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The latest from FDA
Public health emergency response and other updates from FDA since our last MCMi email include:
- May 9, 2023: FDA Roundup including marketing authorization of the first two COVID-19 serology tests through the de novo pathway
- May 5, 2023: FDA Roundup including a safety communication to warn consumers and health care providers to stop using and throw out certain lots of SD Biosensor, Inc. Pilot COVID-19 At-Home Tests (more below, under COVID-19 testing updates)
- May 5, 2023: New web page: Antimicrobial Resistance and Medical Devices
- May 4, 2023: FDA Commissioner Dr. Robert Califf and other HHS officials testified at a U.S. Senate Committee on Health, Education, Labor & Pensions hearing, Preparing for the Next Public Health Emergency: Reauthorizing the Pandemic and All-Hazards Preparedness Act
- May 3, 2023: FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine
Quick links: COVID-19 updates from FDA, FDA Mpox Response
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 COVID-19 resources
End of PHE updates for stakeholders and consumers
On May 11, 2023, the COVID-19 public health emergency (PHE) declared under the Public Health Service Act will expire. While the PHE is ending, people are still getting sick from COVID-19, and the virus remains a leading cause of death in the United States. CDC continues to advise that everyone get vaccinated, get an additional vaccine dose if your doctor advises it, use at-home tests if you’ve been exposed or have symptoms, stay home if you’re sick, and wear a high-quality mask when COVID-19 community levels are high. These precautions are the best ways you can protect yourself and your loved ones.
During this PHE, FDA has provided important tools and flexibilities to manufacturers, health care facilities, providers, patients, and other stakeholders. We remain committed to providing timely recommendations and regulatory information to support response efforts. The ending of the PHE declared by HHS under the PHS Act will not impact FDA’s ability to authorize devices (including tests), treatments, or vaccines for emergency use. Existing Emergency Use Authorizations (EUAs) for products will remain in effect and FDA may continue to issue new EUAs going forward when criteria for issuance are met.
FDA is committed to continuing to use every tool in our toolbox to fight COVID-19, including pivoting as the virus adapts. We’ll continue to post the latest updates at: http://www.fda.gov/covid19.
Stakeholder resources
Consumer resources
FDA approves first respiratory syncytial virus (RSV) vaccine
Arexvy approved for individuals 60 years of age and older
FDA approved Arexvy, the first respiratory syncytial virus (RSV) vaccine approved for use in the United States. Arexvy is approved for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older.
RSV is a highly contagious virus that causes infections of the lungs and breathing passages in individuals of all age groups. RSV circulation is seasonal, typically starting during the fall and peaking in the winter. In older adults, RSV is a common cause of lower respiratory tract disease, which affects the lungs and can cause life-threatening pneumonia and bronchiolitis (swelling of the small airway passages in the lungs).
According to the U.S. Centers for Disease Control and Prevention (CDC), each year in the U.S., RSV leads to approximately 60,000-120,000 hospitalizations and 6,000-10,000 deaths among adults 65 years of age and older. (May 3, 2023)
COVID-19 testing updates
Do Not Use Certain SD Biosensor Pilot COVID-19 At-Home Tests: FDA Safety Communication
FDA is warning consumers and health care providers to stop using and throw out certain lots of recalled SD Biosensor, Inc. Pilot COVID-19 At-Home Tests, distributed by Roche Diagnostics. The FDA has significant concerns of bacterial contamination in the Pilot COVID-19 At-Home Test liquid solution, provided in the test kit. Direct contact with the contaminated liquid solution may pose safety concerns and the bacterial contamination could impact the performance of the test.
SD Biosensor, Inc. has initiated a recall for all impacted SD Biosensor Pilot COVID-19 At-Home Tests that were distributed by Roche Diagnostics to certain retailers in the United States. Approximately 500,000 tests were distributed to CVS Health, as well as about 16,000 tests to Amazon. The FDA is working with Roche Diagnostics to understand how many of those tests were sold to consumers.
Importantly, none of the impacted lots were distributed through COVID.gov/tests - Free at-home COVID-19 tests or as part of other federal testing programs. If you received your tests through the COVID.gov/tests distribution or as part of other federal testing programs, they are not subject to this safety communication or product recall. (May 4, 2023)
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FDA permits marketing of first COVID-19 serology tests through de novo pathway
FDA granted marketing authorization of the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack for use with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack for use with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total, both manufactured by Ortho-Clinical Diagnostics, Inc.
