The break concerns GlaxoSmithKline’s Sotrovimab.
The federal government is abruptly withdrawing one of the authorized monoclonal antibody treatments for COVID-19, suspending its use in eight states over fears it will fail against the BA.2 omicron subvariant.
The therapy, called Sotrovimab from GlaxoSmithKline and Vir Biotechnology, is now unapproved by the Food and Drug Administration in Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont, New Jersey and New York. , as well as Puerto Rico and the Virgin Islands, while BA.2 is the dominant COVID-19 strain, the agency said on Friday.
Distribution of the drug will now be “immediately” halted in those areas, the Department of Health and Human Services said.
In those affected areas, BA.2 is estimated to account for more than 50% of new cases as of March 19, according to data from the Centers for Disease Control and Prevention. BA.2 has been particularly dominant in the North East – a prevalence mirrored by regions where the government is now withdrawing registration of sotrovimab. The CDC estimates that BA.2 accounts for more than a third of new cases nationwide.
Monoclonals have become a mainstay of COVID treatment. Their ability to reduce hospitalization rates, especially among high-risk unvaccinated patients, made them a key part of President Joe Biden’s COVID-19 plan.
GSK told ABC News it was preparing data on a higher dose of their treatment to see if it would be more resistant to BA.2.
Meanwhile, the FDA said it will continue to monitor the subvariant. Officials could withdraw Sotrovimab’s authorization even further if necessary.
At this time, shipments from other states will not be affected. HHS noted on Friday that other alternative treatments, such as oral antivirals from Pfizer and Merck as well as monoclonal antibody therapy from Eli Lilly, are still expected to resist BA.2, with sites able to continue requesting those orders.
This is not the first time new limits have been placed on a COVID-19 treatment when a concerning new variant begins to spread.
In January, the FDA suspended its approval for two previous monoclonal therapies from Regeneron and Eli Lilly, after both failed against omicron. The government has halted the distribution of previous therapies for the sake of effectiveness on several occasions during past variant surges.
But this time it comes as the national supply of functional treatments – especially free treatments – is already shrinking.
The government has dramatically reduced the amount of virus treatments available to states as funding for COVID relief is blocked in Congress, according to internal documents obtained by ABC News.
These supply cuts include the remaining monoclonal treatments that have been shown to be effective against both omicron and the BA.2 subvariant.
Weekly allowances for this treatment, Eli Lilly’s Bebtelovimab, are reduced by more than 30%, from 49,000 to 30,000 doses. Those cuts began on Monday and will go through at least the next few weeks’ allowances, the documents say.
The White House has also warned that antiviral pills from Pfizer and Merck could run out by the end of the summer if more orders are not placed soon.