Coronavirus Disease 2019 (COVID-19) Update

If your email program has trouble displaying this email, view as a webpage. FDA Office of Minority Health and Health Equity 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: June 1, 2021: COVID-19 Update including a safety communication to warn the public to stop using the Lepu Medical Technology SARS-CoV-2 Antigen Rapid Test Kit and the Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) because the FDA has serious concerns about the performance of the tests and believes there is likely a high risk of false results when using these tests May 28, 2021: COVID-19 Update including release of the Medical Countermeasures Initiative (MCMi) Program Update report, which showcases FDA's work each year to prepare for all types of public health emergencies, including COVID-19 May 28, 2021: Stop Using Lepu Medical Technology SARS-CoV-2 Antigen and Leccurate Antibody Tests: FDA Safety Communication May 26, 2021: FDA Authorizes Additional Monoclonal Antibody for Treatment of COVID-19 May 26, 2021: Important update about bamlanivimab/etesevimab with regard to the P.1 and the B.1.351 variants in multiple states (from HHS/ASPR and FDA) Bookmark www.fda.gov/coronavirus for the latest. FDA Science Forum If you missed the FDA Science Forum May 26-27, 2021, recordings are available. The virtual poster session continues, with authors answering questions about their posters via email through June 9, 2021. Agenda Program book (PDF) Webcast recordings Posters Upcoming events New funding opportunity! June 8, 2021: Pre-proposers conference, 12:00 - 1:00 p.m. ET, for the NASA-led multi-agency (including FDA) solicitation Extended Longevity of 3D Tissues and Microphysiological Systems for Modeling of Acute and Chronic Exposures to Stressors New! June 9, 2021: Webinar on Transitioning from Use of Non-NIOSH-Approved Disposable Respirators, 12:00 - 1:00 p.m. ET - FDA will present information about the May 27, 2021, Update: FDA Recommends Transition from Use of Non-NIOSH-Approved and Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities June 9, 2021: Public workshop (virtual): Model Informed Drug Development Approaches for Immunogenicity Assessments - to discuss best practices and future directions of quantitative methods for predicting immunogenicity of biologic products - 8:00 a.m. - 5:00 p.m. ET - Register June 10, 2021: Vaccines and Related Biological Products Advisory Committee (webcast) - During this meeting, FDA will provide a status update on our approach to EUA for COVID-19 vaccines intended for use in individuals 12 through 17 years of age. The committee will also discuss the data needed to support an EUA and a BLA for a COVID-19 vaccine intended for use in children less than 12 years of age. The committee will not discuss any specific products. June 14-18, 2021: Virtual Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories - Apply to attend by May 11, 2021 (deadline extended!) In case you missed it Learn more about FDA's Medical Countermeasures Initiative This new report showcases FDA's work to prepare for all types of public health emergencies. This year's report includes a snapshot of FDA's COVID-19 response during the reporting period. (May 26, 2021) Find a COVID-19 vaccine near you Text your zip code to GETVAX (438829) in English or VACUNA (822862) in Spanish to find out where COVID-19 vaccines are available near you. Learn more at vaccines.gov. COVID-19 communication toolkits Visit our communication toolkits page for materials and messages from the FDA about COVID-19 to communicate with patients, the public, and health care professionals. List of hand sanitizers consumers should not use Some hand sanitizers have been recalled and there are more than 225 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and use our step-by-step search guide to find out if your product is on the list. 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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