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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:
- May 10, 2022: FDA Roundup including approval of a new indication (PDF) for Olumiant (baricitinib) for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO)
- May 10: Do Not Use Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test: FDA Safety Communication
- May 9, 2022: Mesa Biotech, Inc., Recalls Certain Accula SARS-CoV-2 Tests for Risk of False Positives Caused by Contamination
- May 6, 2022: FDA Roundup including an update on an FDA project to sample and sequence SARS-CoV-2 RNA from wastewater
- May 5, 2022: FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals
- May 4, 2022: FDA Updates on Paxlovid for Health Care Providers, including a new eligibility screening checklist tool (PDF). Paxlovid is the preferred therapy for the management of non-hospitalized adults with COVID-19, according to the National Institutes of Health COVID-19 Treatment Guidelines.
Bookmark www.fda.gov/coronavirus for the latest.
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COVID-19 vaccine updates
FDA limits use of Janssen COVID-19 Vaccine to certain individuals
FDA has limited the authorized use of the Janssen COVID-19 Vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.
For more information, see the fact sheets for health care providers (PDF) and recipients and caregivers (PDF).
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COVID-19 treatment updates
FDA approves COVID-19 treatment for certain hospitalized adults
FDA approved a new indication (PDF) for Olumiant (baricitinib) for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Olumiant is the first immunomodulatory treatment for COVID-19 to receive FDA approval.
FDA first issued an Emergency Use Authorization (EUA) for Olumiant in combination with remdesivir to treat COVID-19 in hospitalized adults and pediatric patients on November 19, 2020. On July 28, 2021, the FDA revised the EUA to authorize Olumiant as a standalone treatment. Olumiant remains under EUA status for hospitalized pediatric patients 2 to less than 18 years of age requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.
FDA has revised the Letter of Authorization (PDF) and associated fact sheets to remove the population covered under the approved indication. Common side effects of Olumiant and the recommended dosage for the approved population are included in the prescribing information (PDF).
FDA continues to work with developers, researchers, manufacturers, and partners to help expedite the development and availability of therapeutic drugs and biological products to prevent or treat COVID-19 through its Coronavirus Treatment Acceleration Program. (May 10, 2022)
COVID-19 test updates
Safety communication: Do not use Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test
FDA is warning people to stop using the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold). This test is not authorized, cleared, or approved by the FDA for distribution or use in the United States. The FDA is concerned about the risk of false results when using this test because SML Distribution LLC has not provided the FDA with adequate data to show the test works correctly. (May 10, 2022)
Reminder: Expiration date extensions of COVID-19 at-home tests
Check the Expiration Date column of the List of Authorized At-Home OTC COVID-19 Diagnostic Tests to see if the expiration date for your at-home OTC COVID-19 test has been extended and how to find any new expiration date.
Regulatory science update
Wastewater surveillance from SARS-CoV-2 variants
Through the American Rescue Plan Act of 2021, Congress provided temporary funding for FDA to develop the capacity to sequence SARS-CoV-2 RNA from wastewater samples and to conduct a sampling and sequencing project through 2022. To facilitate sharing of information about progress on this sequencing effort, FDA published a public dashboard that graphically presents information from the project. Studies have shown that SARS-CoV-2 (COVID-19) variants of concern from wastewater can be identified 1-2 weeks prior to being detected in clinical samples from the same area, making wastewater surveillance useful for detecting and monitoring SARS-CoV-2 in the population. Raw sequence data plus a standard suite of metadata is available for download.
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Emergency Use Authorization (EUA) updates
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.
In vitro diagnostic (test) EUAs
As of May 10, 2022, 433 tests and sample collection devices are authorized by FDA under EUAs. These include 298 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 7 molecular tests for serial screening programs. The FDA has also authorized 968 revisions to test EUA authorizations. Also see: Coronavirus Testing Basics
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Events
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May 18, 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 June 1, June 15, and June 29, 2022.
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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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June 6-10, 2022: Regulatory Education for Industry (REdI) Annual Conference 2022 (virtual) - Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics, including a session on FDA’s COVID-19 response.
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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). 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
FDA updates on Paxlovid for health care providers
In a CDER Conversation, Dr. John Farley, director of the Office of Infectious Diseases, provides useful information that can help health care providers in decision-making regarding Paxlovid. FDA also released a Paxlovid Patient Eligibility Screening Checklist (PDF), which includes an alphabetized list of other drugs with potentially significant drug interactions.
FDA authorized (PDF) Paxlovid (nirmatrelvir and ritonavir) in December 2021 for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing who are also at high risk for progression to severe COVID-19, including hospitalization or death.
Paxlovid is now widely available in community pharmacies. The U.S. government maintains a locator tool for COVID-19 therapeutics that lists community pharmacies that have Paxlovid in stock. Although the number of COVID-19 hospitalizations has decreased dramatically since early 2022, some high-risk patients are still getting sick enough to require hospital admission, and early treatment with Paxlovid and other available authorized or approved therapeutics could make a difference. (May 4, 2022)
Mesa Biotech, Inc., recalls certain Accula SARS-CoV-2 tests for risk of false positives caused by contamination
Mesa Biotech is recalling the Accula SARS-CoV-2 Test because certain lots have an increased risk of giving false positive results due to contamination at the manufacturing facility. The Accula SARS-CoV-2 Test is a polymerase chain reaction (PCR) test intended to detect the presence of SARS-CoV-2, the virus that causes COVID-19, based on a nasal swab sample from patients. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death. (May 9, 2022)
Shelf life extension: banlanivimab
FDA authorized an extension to the shelf-life from 18 months to 24 months for specific lots of the refrigerated Eli Lilly monoclonal antibody, bamlanivimab. 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 Emergency Use Authorization 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 U.S. (May 4, 2022)
FDA updates final guidance on PMA and HDE supplements during COVID-19 pandemic
FDA updated the final guidance: Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. This updated version clarifies the examples of circumstances—including changes made to microchips or other associated circuitry and/or software changes—where the FDA currently believes a modification would generally not create an undue risk in light of the public health emergency, and that may be needed to address current manufacturing limitations or supply chain issues due to COVID-19 related disruptions. (May 4, 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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COVID-19 vaccine boosters: Getting the facts straight
In the latest episode of the FDA Health Equity Forum podcast, RADM Richardae Araojo and Dr. Robert Califf discuss COVID-19 vaccines and boosters misinformation. (14 minutes)
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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.
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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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