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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:
- April 12, 2022: FDA Roundup including a warning letter to a company for selling an unapproved product with misleading COVID-19 claims
- April 8, 2022: FDA Roundup including an extension of the shelf life of the refrigerated Janssen COVID-19 Vaccine, allowing the product to be stored at 2-8 degrees Celsius for 11 months
Bookmark www.fda.gov/coronavirus for the latest.
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COVID-19 test updates
FDA authorizes more OTC antigen tests based on data from NIH program
FDA authorized two more over-the-counter (OTC) at-home COVID-19 antigen tests, where validation data were gathered through the FDA’s collaboration with the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP). The Emergency Use Authorizations (EUAs) issued to Osang LLC for their OHC COVID-19 Antigen Self Test (PDF) and Xiamen Boson Biotech Co., Ltd for their Rapid SARS-CoV-2 Antigen Test Card (PDF) are examples of the FDA’s ongoing commitment to help increase the availability of appropriately accurate and reliable at-home COVID-19 diagnostic tests, and to facilitate access to these tests for all Americans. These tests:
- Are OTC at-home COVID-19 antigen diagnostic tests that show results in 15 minutes.
- Can be used as a serial test for people with or without symptoms, meaning the test is done two times over three days, with at least 24 hours and no more than 48 hours between tests.
Can be used for people:
- Age 14 years or older with a self-collected nasal swab sample.
- Age 2 years or older when an adult collects the nasal swab sample.
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Emergency Use Authorization (EUA) updates
ICYMI: New FAQs: 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. FDA also added the following frequently asked question to the FAQs on Testing for SARS-CoV-2: What will happen with tests offered under EUA if the public health emergency expires and is not renewed? (April 6, 2022)
In vitro diagnostic (test) EUAs
As of April 12, 2022, 427 tests and sample collection devices are authorized by FDA under EUAs. These include 293 molecular tests and sample collection devices, 84 antibody and other immune response tests, and 50 antigen tests. There are 74 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 28 antigen tests and 9 molecular tests for serial screening programs. The FDA has also authorized 925 revisions to test EUA authorizations. Also see: Coronavirus Testing Basics
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 Events
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April 20, 2021: 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 hold additional events in this series on May 4, May 18, June 1, June 15, and June 29, 2022.
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April 25-29, 2022: Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories - Registration deadline extended! Apply by April 15, 2022 to attend this free course in-person (Bethesda and Frederick, MD), or virtually.
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New! April 28-29, 2022: 2022 Sentinel Innovation Day and Public Training (virtual) - The Sentinel System is a national electronic system for medical product safety surveillance.
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Information for industry and health care providers
Janssen COVID-19 Vaccine shelf life extension
FDA authorized an extension (PDF) for the shelf life of the refrigerated Janssen COVID-19 Vaccine, allowing the product to be stored at 2-8 degrees Celsius for 11 months. The vaccine was previously authorized to be stored for up to 9 months. This shelf life extension applies to all batches that have been released to the U.S. market, and that have been held in accordance with the manufacturer’s storage conditions. Health care providers administering the vaccine should check the company’s website (https://vaxcheck.jnj) to obtain the most up-to-date expiration dates for specific lots of the Janssen COVID-19 vaccine. (April 7, 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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FDA COVID-19 response infographic
View a snapshot of some FDA COVID-19 response actions from the beginning of the public health emergency through the end of FY 2021. A downloadable PDF and text version of this infographic are available.
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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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Schedule note: We're taking a short break next week. This newsletter will return on April 27.
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(Select Emergency Preparedness and Response,
FDA Medical Countermeasures Initiative (MCMi) News)
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