COVID-19 updates: new monoclonal antibody authorized, variant update, safety communication + more

COVID-19 response updates from FDA

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Coronavirus Disease 2019 (COVID-19) updates Actions by FDA in our ongoing response to the COVID-19 pandemic since our last MCMi 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 Emergency Use Authorization (EUA) updates FDA authorizes additional monoclonal antibody for treatment of COVID-19 FDA issued an EUA (PDF, 388 KB) for the investigational monoclonal antibody therapy sotrovimab for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age 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 progression to severe COVID-19, including hospitalization or death. This includes, for example, individuals who are 65 years of age and older or individuals who have certain medical conditions. Monoclonal antibodies are laboratory-made proteins that mimic the immune system's ability to fight off harmful antigens such as viruses. Sotrovimab is a monoclonal antibody that is specifically directed against the spike protein of SARS-CoV-2 and is designed to block the virus' attachment and entry into human cells. Read more (May 26, 2021)  Important update about bamlanivimab/etesevimab with regard to the P.1 and the B.1.351 variants in multiple states The Assistant Secretary for Preparedness and Response (ASPR) and the FDA, within the U.S. Department of Health and Human Services, are committed to ensuring timely and transparent communication regarding the COVID-19 monoclonal antibody treatments currently authorized for emergency use in certain patients with COVID-19. The Centers for Disease Control and Prevention (CDC) has identified that the combined frequency of the P.1 variant (first identified in Brazil) and the B.1.351 variant (first identified in South Africa) now exceeds 10% in Arizona, California, Florida, Indiana, Oregon and Washington. Results from in vitro assays that are used to assess the susceptibility of viral variants to particular monoclonal antibodies suggest that bamlanivimab and etesevimab administered together are not active against either the P.1 or B.1.351 variants. These assays use "pseudo-virus particles" that help determine likely susceptibility of the live virus. REGEN-COV is an alternative monoclonal antibody therapy that is currently authorized for the same use as bamlanivimab and etesevimab administered together and, based on similar in vitro assay data currently available, REGEN-COV is likely  to retain activity against the P.1 and B.1.351 variants. All treatment delivery sites can continue ordering REGEN-COV from the authorized distributer by following the existing ordering and reporting procedures.  The FDA recommends that health care providers in Arizona, California, Florida, Indiana, Oregon, and Washington use this alternative authorized monoclonal antibody therapy until further notice. ASPR will pause distribution of bamlanivimab and etesevimab together and etesevimab alone (to pair with existing supply of bamlanivimab at a facility for use under EUA 094) to Arizona, California, Florida, Indiana, Oregon and Washington. Read the full update (May 26, 2021)   Diagnostic test EUAs As of today, 380 tests and sample collection devices are authorized by FDA under EUAs. These include 275 molecular tests and sample collection devices, 80 antibody and other immune response tests, and 25 antigen tests. There are 52 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 molecular prescription at-home test, 2 antigen prescription at-home tests, 4 antigen over-the-counter (OTC) at-home tests, and 2 molecular OTC at-home tests. FDA has authorized 9 antigen tests and 3 molecular tests for serial screening programs. The FDA has also authorized 516 revisions to EUA authorizations. Also see: Coronavirus Testing Basics   Events Today! June 2, 2021: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation, 12:15 p.m. - 1:15 p.m. ET - FDA will host additional webinars in this series on Wednesdays in June. 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  Information for industry Update: Letter to Health Care Personnel and Facilities FDA Recommends Transition from Use of Non-NIOSH-Approved and Decontaminated Disposable Respirators - FDA is recommending health care personnel and facilities transition away from crisis capacity conservation strategies, such as using non-NIOSH-approved disposable respirators, including non-NIOSH-approved imported respirators such as KN95s. (May 27, 2021) FDA Safety Communication Stop Using Lepu Medical Technology SARS-CoV-2 Antigen and Leccurate Antibody Tests - FDA is warning 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). The FDA has serious concerns about the performance of the SARS-CoV-2 Antigen Rapid Test Kit and the Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) and believes there is likely a high risk of false results when using these tests. Neither test has been authorized, cleared or approved by FDA for distribution and use in the United States. The FDA has identified this issue as a class I recall, the most serious type of recall. The FDA is aware that these unauthorized tests were distributed to pharmacies to be sold for at-home testing by consumers as well as offered for sale directly to consumers. (May 28, 2021)  FDA is committed to providing timely recommendations, regulatory information, guidance, and technical assistance necessary to support rapid COVID-19 response efforts. FDA has issued more than 75 COVID-19-related guidances to date. 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. 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