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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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FDA actively working to investigate, address potential impacts of omicron variant
As we have with previous emerging COVID-19 variants, the 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 from developing COVID-19. (November 30, 2021)
COVID-19 vaccine updates
 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.
Reminder: Everyone 18 years of age and older may now receive a single booster dose after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine.
COVID-19 vaccine videos available in multiple languages
Earlier this year, FDA's Office of Minority Health and Health Equity released a new set of videos about COVID-19 vaccine safety and diversity. Racial and ethnic minority communities have been disproportionately affected by the COVID-19 pandemic, and it is important to get vaccinated.
Videos are now available in Cantonese, Mandarin, Korean, Tagalog, Vietnamese, Navajo, Cherokee, and American Sign Language along with the previously released English and Spanish versions. Vaccines are one of the safest tools to prevent infectious diseases like COVID-19, and they can help protect you and your loved ones from the virus. You can find the videos on our YouTube Minority Health playlist and our COVID-19 Vaccines page.
MCMi regulatory science update
Expanding next-generation sequencing tools to support pandemic preparedness and response
In a new project funded by FDA, 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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Emergency Use Authorization (EUA) updates
FDA authorizes additional indication for Access Bio COVID-19 Over-the-Counter Antigen Test
FDA reissued the EUA (PDF) for the Access Bio CareStart COVID-19 Antigen Home Test, which gives results in 10 minutes and can be used:
- Without a prescription.
- As a single test for people with COVID-19 symptoms.
- As a serial test for people without COVID-19 symptoms, meaning the test must be done twice over three days.
- For people 14 years of age and older with a self-collected nasal swab sample or 2 years of age and older when an adult collects the nasal swab sample.
FDA reissued the EUA to authorize use of CareStart COVID-19 Antigen Home Test as a single test without a prescription for people with COVID-19 symptoms. The test was already authorized for use as a serial test without a prescription by people with or without symptoms. (November 22, 2021)
FDA authorizes BD Veritor At-Home COVID-19 Test for another OTC use
FDA reissued the EUA (PDF) for the Becton, Dickinson and Company (BD) Veritor At-Home COVID-19 Test, which is a diagnostic antigen test that gives results in 15 minutes. The test can be used:
- Over the counter (OTC), and without a prescription.
- As a single test for people with COVID-19 symptoms.
- As a serial test for people without COVID-19 symptoms, meaning the test must be done twice over three days.
- For people age 14 years and older with a self-collected nasal swab sample or people age 2 years and older when an adult collects the nasal swab sample.
FDA reissued the EUA to authorize use of the BD Veritor At-Home COVID-19 Test as a single test without a prescription for people with COVID-19 symptoms. The test was already authorized for use as a serial test without a prescription by people with or without COVID-19 symptoms. (November 22, 2021)
In vitro diagnostic (test) EUAs
As of November 30, 2021, 423 tests and sample collection devices are authorized by FDA under EUAs. These include 293 molecular tests and sample collection devices, 90 antibody and other immune response tests, and 40 antigen tests. There are 66 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, 11 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 EUAs for molecular OTC at-home tests. FDA has authorized 20 antigen tests and 9 molecular tests for serial screening programs. The FDA has also authorized 696 revisions to test EUA authorizations. Also see: Coronavirus Testing Basics
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Events
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December 1, 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 December 15, 2021, and in January and February 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 (virtual), 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.
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New! December 14, 2021: Webinar on Final Rule for Medical Device De Novo Classification Process, 1:00 p.m. ET
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Information for industry and health care providers
Emergency Use Authorization for vaccines explained
Patients asking questions about EUAs? Check out these questions and answers on vaccine EUAs, also available in Spanish.
Draft guidance: Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products
FDA issued a draft guidance for industry titled Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products. The draft guidance provides sponsors and other stakeholders with considerations when either designing a registry or proposing to use an existing registry to support a regulatory decision about a drug’s effectiveness or safety. Submit comments by February 28, 2022.
New cybersecurity playbook for medical device threat modeling
FDA announced the release of “Playbook for Threat Modeling Medical Devices,” which was developed by MITRE and the Medical Device Innovation Consortium (MDIC). The playbook is an educational resource that discusses best practices for understanding basic threat modeling and processes, and how to apply them to medical devices.
Threat modeling has become a recognized cybersecurity best practice, both generally and in the medical device subsector specifically. However, threat modeling is complex, and involves a specialized set of knowledge and expertise. The Playbook is an educational resource for the medical device sector to learn how to effectively threat model. (November 30, 2021)
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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(Select Emergency Preparedness and Response,
FDA Medical Countermeasures Initiative (MCMi) News)
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