WASHINGTON — Despite a scarce supply, a substantial amount of COVID-19 monoclonal antibody (mAb) treatment courses remain unused, says a new rapid expert consultation from the National Academies of Sciences, Engineering, and Medicine. The rapid expert consultation describes frameworks and allocation strategies that can overcome the logistical difficulties of administering mAb therapy, promote equitable access, and allow for data collection on the safety and effectiveness of mAbs. It also considers strategies that could build manufacturing capacity to scale up the supply of COVID-19 mAbs.

As of January 6, the U.S. Department of Health and Human Services has allocated more than 641,000 COVID-19 mAb therapies to states and territories. However, the available supply far exceeds use for several reasons. Currently, there is limited evidence about the clinical benefit of mAbs, and their safety and efficacy continue to be evaluated in Phase III trials. In addition, the mAb infusion process takes two hours, which can divert clinicians from other COVID-19 care duties.

Patients are eligible for COVID-19 mAb therapy if they have mild to moderate infection and are at high risk for hospitalization. Both of the currently available mAbs — bamlanivimab monotherapy (Eli Lilly) and casirivimab and imdevimab combination therapy (Regeneron Pharmaceuticals) — need to be taken within days of symptom onset, so effective use is contingent on timely diagnostic testing, rapid test turnaround, and immediate referral for treatment.

The goal of equitable mAb allocation is not to get every eligible patient to accept mAb therapy if it is offered, but to identify the right patients at the right time, the rapid expert consultation says. It describes strategies for proactively identifying high-risk individuals, including those in underserved communities, and eliminating barriers to access, such as time, cost, transportation, and lack of paid time off from work. Although mAb therapy is largely administered in the hospital or at stand-alone infusion sites, Federally Qualified Health Centers, Indian Health Service facilities, nursing homes, and long-term care facilities may be able to provide these types of treatments in the future. People already receive routine care in these settings — and often, these facilities have already earned the community’s trust.

As mAbs are administered, it is also critical to collect data and evaluate whether they are working as predicted in clinical trials, the rapid expert consultation says. Data of interest include key patient characteristics, dosage and timing of the mAb used, and clinical outcomes, such as subsequent hospitalization, ICU care, or death.

The National Academies’ Standing Committee on Emerging Infectious Diseases and 21st Century Health Threats, assembled in March 2020 at the request of the White House Office of Science and Technology Policy and the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response in response to the COVID-19 outbreak, has been providing rapid expert consultations on several topics, such as social distancing, severe illness in young adults, and crisis standards of care.

The National Academies are private, nonprofit institutions that provide independent, objective analysis and advice to the nation to solve complex problems and inform public policy decisions related to science, technology, and medicine. They operate under an 1863 congressional charter to the National Academy of Sciences, signed by President Lincoln.

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