MCMi News and Events
Medical countermeasure and public health emergency news and events from FDA and partners
Featured news and events
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Coronavirus Disease 2019 (COVID-19) updates from FDA, including the latest news, FAQs, and more
- FDA has posted the FY23 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science. For funding consideration in FY 2023, submit white papers by 5:00 p.m. EST, January 23, 2023. A recording of the FDA BAA Day held on December 6, 2022 is available, along with BAA Q&A.
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On January 26, 2023, FDA will hold a VRBPAC meeting to discuss future vaccination regimens addressing COVID-19
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January 6, 2023: FDA releases important information about risk of COVID-19 due to certain variants not neutralized by Evusheld (updated)
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January 4, 2023: MCMi email - FDA approves treatment for certain hospitalized adults with COVID-19
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December 21, 2022: HHS Increases Access to Tamiflu through the Strategic National Stockpile (from HHS)
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MCMi Fiscal Year 2021 Program Update - FDA and our partners work every day to help facilitate development of and access to safe, effective medical countermeasures to counter emerging threats. Learn more about the steps we're taking to protect national health and security in this report. View the PDF (1.4 MB).
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January 10, 2023: Pediatric disease modeling for long COVID - In an MCMi Regulatory Science program extramural research project, Children’s Hospital Los Angeles and partners are studying how early inflammatory and tissue responses can predict long-term health consequences of COVID-19 in children.
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January 6, 2023: FDA posted an update that the agency is closely monitoring the emergence of the XBB.1.5 subvariant, a SARS-CoV-2 omicron variant that is currently estimated to account for 27% of circulating variants in the U.S. Because of its similarity to variants that are not neutralized by Evusheld (e.g., XBB), FDA does not anticipate that Evusheld will neutralize XBB.1.5. This means that Evusheld may not provide protection against developing COVID-19 for individuals who have received Evusheld and are later exposed to XBB.1.5. However, we are awaiting additional data to verify that Evusheld is not active against XBB.1.5. We will provide further updates as new information becomes available.
Health care providers should inform individuals of the increased risk, compared to other variants, for COVID-19 due to SARS-CoV-2 variants not neutralized by Evusheld. If signs and symptoms of COVID-19 occur, advise individuals to test for COVID-19 and seek medical attention, including starting treatment for COVID-19 as appropriate.
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January 4, 2023: MCMi email - FDA approves treatment for certain hospitalized adults with COVID-19
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December 29, 2022: FDA updated the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to add the DxTerity SARS-CoV-2 RT PCR CE Test as a test expected to have reduced performance for the SARS-CoV-2 omicron variant and sub-variants.
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December 28, 2022: FDA approved a BLA (1.1 MB) for NexoBrid (anacaulase-bcdb) gel, submitted by MediWound, Ltd, Yavne, Israel. NexoBrid is indicated for eschar removal in adults with deep partial thickness and/or full thickness thermal burns.
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December 23, 2022: FDA issued an EUA (PDF, 399 KB) to Beckton, Dickinson and Company for the VIASURE Monkeypox virus Real Time PCR Reagents for BD MAX System for the qualitative detection of DNA from monkeypox virus in human lesion swab specimens from individuals suspected of mpox by their health care provider. Emergency use of this test is limited to authorized laboratories. Learn more: Monkeypox (mpox) Emergency Use Authorizations for Medical Devices
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December 22, 2022: FDA granted an extension (PDF, 204 KB) of the shelf life of the authorized Pfizer-BioNTech COVID-19 Vaccine. FDA is extending the expiration date of the Pfizer-BioNTech COVID-19 Vaccine PBS/Sucrose formulation (supplied in multiple dose vials with purple caps). Cartons and vials of Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with purple caps with an expiry date of December 2021 through December 2022 printed on the label may remain in use beyond the printed date until the updated expiry date shown here, as long as approved storage conditions noted in the updated fact sheet for health care providers (PDF, 1.3 MB) have been maintained.
