The U.S. Food and Drug Administration (FDA) previously approved monoclonal antibody treatments to combat COVID-19. However, on March 25, the federal agency suspended the use of this treatment in several states immediately due to the belief that it would be ineffective against the BA.2 omicron subvariant, according to ABC News.
Vir Biotechnology and GlaxoSmithKline developed the medication, known as “Sotrovimab,” which the FDA has now prohibited in the Virgin Islands, Puerto Rico, New York, New Jersey, Vermont, Rhode Island, New Hampshire, Massachusetts, Maine, and Connecticut.
“We will continue to monitor BA.2 in all U.S. regions and may revise the authorization further to ensure that patients with COVID-19 have effective treatments available,” said the FDA in a statement.
The ban will last as long as the BA.2 omicron subvariant is the primary COVID-19 strain in these areas. Other states’ shipments will not be affected by this update.
Sotrovimab was designated to treat individuals 12 years of age and older with mild to moderate symptoms of COVID-19. Those included in this population must have a higher risk of disease progression than the average person who is admitted to the hospital or dies of the virus to qualify for this treatment.
The Department of Health and Human Services (HHS) stated that patients could continue to receive alternative treatments, such as the monoclonal antibody therapy by Eli Lilly and the oral antivirals by Merck and Pfizer, as these remedies are expected to maintain their effectiveness against BA.2.
The FDA has restricted COVID-19 treatments due to the appearance of a new strain in the past.
In January, the agency halted the approval of two earlier monoclonal treatments from Regeneron and Eli Lilly after they failed against omicron. The administration also restricted the distribution of previous treatments during earlier variant spikes due to effectiveness concerns.
Data from the Centers for Disease Control and Prevention (CDC) states BA.2 is responsible for over one-third of all new cases in the U.S.
The subvariant has been particularly prevalent in the Northeast, hence the regions where Sotrovimab is currently suspended. As of March 19, BA.2 accounted for more than 50% of new cases in the affected areas.
The government is now cutting back on treatments, specifically free ones, as supplies dwindle after Congress’ suspension of COVID-19 relief funding. Included in the supply cuts are the monoclonal antibody treatments shown to work against omicron and the BA.2 subvariant.
The White House has also cautioned that if additional orders are not placed quickly, antiviral medications from Pfizer and Merck could run out by the end of the summer.
Monoclonals have been foundational in COVID-19 treatment. They are a significant component of President Joe Biden’s COVID-19 plan because of their capacity to reduce hospitalization rates.
