Check your COVID-19 test expiration dates | Monkeypox response updates from FDA

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The latest from FDA

Public health emergency response and other updates from FDA since our last MCMi email include: August 23, 2022: FDA Roundup including an upcoming workshop to solicit feedback from key stakeholders on a Risk Evaluation and Mitigation Strategies (REMS) integration prototype August 22, 2022: Monkeypox response: Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Additional Safety Protections Pertaining to Monkeypox Virus August 19, 2022: FDA Roundup including authorization of Novavax COVID-19 Vaccine, Adjuvanted for the prevention of COVID-19 in individuals 12 through 17 years of age August 18, 2022: Intradermal Jynneos Monkeypox Vaccine Fast Facts (PDF)  August 18, 2022: Monkeypox response: FDA Fast Facts: Jynneos (PDF) is now also available in Chinese (Simplified), Korean, Spanish, Tagalog, and Vietnamese. August 18, 2022: Report: FDA's Work to Combat the COVID-19 Pandemic (PDF)  August 17, 2022: National Center for Toxicological Research (NCTR) Research Highlight: Monitoring SARS-CoV-2 and Its Variants in Arkansas Wastewater August 16, 2022: Monkeypox response: FDA granted an EUA amendment (PDF) for changes to preparation and storage instructions for the Jynneos vaccine Emergency Use Authorization (more info below, under Information for industry and health care providers) Quick links: COVID-19 updates from FDA, FDA Monkeypox Response

Monkeypox response updates

Resources in additional languages New! FDA Fast Facts: Jynneos (PDF) is now also available in Chinese (Simplified), Korean, Spanish, Tagalog, and Vietnamese. Reminders: The Fact Sheet for Recipients and Caregivers about Jynneos (Smallpox and Monkeypox Vaccine, Live, Non-Replicating) is also available in multiple languages. Currently, there is no FDA-approved or authorized medicine for the treatment of monkeypox disease; however, TPOXX (tecovirimat), an antiviral medication, is being made available through the CDC under an FDA authority called Expanded Access, or “compassionate use.” FDA Fast Facts: TPOXX (PDF) is now available in Chinese (Simplified), Korean, Spanish, Tagalog, and Vietnamese.

Intradermal Jynneos Monkeypox Vaccine 

• Making vaccine available to all at risk for monkeypox infection is a top USG priority.
• Jynneos can be safely given by either the subcutaneous or the intradermal route.
• The immune responses are similar using the two different routes of administration.
• Intradermal administration allows the broadest protection of the community right now.

Also see: Key Facts About Vaccines to Prevent Monkeypox Disease (updated August 18, 2022)

COVID-19 vaccine updates

Novavax COVID-19 Vaccine now authorized for 12-17-year-olds FDA authorized the emergency use (PDF) of Novavax COVID-19 Vaccine, Adjuvanted for the prevention of Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 through 17 years of age. This authorization follows a rigorous analysis and evaluation of the safety and effectiveness data conducted by the FDA. The agency previously authorized the vaccine for individuals 18 years and older.  Also see the updated fact sheets for recipients/caregivers and health care providers (PDFs). (August 19, 2022)

FDA's work to combat the COVID-19 pandemic  This new report (PDF) outlines much of the broad range of work the FDA is undertaking to combat the COVID-19 pandemic and prepare for future emergencies. (August 18, 2022)

COVID-19 testing update

Check expiration dates before you throw tests away

Lucira Health, Inc. CHECK-IT COVID-19 Test Kits (PDF) and OraSure Technologies, Inc. InteliSwab COVID-19 Rapid Tests (PDF) that are FDA authorized under EUA now have a longer shelf-life than previously authorized. The expiration dates for these tests have been extended to reflect the longer shelf-life. The extension is based on additional data provided by the manufacturer showing how long the test can be used with the same expected accuracy. (August 19, 2022) Check whether your Lucira Health, Inc. CHECK-IT COVID-19 Test Kit, OraSure Technologies, Inc. InteliSwab COVID-19 Rapid Test, or another test that you have has a new expiration date.

