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Coronavirus Disease 2019 (COVID-19) updates
Updates from FDA in our ongoing response to the COVID-19 pandemic since our last MCMi 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.
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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)
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"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.
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Emergency Use Authorization (EUA) updates
EUA revocations
FDA revoked EUAs for these products, at the request of their sponsors, for the reasons noted in the revocation letters:
Information about revoked EUAs is available on the web page Emergency Use Authorization--Archived Information. For revoked device EUAs, see: Historical Information about Device Emergency Use Authorizations.
In vitro diagnostic (test) EUAs
As of May 17, 2022, 433 tests and sample collection devices are authorized by FDA under EUAs. These include 300 molecular tests and sample collection devices, 83 antibody and other immune response tests, 49 antigen tests, and 1 diagnostic breath test. There are 78 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 17 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 EUAs for molecular OTC at-home tests. FDA has authorized 27 antigen tests and 7 molecular tests for serial screening programs. The FDA has also authorized 972 revisions to test EUA authorizations. Also see: Coronavirus Testing Basics
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 Events
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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.
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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.
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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.
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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.
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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.
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Information for industry and health care providers
Expiration date extension: Sotrovimab
FDA and the Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response (HHS/ASPR) issued a statement that the shelf-life of sotrovimab continues to be evaluated. Due to the high frequency of the omicron BA.2 variant, sotrovimab is not currently authorized in any U.S. region. However, it is recommended that product be retained in the event that future SARS-CoV-2 variants, which may be susceptible to sotrovimab, emerge and become prevalent in the United States.
All sotrovimab vials may be retained until the shelf-life extension evaluation is complete and posted, regardless of the current labeled expiry date or previously provided extension dates. This recommendation applies to all unopened vials of sotrovimab that have been held in accordance with storage conditions (refrigerated temperature at 2°C to 8°C (36°F to 46°F)) detailed in the authorized Fact Sheet for Health Care Providers (PDF) and the Letter of Authorization (PDF). Learn more: Expiration Dating Extension (May 12, 2022)
Reminder: FDA updates on Paxlovid for health care providers
In a CDER Conversation, Dr. John Farley, director of the Office of Infectious Diseases, provides useful information that can help health care providers in decision-making regarding Paxlovid. FDA also released a Paxlovid Patient Eligibility Screening Checklist (PDF), which includes an alphabetized list of other drugs with potentially significant drug interactions. (May 4, 2022)
FDA is committed to providing timely recommendations, regulatory information, guidance, and technical assistance necessary to support rapid COVID-19 response efforts. FDA has issued more than 75 COVID-19-related guidances to date.
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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.)
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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)
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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.
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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.
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