Update: Thursday, September 2, 2021 The Assistant Secretary for Preparedness and Response (ASPR) and the Food and Drug Administration (FDA) within the U.S. Department of Health and Human Services announced that bamlanivimab and etesevimab, administered together, can be used in all U.S. states, territories, and jurisdictions under the conditions of authorization for EUA 94.
The Assistant Secretary for Preparedness and Response (ASPR) and the Food and Drug Administration (FDA) within the U.S. Department of Health and Human Services are committed to ensuring timely and transparent communication regarding the COVID-19 monoclonal antibody treatments currently authorized for emergency use in certain patients with COVID-19.
On August 27, 2021, we informed you of revisions to the authorized use of bamlanivimab and etesevimab administered together under Emergency Use Authorization (EUA) 094. The EUA was revised to authorize the use of bamlanivimab and etesevimab, administered together, only in states, territories, and US jurisdictions in which recent data shows the combined frequency of variants resistant to bamlanivimab and etesevimab administered together is less than or equal to 5%.
Based on FDA’s evaluation of the most recently available SARS-CoV-2 variant frequency data, we are informing you today that bamlanivimab and etesevimab, administered together, can be used in all U.S. states, territories, and jurisdictions under the conditions of authorization for EUA 94. ASPR will resume the distribution of bamlanivimab and etesevimab together and etesevimab alone (to pair with existing supply of bamlanivimab at a facility for use under EUA 094) to all U.S. states, territories, and jurisdictions.
Since June 2021, there has been a sustained increase in the circulation of the Delta variant (B.1.617.2). Based on in vitro assays that are used to assess the susceptibility of viral variants to monoclonal antibodies, bamlanivimab and etesevimab, administered together, are expected to retain activity against the Delta variant (B.1.617.2), which is now the dominant variant in the United States. The increase in prevalence of Delta has been associated with a decrease at the same time in the frequency of identified variants that are expected to be resistant to bamlanivimab and etesevimab.
ASPR and FDA will continue to work with the CDC and the National Institutes of Health on surveillance of variants that may impact the use of the monoclonal antibody therapies authorized for emergency use. We will provide further updates and consider additional action as new information becomes available.
Should you have any questions or concerns, please email COVID19Therapeutics@hhs.gov.
Source: Public Health Emergency
COVID-19 Monoclonal Antibody Therapy Resource Center
As Healthcare providers continue to fight the COVID-19 pandemic, effective treatments are needed to reduce transmission rate, hospitalizations, and the overall burden of COVID-19 on the United States health care system. Depending on age, medical history, and length of time symptomatic, monoclonal antibody (mAb) treatment might be a prudent and beneficial course of treatment for COVID-19 patients. The human body’s immune system creates antibodies to fight off viruses.
Monoclonal antibodies are synthetic antibodies that mimic the immune system’s response to an infection. Initial data shows that mAb treatment reduces the risk of hospitalization and death in COVID-19 patients and slows down progression of the virus in the community. Currently, the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorizations (EUAs) permitting the use of the following mAb therapeutics for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization:
Because clinical outcome data are limited and there are concerns regarding decreased susceptibility of variants, the COVID-19 Treatment Guidelines Panel recommends against the use of bamlanivimab monotherapy (AIII). Click here to access the Statement on Anti-SARS-CoV-2 Monoclonal Antibodies EUA | COVID-19 Treatment Guidelines (nih.gov).
If combination products are not available, the use of bamlanivimab monotherapy can be considered for people who meet the EUA criteria on a case-by-case basis.
This site includes valuable resources for both clinical and non-clinical health care professionals such as information about mAb therapy and specific products as well as infusion and billing guidance. Below are links to informational documents, briefings, videos, training modules, and other sites for additional information.