Your Coronavirus Q&A From FDA

U.S. Food and Drug Administration sent this bulletin at 07/21/2021 08:51 AM EDT

Coronavirus Q&As for Consumers The FDA is working to address the coronavirus disease 2019 (COVID-19) outbreak and keep you and your family informed on the latest developments. Here are answers to some frequently asked questions from consumers about monoclonal antibodies and vaccines. Q: Are the monoclonal antibodies bamlanivimab and etesevimab FDA-approved to treat COVID-19? A: No. Bamlanivimab and etesevimab are not FDA-approved to treat any diseases or conditions, including COVID-19. However, the FDA issued an emergency use authorization (EUA) for bamlanivimab and etesevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (ages 12 and older weighing at least 40 kilograms, about 88 pounds) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19. This includes people ages 65 or older or who have certain chronic medical conditions. On June 25, 2021, the U.S. Department of Health and Human Services Assistant Secretary for Preparedness and Response issued a nationwide pause on the distribution of bamlanivimab and etesevimab. Q: Is the monoclonal antibody tocilizumab approved for the treatment of COVID-19? A: No. Tocilizumab is not approved as a treatment for COVID-19. However, the FDA issued an emergency use authorization (EUA) for use of tocilizumab by health care providers for the treatment of COVID-19 in hospitalized adults and pediatric patients (ages 2 and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation. Actemra is a monoclonal antibody that reduces inflammation by blocking the interleukin-6 receptor. In the case of COVID-19 infection, the immune system can become hyperactive, which may result in the worsening of the disease. Actemra does not directly target SARS-COV-2. Actemra is a prescription medication given by intravenous infusion that is FDA-approved for multiple inflammatory diseases, including rheumatoid arthritis. Q: Do any of the COVID-19 vaccines authorized for emergency use by the FDA contain a live form of the virus that causes COVID-19? A: None of the currently authorized vaccines contain the live SARS-CoV-2 virus, and you can’t get COVID-19 from the vaccines. Q: Are egg products used in COVID-19 vaccines? A: The COVID-19 vaccines currently authorized by the FDA are not manufactured using egg products or egg culture. See COVID-19 vaccines for more information. For the latest information about COVID-19, visit: FDA: Coronavirus Disease 2019 (COVID-19) FDA: COVID-19 Vaccines CDC: Coronavirus (COVID-19)U.S. Department of Health and Human Services