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
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August 19, 2022: FDA authorized the emergency use (PDF, 913 KB) of Novavax COVID-19 Vaccine, Adjuvanted for the prevention of COVID-19 in individuals 12 through 17 years of age
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August 18, 2022: Intradermal Jynneos Monkeypox Vaccine Fast Facts (PDF, 200 KB)
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August 18, 2022: Report: FDA's Work to Combat the COVID-19 Pandemic (PDF, 4.9 MB)
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August 17, 2022: MCMi email - COVID-19 and monkeypox response updates from FDA | Monkeypox vaccine fact sheet in multiple languages
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August 12, 2022: Monkeypox response: FDA Fast Facts: TPOXX (PDF, 655 KB) is now also available in Chinese (Simplified) (PDF, 649 KB), Korean (PDF, 659 KB), Spanish (PDF, 634 KB), Tagalog (PDF, 631 KB), and Vietnamese (PDF, 721 KB)
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August 11, 2022: At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative: FDA Safety Communication
- 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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August 19, 2022: FDA authorized the emergency use (PDF, 913 KB) 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 (PDF, 703 KB) and health care providers (PDF, 1.2 MB).
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August 18, 2022: Monkeypox response: FDA Fast Facts: Jynneos (PDF, 222 KB) is now also available in Chinese (Simplified) (PDF, 698 KB), Korean (PDF, 708 KB), Spanish (PDF, 679 KB), Tagalog (PDF, 669 KB), and Vietnamese (PDF, 769 KB).
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August 18, 2022: Intradermal Jynneos Monkeypox Vaccine Fast Facts (PDF, 200 KB)
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August 18, 2022: Report: FDA's Work to Combat the COVID-19 Pandemic (PDF, 4.9 MB) - Outlines much of the broad range of work the FDA is undertaking to combat the COVID-19 pandemic and prepare for future emergencies.
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August 17, 2022: National Center for Toxicological Research (NCTR) Research Highlight: Monitoring SARS-CoV-2 and Its Variants in Arkansas Wastewater
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August 17, 2022: MCMi email - COVID-19 and monkeypox response updates from FDA | Monkeypox vaccine fact sheet in multiple languages
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August 16, 2022: Monkeypox response: FDA granted an EUA amendment (PDF, 133 KB) 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, 343 KB). Once thawed, the vaccine may be kept at +2°C to +8°C (+36°F to +46°F) for 8 weeks.
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August 16, 2022: Monkeypox response: The Jynneos vaccine EUA fact sheet for recipients and caregivers is now available in five additional languages.
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August 12, 2022: Monkeypox response: FDA Fast Facts: TPOXX (PDF, 655 KB) is now also available in Chinese (Simplified) (PDF, 649 KB), Korean (PDF, 659 KB), Spanish (PDF, 634 KB), Tagalog (PDF, 631 KB), and Vietnamese (PDF, 721 KB)
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August 12, 2022: Information for Blood Establishments Regarding the Monkeypox Virus and Blood Donation
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August 11, 2022: At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative: FDA Safety Communication - FDA is advising people to perform repeat, or serial, testing following a negative result on any at-home COVID-19 antigen test, to reduce the risk an infection may be missed (false negative result) and to help prevent people from unknowingly spreading the SARS-CoV-2 virus to others. The FDA recommends repeat testing following a negative result whether or not you have COVID-19 symptoms.
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August 10, 2022: MCMi email - Public health emergency response updates from FDA: COVID-19 and monkeypox updates
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August 9, 2022: Monkeypox Update: FDA Authorizes Emergency Use of JYNNEOS Vaccine to Increase Vaccine Supply
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August 9, 2022: White House Fact Sheet: Biden Administration Announces Key Actions and Implementation Plan to Increase Vaccine Supply
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August 9, 2022: HHS press release - HHS Secretary Becerra issues 564 determination, paving way for emergency use authorization of monkeypox vaccines - Also see: Determination of a Public Health Emergency or Significant Potential for a Public Health Emergency and Declaration that Circumstances Exist Justifying and Authorization Pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)
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August 5, 2022: New web page: Rumor Control - The growing spread of rumors, misinformation and disinformation about science, medicine, and the FDA, is putting patients and consumers at risk. We’re here to provide the facts.
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July 29, 2022: FDA Provides Update on Agency Response to Monkeypox Outbreak - Also see: FDA Monkeypox Response and Key Facts About Monkeypox Vaccine
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July 29, 2022: FDA and HHS/ASPR authorized an additional extension to the shelf-life for all lots of the refrigerated GSK monoclonal antibody, sotrovimab, from 18 months to 24 months.
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July 26, 2022: Paxlovid shelf-life extension - When FDA first issued the EUA authorizing Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use), it established a 12-month product shelf-life. Four lots of Paxlovid manufactured prior to the EUA issuance were labeled with a 9-month expiry. FDA has authorized extended expiration dates for these lots to reflect the 12-month product shelf-life (see Table 1: Extended Expiry Dating for Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use) Authorized under EUA 105), when stored according to the storage conditions detailed in the authorized Fact Sheet for Health Care Providers and the Letter of Authorization for EUA 105 for Paxlovid.
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July 22, 2022: FDA updated the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to include information about genotyping tests authorized for the identification and differentiation of specific SARS-CoV-2 mutations, lineages, or variants.
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July 20, 2022: New Q&A with FDA Podcast Series: Conversation on Paxlovid and COVID-19
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July 20, 2022: MCMi email - COVID-19 response updates from FDA | Monkeypox testing safety communication
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 2022
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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.
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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.
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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.
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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.
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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.
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September 21-22, 2022: 2022 Public Meeting of the National Antimicrobial Resistance Monitoring System (NARMS) - 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. The NARMS public meeting will be held virtually on Wednesday, September 21, 2022 from 12:00 p.m. to 5:00 p.m. ET and Thursday, September 22, 2022 from 9:30 a.m. to 4:30 p.m. ET. A virtual technical workshop to demonstrate how to access NARMS data online will be held on Tuesday September 20, 2022 from 9:00 a.m. to 4:00 p.m. ET.
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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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November 15-16, 2022: BARDA Industry Day - Save the date! The Biomedical Advanced Research and Development Authority (BARDA), a component of the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR), invites you to participate in its annual conference to learn about U.S. Government medical countermeasure priorities, interact with the BARDA and ASPR teams, and network with public and private sector colleagues.
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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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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
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FDA COVID-19 response infographic (through Sept. 2021)
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FAQs: What happens to EUAs when a public health emergency ends?
Vaccines
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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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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
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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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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
- August 2022: 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.
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MCMi
- MCMi News Archive - MCMi news from 2010 to the present
- MCMi Events Archive - MCMi events from 2010 to the present
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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
- 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