|
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.
|
|
|
Safely using hand sanitizer
Some hand sanitizers have potentially toxic types of alcohol. Check FDA’s do-not-use list at www.fda.gov/handsanitizerlist to learn more. Need help now? Call 911 if the person is unconscious or has trouble breathing. Call the Poison Help Line at 1-800-222-1222 to connect to your local poison center.
We can help stop the spread of COVID-19 by washing our hands regularly with soap and water for 20 seconds – especially after going to the bathroom, before eating, and after coughing, sneezing, or blowing our nose. If soap and water are not available, the Centers for Disease Control and Prevention recommend using alcohol-based hand sanitizers containing at least 60% alcohol to help you avoid getting sick and spreading germs to others.
|
|
Emergency Use Authorization (EUA) updates
FDA updates authorized serology test performance
FDA updated the EUA Authorized Serology Test Performance page. The FDA provided information on the expected predictive value of authorized serology tests that have submitted performance data with SARS-CoV-2 antibody prevalence assumptions ranging from 5% to 50%. These estimates may help health care providers interpret these antibody test results for their patients. Additionally, the updated web page clarifies the use of serology tests when assessing a patient’s adaptive immune response. (April 28, 2021)
FDA revokes EUA for Battelle Decontamination System
FDA revoked (PDF) the EUA of the Battelle CCDS Critical Care Decontamination System which was authorized for use in decontaminating compatible N95 respirators for multiple-user reuse by healthcare personnel. FDA revoked the EUA in response to Battelle’s request for voluntary withdrawal of the authorization. In response to changing customer needs, as of March 31, 2021, Battelle has ceased all Battelle CCDS decontamination site operations and marketing activities.
As a reminder, decontaminated respirators and respirators that have undergone bioburden reduction should be used only when there are insufficient supplies of new filtering facepiece respirators (FFRs) or any new respirators. On April 9, 2021, FDA issued a letter to healthcare providers recommending transitioning from use of decontaminated disposable respirators. Additional information about revoked EUAs is available on the FDA website. (April 30, 2021)
Diagnostic test EUAs
As of today, 369 tests and sample collection devices are authorized by FDA under EUAs. These include 270 molecular tests and sample collection devices, 76 antibody and other immune response tests, and 23 antigen tests. There are 49 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 molecular prescription at-home test, 2 antigen prescription at-home tests, 4 over-the-counter (OTC) at-home antigen tests, and 2 OTC molecular tests. FDA has authorized 8 antigen tests and 3 molecular tests for serial screening programs. The FDA has also authorized 481 revisions to EUA authorizations. Also see: Coronavirus Testing Basics
|
|
|
Events
|
|
Information for industry
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.
|
|
In case you missed it
#VaccineReady social media toolkit
Check out our latest toolkit, with social media posts and graphics on vaccine development and authorization, and the benefits of getting vaccinated against COVID-19.
|
FDA is vigilant in protecting consumers against COVID-19 vaccine scams
Consumers should know the COVID-19 vaccines that the FDA has authorized for emergency use cannot be sold online. Legitimate COVID-19 vaccines are being distributed for free. Learn more
|
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.
|
Did someone forward you this email? Subscribe. (Select Emergency Preparedness and Response, FDA Medical Countermeasures Initiative (MCMi) News)
|
|
|
|
|