These tests are intended for prescription use only for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma samples collected on or after 15 days post-symptom onset as an aid in identifying individuals who have an adaptive immune response to SARS-CoV-2 from either a recent or prior infection.
Serology tests detect the presence of antibodies to SARS-CoV-2 and do not detect the virus itself. This is one reason that serology tests should not be used to diagnose or exclude acute COVID-19 infection. The sensitivity of the tests in early infection is unknown. Negative results do not mean that the tested individual is free from an acute SARS-CoV-2 infection. If acute infection is suspected, diagnostic testing, such as a PCR or antigen test for COVID-19, is necessary. Learn more about de novo classification (May 5, 2023)
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Emergency Use Authorization (EUA) updates
COVID-19 in vitro diagnostic (test) EUAs
As of May 9, 2023, 449 tests and sample collection devices are authorized by FDA under EUAs. These include 302 molecular tests and sample collection devices, 83 antibody and other immune response tests, 63 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, 30 EUAs for antigen over-the-counter (OTC) at-home tests, and 4 EUAs for molecular OTC at-home tests. FDA has authorized 48 antigen tests and 7 molecular tests for serial screening programs. FDA has also authorized 1,362 revisions to diagnostic EUA authorizations. Also see: COVID-19 Test Basics
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Events
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New! May 11, 2023: FDA Commissioner Dr. Robert Califf and other HHS officials will testify at a U.S. House Energy & Commerce Health Subcommittee hearing, Preparing for and Responding to Future Public Health Security Threats (10:00 a.m. ET)
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May 11-12, 2023: Fiscal Year 2023 Generic Drug Science and Research Initiatives Public Workshop (Silver Spring, MD or virtual)
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May 18, 2023: Vaccines and Related Biological Products Advisory Committee meeting (virtual)
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June 5-9, 2023: Regulatory Education for Industry (REdI) Annual Conference 2023 (virtual)
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June 8, 2023: Advancing the Utilization and Supporting the Implementation of Innovative Manufacturing Approaches (Washington, DC or virtual)
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New! June 8, 2023: Antimicrobial Drugs Advisory Committee meeting (virtual) - The committee will meet in open session to discuss biologics license application (BLA) 761328, for nirsevimab, a long-acting respiratory syncytial virus (RSV) F protein inhibitor monoclonal antibody for intramuscular use, submitted by AstraZeneca AB. The proposed indication is prevention of RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
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New! June 15, 2023: Vaccines and Related Biological Products Advisory Committee meeting (virtual) - The committee will meet in open session to discuss and make recommendations on the selection of strain(s) to be included in the periodic updated COVID-19 vaccines for the 2023-2024 vaccination campaign.
Learn more about these events, and see more on the MCMi News and Events page, under Upcoming events.
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Information for industry and health care providers
Shelf life extension reminder: COVID-19 therapeutics
For a searchable and downloadable table listing the original expiration dates and, if applicable, extended expiration dates for the following COVID-19 therapeutic products: bamlanivimab, bebtelovimab, etesevimab, Evusheld, Lagevrio (molnupiravir), REGEN-COV, and sotrovimab, see from HHS/ASPR: COVID-19 Therapeutic Product Expiration Dates. Paxlovid (nirmatrelvir co-packaged with ritonavir) expiry data is available from the manufacturer's website. For more information about shelf life extension, see Expiration Dating Extension. For more information about COVID-19 therapeutics, see Coronavirus (COVID-19) Drugs.
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In March 2023, FDA issued a notice addressing the agency’s COVID-19-related guidance documents, including which of those guidance documents will no longer be in effect after the expiration of the COVID-19 public health emergency (PHE) declared under the Public Health Service (PHS) Act, and which of those guidance documents FDA is revising to temporarily continue in effect. Learn more
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In case you missed it
Update your antibodies
The virus that causes COVID-19 changes over time. Get your updated COVID-19 vaccine to help protect against COVID’s worst outcomes. Search in your zip code to find a location where a bivalent COVID-19 vaccine is available near you.
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List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 400 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and learn more about safely using hand sanitizer.
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FDA Medical Countermeasures Initiative (MCMi) News)
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