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December 21, 2022: FDA approved a new indication for Actemra (tocilizumab) injection (PDF, 2.6 MB) for the treatment of hospitalized adult patients with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). FDA first issued an EUA for Actemra in hospitalized adult and pediatric patients (2 years of age and older) for the same use on June 24, 2021. Actemra remains authorized for emergency use for the same indication for hospitalized pediatric patients 2 to less than 18 years of age who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. FDA has revised the Letter of Authorization (PDF, 249 KB) and associated fact sheets to remove the population covered under the approved indication. Common side effects of Actemra and the recommended dosage for the approved population are included in the prescribing information (PDF, 2.6 MB). Also see: Revised FAQs on EUA for Actemra for Treatment of COVID-19 (PDF, 173 KB)
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December 21, 2022: HHS Increases Access to Tamiflu through the Strategic National Stockpile (from HHS) - HHS/ASPR announced that they are making additional supply of Tamiflu available to jurisdictions to respond to an increased demand for the antiviral during this flu season, including through the Strategic National Stockpile (SNS). Jurisdictions will work with their ASPR Regional Teams to evaluate any requests for Tamiflu through the SNS, ensuring that states, territories, and tribes receive the assistance they need without affecting our nation’s preparedness for a future pandemic flu. Also see from ASPR: Improving Access to Influenza Countermeasures for U.S. Jurisdictions, and from FDA: Expiration Dating Extension - Antivirals
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December 21, 2022: MCMi email - Vaccine advisory committee meeting on future of COVID-19 vaccines | Understanding at-home OTC COVID-19 antigen diagnostic test results
View more news in the MCMi News Archive
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Ongoing: Virtual Town Hall Series – Test Development and Validation During Public Health Emergencies (COVID-19 and mpox) - FDA will host regular town halls to share information and answer questions from attendees. Recordings of previous webinars on the policy for mpox tests are available from CDRH Learn, under Specialty Technical Topics. The next event in this series will be held on January 11, 2023.
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January 12, 2023: Virtual Public Listening Session to Identify Ambiguities, Gaps, and Uncertainties in the Coordinated Framework for the Regulation of Biotechnology (webinar, 1:00 p.m. ET) Also see: FDA and Federal Partners Issue Request for Information on the Regulation of Biotechnology
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January 26, 2023: Vaccines and Related Biological Products Advisory Committee meeting (webcast) - The committee will meet in open session to discuss the future vaccination regimens addressing COVID-19, including consideration of the composition and schedule of the primary series and booster vaccinations. Also see: FDA to Hold Advisory Committee Meeting to Discuss Future Vaccination Regimens Addressing COVID-19
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April 24-27, 2023: 2023 Preparedness Summit (Atlanta, GA) - 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. Registration is now open.
Previous events: MCMi Events Archive
General information
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COVID.gov - Find COVID-19 guidance for your community (a U.S. government website)
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COVID-19 Resources for Health Professionals (updated Oct. 2022)
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Why You Should Not Use Ivermectin to Treat or Prevent COVID-19
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COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders
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FAQs: What happens to EUAs when a public health emergency ends?
Vaccines
- Why should I get the updated COVID-19 vaccine now? (YouTube, Nov. 2022)
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COVID-19 Bivalent Vaccine Boosters (new, August 2022)
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COVID-19 Vaccine Boosters: Getting the Facts Straight (podcast, April 2022)
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FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses and new web page: Update: COVID-19 Vaccine Booster Composition (June 2022)
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Learn More About COVID-19 Vaccines (Consumer Update)
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5 Things You Need to Know about the COVID-19 Vaccine for Adolescents 12 through 17 (Consumer Update)
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The Path for a COVID-19 Vaccine from Research to Emergency Use Authorization (PDF, 723 KB)
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#VaccineReady Social Media Toolkit with resources in English and Spanish, from FDA's Office of Minority Health and Health Equity
Therapeutics
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An Update and Behind the Scenes: FDA’s Coronavirus Treatment Acceleration Program
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FDA Updates on Paxlovid for Health Care Providers (May 2022)
Testing
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Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results (new, Dec. 2022)
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A Closer Look at COVID-19 Diagnostic Testing (for health care providers, test purchasers, and public health staff)
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Screening for COVID-19: Deciding Which Test to Use When Establishing Testing Programs
Regulatory science
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FDA-ARGOS SARS-CoV-2 Reference Grade Sequence Data Now Available
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Investing in Advanced Manufacturing to Support Public Health Preparedness
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Extramural research, including projects supporting the COVID-19 response
- November 28, 2022: NIH is soliciting proposals for (a) the development of medical countermeasures (MCMs) against radiation injury or, (b) biodosimetry approaches targeting radiation-specific biomarker identification and/or device development to predict acute and/or delayed damage to specific organs and tissues beyond dose assessment through a new BAA announcement. Proposals are due by 3:00 p.m. EST February 27, 2023.
