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Coronavirus Disease 2019 (COVID-19) updates
Updates from FDA in our ongoing response to the COVID-19 pandemic since our last MCMi email update include:
Bookmark www.fda.gov/coronavirus for the latest.
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COVID-19 vaccine updates
 FDA shortens interval for booster dose of Moderna COVID-19 Vaccine to five months
FDA amended the EUA (PDF) 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 7, 2022)
 Do I qualify for a COVID-19 vaccine booster and which one?
Use this chart to find out if you're eligible for a COVID-19 vaccine booster and which one. (updated January 7, 2022)
This chart is also available in Spanish:¿Califico para una dosis de refuerzo de la vacuna contra el COVID-19 y para cuál?
Find a vaccine near you
Text your zip code to GETVAX (438829) in English or VACUNA (822862) in Spanish to find out where COVID-19 vaccines are available near you. COVID-19 vaccines are free to all people living in the United States, regardless of their immigration or health insurance status. Learn more at vaccines.gov.
FDA safety communication: Stop using LuSys Laboratories COVID-19 tests
FDA issued a safety communication 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 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. (January 11, 2022)
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Emergency Use Authorization (EUA) updates
EUA revocation
On December 20, 2021, FDA revoked an EUA for a test that was not commercially distributed:
Information about revoked EUAs is available on the web page Emergency Use Authorization--Archived Information.
SARS-CoV-2 viral mutations: Impact on COVID-19 tests
Please bookmark and check this web page often for updates on how viral mutations, including the omicron variant, impact COVID-19 tests: SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests.
In vitro diagnostic (test) EUAs
As of January 11, 2022, 420 tests and sample collection devices are authorized by FDA under EUAs. These include 290 molecular tests and sample collection devices, 87 antibody and other immune response tests, and 43 antigen tests. There are 69 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for molecular prescription at-home test, 3 EUAs for antigen prescription at-home tests, 13 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 EUAs for molecular OTC at-home tests. FDA has authorized 24 antigen tests and 9 molecular tests for serial screening programs. The FDA has also authorized 756 revisions to test EUA authorizations. Also see: Coronavirus Testing Basics
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Events
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January 12, 2021: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation, 12:15 p.m. - 1:15 p.m. ET, hosted by FDA's Center for Devices and Radiological Health (CDRH). FDA will host additional events in this series on January 26 and February 9 and 23, 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, the Medicines and Healthcare products Regulatory Agency (MHRA), and Health Canada Good Clinical Practice Workshop: Global Clinical Trials - Considerations and Lessons Learned from the Changing Landscape (virtual)
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April 25-29, 2022: Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories - register by March 25, 2022
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Information for industry and health care providers
Organ preservation solutions added to FDA device shortage list
FDA added organ preservation solutions (product codes KDL and KDN) to the device shortage list. The presence of a device type on the shortage list does not necessarily indicate that patient care has been affected. There may be certain facilities that may not be able to perform transplants or process donor organs if they are unable to obtain these products. FDA is working with manufacturers, distributors, organ procurement organizations and government partners to support availability of these products to affected facilities and minimize any impact on patients. The device shortage list reflects the categories of devices the FDA has determined to be in shortage at this time. The FDA will update the lists as the COVID-19 public health emergency continues to evolve. (January 7, 2022)
Updated guidance: Investigational COVID-19 Convalescent Plasma
FDA has revised the guidance Investigational COVID-19 Convalescent Plasma to reflect that the EUA (PDF) authorizes 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 receiving immunosuppressive treatment in either the outpatient or inpatient setting. In addition, we have revised certain recommendations pertaining to COVID-19 convalescent plasma donors. In sections III.B.1 and III.C.1, we now recommend that individuals qualify as COVID-19 convalescent plasma donors 10 days following complete resolution of symptoms. We also have revised the recommendations in section III.B.1 that address when individuals who have received an investigational COVID-19 vaccine as a participant in a clinical trial or received an authorized or licensed COVID-19 vaccine, qualify as convalescent plasma donors. Also see: Recommendations for Investigational COVID-19 Convalescent Plasma (January 7, 2022)
New draft guidance on 506J notifications for medical devices
FDA issued a draft guidance: Notifying the FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act. This draft guidance, when finalized, is intended to:
- Assist manufacturers in providing timely, informative notifications about changes in the production of certain medical device products to help prevent or mitigate shortages of such devices.
- Assist stakeholders in the FDA’s implementation of section 506J of the FD&C Act outside of the COVID-19 public health emergency.
- Serve as the baseline for information about notifications under section 506J of the FD&C Act during or in advance of any public health emergency.
This draft guidance is not intended to supersede the COVID-19 Public Health Emergency Guidance, Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device under 506J of the FD&C Act during the COVID-19 Public Health Emergency, which will be withdrawn at the end of the COVID-19 public health emergency.
Note: The new draft guidance is not for implementation at this time. Submit comments by March 14, 2022. (January 10, 2022)
FDA is committed to providing timely recommendations, regulatory information, guidance, and technical assistance necessary to support rapid COVID-19 response efforts. FDA has issued more than 75 COVID-19-related guidances to date.
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In case you missed it
It's a good time to get your flu vaccine
Influenza (flu) viruses typically spread in fall and winter, with activity peaking between December and February. Getting vaccinated now can lower your chances of getting the flu.
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Why you should not use ivermectin to treat or prevent COVID-19
Some people are taking ivermectin, a drug often prescribed for animals, to try to prevent or treat COVID-19. FDA has not approved or authorized ivermectin for this use, and it can be dangerous for people. Information is also available in six additional languages.
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List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 250 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and use our step-by-step search guide to find out if your product is on the list.
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FDA Medical Countermeasures Initiative (MCMi) News)
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