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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:
- June 14, 2022: FDA Roundup including an Emergency Use Authorization (EUA) for the Laboratory Corporation of America (Labcorp) VirSeq SARS-CoV-2 NGS Test (PDF) on the PacBio Sequel II sequencing system
- June 10, 2022: FDA Roundup including a COVID-19 testing update
Bookmark www.fda.gov/coronavirus for the latest.
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COVID-19 vaccine updates
VRBPAC meeting: June 14-15, 2022
Recording available: Day 1
Watch live: Day 2, 8:30 a.m. - 5:00 p.m.
The Vaccines and Related Biological Products Advisory Committee will meet virtually to discuss:
- Amending the EUA of the Moderna COVID-19 mRNA vaccine to include the administration of the primary series to children and adolescents 6 years through 17 years of age, and,
- Amending the EUA of the Moderna COVID-19 mRNA vaccine to include the administration of the primary series to infants and children 6 months through 5 years of age, and amending the EUA of the Pfizer-BioNTech COVID-19 mRNA vaccine to include the administration of the primary series to infants and children 6 months through 4 years of age.
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"Do I need to get a second booster dose of COVID-19 vaccine?"
Here’s Dr. Peter Marks with the answer: Just a Minute! video
COVID-19 test updates
FDA authorizes first COVID-19 test to identify specific SARS-CoV-2 lineages
FDA issued an EUA (PDF) for the Laboratory Corporation of America (Labcorp) VirSeq SARS-CoV-2 NGS Test on the PacBio Sequel II sequencing system. The SARS-CoV-2 virus has mutated over time resulting in genetic variation in circulating virus strains, also called lineages. The Labcorp VirSeq SARS-CoV-2 NGS Test is:
- The first COVID-19 test authorized for the identification and differentiation of SARS-CoV-2 Phylogenetic Assignment of Named Global Outbreak (PANGO) lineages.
- A next-generation sequencing (NGS) based test authorized for testing patient respiratory samples (such as anterior nasal or nasopharyngeal swab samples) identified as SARS-CoV-2 positive using Labcorp’s COVID-19 RT-PCR Test and Labcorp SARS-CoV-2 & Influenza A/B Assay.
- Intended to be used when a health care provider decides, based on a patient’s medical history and other diagnostic information, that the test results may help in deciding the appropriate clinical care for the patient.
The test can be performed at certain laboratories designated by Labcorp that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) that meet the requirements to perform high-complexity testing. Read more: Individual EUAs for Genotyping Tests for SARS-CoV-2 (June 10, 2022)
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Emergency Use Authorization (EUA) updates
EUA revocation
FDA revoked the EUA for this test, at the request of its sponsor, for the reasons noted in the revocation letter:
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 June 14, 2022, 437 tests and sample collection devices are authorized by FDA under EUAs. These include 302 molecular tests and sample collection devices, 85 antibody and other immune response tests, 49 antigen tests, and 1 diagnostic breath test. There are 80 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 8 molecular tests for serial screening programs. The FDA has also authorized 1,003 revisions to test EUAs. Also see: COVID-19 Test Basics
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 Events
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June 14-15, 2022: Vaccines and Related Biological Products Advisory Committee meeting (virtual, 8:30 a.m. - 5:00 p.m. both days) (more info above)
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June 15, 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 an additional event in this series on June 29, 2022.
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New! June 16, 2022: An Update on the Ongoing Federal Response to COVID-19: Current Status and Future Planning - FDA Commissioner Robert Califf, M.D. testifies at a hearing before the U.S. Senate Committee on Health, Education, Labor and Pensions.
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July 19-20, 2022: Office of Study Integrity and Surveillance (OSIS) Workshop 2022: CDER Inspections of Good Laboratory Practice, Animal Rule, and Bioavailability/Bioequivalence Study Sites
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June 28, 2022: Vaccines and Related Biological Products Advisory Committee meeting (virtual, 8:30 a.m. - 5:00 p.m. ET) - To discuss whether and how the SARS-CoV-2 strain composition of COVID-19 vaccines should be modified. Watch live.
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June 28, 2022: FDA Drug Topics: Drug Shortages: Root Causes and Potential Solutions webinar - This webinar will provide a general overview of CDER’s Drug Shortages program, current shortage issues, and challenges.
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July 11-13, 2022: Training Course: Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens (Omaha, Nebraska or virtual) - 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. Registration is now open for in-person and virtual attendance. Please pre-register by June 30, 2022.
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Information for industry and health care providers
COVID-19 frequently asked questions
Questions about COVID-19? Check out these FDA resources:
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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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List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 300 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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