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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 17, 2022: FDA Roundup including an EUA for the Laboratory Corporation of America (Labcorp) Pixel by Labcorp COVID-19+Flu+RSV Test Home Collection Kit for use with the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test May 17, 2022: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Vaccine Booster Dose to Children 5 through 11 Years of Age May 16, 2022: FDA Authorizes First COVID-19 Test Available without a Prescription That Also Detects Flu and RSV May 16, 2022: Woodside Acquisitions Inc Recalls Oral Rapid SARS-CoV-2 Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test Kits (Colloidal Gold) That Are Not Authorized, Cleared, or Approved by the FDA May 13, 2022: FDA Roundup including a warning for consumers about the risk of accidental ingestion, especially by children, of edible products that contain THC. Accidental ingestion of these edible products may cause serious adverse events. May 12, 2022: Statement Regarding Shelf-Life Extension of Sotrovimab (from HHS/ASPR and FDA) Bookmark www.fda.gov/coronavirus for the latest.

COVID-19 vaccine updates

FDA expands eligibility for Pfizer-BioNTech COVID-19 booster dose to individuals 5 through 11 years of age FDA reissued (PDF) the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 5 through 11 years of age at least five months after completion of a primary series with the Pfizer-BioNTech COVID-19 Vaccine. “While it has largely been the case that COVID-19 tends to be less severe in children than adults, the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer term effects, even following initially mild disease,” said FDA Commissioner Robert M. Califf, M.D. “The FDA is authorizing the use of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age to provide continued protection against COVID-19. Vaccination continues to be the most effective way to prevent COVID-19 and its severe consequences, and it is safe. If your child is eligible for the Pfizer-BioNTech COVID-19 Vaccine and has not yet received their primary series, getting them vaccinated can help protect them from the potentially severe consequences that can occur, such as hospitalization and death.”(May 17, 2022)

"Isn't the pandemic over?"

In a new Just a Minute! video, Dr. Peter Marks discusses the state of the pandemic and why people should still get vaccinated.

COVID-19 test updates

FDA authorizes first COVID-19 test available without a prescription that also detects flu and RSV

FDA authorized (PDF) the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test for use without a prescription by individuals with symptoms of respiratory viral infection consistent with COVID-19. This product is the first direct-to-consumer (non-prescription) multi-analyte COVID-19 test authorized by FDA and allows an individual to self-collect a nasal swab sample at home and then send that sample to Labcorp for testing.

The test can identify and differentiate multiple respiratory viruses at the same time, detecting influenza A and B, commonly known as the flu, respiratory syncytial virus, commonly known as RSV, along with SARS-CoV-2, the virus that causes COVID-19. Results are delivered through an online portal, with follow-up from a health care provider for positive or invalid test results.

The EUA authorizes at-home sample collection with testing performed in a laboratory. (May 16, 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.

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). Register by June 6, 2022.
• New! July 11-13, 2022: Training Course: Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens (Omaha, Nebraska or virtual) - Save the date! This course, presented by FDA and the University of Texas Medical Branch, will be held at the National Training, Simulation and Quarantine Center (TSQC) at University of Nebraska Medical Center/Nebraska Medicine, a National Ebola Training and Education Center (NETEC) facility. A virtual option is also available. Registration will open on June 1, 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 280 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