Following the FDA’s weekend authorization of Regeneron’s monoclonal antibody cocktail for mild-moderate COVID-19, the federal government’s Operation Warp Speed (OWS) is swinging into action, officials said Monday.
Department of Health and Human Services (HHS) Secretary Alex Azar said OWS would ship 30,000 doses on Tuesday — each eligible COVID-19 patient receives one dose — with thousands more to go out in the days ahead.
On a phone call with reporters, he also reiterated the government’s promise that the drug would be provided to patients at no cost (Facilities may still charge for administration of the intravenous product, however).
Regeneron’s CEO told CNBC on Monday that the company currently has 80,000 doses on hand and expects to ship 300,000 by early January, with 100,000 additional doses per month to come thereafter.
Getting the product to patients is a major logistical challenge, officials explained, as has been the case with Eli Lilly’s bamlanivimab, another infusion therapy that received emergency authorization 2 weeks ago.
Both drugs are to be used in non-hospitalized patients at risk for illness progression — meaning they are for outpatient administration. Because patients by definition have COVID-19, they need to be isolated, and sites must be prepared to provide infusions to large numbers of them given the current surge in cases.
Janet Woodcock, MD, the FDA’s longtime head of the Center for Drug Evaluation and Research and an OWS leader, said this has meant sites able to meet these goals have to be developed (often essentially from scratch) and their locations and capabilities made known in the community, which takes time.
Over the past 2 weeks, according to Azar, some 85,000 treatment courses of the Lilly agent have been administered at 2,467 sites. Many if not all of these will be able to administer the Regeneron cocktail as well.
Officials around the country are working to develop additional sites, said John Redd, MD, MPH, of HHS. In addition to community clinics, the government will also be sending doses to its own clinical operations, including those operated by the Department of Defense, Indian Health Service, the Veterans Health Administration (VA), and others.
Woodcock drew attention to other issues associated with the new product. One is the potential for confusion between the two infusion medications, which have different dosing requirements; she said instructions are under development to minimize that risk.
Also, she noted that, in clinical studies with Regeneron’s cocktail, it became apparent that patients generating their own anti-SARS-CoV-2 antibodies didn’t benefit from the synthetic agent — only patients with no endogenous antibody production showed responses. That suggests antibody testing should be considered in patients otherwise indicated for the product, particularly while there is a shortage situation.