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. | |  | COVID-19 vaccine updates  COVID-19 Vaccination & the Food and Agriculture Sector Resources in English and Spanish FDA's Center for Food Safety and Applied Nutrition updated its COVID-19 Vaccination & Food and Agriculture Sector web page to include the HHS COVID-19 Vaccination Toolkit for agriculture workers. (April 21, 2021) FDA and CDC lift recommended pause on Johnson & Johnson (Janssen) COVID-19 Vaccine use following thorough safety review Agencies underscore confidence in vaccine's safety and effectiveness following data assessment; available data suggest potential blood clots are very rare events Following a thorough safety review, including two meetings of the CDC's Advisory Committee on Immunization Practices, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention have determined that the recommended pause regarding the use of the Johnson & Johnson (Janssen) COVID-19 Vaccine in the U.S. should be lifted and use of the vaccine should resume. Read more (April 23, 2021) Related links: FDA continues important steps to ensure quality, safety and effectiveness of authorized COVID-19 vaccines FDA takes its responsibility to ensure medical product quality, safety and effectiveness very seriously. The American public puts its trust in the agency to ensure that all medical products, including COVID-19 vaccines, meet the agency's standards for quality, safety and effectiveness. As part of our regulatory processes for reviewing all manufacturing facilities, the FDA recently completed an inspection of Emergent BioSolutions, a proposed manufacturing facility for the Johnson & Johnson COVID-19 Vaccine. As Johnson & Johnson announced last month, the FDA has not authorized this facility to manufacture or distribute any of Johnson & Johnson's COVID-19 Vaccine or components and, to date, no COVID-19 vaccine manufactured at this plant has been distributed for use in the U.S. The FDA's inspections are thorough, and these assessments review the quality of manufacturing procedures, including records, staff training, facility operations, drug production and testing and the systems in place to ensure product quality. During an inspection of Emergent BioSolutions that ended April 20, 2021, the FDA cited a number of observations concerning whether the facility's processes met our requirements and standards. These observations are outlined in our inspection closeout report, also known as a "FDA Form 483." (PDF, 16.7 MB) (April 21, 2021)  Emergency Use Authorization (EUA) updates FDA and CDC lift recommended pause on Johnson & Johnson (Janssen) COVID-19 Vaccine use following thorough safety review See above for information, including EUA granting letter and revised fact sheets. (Also available at: Emergency Use Authorization) Diagnostic test EUAs As of today, 369 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 23 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 8 antigen tests and 2 molecular tests for serial screening programs. The FDA has also authorized 466 revisions to EUA authorizations. Also see: Coronavirus Testing Basics | Upcoming events 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  |
No comments:
Post a Comment