| 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 Vaccines and Related Biological Products Advisory Committee meeting On June 10, 2021, FDA held a meeting of the Vaccines and Related Biological Products Advisory Committee to provide considerations on data to support licensure and Emergency Use Authorization (EUA) for COVID-19 vaccines intended for use in pediatric populations. The committee met in open session, and discussed in general the data needed to support an authorization and/or licensure of a vaccine intended to prevent COVID-19 in these younger age groups. FDA takes steps to increase availability of COVID-19 vaccine Following careful review and deliberation, FDA is taking important steps that will allow a critically needed supply of the Janssen (Johnson & Johnson) COVID-19 Vaccine to be made available. On June 11, 2021, FDA announced that it is authorizing for use (PDF), under the Emergency Use Authorization (EUA) for the Janssen COVID-19 vaccine, two batches of vaccine drug substance manufactured at the Emergent BioSolutions facility in Baltimore. Before making this decision, the FDA conducted a thorough review of facility records and the results of quality testing performed by the manufacturer. Based on this review and considering the current COVID-19 public health emergency, the FDA concluded these batches are suitable for use. While the FDA is not yet ready to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility, the agency continues to work through issues there with Janssen and Emergent BioSolutions management. Additionally, the FDA has extended the expiration dating for the refrigerated Janssen COVID-19 Vaccine after reviewing information submitted by Janssen and determining that the vaccine can be stored at 2-8 degrees Celsius for 4.5 months instead of 3 months. Health care providers may check the expiration date by lot number at the company's website: https://vaxcheck.jnj/ Related links: Updated Pfizer-BioNTech COVID-19 Vaccine recipient fact sheets (translations) Updated Pfizer-BioNTech COVID-19 Vaccine fact sheets for recipients and caregivers are available in multiple languages. (June 12, 2021) FDA approves StrataGraft for the treatment of adults with thermal burns FDA approved StrataGraft for the treatment of adult patients with thermal burns containing intact dermal elements (remaining deep skin layers) for which surgical intervention is clinically indicated (also referred to as deep partial thickness burns). StrataGraft was developed in conjunction with the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority. (June 15, 2021) | | Emergency Use Authorization (EUA) updates  Diagnostic test EUAs As of June 15, 2021, 384 tests and sample collection devices are authorized by FDA under EUAs. These include 275 molecular tests and sample collection devices, 81 antibody and other immune response tests, and 28 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, 3 antigen prescription at-home tests, 5 antigen over-the-counter (OTC) at-home tests, and 2 molecular OTC at-home tests. FDA has authorized 11 antigen tests and 3 molecular tests for serial screening programs. The FDA has also authorized 534 revisions to EUA authorizations. Also see: Coronavirus Testing Basics | | | Events - June 16, 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! June 22, 2021: Sentinel Innovation and Methods Seminar series - Measure what you treasure- the challenges and opportunities of collecting real world endpoints, 1:00 p.m. ET
- New! June 22, 2021: FDA Drug Topics webinar: Overview of Risk Evaluation and Mitigation Strategies (REMS) for Health Care Providers, 1:00 - 2:00 p.m. ET
- July 19-23, 2021: Regulatory Education for Industry (REdI) Annual Conference 2021 - Learn directly from the FDA's regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA's regulatory requirements. The keynote speaker, Acting Commissioner Janet Woodcock, MD, will reflect on FDA's use of EUAs and other resources in making drug, device, and biological products available to support the public health response to the COVID-19 pandemic.
- Save the date! August 2-4, 2021: Virtual Training Course: Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens
| | Information for industry Medical device shortages during the COVID-19 public health emergency Stop Using Innova SARS-CoV-2 Antigen Rapid Qualitative Test - FDA Safety Communication - FDA issued a safety communication warning the public to stop using the Innova SARS-CoV-2 Antigen Rapid Qualitative Test for diagnostic use. The FDA has significant concerns that the performance of the test has not been adequately established, presenting a risk to health. The test labeling distributed with certain configurations of the test includes performance claims that did not accurately reflect the performance estimates observed during the clinical studies of the tests. In addition, the test has not been authorized, cleared, or approved by the FDA for commercial distribution or use in the United States, as required by law. The Innova SARS-CoV-2 Antigen Rapid Qualitative Test is also distributed under the names Innova COVID-19 Self-Test Kit (3T Configuration), InnovaSARS-CoV-2-Antigen Rapid Qualitative Test (7T Configuration), and Innova SARS-CoV-2-Antigen Rapid Qualitative Test (25T Configuration). (June 10, 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  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. |  Your EUA questions answered In a new episode of FDA's Health Equity Forum podcast, Associate Commissioner for Minority Health RADM Richardae Araojo discusses FDA's EUA process with FDA Chief Scientist RADM Denise Hinton. |  List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 250 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.
(Select Emergency Preparedness and Response,
FDA Medical Countermeasures Initiative (MCMi) News)
| | | | |
No comments:
Post a Comment