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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: January 11, 2022: FDA Roundup including revisions to the Janssen COVID-19 Vaccine fact sheets January 11, 2022: Stop Using LuSys Laboratories COVID-19 Tests - FDA Safety Communication January 11, 2022: Addressing New Variants: A Federal Perspective on the COVID-19 Response, testimony by Acting Commissioner of Food and Drugs, Janet Woodcock, MD January 7, 2022: FDA Roundup including addition of organ preservation solutions to the device shortage list January 7, 2022: Updated printable chart: Do I qualify for a COVID-19 vaccine booster and which one?, now also available in Spanish Bookmark www.fda.gov/coronavirus for the latest.

COVID-19 vaccine updates

FDA shortens interval for booster dose of Moderna COVID-19 Vaccine to five months

FDA amended the EUA (PDF) for the Moderna COVID-19 Vaccine to shorten the time between the completion of a primary series of the vaccine and a booster dose to at least five months for individuals 18 years of age and older. (January 7, 2022)

Do I qualify for a COVID-19 vaccine booster and which one?

Use this chart to find out if you're eligible for a COVID-19 vaccine booster and which one. (updated January 7, 2022)

This chart is also available in Spanish:¿Califico para una dosis de refuerzo de la vacuna contra el COVID-19 y para cuál?

Find a 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. 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.

FDA safety communication: Stop using LuSys Laboratories COVID-19 tests

FDA issued a safety communication warning people to stop using the LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and the LuSys Laboratories COVID-19 IgG/IgM Antibody Test. The performance of these tests has not been adequately established and the FDA believes there is likely high risk of false results when using these tests. Neither test has been authorized, cleared, or approved by the FDA for distribution or use in the United States.

The LuSys Laboratories COVID-19 Antigen Tests (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Tests may also be sold under the company names Luscient Diagnostics or Vivera Pharmaceuticals, or with the trade name EagleDx. (January 11, 2022)

Events

• January 12, 2022: 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 additional events in this series on January 26 and February 9 and 23, 2022.
• January 26, 2022: 2022 Filovirus Vaccine Development Workshop (virtual) - HHS/ASPR will convene a USG workshop focused on development of medical countermeasures against Marburg virus (MARV) and Sudan ebolavirus (SUDV). Companies, USG interagency partners, and others interested in the topic area are encouraged to attend this workshop. The event is open to the public, but space is limited. Register by January 21, 2022.
• February 22, 2022: Webinar on Draft Guidances on Transition Plans for COVID-19 Related Medical Devices, 1:00 - 2:30 p.m. ET
• 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: Save the date! Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories - register by March 25, 2022

In case you missed it

Regulatory science funding FDA funds regulatory science research through a Broad Agency Announcement (BAA). Proposers are encouraged to submit white papers by 5:00 p.m. ET, January 21, 2022. Learn more about MCM- and advanced manufacturing-related areas of interest.

It's a good time to get your flu vaccine Influenza (flu) viruses typically spread in fall and winter, with activity peaking between December and February. Getting vaccinated now can lower your chances of getting the flu.

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