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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January 5, 2022: MCMi email - Boosters are now authorized for people 12 years of age and older
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January 3, 2022: FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine - FDA expands eligibility for the Pfizer-BioNTech COVID-19 Vaccine to include the use of a single booster dose in individuals 12 and older at least 5 months after primary vaccination with Pfizer-BioNTech COVID-19 Vaccine.
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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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January 5, 2022: MCMi email - Boosters are now authorized for people 12 years of age and older
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January 3, 2022: FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine - FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine to: 1) expand the use of a single booster dose to include use in individuals 12 through 15 years of age; 2) shorten the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 Vaccine and a booster dose to at least five months; and 3) allow for a third primary series dose for certain immunocompromised children 5 through 11 years of age. Also see: Do I qualify for a COVID-19 vaccine booster and which one?
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December 30, 2021: MCMi email - FDA authorizes first two oral antivirals for treatment of COVID-19 | EUA updates for COVID-19 treatments and tests
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December 29, 2021: Two New Over-the-Counter At-Home COVID-19 Tests Brought to U.S. Market Quickly (HHS press release)
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December 28, 2021: FDA updated the EUA (PDF, 365 KB) for COVID-19 convalescent plasma. The update limits the authorization to the use of COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies for the treatment of COVID-19 in patients with immunosuppressive disease or who are receiving immunosuppressive treatment. These patients may be treated in outpatient or inpatient settings. Additionally, to help assure the manufacture of high titer COVID-19 convalescent plasma, the revisions to the EUA revise acceptable tests and increase qualifying result cutoffs to be used for manufacturing COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies.
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December 23, 2021: ASPR pauses allocation of bamlanivimab and etesevimab together, etesevimab alone, and REGEN-COV - ASPR will pause any further allocation of bamlanivimab and etesevimab together, etesevimab alone, and REGEN-COV pending updated data from the CDC. Shipments of sotrovimab did resume this week, and delivery of 55,000 doses of product has begun. An additional 300,000 doses of sotrovimab will be available for distribution in January.
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December 23, 2021: FDA Authorizes Additional Oral Antiviral for Treatment of COVID-19 in Certain Adults - FDA issued an EUA (PDF, 411 KB) for Merck’s molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate. Molnupiravir is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset.
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December 22, 2021: FDA Authorizes First Oral Antiviral for Treatment of COVID-19 - FDA issued an EUA (PDF, 359 KB) for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset.
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December 22, 2021: MCMi email - Are you eligible for a booster? | Strengthening coronavirus models with systems biology and machine learning
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December 21, 2021: FDA published a new web page, Wastewater Surveillance for SARS-CoV-2 Variants, to explain how sequencing SARS-CoV-2 RNA from wastewater samples and then monitoring for both known and unknown variants of the virus, can provide information about the evolution of the virus, which is critical to evaluating the effectiveness of FDA-regulated COVID-19 vaccines, therapeutics, and diagnostics.
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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January 26, 2022: 2022 Filovirus Vaccine Development Workshop (virtual) - HHS/ASPR will convene a USG workshop focused on development of medical countermeasures against Marburg virus (MARV) and Sudan ebolavirus (SUDV). Companies, USG interagency partners, and others interested in the topic area are encouraged to attend this workshop. The event is open to the public, but space is limited. Register by January 21, 2022.
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February 22, 2022: Webinar on Draft Guidances on Transition Plans for COVID-19 Related Medical Devices, 1:00 - 2:30 p.m. ET
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March 7-9, 2022: FDA, MHRA, and Health Canada Good Clinical Practice Workshop: Global Clinical Trials - Considerations and Lessons Learned from the Changing Landscape (virtual) - FDA, the Medicines and Healthcare products Regulatory Agency (MHRA), and Health Canada will provide attendees with insight into key topics, compliance trends and the opportunity to hear first-hand from regulators about lessons learned from the changing clinical trial landscape.
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April 25-29, 2022: Save the date! Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories - register by March 25, 2022
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
Connect with us
View previous editions of the MCMi email newsletter
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