Emergency Use Authorization Published for Monoclonal Antibody Therapy for COVID-19
On November 11, 2020 by Kari Everson
Monoclonal antibody therapy is a COVID-19 treatment that appears to prevent the progression of COVID-19 disease, decrease the length of illness, and may prevent hospitalizations. An Emergency Use Authorization (EUA) was published today allowing the emergency use of monoclonal antibody therapy (Bamlanivimab) for adults and children with a positive COVID-19 test. Recipients must be 12 years of age or older or at least 40kg in weight. There are specific criteria for use of this therapy including:
- The recipient should have a confirmed COVID-19 infection;
- The recipient should be early in the disease progression; and
- The recipient should be symptomatic but not severely ill.
Bamlanivimab is not authorized for those individuals hospitalized due to COVID-19, require oxygen therapy due to COVID-19, or who have an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to an underlying non-COVID-19 condition.
This therapy is administered by IV infusion and is most effective early on in the infectious process defined as within 3 days of a positive test or 10 days of symptom onset. After infusion there is a one-hour monitoring period for adverse/allergic reactions. Detailed administration guidelines are found in the fact sheet document.
MDH is finishing work on a statewide allocation plan. Currently, the proposed plan has two phases. Early reports indicate the first few weeks of administration, or phase 1, will be done in emergency departments and perhaps other inpatient areas within hospitals. Under the hospital-without-walls waiver, a hospital staff person could administer the drug outside of the hospital itself and could travel up to 35 miles to do so. Hospital-affiliated home care providers may also have the ability to provide therapy within long-term care settings. Long-term care communities with the capability to administer the monoclonal antibody therapy may have the option available during Phase 2 which is tentatively projected to start sometime in December. Those facilities should reach out to their regional healthcare coalition to begin preparing for this possibility. You can locate your regional healthcare coalition contact here.
The Department of Health released the Monoclonal Antibody Therapy Playbook during two training calls this week which provides further detail. More information can also be found on the FDA website—scroll down until you find an entry for 11/09/2020 Bamlanivimab. For questions, please contact Kari Everson at email@example.com or 651-380-2032.