- November 9, 2022: Funding opportunity - Innovation Award: COVID-19 and Health Equity - FDA's Office of Minority Health and Health Equity (OMHHE) has posted a funding opportunity for to COVID-19 research that will strengthen and advance research in minority health and healthy equity, increase understanding of health disparities, and provide future direction for research that will contribute to regulatory decision making. OMHHE is interested in research proposals that will contribute to advancing understanding of COVID and long COVID or post-COVID conditions for racial and ethnic minorities or contribute to informing the continued evaluation of the safety and efficacy of FDA approved products (therapeutics, diagnostics, and vaccines) for the treatment, prevention, or diagnosis of COVID-19. These research proposals should support evaluation of outcomes by demographic data including, but not limited to, ethnicity, race, age, disability and geography. Letters of intent are due by December 6, 2022, and applications are due by January 16, 2023.
- October 6, 2022: FDA is seeking applications for Centers of Excellence in Regulatory Science and Innovation (CERSIs), to conduct collaborative regulatory science research and foster information sharing. Letters of intent are due by October 31, 2022, and applications are due by December 22, 2022.
- September 20, 2022: FDA announced a collaboration with NIH for funding opportunities to support small businesses in developing medical device development tools (MDDTs).
- September 8, 2022: NIH seeks the next generation of COVID-19 diagnostics - The National Institutes of Health has issued two new funding opportunities for diagnostic test manufacturers to develop the next generation of COVID-19 tests, with a major focus on accessibility. The funding opportunities are part of the Rapid Acceleration of Diagnostics (RADx) Tech program, managed by the National Institute of Biomedical Imaging and Bioengineering (NIBIB). The new programs may award up to $300 million in funds from the American Rescue Plan Act of 2021 to support the accelerated development of tests and provide regulatory guidance during the COVID-19 pandemic and beyond. More from NIH: RADx® Tech and ATP Programs
- September 7, 2022: The National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative established the Independent Test Assessment Program (ITAP) to accelerate regulatory review and availability of high-quality, accurate, and reliable over-the-counter COVID-19 tests to the public. ITAP is accepting new proposals on a rolling basis to address the diagnostic needs of the monkeypox outbreak. ITAP support will help accelerate the validation, regulatory authorization, and commercialization of point-of-care (POC) and home monkeypox virus tests. Proposals for POC and home tests that can directly detect the monkeypox virus and kits for at-home monkeypox virus self-collection are being accepted as of September 7, 2022. NIBIB will consider applications only from test manufacturers with existing technologies for monkeypox virus that can quickly scale production and meet FDA's performance/quality standards. More information is available on the submission portal.
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For more information
MCMi
- MCMi News Archive - MCMi news from 2010 to the present
- MCMi Events Archive - MCMi events from 2010 to the present
- Publications and Reports - including annual MCMi program updates
Emergency use
- Emergency Use Authorization (all current EUAs, including information about amendments)
- Expiration Dating Extension (including the Shelf Life Extension Program, and product-specific information)
- Emergency Use Authorizations (devices)
- MCM Emergency Use Authorities (information about, including EUA)
- Emergency Dispensing Orders and Emergency Use Instructions (EUI)
Guidance and industry information
- MCM-Related Guidance by Date (including comment deadlines, where applicable)
- Guidance and Other Information of Special Interest to MCM Stakeholders (by topic)
- Search for FDA Guidance Documents
Public health emergency response updates and MCM-related issues
- Antimicrobial resistance information from FDA
- Ebola Preparedness and Response
- FDA/DoD Collaborations
- Preparedness Information for Consumers
- More topic-specific pages, including Zika virus, radiological and nuclear emergency preparedness, smallpox preparedness, pediatric MCMs, and MCM monitoring and assessment
Product shortages and availability
- Drug Shortages
- CBER-Regulated Products: Shortages and Discontinuations (vaccines, blood, biologics)
- Drug Shortages Database
- How to report a product shortage or supply issue to FDA
More FDA news and events
- FDA Newsroom - press announcements, fast facts, speeches, and more
- FDA Voices - perspectives from FDA experts