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. | SARS-CoV-2 omicron variant: Impact on COVID-19 tests On December 3, 2021, FDA updated the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to add new information about SARS-CoV-2 tests whose performance could be impacted by SARS-CoV-2 genetic mutations, specifically those found in the omicron variant, in patient samples. This includes certain tests where viral mutations cause a specific detection pattern that may help to signal the presence of the omicron variant, but genetic sequencing would be needed to confirm. Since these tests are designed to detect multiple genetic targets, it is expected these tests will continue to detect SARS-CoV-2 including when the omicron variant is present. On December 6, 2021, FDA updated the page to add new information about: - FDA recommendations for clinical laboratory staff and health care providers.
- The Tide Laboratories, LLC, DTPM COVID-19 RT-PCR Test, including:
- The impact of the SARS-CoV-2 omicron variant on test performance. Since the Tide Laboratories test is a single target test that targets a portion of the N-gene where deletions occur with the omicron variant, the test is expected to fail to detect the SARS-CoV-2 omicron variant.
- Laboratories where the test is performed (it is not believed to be used for high volume testing).
- Updates to the list of tests with S-gene drop out. Since these tests are designed to detect multiple genetic targets, the overall test sensitivity should not be impacted.
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. Events 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. | | | 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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