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Coronavirus Disease 2019 (COVID-19) updates
Updates from FDA in our ongoing response to the COVID-19 pandemic since our last MCMi email update include:
- February 22, 2022: FDA Roundup including a new resource, At-Home OTC COVID-19 Diagnostic Tests, that provides a list of all FDA-authorized at-home over-the-counter (OTC) COVID-19 diagnostic tests
- February 18, 2022: FDA Roundup including that FDA has found an additional four lots of AstraZeneca COVID-19 vaccine drug substance manufactured at the Emergent facility in Baltimore, Maryland, to be acceptable for use for potential export. The AstraZeneca vaccine is not authorized for use in the U.S., but FDA understands that these AstraZeneca lots, or vaccine made from these lots, may now be exported for use. The agency conducted a thorough review of facility records and the results of quality testing performed by the manufacturer and reached its decision based on this review, taking into consideration the current worldwide COVID-19 public health emergency. At this time, the agency does not anticipate making any more determinations on additional AstraZeneca lots manufactured at the Emergent facility.
- February 18, 2022: E25Bio Recalls COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA
- February 17, 2022: Vyaire Medical Recalls bellavista 1000 and 1000e Series Ventilators Due to Issues with Software Configurations
- February 17, 2022: Robert M. Califf, M.D., was sworn in as Commissioner of Food and Drugs
Bookmark www.fda.gov/coronavirus for the latest.
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New resource: At-Home OTC COVID-19 Diagnostic Tests
On February 22, 2022, FDA posted a new resource, At-Home OTC COVID-19 Diagnostic Tests, that provides a list of all FDA-authorized at-home OTC COVID-19 diagnostic tests. Testing and other protective steps like mask-wearing and COVID-19 vaccination are essential to stop the spread of COVID-19. At-home OTC COVID-19 diagnostic tests play a key role in the fight against COVID-19.
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Recall: E25Bio COVID-19 Direct Antigen Rapid Tests
E25Bio is recalling its COVID-19 Direct Antigen Response Tests (DART) for several reasons, particularly that these tests were marketed and distributed to U.S. customers without authorization, clearance, or approval from the FDA. Labeling distributed with some of the tests also includes inaccurate claims and instructions, including a statement that misrepresents the test as FDA-authorized. FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death. If you have questions about this recall, contact E25Bio at info@e25bio.com. (February 18, 2022)
Join FDA's Medical Countermeasures Initiative (MCMi)
Job opening: Interdisciplinary scientist (biologist)
Apply to join the MCMi regulatory science team, to help advance public health emergency preparedness through development of tools, standards, and approaches to assess medical countermeasure safety, efficacy, quality, and performance. More information is available in the USAJobs listing, which closes March 1, 2022.
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Emergency Use Authorization (EUA) updates
EUA revocation
FDA revoked the following EUA:
Information about revoked EUAs is available on the web page Emergency Use Authorization--Archived Information.
SARS-CoV-2 viral mutations: Impact on COVID-19 tests
Please bookmark and check this web page often for updates on how viral mutations, including the omicron variant, impact COVID-19 tests: SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests.
In vitro diagnostic (test) EUAs
As of February 22, 2022, 420 tests and sample collection devices are authorized by FDA under EUAs. These include 290 molecular tests and sample collection devices, 85 antibody and other immune response tests, and 45 antigen tests. There are 70 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for molecular prescription at-home test, 3 EUAs for antigen prescription at-home tests, 15 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 EUAs for molecular OTC at-home tests. FDA has authorized 26 antigen tests and 10 molecular tests for serial screening programs. The FDA has also authorized 843 revisions to test EUA authorizations. Also see: Coronavirus Testing Basics
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Events
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February 23, 2021: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation, 12:15 p.m. - 1:15 p.m. ET, hosted by FDA's Center for Devices and Radiological Health (CDRH). FDA will hold additional events in this series on March 9, March 23, April 6, and April 20, 2022.
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March 3, 2022: Vaccines and Related Biological Products Advisory Committee (virtual) - The committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2022-2023 influenza season.
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March 7-9, 2022: FDA, the Medicines and Healthcare products Regulatory Agency (MHRA), and Health Canada Good Clinical Practice Workshop: Global Clinical Trials - Considerations and Lessons Learned from the Changing Landscape (virtual)
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New! March 9, 2022: 2022 Next-Gen Filovirus Therapeutics Workshop, hosted by the Biomedical Advanced Research and Development Authority (BARDA) to discuss medical countermeasure approaches to address severe filovirus infection and eliminate persistent infection in filovirus survivors. Register by March 2, 2022.
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New! March 16-17, 2022: Virtual Public Workshop - 3D Printing in Hospitals: Veteran’s Health Administration’s Experiences in Point of Care 3D Printing of Device and Implementing a Quality Management System - FDA is hosting a virtual public workshop in collaboration with the Veteran’s Health Administration (VHA) to share VHA’s experiences using 3D printing/additive manufacturing in their hospitals. The workshop is also intended to provide a forum for VHA and other stakeholders to present and discuss their experience that could be useful for health care facilities considering 3D printing medical devices. Register by March 14, 2022.
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April 25-29, 2022: Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories - register by March 25, 2022
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Information for industry and health care providers
FDA publishes product-specific guidances to facilitate generic drug development
On February 17, 2022, FDA published a new batch of product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating the evidence needed to support abbreviated new drug application (ANDA) approval, thereby helping to streamline generic drug product development by industry and ANDA assessment by FDA.
This batch of 43 PSGs includes new PSGs for products used as treatments for various diseases or conditions, such as COVID-19. FDA developed PSGs for remdesivir powder (PDF) and solution (PDF) (RLD: VEKLURY, NDA 214787), which are for the drug originally approved in October 2020 for the treatment of certain patients with COVID-19.
Vyaire Medical recalls bellavista 1000 and 1000e Series Ventilators due to issues with software configurations
Vyaire Medical is recalling bellavista 1000 and 1000e Series Ventilators after reports of ventilators failing to ventilate and generating a technical failure alarm, with specific software versions and configure combinations. If this occurs, it may cause serious adverse events. FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. If you have questions about this recall, contact Vyaire Medical at 833-327-3284 between 5 a.m. and 5 p.m. PST, Monday through Friday, or email GMB-AMS-FSCAresponsecentre@vyaire.com. (February 17, 2022)
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.
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In case you missed it
Find a COVID-19 vaccine or booster 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. COVID-19 vaccines are free to all people living in the United States, regardless of their immigration or health insurance status. Learn more at vaccines.gov.
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Why you should not use ivermectin to treat or prevent COVID-19
Some people are taking ivermectin, a drug often prescribed for animals, to try to prevent or treat COVID-19. FDA has not approved or authorized ivermectin for this use, and it can be dangerous for people. Information is also available in six additional languages.
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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.
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FDA Medical Countermeasures Initiative (MCMi) News)
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