Coronavirus Disease 2019 (COVID-19) updates Updates from FDA in our ongoing response to the COVID-19 pandemic since our last email update include: Bookmark www.fda.gov/coronavirus for the latest. | COVID-19 treatment updates Know your treatment options for COVID-19 Patients today have more treatment options in the battle against coronavirus disease. The U.S. Food and Drug Administration has approved two drug treatments for COVID-19 and has authorized others for emergency use during this public health emergency. In addition, many more therapies are being tested in clinical trials to evaluate whether they are safe and effective in combating COVID-19. 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. (updated May 19, 2022) COVID-19 vaccine updates Revised VRBPAC dates FDA revised the dates of some upcoming Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings due to new data from sponsors and expected submissions of Emergency Use Authorization (EUA) requests. The new dates are as follows: - June 14, 2022, will be the new meeting date for the FDA and its advisory committee of external experts to discuss Moderna's EUA request for 6 years through 17 years of age.
- June 15, 2022, will be the new meeting date for the Moderna EUA request for 6 months through 5 years of age and Pfizer-BioNTech EUA request for 6 months through 4 years of age, based on expected completion of an EUA submission.
| "Isn't the pandemic over?" In a Just a Minute! video, Dr. Peter Marks discusses the state of the pandemic and why people should still get vaccinated. COVID-19 test updates Reminder: Expiration date extensions of COVID-19 at-home tests Check the Expiration Date column of the List of Authorized At-Home OTC COVID-19 Diagnostic Tests to see if the expiration date for your at-home OTC COVID-19 test has been extended and how to find any new expiration date. More medical countermeasure updates On May 18, 2022, FDA approved an intravenous (IV) formulation (PDF) of TPOXX (tecovirimat) to treat smallpox. The oral formulation of the drug was originally approved in 2018. The IV formulation is an option for those who are unable to swallow the oral capsule. Also see: Smallpox Preparedness and Response Updates from FDA Events - May 24-25, 2022: FDA and Duke-Margolis Virtual Public Workshop - Translational Science in Drug Development: Surrogate Endpoints, Biomarkers, and More (webcast) - To present best practices and use cases for successfully bringing forward evidence generated through translational science for regulatory submissions.
- June 1, 2021: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation, 12:05 - 1:00 p.m. ET, hosted by FDA's Center for Devices and Radiological Health (CDRH). FDA will hold additional events in this series on June 15 and June 29, 2022.
- June 6-10, 2022: Regulatory Education for Industry (REdI) Annual Conference 2022 (virtual) - Learn directly from the FDA's regulatory experts in medical product centers: drugs, devices, and biologics, including a session on FDA's COVID-19 response.
- June 7-9, 2022: Virtual Public Workshop - Building Medical Device Supply Chain Resilience: A Healthcare and Public Health Ecosystem-Wide Collaboration (webcast) - To discuss ways to foster resiliency in the medical device supply chain and to seek input on the new Resilient Supply Chain Program (RSCP). Register by June 6, 2022.
- New! June 9, 2022: FDA Grand Rounds: Some Perspectives on Data Science and Coronaviruses (virtual), 9:00 - 10:00 a.m. ET - Presented by Seshadri S. Vasan from CSIRO, Australia's science agency, including updates on some FDA-funded research. Please register in advance.
- July 11-13, 2022: Training Course: Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens (Omaha, Nebraska or virtual) - Save the date! This course, presented by FDA and the University of Texas Medical Branch, will be held at the National Training, Simulation and Quarantine Center (TSQC) at University of Nebraska Medical Center/Nebraska Medicine, a National Ebola Training and Education Center (NETEC) facility. A virtual option is also available. Registration will open on June 1, 2022.
In case you missed it Resources to keep yourself and others safe from COVID-19 Find out where to get a COVID-19 vaccine, test, or treatment in your community at COVID.gov. Call 1-800-232-0233 (TTY 1-888-720-7489) with questions. (Also available in Spanish and Simplified Chinese.) | | | COVID-19 vaccine boosters: Getting the facts straight In the latest episode of the FDA Health Equity Forum podcast, RADM Richardae Araojo and Dr. Robert Califf discuss COVID-19 vaccines and boosters misinformation. (14 minutes) | | | What happens to EUAs when a public health emergency ends? Visit our website for answers to frequently asked questions about what happens to EUAs, and products available under EUA, when a public health emergency ends. | | | List of hand sanitizers consumers should not use Some hand sanitizers have been recalled and there are more than 280 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. | | | Find additional coronavirus disease 2019 (COVID-19) updates on our website and in the Medical Countermeasures Initiative newsletter. Visit the FDA OMHHE website and follow us on Twitter at @FDAHealthEquity "Creating a world where health equity is a reality for all." www.fda.gov/healthequity |
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