Coronavirus Disease 2019 (COVID-19) updates | Actions by the FDA in our ongoing response to the COVID-19 pandemic since our last email update include: Bookmark www.fda.gov/coronavirus for the latest. | |  | FDA authorizes monoclonal antibodies for treatment of COVID-19 On February 9, 2021, FDA issued an Emergency Use Authorization (EUA) for a new monoclonal antibody combination administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19. The authorized use includes treatment for those who are 65 years of age or older or who have certain chronic medical conditions. Monoclonal antibodies are laboratory-made proteins that mimic the immune system's ability to fight off harmful pathogens such as viruses.
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 COVID-19 therapeutics resources New resources are available from the Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR), focused on monoclonal antibody therapies that can help eligible high-risk adults and children (12-17) who have tested positive for COVID-19 and have mild to moderate symptoms. Resources from HHS/ASPR: FDA continues important work to support medical product development to address new virus variants Statement from Janet Woodcock, M.D., Acting Commissioner of Food and Drugs As the public health agency responsible for regulating medical products, we must ensure that health care providers have the most up-to-date diagnostics, treatments and vaccines in their toolbox to fight this pandemic. We understand the need to adapt and pivot to support modification or development of these lifesaving tools as new variants of coronavirus are identified. Since the beginning of the pandemic, the U.S. Food and Drug Administration has anticipated the possible emergence of coronavirus variants. The FDA continues to monitor the identified and emerging variants circulating globally, as well as their detection in the U.S. We have been actively assessing the impact of new strains on authorized products and continue to work with medical product sponsors and our international partners to evaluate the impact that each variant may have on effectiveness or utility of authorized medical products. Upcoming events - February 23, 2021: Save the date for the next webinar in the series Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic,12:00 - 1:00 p.m. ET.
- New! February 26, 2021: Vaccines and Related Biological Products Advisory Committee meeting (webcast) to discuss the EUA request for a COVID-19 vaccine from Janssen Biotech Inc.
- New! March 10, 2021: Precisely practicing medicine for COVID, from a half million tested patients and a trillion points of data (Zoom webcast), 3:00 - 4:00 p.m. ET - This Center of Excellence in Regulatory Science and Innovation (CERSI) lecture is presented by Atul Butte, MD, PhD, University of California, San Francisco (UCSF) -Stanford CERSI. Registration is not required.
- May 26-27, 2021: Save the date! 2021 FDA Science Forum: Science as the Foundation for Protecting and Promoting Public Health (virtual) - FDA scientific experts and nationally renowned scientists will discuss eight topic areas including one on medical countermeasures, infectious disease, and pathogen reduction technologies. This year's keynote speaker is NIAID Director Anthony Fauci, MD.
Find additional coronavirus disease 2019 (COVID-19) updates on our website and in the Medical Countermeasures Initiative newsletter. Visit the FDA OMHHE website and follow us on Twitter at @FDAHealthEquity "Creating a world where health equity is a reality for all." www.fda.gov/healthequity  |
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