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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:
Bookmark www.fda.gov/coronavirus for the latest.
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COVID-19 treatment updates
FDA approves first COVID-19 treatment for young children
On April 25, 2022, FDA expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds) with positive results of direct SARS-CoV-2 viral testing, who are:
- Hospitalized, or
- Not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.
This action makes Veklury the first approved COVID-19 treatment for children less than 12 years of age. As a result of today’s approval action, the agency also revoked the Emergency Use Authorization (EUA) for Veklury that previously covered this pediatric population.
Before now, Veklury was only approved to treat certain adults and pediatric patients (12 years of age and older who weigh at least 40 kilograms, which is about 88 pounds) with COVID-19.
COVID-19 test updates
FDA authorizes first COVID-19 diagnostic test using breath samples
FDA issued an EUA (PDF) for the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection. The test can be performed in environments where the patient specimen is both collected and analyzed, such as doctor’s offices, hospitals and mobile testing sites, using an instrument about the size of a piece of carry-on luggage.
The test is performed by a qualified, trained operator under the supervision of a health care provider licensed or authorized by state law to prescribe tests and can provide results in less than three minutes.
Also see the new web page: In Vitro Diagnostics - Novel Diagnostic Tests for SARS-CoV-2. (April 14, 2022)
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Emergency Use Authorization (EUA) updates
Paxlovid EUA update
On April 14, 2022, FDA reissued the EUA for Paxlovid (PDF) to authorize an additional dose pack presentation of Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) with appropriate dosing for patients within the scope of this authorization with moderate renal impairment. Corresponding revisions were incorporated into the “How Supplied” section of the Fact Sheet for Healthcare Providers (PDF).
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.
ICYMI: 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.
In vitro diagnostic (test) EUAs
As of April 26, 2022, 431 tests and sample collection devices are authorized by FDA under EUAs. These include 296 molecular tests and sample collection devices, 84 antibody and other immune response tests, 50 antigen tests, and 1 diagnostic breath test. There are 77 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 945 revisions to test EUA authorizations. Also see: Coronavirus Testing Basics
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Events
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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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May 4, 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 May 18, June 1, June 15, and June 29, 2022. Please note new time.
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New! 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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New! 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). The RSCP aims to build upon a foundation of strong partnerships to improve supply chain resiliency through proactive communication, collaboration, and engagement with patient advocates, health care providers, distributors, group purchasing organizations, manufacturers, as well as key component and material suppliers. To participate in breakout sessions, register by May 17, 2022. To attend, register by June 6, 2022.
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Information for industry and health care providers
Shelf life extension of bamlanivimab and etesivimab: Recommendation to retain all vials
On December 21, 2021, FDA and ASPR announced the authorization of an extension to the shelf-life from 12 months to 18 months for specific lots of the refrigerated Eli Lilly monoclonal antibodies, bamlanivimab and etesevimab. Due to the high frequency of the omicron variant, bamlanivimab and etesevimab are not currently authorized in any U.S. region. Therefore, these drugs may not be administered for treatment or post-exposure prevention of COVID-19 under the EUA until further notice by the Agency. However, it is the recommendation of the U.S. Government that product be retained in the event that future SARS-CoV-2 variants, which may be susceptible to bamlanivimab and etesevimab, emerge and become prevalent in the United States. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF) and the Letter of Authorization for EUA 094 (PDF).
Evaluation of future extension of shelf-life for bamlanivimab and etesevimab is ongoing and an update regarding shelf-life extension for bamlanivimab and/or etesevimab is planned for early May 2022. Therefore, in the interim, all bamlanivimab and etesevimab 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.(April 13, 2022)
Final guidance on nanomaterials
FDA announced availability of the final guidance for industry: Drug Products, Including Biological Products, that Contain Nanomaterials. This guidance provides industry with the agency's current thinking for the development of human drugs, including biologics, in which a nanomaterial is present in the finished dosage form. This guidance finalizes the draft guidance of the same name issued on December 18, 2017. (April 21, 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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FDA Medical Countermeasures Initiative (MCMi) News)
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