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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: February 8, 2022: FDA Roundup including an alert warning people not to use the E25Bio COVID-19 Direct Antigen Rapid Test (DART) February 4, 2022: FDA Roundup including an update that FDA will resume conducting domestic surveillance inspections across all commodities given the decline in COVID-19 cases across the U.S. February 2, 2022: New web page: From House Cats to Big Cats: How FDA Evaluated Methods for Detecting SARS-CoV-2 in Animals February 2, 2022: New web page: Q&A for Spikevax (COVID-19 Vaccine mRNA), also available in Spanish: Preguntas y respuestas sobre Spikevax (vacuna de ARNm contra el COVID-19) Bookmark www.fda.gov/coronavirus for the latest.

COVID-19 test safety alert

Do not use E25Bio COVID-19 Tests: FDA safety communication

FDA is warning people not to use the E25Bio COVID-19 Direct Antigen Rapid Test. This test has not been authorized, cleared, or approved by the FDA for distribution or use in the United States, and it may include false labeling representing that the test is authorized by the FDA. The E25Bio COVID-19 Direct Antigen Rapid Test may also be sold under the trade name E25Bio SARS-CoV-2 Antigen Test Kit.

The FDA is concerned about the risk of false results when using this test because E25Bio has not provided the FDA with adequate data demonstrating that the test’s performance is accurate. In addition, the FDA is aware that the E25Bio COVID-19 Direct Antigen Rapid Test (DART) was sold directly to consumers and may have been accompanied by labeling with instructions for collecting a sample from deep inside the nose, reaching the back of the throat (nasopharyngeal) or from the middle part of the throat (pharynx) just beyond the mouth (oropharyngeal), which could result in serious injury when this is not done by trained professionals.

The FDA has not received reports of injuries, adverse health consequences, or death associated with use of the E25Bio COVID-19 Direct Antigen Rapid Test. (February 4, 2022)

COVID-19 Lessons Learned: Clinical Evaluation of Therapeutics

Report issued by the Reagan-Udall Foundation for the FDA The Reagan-Udall Foundation for the FDA, at the request of the FDA, has released a report that outlines initial lessons learned from the federal government’s and research communities’ COVID-19 response and provides actionable recommendations to enhance the scope, prioritization, and communication of research activities within the context of a public health emergency. (February 4, 2022)

Regulatory science update

Using real-world evidence to advance COVID-19 medical countermeasures The rapid assessment of inpatient treatments has emerged as particularly critical for effective COVID-19 care, because the majority of life-threatening cases of COVID-19 are treated in inpatient settings. An FDA-funded extramural research project aims to develop a system of studies for the rapid assessment of the safety and effectiveness of COVID-19 inpatient medical countermeasures using real-world evidence (RWE). (February 7, 2022)

Events

• February 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 host an additional event in this series on February 23, 2022.
• February 15, 2022: Vaccines and Related Biological Products Advisory Committee (virtual) - The committee will meet in open session to discuss to discuss the request for EUA of the Pfizer-BioNTech COVID-19 Vaccine for use in children 6 months through 4 years of age.
• February 22, 2022: Webinar on Draft Guidances on Transition Plans for COVID-19 Related Medical Devices, 1:00 - 2:30 p.m. ET
• 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)
• 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

It's a good time to get your flu vaccine 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