| 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: Bookmark www.fda.gov/coronavirus for the latest. | | | COVID-19 vaccine updates FDA authorizes Pfizer-BioNTech COVID-19 Vaccine for emergency use in adolescents FDA expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents 12 through 15 years of age. The FDA amended the EUA originally issued on Dec. 11, 2020 for administration in individuals 16 years of age and older. (May 10, 2021) Related links: FDA to hold VRBPAC meeting to discuss pediatric use of COVID-19 vaccines June 10, 2021 FDA's Center for Biologics Evaluation and Research (CBER) will convene a virtual meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on June 10, 2021, via webcast. During this meeting, the agency will provide a status update on our approach to Emergency Use Authorization (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 Biologics License Application (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.  Hurricane season: Be prepared May 9-15, 2021 is National Hurricane Preparedness Week When gale-force winds start blowing and torrential rains raise water levels, you need to be ready. Power outages mean refrigerated food and medicine supplies may spoil. Floods may contaminate tap water and emergency supplies not stored properly with sewage, chemicals, heavy metals, pathogenic microorganisms, or other contaminants. If the storm or flood is severe enough, you may need to evacuate with little time to prepare. Don't put off being prepared until the emergency hits. | | Emergency Use Authorization (EUA) updates  Important update about bamlanivimab/etesevimab with regard to the P.1 variant in the state of Illinois The Office of 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 for the treatment of COVID-19. As of May 4, 2021, the Centers for Disease Control and Prevention (CDC) have identified that the P.1 variant (originally identified in Brazil) is circulating with increasing frequency in the state of Illinois. 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 the P.1 variant. These assays use "pseudo-virus particles" that help determine likely susceptibility of the live virus. REGEN-COV (PDF) is an alternative monoclonal antibody therapy that is currently authorized for the same use as bamlanivimab and etesevimab administered together (PDF) and, based on similar in vitro assay data currently available, REGEN-COV is likely to retain activity against the P.1 variant. 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 the State of Illinois 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 Illinois. Read more (May 7, 2021) Diagnostic test EUAs As of today, 370 tests and sample collection devices are authorized by FDA under EUAs. These include 270 molecular tests and sample collection devices, 76 antibody and other immune response tests, and 24 antigen tests. There are 49 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 over-the-counter (OTC) at-home antigen tests, and 2 OTC molecular tests. FDA has authorized 9 antigen tests and 3 molecular tests for serial screening programs. The FDA has also authorized 488 revisions to EUA authorizations. Also see: Coronavirus Testing Basics | | |  Events - Today! May 12, 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 May and June.
- May 26-27, 2021: 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. Register now
- 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
- New! 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 14, 2021 (deadline extended!)
| | Information for industry 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  #VaccineReady social media toolkit Check out our latest toolkit, with social media posts and graphics on vaccine development and authorization, and the benefits of getting vaccinated against COVID-19. |  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. | Did someone forward you this email? Subscribe.
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