The FDA is stopping COVID-19 antibody treatment in some states
The FDA is stopping COVID-19 antibody treatment in some states

The FDA is stopping COVID-19 antibody treatment in some states

The US Federal Drug Administration (FDA) last Friday updated the use permit for the monoclonal antibody treatment sotrovimab from GlaxoSmithKline and Vir Biotechnology, which restricted its use.

In a announcement, the agency said the treatment is no longer approved for use in several states in New England and the New York, New Jersey area. Shipments of the drug to these states have also been suspended, according to the Department of Health and Human Services (HHS).

These changes follow new data suggesting that the monoclonal antibody treatment is not as effective on the BA.2 subvariant as the original omicron and earlier variants. In a study published in Natureresearchers found that the BA.2 strain was resistant to 17 out of 19 antibody treatments in laboratory environments.


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Earlier this year during the initial omicron rise in the United States, shipments of other antibody treatments were put on hold for similar reasons that they were not as effective on the new variant.

A newly approved antibody treatment may take effect now that sotrovimab and other treatments appear to be ineffective. Last month FDA approved emergency use permit for bebtelovimab to be prescribed to persons with mild to moderate illness. The authors of the Nature study found that only the newly approved bebtelovimab could adequately cover all omicron sublineages adequately.

The government has ordered 600,000 courses of treatment of the drug, according to HHS. More than 306.00 of these have been distributed this week, according to data from the agency.

There is evidence that another already approved antibody treatment may be effective against BA.2. ONE pre-print survey which has not yet been peer reviewed, found that the mixture of two types of antibodies in Evusheld (AZD8895 + AZD1061) “retained significant neutralizing power” against the BA.2 subvariant. However, this treatment is intended to be given before exposure to SARS-CoV-2 coronavirus. It is intended to help immunocompromised individuals before potential infection and is not intended to be given to humans after being tested positive.


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