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FDA Office of Minority Health and Health Equity

Coronavirus Disease 2019 (COVID-19) updates

Updates from FDA in our ongoing response to the COVID-19 pandemic since our last email update include: March 1, 2022: FDA Roundup including several safety communications February 25, 2022: FDA updates sotrovimab Emergency Use Authorization February 25, 2022: FDA Roundup including updates to testing information on FDA's website February 24, 2022: FDA authorizes revisions to Evusheld dosing February 24, 2022: HHS news release: HHS Secretary Becerra Highlights Progress Made in Strengthening U.S. Medical Supply Chain and Industrial Base - Also see the updated FDA page: Executive Order 14017 on America’s Supply Chains February 23, 2022: Center for Drug Evaluation and Research Office of Pharmaceutical Quality 2021 Annual Report (PDF) Bookmark www.fda.gov/coronavirus for the latest.

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 safety communication warning people not to use the Celltrion DiaTrust COVID-19 Ag Rapid Test that is in green and white packaging (see image). 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)

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)

Do not use certain ACON Flowflex COVID-19 tests FDA issued a safety communication warning people not to use the ACON Laboratories “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing).” This test is packaged in a dark blue 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) Larger images are available on each page linked above.

Events

• 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.
• 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)
• 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.
• 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.
• 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.
• April 25-29, 2022: Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories - register by March 25, 2022

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.

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.

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.

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