Mary Madison, RN, RAC-CT, CDP
Clinical Consultant – Briggs Healthcare
FDA Revoked Emergency Use Authorization for Monoclonal Antibody Bamlanivimab on Friday, April 16, 2021. The U.S. Food and Drug Administration revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients. Based on its ongoing analysis of emerging scientific data, specifically the sustained increase of SARS-CoV-2 viral variants that are resistant to bamlanivimab alone resulting in the increased risk for treatment failure, the FDA has determined that the known and potential benefits of bamlanivimab, when administered alone, no longer outweigh the known and potential risks for its authorized use. Therefore, the agency determined that the criteria for issuance of an authorization are no longer met and has revoked the EUA.
Newly posted materials from NHSNfor LTCFs:
- Point of Care Test Reporting Tool Recently Asked Questions and Common Mistakes – April 2021. This is a 45 minute, 8 second YouTube video.
- COVID-19 Resident Therapeutics Reporting Pathway – April, 2021. This is a 35 minute, 36 second YouTube video. The corresponding slide deck (39 slides) is also available.
- COVID-19 Resident Therapeutics Form and the corresponding Table of Instructions.
- Instructions for Point of Care Testing Form – updated April 2021.
- Scroll down the NHSN page to find several templates for file layouts for CSV data uploads. There are several that carry dates of April 16, 2021.
CDC has posted updates to these vaccination websites:
- What You Should Know About the Possibility of COVID-19 Illness After Vaccination
- COVID-19 Breakthrough Case Investigations and Reporting
- Frequently Asked Questions about COVID-19 Vaccination
- The Importance of COVID-19 Vaccination for Healthcare Personnel
- COVID-19 Vaccines for People at Increased Risk for Severe Illness from COVID-19
- Frequently Asked Questions about VAERS Reporting for COVID-19 Vaccines
- Frequently Asked Questions about the J&J Vaccine Pause