More video FAQs on COVID-19 vaccines | Regulatory science update: 3D tissue chips

Updates from FDA in our ongoing response to the COVID-19 pandemic since our last MCMi email update include:

• March 8, 2022: FDA Roundup including COVID-19 testing updates
• March 4, 2022: FDA Roundup including the award, with NASA, NIH, and HHS, of eight contracts to extend longevity of complex in vitro (human) models, such as 3D tissue chips and microphysiological systems

Bookmark www.fda.gov/coronavirus for the latest.

• When might we have vaccines for our youngest children?
• Do the current COVID-19 vaccines work?
• Why should I get a COVID-19 booster?
• Do you need a booster if you've already had COVID-19?
• How else to help your community after you've been vaccinated

NASA, the National Institutes of Health (NIH), the Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA), and FDA announced the award of eight contracts in a multi-agency collaboration to extend longevity of complex in vitro (human) models, such as 3D tissue chips and microphysiological systems, to at least six months. Currently, such chips are viable for about one month, limiting researchers’ ability to track longer-term effects of treatments on tissues using these systems. Results from longer studies could be used to better understand disease models, supporting development of and clinical trial design for a variety of medical countermeasures. (March 1, 2022)   

SARS-CoV-2 viral mutations: Impact on COVID-19 tests

Please bookmark and check this web page often for updates on how viral mutations, including the omicron variant, impact COVID-19 tests: SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests.  

In vitro diagnostic (test) EUAs

As of March 8, 2022, 420 tests and sample collection devices are authorized by FDA under EUAs. These include 290 molecular tests and sample collection devices, 85 antibody and other immune response tests, and 45 antigen tests. There are 70 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 14 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 EUAs for molecular OTC at-home tests. FDA has authorized 25 antigen tests and 9 molecular tests for serial screening programs. The FDA has also authorized 868 revisions to test EUA authorizations. Also see: Coronavirus Testing Basics   

Find a COVID-19 vaccine or booster 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.  

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.