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FDA Orders New Covid Antibody Treatment Shutdown

'This report does not change the positive benefit-risk of sotrovimab for use in the treatment of mild to moderate Covid-19 in patients at high risk of progression,...'

(John RansomHeadline USA) The US Food and Drug Administration recently pulled authorization for the antibody treatment sotrovimab, saying that it was no longer effective against the latest strains of the COVID-19 virus.

The monoclonal antibody treatment, made by GlaxoSmithKline, was pulled in the northeast regions of the United States, even as rumors swirl about a stealth variant of the virus, called by some experts the “most infectious strain of Covid yet,” according to the Daily Mail.

For the FDA, it means putting all of their COVID eggs in the vaccine basket as the agency has already pulled approval for two other monoclonal antibody treatments in January said the Daily Mail.

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GSK is putting together a package for regulators that would suggest using a higher dosage of sotrovimab in order to work against the new variants, said pharmaceutical-technology.com.

Previously, some studies have reported that the use of sotrovimab might be responsible for creating treatment-resistant variants of the coronavirus.

“Resistance is also seen in studies for other Covid-19 monoclonal antibodies and oral treatments, and relates to how the immune system interacts with the virus,” said GSK in a statement, according to the UK’s Guardian.

“This report does not change the positive benefit-risk of sotrovimab for use in the treatment of mild to moderate Covid-19 in patients at high risk of progression,” added GSK.

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Some experts have also suggested that vaccines themselves create treatment-resistant variants of the coronavirus.

A study published in the journal Nature in July suggested that treatment-resistant strains of the virus are created when populations have a high degree of vaccinations, but have not yet reached herd immunity—exactly the situation the world faces now.

“By contrast, a counterintuitive result of our analysis is that the highest risk of resistant strain establishment occurs when a large fraction of the population has already been vaccinated but the transmission is not controlled,’ said the study published at Nature.

Places where sotrovimab has been pulled include Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont, New York, New Jersey, along with the territories of Puerto Rico and the U.S. Virgin Islands, said the Daily Mail.

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