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COVID-19 therapeutics updates
Latest information and updates about Evusheld for PrEP for COVID-19
FDA added important information to the authorized Fact Sheets for Evusheld (tixagevimab co-packaged with cilgavimab) to inform health care providers and individuals receiving Evusheld of the increased risk for developing COVID-19 when exposed to variants of SARS-CoV-2 that are not neutralized by Evusheld. Detailed neutralization data can be found in the revised authorized Fact Sheet for Health Care Providers (PDF). Health care professionals should inform patients of this risk and advise patients who develop signs or symptoms of COVID-19 to test for SARS-CoV-2 infection and promptly seek medical attention, including starting treatment for COVID-19, as appropriate if they test positive.
Evusheld is currently the only option for pre-exposure prophylaxis (PrEP) of COVID-19 and is authorized under Emergency Use Authorization (EUA) for use in immunocompromised individuals who may not mount an adequate response to COVID-19 vaccination, and for individuals for whom COVID-19 vaccination is not recommended due to a history of a severe adverse reaction. It is authorized to be administered every six months. Use of Evusheld is not a substitute for COVID-19 vaccination, and individuals for whom COVID-19 vaccination is recommended should get vaccinated. Individuals who received Evusheld but who develop COVID-19 remain eligible for use of any of the available treatments for COVID-19 if the criteria for use are met.
FDA continues to recommend Evusheld as an appropriate option for PrEP to prevent COVID-19, in combination with other preventative measures like getting vaccinated and boosted as recommended, as Evusheld still offers protection against many of the currently circulating variants and may offer protection against future variants. (October 3, 2022)
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Emergency Use Authorization (EUA) updates
Reminder: COVID-19 test policy update
Developers encouraged to seek traditional premarket review for most test types
FDA announced updates to its COVID-19 test policy, encouraging most COVID-19 test developers to pursue a traditional premarket review pathway for their tests, rather than EUA. See: Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)
Reminder: Monkeypox test EUA templates
FDA is providing voluntary templates that test developers may use when validating a test or when submitting an EUA request. Also see: Policy for Monkeypox Tests to Address the Public Health Emergency and FAQs on Testing for Monkeypox
In vitro diagnostic (test) EUAs
As of October 4, 2022, 437 tests and sample collection devices are authorized by FDA under EUAs. These include 300 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 antigen tests, and 1 diagnostic breath test. There are 79 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 31 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1,125 revisions to test EUAs. Also see: COVID-19 Test Basics
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Events
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October 5, 2022: Virtual Town Hall Series - Test Development and Validation During Public Health Emergencies (COVID-19 and Monkeypox) (12:05 - 1:00 p.m. ET) - No registration required. There will be an opportunity to ask questions live on the call, and questions may also be submitted in advance by emailing CDRHWebinars@fda.hhs.gov. The town hall scheduled for October 12, 2022, will be on the topic of monkeypox only.
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October 5, 2022: Study Data Standards Update for CBER: Your Guide to a Successful Submission (webcast, 1:00 - 2:00 p.m. ET) - CBER will discuss CBER’s support and requirement starting March 15, 2023 for the Standard for the Exchange of Nonclinical Data (SEND), which was published in the Federal Register on July 14, 2020, and the addition of SEND for CBER to the FDA Data Standards Catalog.
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October 6, 2022: Vaccines and Related Biological Products Advisory Committee meeting (virtual, 8:30 a.m. - 12:40 p.m. ET) - The committee will meet in open session to discuss strain selection for influenza virus vaccines for the 2023 Southern Hemisphere influenza season.
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October 11, 2022: FDA NanoDay Symposium 2022 (webinar) - To address drug development of products that contain nanomaterials in their formulation and how the guidance to industry for products that contain nanomaterials finalized in April 2022 can be implemented in filings to the FDA. Discussion will include case studies on the development of the COVID mRNA lipid nanoparticle vaccine products.
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New! October 13, 2022: FDA Grand Rounds - Quality Considerations for the Multi-Attribute Method (MAM) for Therapeutic Proteins (webcast, 12:00 - 1:00 p.m. ET) - MAM is a liquid chromatography-mass spectrometry based peptide mapping approach used for the identification and quantitation of product quality attributes in therapeutic proteins.
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October 20, 2022: COVID-19 Evidence Accelerator: What We've Learned, Where We're Headed (webinar, 1:00 p.m. ET) - A public meeting hosted by the Reagan-Udall Foundation for the FDA and Friends of Cancer Research, to highlight accomplishments and share learnings, including how best to leverage real-world data and improve data interoperability, to address current and future health challenges.
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December 6, 2022: Save the date for FDA Broad Agency Announcement Day (webinar) to learn more about how FDA funds research, the types of projects we’re looking for to support regulatory science and innovation, and how you can apply.
Call for abstracts: 2023 Preparedness Summit
The Preparedness Summit, the country’s first and longest running national conference on public health preparedness, is now accepting abstracts. The theme, Recover. Renew: Reprioritizing All-Hazards Preparedness, will provide an opportunity to revisit pressing issues in preparedness and share resources, shape policies, and build skills to mitigate a variety of threats. The event will be held April 24-27, 2023 in Atlanta, GA. Submit abstracts by October 24, 2022.
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Information for industry and health care providers
COVID-19 vaccines: Updated wall charts
Reminder: Check the FDA Moderna COVID-19 Vaccines and Pfizer-BioNTech COVID-19 Vaccines pages for updated information, including printable wall charts updated to include the bivalent booster presentations:
FDA launches biosimilar regulatory science program
As outlined in the biosimilar user fee act (BsUFA) reauthorization commitment letter (PDF) for fiscal years 2023-2027 (BsUFA III), FDA will pilot a regulatory science program to further advance biosimilar and interchangeable biological product development. The program will focus on enhancing regulatory decision-making and facilitating science-based recommendations in areas foundational to biosimilar and interchangeable product development. (October 4, 2022)
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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
Update your antibodies
The virus that causes COVID-19 changes over time. Keep your protection against COVID-19 up to date by getting a bivalent COVID-19 vaccine booster dose. Search in your zip code to find a location where a bivalent COVID-19 vaccine booster dose 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 350 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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