FDA Authorizes Monoclonal Antibody Therapy for Post-Exposure Prophylaxis for COVID-19 – Drug Information Update

If your email program has trouble displaying this email, view it as a web page. FDA authorizes bamlanivimab and etesevimab monoclonal antibody therapy for post-exposure prophylaxis (prevention) for COVID-19 The U.S. Food and Drug Administration today revised the emergency use authorization (EUA) for bamlanivimab and etesevimab, administered together, to include emergency use as post-exposure prophylaxis (prevention) for COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death. Bamlanivimab and etesevimab are monoclonal antibodies. Monoclonal antibodies are laboratory-made proteins that mimic the immune system's ability to fight off harmful pathogens, such as viruses like SARS-CoV-2. In this revision of the EUA, bamlanivimab and etesevimab, administered together, are authorized for use after exposure to the virus and are not authorized for pre-exposure prophylaxis to prevent COVID-19 before being exposed to the SARS-CoV-2 virus. Health care providers should review the fact sheet for detailed information about use of this therapy for post-exposure prophylaxis. Bamlanivimab and etesevimab, administered together, also remain authorized 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 progression to severe COVID-19, including hospitalization or death. Post-exposure prophylaxis as authorized with bamlanivimab and etesevimab, administered together, is not a substitute for vaccination against COVID-19. FDA has approved one vaccine and authorized others to prevent COVID-19 and serious clinical outcomes caused by COVID-19, including hospitalization and death. FDA urges you to get vaccinated if you are eligible. Learn more about FDA-approved or -authorized COVID-19 vaccines. Bamlanivimab and etesevimab, administered together, may only be used as post-exposure prophylaxis for adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are: at high risk for progression to severe COVID-19, including hospitalization or death, and not fully vaccinated or who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (for example, people with immunocompromising conditions, including those taking immunosuppressive medications), and have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per Centers for Disease Control and Prevention (CDC), or who are at high risk of exposure to an individual infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (for example, nursing homes or prisons) In general, people are considered fully vaccinated two weeks after their second dose in a two-dose series (the Pfizer or Moderna vaccines) or two weeks after a single-dose vaccine (the Janssen vaccine). The CDC defines close contact as someone who has been within six feet of an infected person (laboratory-confirmed or a clinically compatible illness) for a cumulative total of 15 minutes or more over a 24-hour period. Learn More This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO- FDA (1-888-463-6332) or 301-796-3400 from 8:00 am - 4:30 pm ET Monday - Friday. You can also email us at: druginfo@fda.hhs.gov. Stay Connected with U.S. Food and Drug Administration:         SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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