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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: May 10, 2022: FDA Roundup including approval of a new indication (PDF) for Olumiant (baricitinib) for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) May 10: Do Not Use Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test: FDA Safety Communication May 9, 2022: Mesa Biotech, Inc., Recalls Certain Accula SARS-CoV-2 Tests for Risk of False Positives Caused by Contamination May 6, 2022: FDA Roundup including an update on an FDA project to sample and sequence SARS-CoV-2 RNA from wastewater May 5, 2022: FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals May 4, 2022: FDA Updates on Paxlovid for Health Care Providers, including a new eligibility screening checklist tool (PDF). Paxlovid is the preferred therapy for the management of non-hospitalized adults with COVID-19, according to the National Institutes of Health COVID-19 Treatment Guidelines. Bookmark www.fda.gov/coronavirus for the latest.

COVID-19 vaccine updates

FDA limits use of Janssen COVID-19 Vaccine to certain individuals

FDA has limited the authorized use of the Janssen COVID-19 Vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. For more information, see the fact sheets for health care providers (PDF) and recipients and caregivers (PDF).

COVID-19 treatment updates

FDA approves COVID-19 treatment for certain hospitalized adults

FDA approved a new indication (PDF) for Olumiant (baricitinib) for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Olumiant is the first immunomodulatory treatment for COVID-19 to receive FDA approval.

FDA first issued an Emergency Use Authorization (EUA) for Olumiant in combination with remdesivir to treat COVID-19 in hospitalized adults and pediatric patients on November 19, 2020. On July 28, 2021, the FDA revised the EUA to authorize Olumiant as a standalone treatment. Olumiant remains under EUA status for hospitalized pediatric patients 2 to less than 18 years of age requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.

FDA has revised the Letter of Authorization (PDF) and associated fact sheets to remove the population covered under the approved indication. Common side effects of Olumiant and the recommended dosage for the approved population are included in the prescribing information (PDF).

FDA continues to work with developers, researchers, manufacturers, and partners to help expedite the development and availability of therapeutic drugs and biological products to prevent or treat COVID-19 through its Coronavirus Treatment Acceleration Program. (May 10, 2022)

COVID-19 test updates

Safety communication: Do not use Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test

FDA is warning people to stop using the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold). This test is not 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 test because SML Distribution LLC has not provided the FDA with adequate data to show the test works correctly. (May 10, 2022)

Reminder: Expiration date extensions of COVID-19 at-home tests

Check the Expiration Date column of the List of Authorized At-Home OTC COVID-19 Diagnostic Tests to see if the expiration date for your at-home OTC COVID-19 test has been extended and how to find any new expiration date.

Regulatory science update

Wastewater surveillance from SARS-CoV-2 variants

Through the American Rescue Plan Act of 2021, Congress provided temporary funding for FDA to develop the capacity to sequence SARS-CoV-2 RNA from wastewater samples and to conduct a sampling and sequencing project through 2022. To facilitate sharing of information about progress on this sequencing effort, FDA published a public dashboard that graphically presents information from the project. Studies have shown that SARS-CoV-2 (COVID-19) variants of concern from wastewater can be identified 1-2 weeks prior to being detected in clinical samples from the same area, making wastewater surveillance useful for detecting and monitoring SARS-CoV-2 in the population. Raw sequence data plus a standard suite of metadata is available for download.

Events

• May 18, 2021: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation, 12:05 - 1:00 p.m. ET, hosted by FDA's Center for Devices and Radiological Health (CDRH). FDA will hold additional events in this series on June 1, June 15, and June 29, 2022.
• May 24-25, 2022: FDA and Duke-Margolis Virtual Public Workshop - Translational Science in Drug Development: Surrogate Endpoints, Biomarkers, and More (webcast) - To present best practices and use cases for successfully bringing forward evidence generated through translational science for regulatory submissions.
• June 6-10, 2022: Regulatory Education for Industry (REdI) Annual Conference 2022 (virtual) - Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics, including a session on FDA's COVID-19 response.
• June 7-9, 2022: Virtual Public Workshop - Building Medical Device Supply Chain Resilience: A Healthcare and Public Health Ecosystem-Wide Collaboration (webcast) - To discuss ways to foster resiliency in the medical device supply chain and to seek input on the new Resilient Supply Chain Program (RSCP). To participate in breakout sessions, register by May 17, 2022. To attend, register by June 6, 2022.

In case you missed it

Resources to keep yourself and others safe from COVID-19 Find out where to get a COVID-19 vaccine, test, or treatment in your community at COVID.gov. Call 1-800-232-0233 (TTY 1-888-720-7489) with questions. (Also available in Spanish and Simplified Chinese.)

COVID-19 vaccine boosters: Getting the facts straight In the latest episode of the FDA Health Equity Forum podcast, RADM Richardae Araojo and Dr. Robert Califf discuss COVID-19 vaccines and boosters misinformation. (14 minutes)

What happens to EUAs when a public health emergency ends? Visit our website for answers to frequently asked questions about what happens to EUAs, and products available under EUA, when a public health emergency ends.

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