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Monkeypox response updates
FDA releases additional TPOXX (tecovirimat) virology information
FDA released additional information in publicly posted reviews supporting approval of the new drug application for tecovirimat to describe specific changes in the VP37 proteins of orthopoxviruses (e.g., vaccinia virus and monkeypox virus) that are associated with tecovirimat drug resistance.
FDA is releasing this information to aid the scientific community’s genomic sequencing efforts to support national surveillance of the current monkeypox virus outbreak in the U.S. We believe this additional information will further facilitate the ability to monitor for the development and spread of tecovirimat-resistant virus and therefore is important in promoting public health.
Additional information on FDA’s response to the public health emergency, including summary information on tecovirimat drug resistance, is available here. (September 12, 2022)
Also see from CDC: Guidance for Tecovirimat Use Under Expanded Access Investigational New Drug Protocol during 2022 U.S. Monkeypox Outbreak (September 15, 2022)
New webinar series: Monkeypox Test Development and Validation
FDA will host regular virtual town halls for monkeypox test developers, where the agency will share information and answer questions from attendees. Join us for the first webinar in this series today, September 21, 2022 (12:05 - 1:00 p.m. ET).
ICYMI
- The presentation recording, slides, and transcript for the September 14, 2022, Policy for Monkeypox Tests webinar is now available from CDRH Learn (under Specialty Technical Topics)
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Fast Facts on the Intradermal JYNNEOS Monkeypox Vaccine (PDF) is now available in Chinese (Simplified), Korean, Spanish, Tagalog, and Vietnamese (September 15, 2022)
- On September 14, 2022, FDA Commissioner Dr. Robert Califf testified before the U.S. Senate Committee on Health, Education, Labor & Pensions: Stopping the Spread of Monkeypox: Examining the Federal Response.
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Emergency Use Authorization (EUA) updates
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 September 20, 2022, 438 tests and sample collection devices are authorized by FDA under EUAs. These include 301 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 1,116 revisions to test EUAs. Also see: COVID-19 Test Basics
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Events
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New! September 21, 2022: Virtual Town Hall Series – Monkeypox Test Development and Validation (12:05 - 1:00 p.m. ET) - FDA will host regular virtual town halls for monkeypox test developers. During the virtual town halls, the FDA will share information and answer questions from attendees.
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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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September 27, 2022: FDA Drug Topics: Development and U.S. Regulation of Preventative Vaccines (webinar, 1:00 - 2:15 p.m. ET) - To provide an overview of the development and federal regulations for vaccines in the United States, including key statutes that grant FDA authority to regulate vaccines, precipitating historical events, and current regulatory requirements for vaccine licensure and marketing approval.
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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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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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New! December 6, 2022: Save the date for BAA Industry 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.
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Information for industry and health care providers
COVID-19 vaccines: Bivalent boosters
New: FDA posted to YouTube a recording (45 minutes) of a stakeholder call held on September 2, 2022, to discuss the updated COVID-19 boosters. FDA Commissioner Dr. Robert M. Califf and CBER Director Dr. Peter Marks answer questions from health care providers and other stakeholders.
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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
Focus Areas of Regulatory Science In September, FDA published the 2022 Focus Areas of Regulatory Science (FARS) report. Updates on FDA research include public health emergency preparedness and response, increasing choice and competition, unleashing the power of data, and much more.
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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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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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