Surge in demand for monoclonal antibodies to treat COVID-19 prompts Biden administration to impose new limits


After urging suppliers for months to ramp up use of monoclonal antibody remedies that might stop some folks with COVID-19 from ending up in the hospital, the Biden administration says a “substantial” surge in demand from a handful of states has compelled officers to impose new limits on orders for the medicine.

Seven states — Alabama, Florida, Texas, Mississippi, Tennessee, Georgia, and Louisiana — made up 70% of orders for monoclonal antibodies in latest weeks, in accordance to the spokesperson for the Department of Health and Human Services, which manages provides of the remedies bought by the federal authorities. Overall, orders for the medicine since mid-July have climbed 20-fold.

Of these states, solely Florida has totally vaccinated greater than half of its complete inhabitants, in accordance to the Centers for Disease Control and Prevention. The others rank in the underside 10 states for vaccinations nationwide. All seven rank among the many prime half of states with the very best charges of each day COVID-19 hospitalizations in recent weeks.

“Given this reality, we must work to ensure our supply of these life-saving therapies remains available for all states and territories, not just some,” mentioned the spokesperson. Instead of suppliers ordering the medicine straight from the federal authorities’s provider, AmeriSourceBergen, doses of monoclonal antibodies at the moment are being allotted by HHS to state well being departments, “based on COVID-19 case burden” and demand for the medicine.

States will probably be accountable for deciding how to distribute the doses of Regeneron’s REGEN-COV and Eli Lilly’s mixture bamlanavimab and etesevimab to docs, clinics, and pharmacies inside their borders.

But some states declare they have been blindsided by the administration’s change, and say the new allocations will go away some suppliers empty-handed in the face of a surge of instances fueled by the highly-contagious Delta variant.

“We’re responsible not only for sourcing our sites, which we’re happy to do, but any infusion center, any provider, any hospital will have to come through the state,” Florida Governor Ron DeSantis mentioned at a press conference Thursday.

“To just spring this on us starting next week, we’re going to have to do that. There’s going to be a huge disruption and patients are going to suffer as a result of this,” the governor mentioned.

A spokesperson for DeSantis, Christina Pushaw, cited emails from federal well being officers to the state’s well being division in latest weeks that she mentioned “did not provide any indication of any upcoming limitation to supply.” Pushaw mentioned the state was now projecting a 41,050 deficit in doses of the monoclonal antibody remedies subsequent week, beneath the federal authorities’s new allocations.

In Texas, state well being officers mentioned that the Biden administration had warned them “national supply has considerably decreased.”. The state is now working to rise up a system to deal with orders for the medicine “as quickly as possible.”

“We just don’t know what the supply will be over the long term and can’t predict what the effect will be,” mentioned Douglas Loveday, a spokesperson for the Texas Department of State Health Services.

The Biden administration spokesperson rejected accusations that the transfer got here as a shock, citing calls final week with state well being officers to clarify the change.

“This was not just like we flipped the switch and all of a sudden it happened. That’s not how this works. It’s never worked that way,” mentioned the spokesperson.

The new caps on orders additionally come because the U.S. has struck extra offers to enhance provides of the antibody remedies, after demand had initially plummeted amid falling instances earlier this year.

Eli Lilly announced Wednesday that the U.S. authorities had bought an extra 388,000 doses of part of its mixture antibody remedy. Regeneron said Tuesday that the federal authorities had purchased 1.4 million extra doses of their remedy.

The Food and Drug Administration additionally moved Thursday to amend its emergency use authorization for Eli Lilly’s drug, permitting for it to be used as “post-exposure prophylaxis” in some adults and youngsters at excessive threat of extreme COVID-19 — which means it may very well be given as a safety measure after somebody was uncovered to the virus, even when they have not examined optimistic. Regeneron’s monoclonal antibody drug was beforehand approved for this use in August.

Federal well being officers mentioned they’d thus far not seen widespread stockpiling or misuse of the medicine. Both the FDA and HHS had urged suppliers to make sure that the medicine weren’t getting used as a “substitute for vaccination.” 

However, earlier than returning to the present allocation course of — related to a system the federal authorities had used to ration monoclonal antibodies to states earlier in the pandemic — the Biden administration had first said earlier this month that it might be “reviewing all orders for alignment with utilization.”

But that call had additionally pissed off suppliers, a number of state well being officers mentioned, delaying shipments and creating uncertainty for well being methods attempting to schedule sufferers in the quick window when the medicine can be utilized earlier than they could want to be hospitalized.

“On Monday morning, one of our hospitals serving as an infusion center alerted us that last week they received only 25 percent of what they ordered and that their order for this week was still under review,” mentioned Shareese DeLeaver-Churchill, a spokesperson for Maryland’s Governor Larry Hogan.

Hogan said Tuesday he raised the difficulty on the White House’s weekly name with governors, decrying it as “another example of confusing and conflicting guidance coming from the federal government.”

“The immediate concern is that while we have more than 30 facilities statewide that offer these treatments, some serve as the only hub in their area so these changes may dramatically affect access to care,” mentioned DeLeaver-Churchill.