MCMi News and Events
Medical countermeasure and public health emergency news and events from FDA and partners
Featured news and events
-
Coronavirus Disease 2019 (COVID-19) updates from FDA, including the latest news, FAQs, and more
-
Webcast: February 15, 2022: Vaccines and Related Biological Products Advisory Committee - The committee will discuss the request for EUA of the Pfizer-BioNTech COVID-19 Vaccine for use in children 6 months through 4 years of age.
-
February 2, 2022: MCMi email - FDA approves 2nd COVID-19 vaccine | Feb. 15 advisory committee scheduled
-
January 31, 2022: FDA Takes Key Action By Approving Second COVID-19 Vaccine
-
January 28, 2022: Stop Using Empowered Diagnostics COVID-19 Tests: FDA Safety Communication
-
January 26, 2022: MCMi email - FDA takes actions to expand use of treatment for outpatients with mild-to-moderate COVID-19 | At-home diagnostic test updates
-
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).
-
February 2, 2022: MCMi email - FDA approves 2nd COVID-19 vaccine | Feb. 15 advisory committee scheduled
-
February 1, 2022: FDA Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age - The Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session on Feb. 15 to discuss the request for EUA of the Pfizer-BioNTech COVID-19 Vaccine for use in children 6 months through 4 years of age.
-
January 31, 2022: FDA Takes Key Action By Approving Second COVID-19 Vaccine - The vaccine has been known as the Moderna COVID-19 Vaccine; the approved vaccine will be marketed as Spikevax for the prevention of COVID-19 in individuals 18 years of age and older. Spikevax meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality required for approval. Moderna COVID-19 Vaccine has been available under Emergency Use Authorization (EUA) for individuals 18 years of age and older since Dec. 18, 2020.
-
January 28, 2022: Stop Using Empowered Diagnostics COVID-19 Tests: FDA Safety Communication - FDA issued a safety communication warning people to stop using the Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test. These tests were distributed with labeling indicating they are authorized by the FDA, but neither test has been authorized, cleared, or approved by the FDA for distribution or use in the United States. The FDA is concerned about the potentially higher risk of false results when using unauthorized tests. Empowered Diagnostics is recalling the CovClear COVID-19 Rapid Antigen Test and the ImmunoPass COVID-19 Neutralizing Antibody Rapid Test, and the FDA has identified this issue as a class I recall, the most serious type of recall.
-
January 26, 2022: MCMi email - FDA takes actions to expand use of treatment for outpatients with mild-to-moderate COVID-19 | At-home diagnostic test updates
-
January 24, 2022: FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant - As we have throughout the COVID-19 pandemic, FDA has used the best available science as the virus has evolved to make informed decisions with the health and safety of the American public in mind. Ensuring that healthcare providers on the frontlines have the best tools available to treat patients is a top priority for the agency. In light of the most recent information and data available, today, the FDA revised the authorizations for two monoclonal antibody treatments – bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab) – to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments. Because data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States, these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time. In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions.
-
January 21, 2022: FDA Takes Actions to Expand Use of Treatment for Outpatients with Mild-to-Moderate COVID-19 - FDA took two actions to expand the use of the antiviral drug Veklury (remdesivir) to certain non-hospitalized adults and pediatric patients for the treatment of mild-to-moderate COVID-19 disease. This provides another treatment option to reduce the risk of hospitalization in high-risk patients. Previously, the use of Veklury was limited to patients requiring hospitalization.
-
January 19, 2022: UPDATE: Blood Specimen Collection Tube Conservation Strategies - Letter to Health Care and Laboratory Personnel - FDA updated the device shortage list to include all blood specimen collection tubes (product codes GIM and JKA) to the testing supplies and equipment – specimen collection category on the device shortage list. The list previously included sodium citrate (light blue top) tubes only. The device shortage list reflects the categories of devices the FDA has determined to be in shortage at this time. The FDA will continue to update the list as the COVID-19 public health emergency evolves. To mitigate ongoing shortages, FDA is providing blood specimen collection tube conservation strategies. Also see: Blood Specimen Collection Tube Shortage: Frequently Asked Questions
-
January 19, 2022: MCMi email - Video FAQs about COVID-19 vaccines | Apply by Jan. 21 for regulatory science funding
-
January 13, 2022: FDA 2021 Year in Review (PDF, 5.9 MB) - This year-end report highlights key FDA actions in 2021 to protect and improve public health, including a COVID-19 vaccine approval and authorizations of COVID-19 tests and treatments.
-
January 12, 2022: MCMi email - COVID-19 response updates: tests, vaccines, events, and more
-
January 11, 2022: FDA announced revisions to the Janssen COVID-19 Vaccine Fact Sheet for Heath Care Providers Administering Vaccine (PDF, 1.5 MB) and the Fact Sheet for Recipients and Caregivers (PDF, 776 KB). These revisions are in response to new safety information regarding the serious risk of Immune Thrombocytopenia (ITP), a disorder that can cause easy or excessive bruising and bleeding due to very low levels of platelets, following administration of the Janssen COVID-19 Vaccine.
-
January 11, 2022: Stop Using LuSys Laboratories COVID-19 Tests: FDA Safety Communication - FDA is warning people to stop using the LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and the LuSys Laboratories COVID-19 IgG/IgM Antibody Test. The performance of these tests has not been adequately established and the FDA believes there is likely a high risk of false results when using these tests. Neither test has been authorized, cleared, or approved by the FDA for distribution or use in the United States. The LuSys Laboratories COVID-19 Antigen Tests (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Tests may also be sold under the company names Luscient Diagnostics or Vivera Pharmaceuticals, or with the trade name EagleDx. The FDA believes that these tests were distributed for use in laboratories or for at-home testing.
-
January 7, 2022: FDA Shortens Interval for Booster Dose of Moderna COVID-19 Vaccine to Five Months - FDA amended the EUA for the Moderna COVID-19 Vaccine to shorten the time between the completion of a primary series of the vaccine and a booster dose to at least five months for individuals 18 years of age and older.
-
January 5, 2022: MCMi email - Boosters are now authorized for people 12 years of age and older
View more news in the MCMi News Archive
-
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.
-
February 15, 2022: Vaccines and Related Biological Products Advisory Committee (webcast) - The committee will meet in open session to discuss the request for Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine for use in children 6 months through 4 years of age.
-
February 22, 2022: Webinar on Draft Guidances on Transition Plans for COVID-19 Related Medical Devices, 1:00 - 2:30 p.m. ET
-
March 3, 2022: Vaccines and Related Biological Products Advisory Committee (virtual) - The committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2022-2023 influenza season.
-
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.
-
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
-
Why You Should Not Use Ivermectin to Treat or Prevent COVID-19
-
COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders
-
Coronavirus Disease 2019 (COVID-19) Resources for Health Professionals
Vaccines
-
Multilingual COVID-19 Vaccines Myths Social Media Toolkit (new, September 2021)
-
Learn More About COVID-19 Vaccines (Consumer Update)
-
5 Things You Need to Know about the COVID-19 Vaccine for Adolescents 12 through 17 (Consumer Update)
-
The Path for a COVID-19 Vaccine from Research to Emergency Use Authorization (PDF, 723 KB)
-
#VaccineReady Social Media Toolkit with resources in English and Spanish, from FDA's Office of Minority Health and Health Equity
Therapeutics
Testing
-
A Closer Look at COVID-19 Diagnostic Testing (for health care providers, test purchasers, and public health staff)
-
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