WASHINGTON — The Biden administration moved this week to stave off a shortage of monoclonal antibodies, taking over distribution of the critical COVID-19 therapy while it tries to purchase more.
The policy change that went into effect Monday is all but certain to result in cuts of the medication to some states, especially seven in the Deep South with high infection rates that have been using about 70% of the national supply.
Soaring demand for the therapy represents a sharp turn from just two months ago, when monoclonal antibodies were widely available and awareness of them was low. With little promotion by the government, consumers, doctors and states were using just a tiny fraction of the available supply.
Since then, however, word of the highly effective therapy — which is free to patients — has spread, with federal officials and Republican lawmakers including Florida Gov. Ron DeSantis urging their use. Now, the U.S. Department of Health and Human Services will, at least temporarily, set the rules for distribution of monoclonal antibodies instead of allowing states, medical facilities and doctors to order them directly.
“HHS will determine the amount of product each state and territory receives on a weekly basis. State and territorial health departments will subsequently identify sites that will receive product and how much,” an HHS spokesman said. He spoke on the condition of anonymity to describe new procedures that are still being explained to communities around the country.
“This system will help maintain equitable distribution, both geographically and temporally, across the country, providing states and territories with consistent, fairly-distributed supply over the coming weeks,” he added.
The move already has prompted concern in one state, Alabama, where the president of the state medical association, Aruna Arora, released a statement Monday saying that “Alabama’s hospitals are full and under tremendous stress. That’s why physicians are very concerned about federal efforts that will end up limiting our supply and access to this effective treatment.”
Alabama, Florida, Texas, Mississippi, Tennessee, Georgia and Louisiana — all states where vaccination rates are low and the delta variant of the virus has been surging in recent months — have been using 70% of the monoclonal antibody supply in recent weeks, according to HHS data distributed at a meeting Friday and a person familiar with the situation.
President Joe Biden vowed in a speech last week to ramp up use of COVID-19 therapeutics as part of a renewed effort to quell the pandemic in the United States. According to data from the meeting with stakeholders involved in monoclonal antibody distribution, 2.17 million doses of the therapy have been shipped to 8,003 sites, and 938,000 have been used. The large difference may reflect a lag in reporting, according to one person tracking usage of the medication.
Monoclonal antibodies are highly effective in preventing hospitalization among people with mild to moderate COVID-19, the disease caused by the coronavirus, if given within 7 to 10 days after symptoms appear. Administered via a half-hour infusion or four injections, the antibodies mimic the body’s own immune response to the coronavirus, moving quickly into action while the natural response is gearing up.
Under the new plan, the government will examine hospitalization data and case rates in states and territories, then determine how much each will receive each week. Each state then can set distribution of the medication to its own sites. A similar system was used late last winter, but abandoned when demand for the therapy remained low.
HHS also will limit supply to sites that have accounts with the government and can provide utilization data.
Two companies currently have emergency authorization from the Food and Drug Administration to produce monoclonal antibodies. Regeneron’s product is a cocktail of two monoclonal antibodies, casirivimab and imdevimab.
On Sept. 2, the FDA renewed authorization for Lilly’s product, a combination of bamlanivimab and etesevimab, after pausing it in June to determine whether it is effective against the delta variant of the virus.
A spokeswoman for Regeneron, Alexandra Bowie, said the government is in talks with the company to purchase more of the medication but declined to say how much or at what price. HHS already has bought more than 1.5 million doses from Regeneron, most of them at $2,100 per dose.
Bowie said it takes four to eight weeks to produce a batch of the medication and the company has ramped up production to try to meet the surge in demand. A spokeswoman for Lilly did not immediately return an email seeking comment.