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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:
Bookmark www.fda.gov/coronavirus for the latest.
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COVID-19 testing updates
Antibody (serology) testing for COVID-19: Information for patients and consumers
FDA updated the Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers page on FDA.gov to answer questions about SARS-CoV-2 antibody testing. The update includes information about:
- Antibodies and Antibody Tests: The Basics
- Antibody Tests: Not for Use to Check Immunity
- Antibody Tests: Results and Terms
Updated FAQs
FDA updated the page COVID-19 Test Uses: FAQs on Testing for SARS-CoV-2 to update the question and answer: Should SARS-CoV-2 antibody test results be used to assess whether or not a person is protected from COVID-19?
For test developers, FDA also updated the page COVID-19 Test Development and Review: FAQs on Testing for SARS-CoV-2 to add the question and answer: I am developing a SARS-CoV-2 antibody test. What are the recommendations for traceability to an international standard material?
Testing basics
Understanding COVID-19 testing is key to making an informed decision that meets your needs. Learn more in our Consumer Update: Coronavirus Disease 2019 Testing Basics.
Safety communication: Do not use these tests
Do not use certain Celltrion DiaTrust COVID-19 tests
FDA issued a warning people not to use the Celltrion DiaTrust COVID-19 Ag Rapid Test that is in green and white packaging The test has not been authorized, cleared or approved by the FDA for distribution or use in the United States. The FDA is concerned about the risk of false results when using this unauthorized test. (March 1, 2022)
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Do not use SD Biosensor STANDARD Q COVID-19 Ag Home tests
FDA issued a safety communication warning people not to use the SD Biosensor STANDARD Q COVID-19 Ag Home Test. This test is packaged in a white and magenta box (see image) and has not been authorized, cleared or approved by the FDA for distribution or use in the United States. The FDA is concerned about the risk of false results when using this unauthorized test. (March 1, 2022)
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Do not use certain ACON Flowflex COVID-19 tests
FDA issued a safety communication warning people not to use the ACON Laboratories “F SARS-CoV-2 Antigen Rapid Test (Self-Testing).” This test is packaged in a dark blue box () and has not been authorized, cleared or approved by the FDA for distribution or use in the United States. The FDA is concerned about the risk of false results when using this unauthorized test. (March 1, 2022)
Larger images are available on each page linked above.
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Emergency Use Authorization (EUA) updates
FDA updates sotrovimab EUA
FDA is continually monitoring how authorized and approved treatments for COVID-19 are affected by changing variants—currently omicron and the omicron subvariants.
On February 23, 2022, FDA revised the EUA for sotrovimab to clarify that sotrovimab is not authorized for treatment of mild-to-moderate COVID-19 in geographic regions where infection is likely to have been caused by a variant that is not susceptible to this treatment. However, sotrovimab is currently authorized in all U.S. regions until further notice by FDA. For other limitations and conditions, refer to the EUA (PDF).
FDA authorizes revisions to Evusheld dosing
On February 24, 2022, FDA revised the EUA (PDF) for Evusheld (tixagevimab co-packaged with cilgavimab) to change the initial dose for the authorized use as pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric patients. Based on the most recent information and data available, Evusheld may be less active against certain omicron subvariants. The dosing regimen was revised because available data indicate that a higher dose of Evusheld may be more likely to prevent infection by the COVID-19 omicron subvariants BA.1 and BA.1.1 than the originally authorized Evusheld dose. Updated materials (PDFs) include:
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 March 1, 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, 2 EUAs for antigen prescription at-home tests, 14 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 EUAs for molecular OTC at-home tests. FDA has authorized 25 antigen tests and 9 molecular tests for serial screening programs. The FDA has also authorized 850 revisions to test EUA authorizations. Also see: Coronavirus Testing Basics
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Events
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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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March 9, 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 23, April 6, and April 20, 2022.
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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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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
CDER scientific review documents supporting EUAs
To promote public confidence in FDA’s scientific review process and in ultimately appropriately using products authorized for emergency use, FDA's Center for Drug Evaluation and Research (CDER) discloses information from our scientific review documents supporting EUAs for drug and biological therapeutic products as appropriate and consistent with our longstanding practice of posting scientific reviews after new drug and biological product approvals. This page is updated regularly, as new review information becomes available.
Review information about vaccines under EUA is available on the FDA EUA page, in the COVID-19 Vaccines table, under "Additional Information and Decision Memoranda."
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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