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. | FDA updates COVID-19 test policies Actions will help ensure accuracy and reliability of tests, increase access to at-home tests On November 15, 2021, FDA announced several important actions to support ongoing nationwide COVID-19 testing efforts. These actions are aimed at further increasing access to accurate and reliable COVID-19 tests, particularly diagnostic tests that can be performed at home or in places like doctor's offices, hospitals, urgent care centers, and emergency rooms without having to be sent to a central lab for testing. As part of this effort, FDA: Also see: Statement by HHS Secretary Xavier Becerra on Withdrawal of HHS Policy on Laboratory-Developed Tests (LDTs). More information for test developers is available under EUA updates below. COVID-19 vaccine updates Vaccine fact sheet translations The revised Pfizer-BioNTech COVID-19 Vaccine Fact Sheets for Recipients and Caregivers are being posted in multiple languages as translations become available on the FDA web page Comirnaty and Pfizer-BioNTech COVID-19 Vaccine. Updated translations are now available in Spanish, Chinese (Simplified), Dari, Haitian Creole, Hmong, Khmer, Korean, Portuguese, Russian, Tagalog, Vietnamese, and Uzbek. Upcoming events - November 30, 2021: Antimicrobial Drugs Advisory Committee (AMDAC) meeting (webcast) - To discuss Merck and Ridgeback's request for an EUA for molnupiravir, an investigational antiviral drug to treat COVID-19. The committee will discuss the available data supporting the use of molnupiravir to treat mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who have tested positive for COVID-19, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
- 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.
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. | | | 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. | | | 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. | | | Learn more about COVID-19 vaccines Getting vaccinated to prevent COVID-19 will help protect you from COVID-19, and it may also protect the people around you. Learn about the evidence supporting FDA approval of Comirnaty and FDA emergency use authorization of COVID-19 vaccines. | | | 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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