About a month after the FDA issued emergency authorizations for COVID-19 antibodies from Eli Lilly and Regeneron, most of them have gone unused, a federal official said Wednesday. As hospitals and healthcare officials scramble to get the treatments to more people who need them, the companies said they're also involved in efforts to make the drugs more available.
So far, the government has distributed 250,000 antibody doses to states and territories, federal data show, but only around 5% to 20% have been used, Operation Warp Speed head Moncef Slaoui told CNBC.
The drugs—which scored emergency nods last month—are authorized for patients with mild to moderate COVID-19 and who are at a high risk of developing severe disease because of their age or underlying health conditions.
But the treatments are infused, and many patients who could benefit aren’t already in a healthcare setting—such as a hospital—where they can be identified and treated. Even if they were to get a prescription, they might not have easy access to an infusion center where doses can be administered. Complicating matters is the fact that infectious patients need to be isolated, as Reuters notes.
A Lilly spokeswoman said the government purchased 950,000 doses of bamlanivimab, its antibody therapy, to be delivered through the end of January. So far, the government has delivered nearly 200,000 doses of the drug to states and other authorities.
“The intravenous administration of therapeutics to patients with confirmed mild to moderate COVID-19 presents unique challenges to the healthcare system, which could contribute to the utilization rates shared by [Operation Warp Speed],” she said. “Lilly is partnering with stakeholders to address challenges and ensure patients who need bamlanivimab can get it.”
Hospitals and health officials are scrambling to respond. In Utah, for instance, the Intermountain Healthcare system is testing “MAb Squads," which quickly get in touch with high-risk patients after a diagnosis and offer information about infusion centers, Reuters reports.
Operation Warp Speed is testing a pilot with CVS for at-home infusions, Lilly’s spokeswoman said. New infusion sites are coming online, she added, and some existing sites are expanding their hours.
For its part, Regeneron “has provided tens of thousands of doses for distribution,” a spokeswoman said. While the government is in charge of allocating the drug, Regeneron is “committed to ensuring equitable access to the antibody cocktail" and is also working on solutions, she added.
Regeneron expects to have doses for around 200,000 patients ready by the first week in January and enough for 300,000 patients by the end of January. The company is partnered with Roche to make at least 2 million doses in 2021.
Meanwhile, even as the first COVID-19 vaccines reach Americans, former FDA commissioner Scott Gottlieb is calling on the federal government to assist with a scale-up of antibody supplies as an “insurance policy” against the coronavirus pandemic next year. If vaccines fall short of expectations, antibodies could provide a major boost in the fight against the virus, he wrote in a Wall Street Journal op-ed.