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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:
- July 19, 2022: FDA Roundup including updates on the supplies of medical devices for COVID-19
- July 19, 2022: FDA updated the device shortage list and the device discontinuance list on the web page Medical Device Shortages During the COVID-19 Public Health Emergency, and provided information about devices that have been removed from the device shortage list
- July 19, 2022: FDA updated the Supplies of Medical Devices for COVID-19: Frequently Asked Questions web page to provide information about how FDA determines to remove product codes from the device shortage list and what FDA is doing to help medical device manufacturers with the global shortage of semiconductor chips
- July 15, 2022: For Monkeypox Testing, Use Lesion Swab Samples to Avoid False Results: FDA Safety Communication
- July 15, 2022: FDA Roundup including authorization of additional over-the-counter at-home COVID-19 antigen tests
- July 15, 2022: HHS orders additional vaccine, increases testing capacity to respond to monkeypox outbreak (HHS press release)
- July 13, 2022: FDA authorizes emergency use of Novavax COVID-19 Vaccine, Adjuvanted
Bookmark www.fda.gov/coronavirus for the latest.
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COVID-19 vaccine update
FDA authorizes emergency use of Novavax COVID-19 Vaccine, Adjuvanted
On July 13, 2022, FDA issued an EUA (PDF) for the Novavax COVID-19 Vaccine, Adjuvanted for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.
“Authorizing an additional COVID-19 vaccine expands the available vaccine options for the prevention of COVID-19, including the most severe outcomes that can occur such as hospitalization and death,” said FDA Commissioner Robert M. Califf, M.D. “Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization. COVID-19 vaccines remain the best preventive measure against severe disease caused by COVID-19 and I encourage anyone who is eligible for, but has not yet received a COVID-19 vaccine, to consider doing so.”
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Safety communication
For monkeypox testing, use lesion swab samples to avoid false results
FDA issued a safety communication advising people to use swab samples taken directly from a lesion (rash or growth) when testing for the monkeypox virus. The FDA is not aware of clinical data supporting the use of other sample types, such as blood or saliva, for monkeypox virus testing. Testing samples not taken from a lesion may lead to false test results. (July 15, 2022)
Join FDA's Medical Countermeasures Initiative (MCMi)
Job openings: Advanced manufacturing staff fellows
Apply to join the FDA Office of Counterterrorism and Emerging Threats (OCET) Advanced Manufacturing team, to help advance public health emergency preparedness and patient access to medical products through development of tools and approaches to enhance the evaluation of advanced manufacturing technologies and facilitate their adoption by regulated industries. Apply by August 1, 2022. For more information see the job announcements:
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Emergency Use Authorization (EUA) updates
In vitro diagnostic (test) EUAs
As of July 19, 2022, 441 tests and sample collection devices are authorized by FDA under EUAs. These include 304 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 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, 19 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 8 molecular tests for serial screening programs. The FDA has also authorized 1,032 revisions to test EUAs. Also see: COVID-19 Test Basics
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Events
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July 27, 2022: 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 host the next event in this series on August 24, 2022.
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August 11, 2022: 2022 FDA CVM Advanced Manufacturing Public Meeting, 1:00 - 4:00 p.m. EDT - CVM will host a virtual public meeting on the FDA’s oversight of advanced manufacturing technologies for animal drugs. The meeting will be a listening session to provide stakeholders with an opportunity to share information and insight on this topic with CVM. Learn more: FDA Announces Virtual Public Meeting on Advanced Manufacturing for Animal Drugs
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August 30, 2022: Virtual public workshop - Drug Development Considerations for the Prevention of Healthcare-Associated Infections - FDA and the Centers for Disease Control and Prevention (CDC) are co-sponsoring this workshop to discuss topics including the current state of development of pathogen-directed products used to prevent healthcare-associated infections, and antimicrobial resistance threats as potential targets for decolonization and pathogen reduction. To attend, register by 12:00 p.m. EDT August 29, 2022. Requests to make oral presentations must be received by August 15, 2022.
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September 21-22, 2022: 2022 Public Meeting of the National Antimicrobial Resistance Monitoring System (NARMS) (virtual) - FDA, in cooperation with the U.S. Centers for Disease Control and Prevention and the U.S. Department of Agriculture’s Food Safety and Inspection Service, its partners in the National Antimicrobial Resistance Monitoring System (NARMS), opened registration for the 2022 Public Meeting of NARMS. The meeting is open to all stakeholders at no cost.
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Information for industry and health care providers
American Contract Systems recalls COVID Test Kits Nonsterile and Clean Catch Urine Kits for risk of false results
American Contract Systems is recalling COVID Test Kit Nonsterile and Clean Catch Urine Kit products because they were assembled in an uncontrolled facility by people without proper training. As a result, the company is unable to verify that the kits will perform as expected. These kits have the potential to give false negative or false positive results or lead to misinterpretation of test results. (July 14, 2022)
SARS-CoV-2 viral mutations: Impact on COVID-19 tests
FDA updated the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to include information about genotyping tests authorized for the identification and differentiation of specific SARS-CoV-2 mutations, lineages, or variants. (July 14, 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 seeking consumer representatives
FDA is requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees as detailed in this notice, Submit your nomination materials by August 15, 2022.
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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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Schedule note: This newsletter will return on August 10, 2022. In the meantime, check out these other FDA newsletters and accounts for the latest.
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(Select Emergency Preparedness and Response,
FDA Medical Countermeasures Initiative (MCMi) News)
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