…
Emergency Use Authorization 094 (FDA) | http://pi.lilly.com/eua/bam-and-ete-e…
What is a Pseudovirus? (News Medical) | https://www.news-medical.net/health/W…
B.1.1.529 escapes the majority of SARS-CoV-2 neutralizing antibodies of diverse epitopes (bioRxiv) | https://www.biorxiv.org/content/10.11…
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