MCMi News and Events
Medical countermeasure and public health emergency news and events from FDA and partners
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Featured news and events
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Coronavirus Disease 2019 (COVID-19) updates from FDA, including the latest news, FAQs, and more
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December 3, 2021: Update: SARS-CoV-2 Omicron Variant: Impact on COVID-19 Tests
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December 3, 2021: FDA Expands Authorization of Two Monoclonal Antibodies for Treatment and Post-Exposure Prevention of COVID-19 to Younger Pediatric Patients, Including Newborns
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December 1, 2021: MCMi email - FDA actively working to investigate, address potential impacts of omicron variant
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November 30, 2021: FDA Actively Working to Investigate, Address Potential Impacts of Omicron Variant; Urges Vaccination and Boosters
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MCMi Fiscal Year 2020 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 (4.3 MB).
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December 3, 2021: FDA updated the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to add new information about SARS-CoV-2 tests whose performance could be impacted by SARS-CoV-2 genetic mutations, specifically those found in the omicron variant, in patient samples. This includes certain tests where viral mutations cause a specific detection pattern that may help to signal the presence of the omicron variant, but genetic sequencing would be needed to confirm. Since these tests are designed to detect multiple genetic targets, it is expected these tests will continue to detect SARS-CoV-2 including when the omicron variant is present
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December 3, 2021: FDA Expands Authorization of Two Monoclonal Antibodies for Treatment and Post-Exposure Prevention of COVID-19 to Younger Pediatric Patients, Including Newborns - FDA revised the EUA (PDF, 488 KB) of bamlanivimab and etesevimab (previously authorized for pediatric patients 12 years of age and older weighing at least 40 kilograms, or about 88 pounds), to additionally authorize bamlanivimab and etesivimab administered together for the treatment of mild to moderate COVID-19 in all younger pediatric patients, including newborns, who have a positive COVID-19 test and are at high risk for progression to severe COVID-19, including hospitalization or death. This revision also authorizes bamlanivimab and etesevimab, to be administered together, for post-exposure prophylaxis for prevention of COVID-19 in all pediatric patients, including newborns, at high risk of progression to severe COVID-19, including hospitalization or death. Also see: Frequently Asked Questions on the Emergency Use Authorization for Bamlanivimab and Etesevimab (PDF, 328 KB)
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December 1, 2021: MCMi email - FDA actively working to investigate, address potential impacts of omicron variant
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November 30, 2021: FDA Actively Working to Investigate, Address Potential Impacts of Omicron Variant; Urges Vaccination and Boosters - As we have with previous emerging COVID-19 variants, FDA is actively working with our federal partners, international regulators and medical product companies to quickly address any potential impacts of the new omicron variant on the tools to fight the pandemic. The agency is working as quickly as possible to evaluate the potential impact of this variant on the currently available diagnostics, therapeutics and vaccines. We are closely monitoring the situation and are committed to communicating with the public as we learn more. Getting vaccinated or receiving a booster with one of the currently available vaccines is the best thing that you can do right now (in addition to standard precautions like masking) to help protect yourself, your family and friends.
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November 24, 2021: In a new project funded by FDA's Medical Countermeasures Initiative, Embleema and George Washington University will conduct bioinformatic research and system development to expand the FDA-ARGOS database. FDA-ARGOS contains curated, quality-controlled genomic sequence data to support research and regulatory decisions. For example, researchers can use FDA-ARGOS along with bioinformatics tools to validate the performance, sensitivity, and specificity of diagnostic tests with computer modeling. Building on expansions during the COVID-19 pandemic, this project aims to further improve the utility of the FDA-ARGOS database as a key tool for medical countermeasure development and validation.
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November 23, 2021: MCMi email - FDA expands eligibility for COVID-19 vaccine boosters to individuals 18 and older after completion of primary vaccination | Regulatory science funding available
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November 19, 2021: FDA Expands Eligibility for COVID-19 Vaccine Boosters - FDA amended the Emergency Use Authorizations (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet later today to discuss further clinical recommendations.
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November 17, 2021: MCMi email - FDA updates COVID-19 testing policies to help ensure accuracy and reliability, increase access to at-home tests
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November 15, 2021: FDA Updates Test Policies to Help to Ensure Accuracy and Reliability of Tests and Increase Access to At-Home Tests - FDA is taking several important actions to support ongoing nationwide COVID-19 testing efforts. These actions are aimed at further increasing access to accurate and reliable COVID-19 tests, particularly diagnostic tests that can be performed at home or in places like doctor’s offices, hospitals, urgent care centers and emergency rooms without having to be sent to a central lab for testing. Also see: Statement by HHS Secretary Xavier Becerra on Withdrawal of HHS Policy on Laboratory-Developed Tests and Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)
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November 10, 2021: Trust in the Time of Covid-19: 3D Printing and Additive Manufacturing (3DP/AM) as a Solution to Supply Chain Gaps - FDA and partners published a commentary in NEJM Catalyst Innovations in Care Delivery on how a public-private collaboration, Covid 3D TRUST, has helped to address critical supply shortages by empowering designers, manufacturers, and users of 3D-printed personal protective equipment (PPE) during the COVID-19 pandemic.
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November 10, 2021: Ellume Recalls COVID-19 Home Test for Potential False Positive SARS-CoV-2 Test Results
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November 10, 2021: MCMi email - Fighting COVID-19 with science | More OTC diagnostic tests authorized
View more news in the MCMi News Archive
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Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - During the virtual town hall, the FDA will share information and answer your questions about the development and validation of tests for SARS-CoV-2. Registration is not required. If you are unable to attend the live virtual town hall, the recording and transcript will be available for viewing the Tuesday after the live event. FDA will host additional webinars in this series in 2021 and 2022.
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December 3, 2021: Real-World Data Webinar Series: Data Standards for Drug and Biological Product Submissions Containing Real-World Data, hosted by the Reagan-Udall Foundation for the FDA, 1:00 - 2:00 p.m. ET
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December 7-8, 2021: Clinical Investigator Training Course (CITC) Update, including a review of the development and emergency use authorization of medical products for the prevention and treatment of COVID-19, and investigator responsibilities during the pandemic.
Previous events: MCMi Events Archive
General information
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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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Coronavirus Disease 2019 (COVID-19) Resources for Health Professionals
Vaccines
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Multilingual COVID-19 Vaccines Myths Social Media Toolkit (new, September 2021)
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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
Testing
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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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September 29, 2021: FDA Office of Minority Health and Health Equity (OMHHE) announces a new funding opportunity: COVID-19 and Health Equity Innovation Award - OMHHE continues to work to promote and protect the health of racial and ethnic minorities, underrepresented and underserved populations through research and communication strategies that address health disparities. The COVID-19 and Health Equity Innovation award helps support this work. Applications are due by November 29, 2021.
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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)
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Guidance and industry information
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- 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
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- 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