Funding opportunity announcement

Academic development of a training program for Good Laboratory Practices in high-containment environments

FDA seeks to continue a robust, collaborative, and educational program using problem-based learning techniques designed to bring researchers and regulators together to educate each other on the challenges related to these issues and to identify solutions that are acceptable from both scientific and regulatory perspectives. This program consists of the continued development and implementation of a certified, academic training course for instruction in Good Laboratory Practices (GLP) in a biosafety level (BSL) 4 high-containment environment. Applications are due by 11:59 p.m. ET, October 3, 2022.

Emergency Use Authorization (EUA) updates

In vitro diagnostic (test) EUAs As of August 23, 2022, 439 tests and sample collection devices are authorized by FDA under EUAs. These include 302 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 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, 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 1,091 revisions to test EUAs. Also see: COVID-19 Test Basics

Events

• August 24, 2022: 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). 
• August 30, 2022: Virtual public workshop - Drug Development Considerations for the Prevention of Healthcare-Associated Infections - FDA and the Centers for Disease Control and Prevention (CDC) are co-sponsoring this workshop to discuss topics including the current state of development of pathogen-directed products used to prevent healthcare-associated infections, and antimicrobial resistance threats as potential targets for decolonization and pathogen reduction. To attend, register by 12:00 p.m. EDT August 29, 2022. 
• September 12-13, 2022: DIA-USFDA-PMDA-TGA-CDSCO Advanced Manufacturing Workshop (virtual, 5:30 - 9:30 a.m. EDT) - Embracing The Future: Regulatory Considerations And Industry Perspectives On Advanced Manufacturing - FDA's India Office and the Drug Information Association (DIA) India Office will host a two-day workshop on regulatory policies, guidance and support for the adoption of advanced manufacturing technologies.
• New! September 14, 2022: An Overview of Sentinel’s Publicly Available Analytics Tools webinar (12:00 p.m. ET) - This webinar will explore the resources available in Sentinel for individuals unfamiliar with Sentinel’s analytics tools and the Sentinel Common Data Model. Please register in advance.
• September 19, 2022: FDA Workshop: Increasing the Efficiency of Biosimilar Development Programs (virtual) - The workshop will focus on comparative clinical studies associated with biosimilar development programs and will discuss possible innovative ideas that have the potential to streamline and improve the efficiency of biosimilar development. Advance registration required.
• New! September 20-22, 2022: 2022 Center for Biologics Evaluation and Research (CBER) Science Symposium (12:00 - 4:00 p.m. ET, virtual) - To discuss scientific topics related to the regulation of biologics and highlight science conducted at CBER by showcasing how scientific research informs regulatory decision making, and to provide a forum for developing collaborations within FDA and with external organizations. Advance registration required.
• 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.
• New! 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.

Monkeypox response: Information for industry and health care providers

Jynneos vaccine EUA fact sheet and storage updates

FDA granted an EUA amendment (PDF) for changes to preparation and storage instructions on the Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization of Jynneos (Smallpox and Monkeypox Vaccine, Live, Non-Replicating) for Prevention of Monkeypox Disease in Individuals Determined to be at High Risk for Monkeypox Infection (PDF). Once thawed, the vaccine may be kept at +2°C to +8°C (+36°F to +46°F) for 8 weeks. To get the most 0.1 mL doses for intradermal use from each vial make sure to use low dead volume needles and syringes. (August 16, 2022)

Safety alert regarding use of fecal microbiota for transplantation and additional safety protections pertaining to monkeypox virus 

FDA is informing health care providers and patients of the potential risk of transmission of monkeypox virus through fecal microbiota for transplantation (FMT) products and that FDA has determined that additional safety protections are needed. (August 22, 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.

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.)

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.

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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FDA Medical Countermeasures Initiative (MCMi) News)