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Coronavirus Disease 2019 (COVID-19) updates
Actions by 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
Vaccine information in multiple languages, including Spanish
When you get a COVID-19 vaccine, you are choosing to protect yourself and make a difference for your children, parents, grandparents, and other loved ones. Millions of people in the U.S. have already received a COVID-19 vaccine. For a community to be fully protected, most community members need to get the vaccine. Getting vaccinated to prevent COVID-19 will help protect you from COVID-19, and it may also protect the people around you.
Resources for the FDA-approved COVID-19 vaccine:
Resources for vaccines available under Emergency Use Authorization (EUA):
General COVID-19 vaccine resources:
Additional languages: FDA will continue to post updated translations as they become available, including translations of the fact sheets for vaccine recipients and caregivers. Once available, updated translations will be posted here: Comirnaty and Pfizer-BioNTech COVID-19 Vaccine; Moderna COVID-19 Vaccine; and Janssen COVID-19 Vaccine.
Know your treatment options for COVID-19
Treatment information in multiple languages
Here’s a closer look at some of the available COVID-19 treatments and how to get more information about them and others. Talk to your health care provider about available treatment options if you have COVID-19.
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Emergency Use Authorization (EUA) updates
Resumption in use and distribution of bamlanivimab/etesevimab in certain states
HHS/ASPR and FDA announced changes in the authorized use of bamlanivimab and etesevimab administered together under EUA 094 (PDF). Specifically, the EUA now authorizes the use of bamlanivimab and etesevimab, administered together, only in states, territories, and U.S. jurisdictions in which recent data shows the combined frequency of variants resistant to bamlanivimab and etesevimab administered together is less than or equal to 5%.
FDA has posted a list of states, territories, and U.S. jurisdictions (PDF) in which bamlanivimab and etesevimab administered together are currently authorized, and a list of states, territories, and U.S. jurisdictions in which bamlanivimab and etesevimab, administered together, are not currently authorized and will periodically update both lists as new data and information becomes available. FDA will make this determination considering current variant frequency data, trends in variant frequency over time, and the precision of the estimates and information regarding emerging variants of concern. (August 27, 2021)
Other EUA updates
In vitro diagnostic (test) EUAs
As of August 31, 2021, 409 tests and sample collection devices are authorized by FDA under EUAs. These include 287 molecular tests and sample collection devices, 88 antibody and other immune response tests, and 34 antigen tests. There are 61 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 molecular prescription at-home test, 3 antigen prescription at-home tests, 7 antigen over-the-counter (OTC) at-home tests, and 2 molecular OTC at-home tests. FDA has authorized 14 antigen tests and 8 molecular tests for serial screening programs. The FDA has also revised 619 test EUAs. Also see: Coronavirus Testing Basics
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Events
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September 1-2, 2021: FDA-M CERSI: Advancing the Development of Pediatric Therapeutics Complex Innovative Trial Design Public Workshop, hosted by FDA’s Division of Pediatrics and Maternal Health and Complex Innovative Trial Design Pilot Meeting Program in CDER and The University of Maryland CERSI
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September 8, 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 an additional webinar in this series on September 22, 2021.
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New! September 9, 2021: Authorities Associated with Respiratory Protection - The Role of NIOSH, the FDA, and OSHA , 3:00 - 4:00 p.m. ET - The National Institute for Occupational Safety and Health (NIOSH), National Personal Protective Technology Laboratory (NPPTL), is hosting a webinar to clarify information regarding U.S. Respiratory Protection authorities, as part of Respiratory Protection Week. Speakers from NIOSH, FDA, and OSHA will discuss the roles of these agencies during conventional operations and emergency response scenarios, and how the respiratory protection landscape has evolved over the last year.
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New! September 9, 2021: FDA Grand Rounds - Immune System Responses to Therapeutic Proteins: Getting Up Close and Personal (webcast), 12:00 - 1:00 p.m. ET
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September 20-21, 2021: Pharmacodynamic Biomarkers for Biosimilar Development and Approval public workshop, hosted by FDA and Duke-Margolis, 10:00 a.m. - 2:30 p.m. ET both days - advance registration required
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September 30, 2021: The Vaccines and Related Biological Products Advisory Committee will meet in open session (8:30 a.m. - 3:40 p.m. ET, virtual) to hear an overview of the research programs in the Laboratory of Bacterial Polysaccharides, Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review, and the Center for Biologics Evaluation and Research (CBER), and to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2021 to 2022 southern hemisphere influenza season.
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Information for industry and health care providers
Stop using certain N95 respirators manufactured by Shanghai Dasheng - Letter to Health Care Providers
FDA is alerting health care facility risk managers, procurement staff, and health care personnel to stop using certain N95 respirators manufactured by Shanghai Dasheng Health Products Manufacture Co., Ltd. (Shanghai Dasheng).
The Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH) revoked all respirator approvals previously issued to Shanghai Dasheng Health Products Manufacture Co., Ltd. (Shanghai Dasheng) because the firm did not implement, maintain, and control a quality management system. All previously authorized Shanghai Dasheng respirators are no longer authorized for emergency use as a result of the loss of NIOSH-approval. (August 25, 2021)
Veterinarians and animal drug retailers: Help stop misuse of animal ivermectin to prevent or treat COVID-19 in humans
As noted in many recent news stories and in a Health Alert from the U.S. Centers for Disease Control and Prevention, poison control centers across the United States are seeing a sharp spike in reports of people suffering adverse health effects after taking animal ivermectin. People are purchasing various highly concentrated animal ivermectin drug formulations such as “pour-on,” injectable, paste, and “drench” that are intended for horses, cattle, and sheep, and taking these drugs has made some people very sick.
Even if animal drugs have the same active ingredient as an approved human drug, animal drugs have not been evaluated for safety or effectiveness in humans. Treating human medical conditions with veterinary drugs can be very dangerous. The drug may not work at all, or it could worsen the illness and/or lead to serious, potentially life-threatening health complications. People should not take products approved for veterinary use, “for research only,” or otherwise not for human consumption.
We are asking for your help in sharing important safety information about the misuse of animal ivermectin to prevent or treat COVID-19 in people. To assist you, we have developed a sign that is available for download (PDF) if you’d like to pass it out or post it at your place of business to remind people about the dangers of treating themselves with animal ivermectin. Read more (August 30, 2021)
FDA addresses inquiry about re-monitoring data after the pandemic in Q&A Appendix, Guidance on Clinical Trials of Medical Products During COVID-19
FDA has added content to the question-and-answer appendix in the guidance, Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency. The updated guidance includes a new question and answer relevant to sponsors who used remote monitoring to oversee study conduct during the COVID-19 pandemic. The new language addresses whether data that were initially monitored remotely should be re-monitored on-site after pandemic-related restrictions are lifted. (August 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
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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